SPPI
ZEVALIN
Non-Hodgkin’s lymphoma
CRL
07/05/2009
CRL received July 5, 2009.
ZGNX
Sumavel
Migraine
Approved
07/16/2009
Approved July 16, 2009.
SPPI
ZEVALIN
Non-Hodgkin’s lymphoma
Approved
09/04/2009
Approved September 4, 2009.
SPPI
FUSILEV
Colorectal cancer
CRL
10/09/2009
CRL received October 9, 2009.
PRTK
Intermezzo
Insomnia
CRL
11/02/2009
CRL issued November 2, 2009.
AIM
Ampligen
CFS
CRL
12/01/2009
CRL issued December 1, 2009.
ACOR
Ampyra
Improve walking in patients with multiple sclerosis
Approved
01/22/2010
Approved January 22, 2010.
ALKS
BYDUREON
Type 2 diabetes
Approved
01/27/2010
Approved January 27, 2010.
ALKS
BYDUREON
Type 2 diabetes
CRL
03/15/2010
CRL received March 15, 2010.
MNKD
AFREZZA
Type 1/2 diabetes
CRL
03/15/2010
CRL issued March 15, 2010.
HRTX
APF530 - Sustol
Prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV)
CRL
03/19/2010
CRL issued March 19, 2010.
CTIC
PIXUVRI - PIX306 Trial
B-cell non-Hodgkin lymphoma
CRL
04/09/2010
CRL received April 9, 2010.
JAZZ
JZP-6
Fibromyalgia
CRL
10/11/2010
CRL received October 11, 2010.
VVUS
Qnexa
Obesity
CRL
10/28/2010
October 28, 2010.
MNKD
AFREZZA
Type 1/2 diabetes
CRL
01/19/2011
CRL received January 19, 2011.
ASRT
GRALISE
Postherpetic neuralgia - shingles
Approved
01/28/2011
Approved January 28, 2011.
PLX
Taliglucerase alfa
Gaucher disease
CRL
02/25/2011
CRL issued February 25, 2011.
SPPI
FUSILEV
Colorectal cancer
Approved
04/29/2011
Approved April 29, 2011.
SGEN
ADCETRIS
Hodgkin lymphoma and Anaplastic large cell lymphoma
Approved
08/19/2011
Approval announced August 19, 2011.
TAK
ADCETRIS
Hodgkin lymphoma and Anaplastic large cell lymphoma
Approved
08/19/2011
Approval announced August 19, 2011.
PCRX
EXPAREL
Postsurgical pain
Approved
10/31/2011
Approved October 31, 2011.
EYPT
Iluvien
Diabetic macular edema
CRL
11/11/2011
CRL November 11, 2011.
ALIM
Iluvien
Diabetic macular edema
CRL
11/11/2011
CRL November 2011.
INCY
Jakafi
Myelofibrosis
Approved
11/16/2011
Approved November 16, 2011.
PRTK
Intermezzo
Insomnia
Approved
11/23/2011
Approved November 23, 2011.
ATRS
Anturol
Overactive bladder
Approved
12/08/2011
Approved December 8, 2011.
CRIS
Vismodegib
Basal Cell Carcinoma
Approved
01/30/2012
Approved January 30, 2012.
CORT
Corlux - Korlym
Cushing's Syndrome
Approved
02/17/2012
Approved February 17, 2012.
VVUS
Avanafil
Erectile dysfunction
Approved
04/27/2012
Approved April 27, 2012.
PLX
Taliglucerase alfa
Gaucher disease
Approved
05/01/2012
Approved May 1, 2012.
EBS
BioThrax
Anthrax Vaccine
Approved
05/17/2012
Approved May 17, 2012.
RGEN
RG1068
Detection of pancreatic duct abnormalities
CRL
06/22/2012
CRL received June 22, 2012.
ARNA
Lorcaserin
Obesity
Approved
06/27/2012
Approved June 27, 2012.
VVUS
Qnexa
Obesity
Approved
07/17/2012
Approved July 17, 2012.
AMRN
Vascepa
High Triglycerides With Mixed Dyslipidemia
Approved
07/26/2012
Approved July 26, 2012.
HALO
HYQVIA
Subcutaneous treatment for patients with primary immunodeficiency (PI)
CRL
08/01/2012
CRL issued August 1, 2012.
NAVB
Lymphoseek
Lymphatic-tissue tracing agent
CRL
09/10/2012
CRL issued September 10, 2012.
SUPN
Oxtellar
Epilepsy
Approved
10/22/2012
Approved October 22, 2012.
EXEL
Cabozantinib
Medullary thyroid cancer
Approved
11/29/2012
Approved November 29, 2012.
TAK
Cabozantinib
Medullary thyroid cancer
Approved
11/29/2012
Approved November 29, 2012.
AIM
Ampligen
CFS
CRL
02/04/2013
CRL February 4, 2013.
IMGN
Kadcyla
2nd-line HER2+ Metastatic Breast Cancer
Approved
02/22/2013
Approved February 22, 2013 - under priority review.
DVAX
HEPLISAV-B
Hepatitis B
CRL
02/25/2013
CRL issued February 25, 2013.
NAVB
Lymphoseek
Lymphatic-tissue tracing agent
Approved
03/13/2013
Approved March 13, 2013.
HRTX
APF530 - Sustol
Prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV)
CRL
03/28/2013
CRL March, 28 2013.
TTNP
Probuphine
Opioid dependence
CRL
04/30/2013
CRL issued April 30, 2013.
ENDP
AVEED (testosterone undecanoate) intramuscular injection
Men diagnosed with hypogonadism
CRL
05/30/2013
CRL issued September 5, 2013.
ASRT
SEFELSA
Hot flashes
CRL
05/31/2013
CRL issued May 31, 2013.
AVDL
Bloxiverz (neostigmine methylsulfate)
Reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery
Approved
06/03/2013
Approved June 3, 2013.
AVEO
Tivozanib
Third line treatment of patients with renal cell cancer
CRL
06/10/2013
CRL issued June 10, 2013.
TBPH
VIBATIV (telavancin hydrochloride) for injection
Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP)
Approved
06/21/2013
Approved June 21, 2013.
SUPN
Trokendi
Epilepsy
Approved
08/19/2013
Approved Aug 19, 2013.
ATRS
OTREXUP
Rheumatoid arthritis (RA)
Approved
10/14/2013
Approved Oct 14, 2013.
ALIM
Iluvien
Diabetic macular edema
CRL
10/17/2013
Second CRL October 17, 2013.
EYPT
Iluvien
Diabetic macular edema
CRL
10/18/2013
Second CRL October 18, 2013.
ZGNX
Zohydro ER
Moderate to severe pain
Approved
10/25/2013
Approved October 25, 2013.
ABBV
Ibrutinib
Relapsed or refractory MCL mantle cell lymphoma
Approved
11/13/2013
Approved November 13, 2013.
AMAG
Feraheme
Adults with iron deficiency anemia (IDA)
CRL
01/22/2014
CRL issued January 22, 2014.
VNDA
HETLIOZ (tasimelteon)
Insomnia
Approved
01/31/2014
Approved January 31, 2014.
DRRX
Posidur
Post-operative pain relief
CRL
02/12/2014
CRL issued February 12, 2014.
ABBV
Imbruvica
Cancer - Chronic Lymphocytic Leukemia Who Have Received at Least One Prior Therapy
Approved
02/12/2014
Approved February 12, 2014.
BMRN
Vimizim (GALNS)
(MPS IVA) Morquio A Syndrome
Approved
02/14/2014
Approved February 14, 2014.
ENDP
AVEED (testosterone undecanoate) intramuscular injection
Men diagnosed with hypogonadism
Approved
03/06/2014
Approved March 6, 2014.
NVS
Cangrelor
Reduction of thrombotic cardiovascular events including stent thrombosis in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI)
CRL
04/30/2014
CRL April 30 2014.
OMER
Omidria
Cataract surgery
Approved
06/02/2014
Approved June 2, 2014.
BDSI
BEMA Buprenorphine/Naloxone (BNX) - BUNAVAIL
Opioid dependence
Approved
06/06/2014
Approved June 6, 2014.
NAVB
Lymphoseek
Head and Neck Cancer
Approved
06/13/2014
Approved June 13, 2014.
MNKD
AFREZZA
Type 1/2 diabetes
Approved
06/27/2014
Approved June 27, 2014.
AVDL
VAZCULEP (phenylephrine hydrochloride)
Clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia
Approved
06/30/2014
Approved June 30, 2014.
EGRX
EP-3101 (bendamustine RTD)
Chronic lymphocytic leukemia; Indolent non-Hodgkin's lymphoma - cancer
Approved
07/02/2014
Tentative approval July 2 2014. Teva has also received orphan drug and related pediatric exclusivity expiring in September 2015 and May 2016 for the CLL and NHL indications, respectively.
SPPI
Belinostat
Peripheral T-Cell Lymphoma cancer
Approved
07/07/2014
Approved July 7, 2014.
ABBV
Imbruvica
Deletion 17p
Approved
07/19/2014
Approved July 19, 2014.
EGRX
Ryanodex
Malignant hyperthermia - cancer
Approved
07/23/2014
Approved July 23, 2014 under priority review.
ACRX
Zalviso
Post-operative pain following open abdominal surgery and hip or knee replacement surgery
CRL
07/25/2014
CRL issued July 25 2014.
NVS
Oritavancin
ABSSSI
Approved
08/06/2014
Approved August 6, 2014 under priority review
AKBA
Auryxia
Hyperphosphatemia
Approved
09/05/2014
Approved Sept 5, 2014.
HALO
HYQVIA
Subcutaneous treatment for patients with primary immunodeficiency (PI)
Approved
09/12/2014
Approved September 12, 2014.
NKTR
MOVANTIK (Naloxegol)
Opioid-induced constipation (OIC)
Approved
09/16/2014
Approved September 16, 2014.
EYPT
Iluvien
Diabetic macular edema
Approved
09/26/2014
Approved Sept 26 2014.
ALIM
Iluvien
Diabetic macular edema
Approved
09/26/2014
Approved September 26, 2014,
LNTH
Subcutaneous RELISTOR
Chronic pain
Approved
09/29/2014
Approved September 29, 2014.
AEZS
Macimorelin Acetate - Macrilen
Adult Growth Deficiency
CRL
11/06/2014
CRL issued November 6, 2014.
INCY
Jakafi (ruxolitinib) (RESPONSE)
Polycythemia Vera
Approved
12/04/2014
Approved December 4, 2014.
ABBV
VIEKIRA PAK
HCV - genotype 1
Approved
12/19/2014
Approved December 19, 2014.
ENTA
VIEKIRA PAK
HCV - genotype 1
Approved
12/19/2014
Approved December 19, 2014.
BCRX
RAPIVAB (peramivir)
INFLUENZA ACUTE
Approved
12/22/2014
Approved December 22, 2014.
ADMS
Namzaric
Moderate to severe dementia of the Alzheimer's type.
Approved
12/24/2014
Approved December, 24 2014.
VRTX
KALYDECO
Cystic fibrosis (CF) ages 6 and older who have the R117H mutation
Approved
12/29/2014
Approved December 29, 2014.
NBIX
Elagolix
Endometriosis
Phase 3
01/08/2015
First Phase 3 trial met both co-primary endpoints - January 8, 2015.
ABBV
Elagolix
Endometriosis
Phase 3
01/08/2015
First Phase 3 trial met both co-primary endpoints - January 8, 2015.
RMTI
Soluble Ferric Pyrophosphate
Anemia
Approved
01/26/2015
Approved January 26, 2015.
ABBV
IMBRUVICA
Waldenström’s Macroglobulinemia
Approved
01/29/2015
Approved January 29, 2015 - PCYC
ZGNX
Abuse deterrent formulations of Zohydro ER
Moderate to severe pain
Approved
01/30/2015
Approved January 30, 2015.
PCRX
EXPAREL
Post surgical pain
CRL
03/02/2015
CRL March 2, 2015.
VRTX
KALYDECO (ivacaftor)
Children ages 2 to 5 with cystic fibrosis who have the G551D or one of the eight additional gating mutations
Approved
03/17/2015
Approved March 17, 2015.
NKTR
Etirinotecan pegol NKTR-102 (BEACON)
Cancer - Metastatic Breast Cancer
Phase 3
03/17/2015
Phase 3 topline data mid March 17, 2015 did not reach primary endpoint.
ADMP
Epinephrine Pre-filled Syringe (PFS)
Emergency treatment of anaphylaxis.
CRL
03/25/2015
CRL issued March 27 2015.
EBS
Anthrax Immune Globulin Intravenous (Human) [AIGIV]
Anthrax
PDUFA
03/25/2015
Approved March 25, 2015.
AMGN
Corlanor
Chronic Heart Failure
Approved
04/15/2015
Approved April 15, 2015.
JNJ
Generic Copaxone
Multiple sclerosis
Approved
04/16/2015
Approved April 16 2015.
MNK
RAPLIXA
Hemostasis
Approved
04/30/2015
Approved April 30, 2015.
TBPH
BREO ELLIPTA
Asthma
Approved
04/30/2015
Approved April 30, 2015.
NVS
IONSYS
Acute postoperative pain
Approved
04/30/2015
Approved April 30, 2015.
VRTX
Lumacaftor and ivacaftor
Cystic fibrosis (CF) ages 12 and older who have two copies of the F508del mutation
Approved
07/02/2015
Approved July 2, 2015.
NYMX
NX-1207 Fexapotide
BPH
Phase 3
07/27/2015
Phase 3 endpoints met in extension trial July 2015.
SGEN
ADCETRIS - AETHERA
Post-transplant Hodgkin lymphoma (HL) cancer
Approved
08/17/2015
Approved August 17, 2015 under priority review.
TAK
ADCETRIS - AETHERA
Post-transplant Hodgkin lymphoma (HL) cancer
Approved
08/17/2015
Approved August 17, 2015 under priority review.
MACK
ONIVYDE
Cancer - second line pancreatic
Approved
10/22/2015
Approved October 22, 2015.
IMGN
Kadcyla GATSBY trial
Cancer - metastatic HER2+ gastric cancer
Phase 3
10/22/2015
Phase 3 endpoint not met - October 22, 2015.
SPPI
EVOMELA (melphalan) for Injection
Conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma
CRL
10/23/2015
CRL issued October 23, 2015.
BDSI
BEMA Buprenorphine
Pain
Approved
10/25/2015
Approved October 26, 2015.
ENDP
BEMA Buprenorphine
Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate
Approved
10/26/2015
Approved October 26, 2015.
EXEL
Vemurafenib
BRAF V600 Mutation-Positive Advanced Melanoma - Cancer
Approved
11/10/2015
Approved November 10, 2015.
NKTR
ADYNOVATE
Hemophilia A
Approved
11/16/2015
Approved November 16, 2015.
EBS
BioThrax
Anthrax Vaccine Adsorbed
Approved
11/24/2015
Approved November 24, 2015.
OTIC
OTIPRIO (ciprofloxacin otic suspension)
Ear Tube Placement Surgery
Approved
12/11/2015
Approved December 11, 2015.
ADMS
GOCOVRI (ADS-5102)
Levodopa-Induced Dyskinesia + Parkinson's disease patients receiving levodopa and experiencing OFF episodes
Phase 3
12/23/2015
Phase 3 data released December 23, 2015.
EGRX
Docetaxel Injection
Breast, non-small cell lung, prostate gastric adenocarcinoma, and head and neck cancer
Approved
12/24/2015
Approved December 24, 2015.
CHRS
CHS-0214
Rheumatoid arthritis
Phase 3
01/11/2016
Phase 3 data released January 2016. Endpoints met. However, commercialization not possible in US before 2029 due to patent issues
BMRN
Kyndrisa
Duchenne Muscular Dystrophy (DMD)
CRL
01/14/2016
CRL issued January 14 2016.
NEOS
Adzenys XR-ODT
Attention deficit hyperactivity disorder (ADHD)
Approved
01/27/2016
Approved January 27, 2016.
VRTX
KALYDECO (ivacaftor)
Cystic fibrosis (CF) ages 2 and older who have one of 23 residual function mutations.
CRL
02/05/2016
CRL issued February 5, 2016.
NBIX
Elagolix
Endometriosis
Phase 3
02/10/2016
First Phase 3 trial met both co-primary endpoints - Jan 2015. Data from second Phase 3 released February 2016 also met endpoints.
ABBV
Elagolix
Endometriosis
Phase 3
02/10/2016
First Phase 3 trial met both co-primary endpoints - Jan 2015. Data from second Phase 3 released February 2016 also met endpoints.
RDHL
Talicia RHB-105
H. pylori
Phase 3
03/08/2016
Phase 3 final data released March 8, 2016.
GWPH
Epidiolex
Dravet Syndrome and Lennox-Gastaut syndrome
Phase 3
03/14/2016
Top line Phase 3 data released March 14, 2016 met primary endpoint.
SPPI
EVOMELA (melphalan) for Injection
Conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma
Approved
03/15/2016
Approved March 15 2016.
EGRX
KANGIO (bivalirudin injection)
Percutaneous Coronary Intervention (PCI) and Percutaneous Transluminal Coronary Angioplasty (PTCA)
CRL
03/18/2016
CRL March 18 2016. FDA requested further characterization of bivalirudin-related substances in the drug product.
ALXN
Bevyxxa (betrixaban)
Venous thromboembolism (VTE) Prevention
Phase 3
03/24/2016
Phase 3 data released March 24, 2016 did not meet primary endpoint.
OPK
RAYALDEE
Secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) and vitamin D insufficiency - Stage 3 and 4
CRL
03/30/2016
CRL issued March 30, 2016.
CHMA
Mycapssa
Acromegaly
CRL
04/15/2016
CRL April 15, 2016.
EXEL
CABOMETYX (cabozantinib)
Metastatic renal cell cancer (RCC)
Approved
04/25/2016
Approved April 25, 2016.
ACAD
Pimavanserin
Parkinson’s disease psychosis (PDP)
Approved
04/29/2016
Approved April 29, 2016.
AVDL
Akovaz
Hypotension
Approved
05/02/2016
Approved May 2, 2016.
TTNP
Probuphine
Opioid dependence
Approved
05/26/2016
CRL issued April 30, 2013. Approved May 26, 2016.
VNDA
Fanapt
Supplemental New Drug Application (sNDA) as a maintenance treatment of schizophrenia in adults.
Approved
05/26/2016
Approved May 26, 2016.
AZN
Lokelma (ZS-9)
Hyperkalaemia
CRL
05/26/2016
CRL issued May 26, 2016.
ICPT
Obeticholic acid (Ocaliva)
Primary biliary cirrhosis (PBC) - POISE
Approved
05/27/2016
Approved May 27 2016.
OCUL
DEXTENZA
Allergic conjunctivitis
Phase 3
06/06/2016
Phase 3 trial did not meet primary endpoint - June 6, 2016.
ADMP
Epinephrine Pre-filled Syringe (PFS)
Emergency treatment of anaphylaxis.
CRL
06/06/2016
CRL issued March 27 2015. CRL issued again June 6, 2016.
RVNC
DAXI (RT002)
Lateral Canthal (Crow’s Feet) Lines
Phase 3
06/13/2016
Phase 3 endpoints not met June 13, 2016.
MRNS
Ganaxolone
Focal onset seizures
Phase 3
06/13/2016
Phase 3 data did not meet endpoints - June 13, 2016
PRTK
Omadacycline
Acute bacterial skin and skin structure infections (ABSSSI)
Phase 3
06/16/2016
Phase 3 top-line data met endpoints - June 16, 2016
OPK
RAYALDEE
Secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) and vitamin D insufficiency - Stage 3 and 4
Approved
06/21/2016
Announced FDA Approval June 21, 2016.
NVS
Meropenem-vaborbactam
Complicated urinary tract infections (cUTI)
Phase 3
06/27/2016
Phase 3 data met endpoints June 27, 2016.
CLVS
Rociletinib
Mutant EGFR T790M-positive lung cancer
CRL
06/28/2016
CRL June 28, 2016. Phase 3 TIGER-3 also terminated.
GSK
Niraparib - NOVA (Niraparib Ovarian)
Cancer - ovarian
Phase 3
06/29/2016
Phase 3 data met endpoints - June 2016.
LPCN
TLANDO - LPCN 1021
Men with low testosterone (Low T)
CRL
06/29/2016
CRL issued June 29, 2016.
AMPE
Ampion
Osteoarthritis of the Knee
Phase 3
06/30/2016
STRIDE study mid April 2015 did not meet endpoint. Second Phase 3 trial also did not meet primary endpoint - June 2016
RARE
MEPSEVII (vestronidase alfa)
Mucopolysaccharidosis 7 (MPS 7)
Phase 3
07/14/2016
Phase 3 data released July 2016. Primary endpoint hit. Secondary missed.
LNTH
Oral RELISTOR
Chronic pain
Approved
07/19/2016
Approved July 19 2016.
OCUL
DEXTENZA
Ocular inflammation and pain following cataract surgery
CRL
07/25/2016
CRL July 25 2016 - due to manufacturing deficiencies.
MCRB
SER-109 - ECOSPOR III
Recurrent C. Difficile infection
Phase 2
07/29/2016
Phase 2 interim data did not meet primary endpoint.
ADMA
ASCENIV (RI-002)
Primary Immune Deficiency Diseases
CRL
07/29/2016
CRL issued July 29 2016. Third-party manufacturing issues cited.
IONS
SPINRAZA - Nusinersen
Spinal muscular atrophy (SMA)
Phase 3
08/01/2016
Phase 3 ENDEAR trial met primary endpoint August 1, 2016.
HRTX
APF530 - Sustol
Prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV)
Approved
08/10/2016
CRL Mar 28 2013. Approved August 10, 2016.
AUPH
Voclosporin - AURORA
Lupus
Phase 2b
08/15/2016
Phase 2b data released August 2016. Primary endpoint met but with high number of deaths.
ACRX
DSUVIA (ARX-04)
Moderate-to-severe acute pain following a surgical procedure
Phase 3
08/15/2016
Phase 3 data released August 15, 2016.
ALXN
Andexxa
Factor Xa inhibitor reversal agent
CRL
08/17/2016
CRL August 17 2016.
ACRS
A-101 THWART-1 and THWART-2
Common warts (verruca vulgaris)
Phase 2
08/18/2016
Phase 2 data released August 2016.
EARS
AM-101 (Keyzilen) - TACTT2
Acute inner ear tinnitus
Phase 3
08/18/2016
Phase 3 trial did not meet primary endpoints.
KMDA
Inhaled formulation of AAT
AATD - Alpha-1 Antitrypsin deficiency
Phase 2
08/30/2016
Top-line data released August 30, 2016. Primary endpoint met
RIGL
Tavalissetm (Fostamatinib)
Immune Thrombocytopenic Purpura (ITP)
Phase 3
08/30/2016
Phase 3 data from the first trial released August 30 2016. Primary endpoint met.
GSK
Rolapitant
Prevention of chemotherapy induced nausea and vomiting, or CINV in HEC patients
Approved
09/02/2016
Approved September 2, 2015.
OPK
Rolapitant
Prevention of chemotherapy induced nausea and vomiting, or CINV
Approved
09/02/2016
Approved September 2, 2015.
TNXP
TNX-102 SL (Tonmya)
Fibromyalgia
Phase 3
09/06/2016
Phase 3 data released September 6, 2016. Primary endpoint not met. Program discontinued
KPTI
Selinexor
Quadruple Refractory Multiple Myeloma
Phase 2
09/06/2016
Phase 2 positive top-line data released September 6, 2016
AERI
Roclatan
Glaucoma
Phase 3
09/14/2016
Phase 3 Mercury 1 data released September 14, 2016. Primary endpoint met.
NVAX
RSV vaccine - Resolve trial
Respiratory Syncytial Virus (RSV) in older adults
Phase 3
09/15/2016
Phase 3 released September 15, 2016 did not demonstrate efficacy.
SRPT
Eteplirsen - Exon 51
Duchenne muscular dystrophy
Approved
09/19/2016
Approved September 19, 2016.
ITCI
Lumateperone
Schizophrenia
Phase 3
09/28/2016
Phase 3 trial failed - September 28, 2016.
GNCA
GEN-003
Genital herpes
Phase 2b
09/29/2016
Phase 2b virologic efficacy data released September 2016.
TENX
Levosimendan
Septic shock
Phase 2b
10/05/2016
Phase 2b trial did not meet primary endpoint.
ALKS
ALKS 5461
Major depressive disorder
Phase 3
10/20/2016
Phase 3 data from first two trials did not meet their endpoints. FORWARD-5 data, the third of three trials did meet endpoints - October 2016.
PLXP
Locilex
Mild infections of diabetic foot ulcers
Phase 3
10/25/2016
Phase 3 top-line data did not meet endpoints - October 25, 2016 - TICKER CHANGED FROM DPRX FOLLOWING MERGER
RIGL
Tavalissetm (Fostamatinib)
Immune Thrombocytopenic Purpura (ITP)
Phase 3
10/30/2016
Phase 3 data from second trial did not meet the primary endpoint.
AMAG
Vyleesi (Bremelanotide)
Female sexual dysfunction (FSD)
Phase 3
11/01/2016
Phase 3 data released November 1, 2016.
PTN
Vyleesi (Bremelanotide)
Female sexual dysfunction (FSD)
Phase 3
11/01/2016
Phase 3 data released November 1, 2016.
IONS
SPINRAZA - Nusinersen
Spinal muscular atrophy (SMA)
Phase 3
11/07/2016
Phase 3 CHERISH data met primary endpoint - November 7, 2016.
DVAX
HEPLISAV-B
Hepatitis B
CRL
11/14/2016
CRL November 14, 2016
ACRS
ESKATA (hydrogen peroxide)
Seborrheic keratosis (SK)
Phase 3
11/15/2016
Phase 3 trial met endpoints - November 15, 2016.
ALNY
Inclisiran
Hyperlipidemia
Phase 2
11/15/2016
Phase 2 Day 180 data presented at AHA Scientific Sessions on November 15, 2016.
NVS
Inclisiran
Hyperlipidemia
Phase 2
11/15/2016
Phase 2 Day 180 data presented at AHA Scientific Sessions on November 15, 2016.
ENDP
QWO
Edematous fibrosclerotic panniculopathy (“cellulite”)
Phase 2b
11/17/2016
Phase 2b data released November 17, 2016. Met endpoints
ACOR
Dalfampridine
Post stroke deficits
Phase 3
11/21/2016
Phase 3 data released November 21, 2016 - failed to show efficacy, development to be discontinued.
BXRX
Intravenous (IV) meloxicam
Acute pain following bunionectomy surgery
Phase 3
11/28/2016
Phase 3 data from second trial released November 28, 2016. Primary endpoint met.
CERC
CERC-301
Major depressive disorder (MDD)
Phase 2
11/29/2016
Phase 2 top-line data released November 29, 2016 failed to meet primary endpoint.
NOVN
SB206
Human papillomavirus (HPV)
Phase 2
11/29/2016
Phase 2 data released November 29, 2016. Primary endpoint met.
HTBX
HS-410
Bladder cancer
Phase 2
11/30/2016
Phase 2 trial did not meet primary endpoint - November 30, 2016.
HZNP
ACTIMMUNE
Friedreich's Ataxia (FA)
Phase 3
12/08/2016
Phase 3 data released December 8, 2016 - primary endpoint not met
ISEE
Fovista
Wet age-related macular degeneration (Wet-AMD)
Phase 3
12/12/2016
Phase 3 data released December 12, 2016 - primary endpoint not met.
VCEL
MACI
Focal chondral cartilage defects in the knee.
Approved
12/13/2016
FDA Approval announced December 13, 2016 ahead of PDUFA date of January 3 2017.
BDSI
Clonidine gel
Painful diabetic neuropathy (PDN)
Phase 2b
12/13/2016
Phase 2b data released December 13, 2016 - primary endpoints not met.
VTVT
TTP273 - LOGRA
Type 2 Diabetes
Phase 2
12/14/2016
Phase 2 primary endpoint met - December 14, 2016.
CLVS
Rucaparib ARIEL2
Cancer - ovarian second line
Approved
12/19/2016
Approved December 19, 2016. Original PDUFA date under priority review was February 23, 2017.
ACAD
Pimavanserin - Harmony
Alzheimer’s disease psychosis
Phase 2
12/20/2016
Phase 2 top-line data released December 20, 2016. Primary endpoint met. Key secondary endpoint missed.
LXRX
Sotagliflozin
Type 1 Diabetes
Phase 3
12/21/2016
Phase 3 data from second trial released December 21, 2016 - primary endpoint met.
MACK
MM-302 HERMIONE
Cancer - HER2-positive locally advanced or metastatic breast cancer
Phase 2
12/21/2016
Phase 2 trial discontinued December 21, 2016 due to poor efficacy.
NVS
Lutathera
Inoperable progressive midgut NETs
CRL
12/21/2016
PDUFA date under priority review was December 28, 2016. CRL issued December 21, 2016.
IRWD
Linaclotide
Irritable Bowel Syndrome with Constipation (IBS-C)
Phase 2b
12/22/2016
Phase 2b data released December 22, 2016.
IONS
SPINRAZA - Nusinersen
Spinal muscular atrophy (SMA)
Approved
12/23/2016
Approved December 23, 2016.
AMPH
Primatene Mist (epinephrine inhalation aerosol)
Asthma
CRL
12/27/2016
CRL issued December 27, 2016.
OPK
hGH-CTP
Adults - growth hormone deficiency
Phase 3
12/30/2016
Phase 3 data released December 30, 2016 - primary endpoint not met.
AGRX
Twirla
Contraceptive patch
Phase 3
01/03/2017
CRL issued 2013. Phase 3 top-line data released January 3, 2017 - poor data but intends to reflile NDA 1H 2017.
AEZS
Macimorelin Acetate - Macrilen
Adult Growth Deficiency
Phase 3
01/04/2017
Phase 3 data released January 4, 2017 - trial failed.
HALO
HALO-301
Pancreatic cancer
Phase 2
01/05/2017
Primary endpoint met.
GNCA
GEN-003
Genital herpes
Phase 2b
01/05/2017
Phase 2b data released January 5, 2017.
OTIC
OTIPRIO
Acute otitis externa
Phase 3
01/05/2017
Phase 3 trial met primary endpoint - January 5, 2017.
CHRS
CHS-1420
Psoriasis
Phase 3
01/10/2017
Phase 3 top-line data met endpoints August 2016. Full data due released January 10, 2016.
GSK
Rolapitant - intravenous (IV)
Prevention of chemotherapy induced nausea and vomiting, or CINV in HEC patients
CRL
01/11/2017
CRL issued January 11 2017.
FGEN
Pamrevlumab (LAPIS)
Pancreatic cancer
Phase 2
01/17/2017
Phase 2 abstract released January 17, 2017.
NBIX
INGREZZA
Tourette syndrome - adults
Phase 2
01/18/2017
Phase 2 data released January 18, 2017 did not meet primary endpoint.
ABBV
Oxymetazoline HCl cream 1.0%
Facial Erythema (Redness) Associated with Rosacea
Approved
01/19/2017
Approved January 19, 2017.
ABBV
Imbruvica
Marginal zone lymphoma
Approved
01/19/2017
sNDA filing under priority review approved January 19, 2017.
MRNS
Ganaxolone - Marigold
CDKL5 Deficiency Disorder (CDD)
Phase 2
01/23/2017
Phase 2 preliminary CDKL5 cohort data released January 23, 2017.
IRWD
Linaclotide 72 mcg dose for use in the treatment of adults
Chronic idiopathic constipation (CIC)
Approved
01/26/2017
sNDA approval announced January 26, 2017.
NOVN
SB204
Acne vulgaris
Phase 3
01/27/2017
Phase 3 top-line data released January 27, 2017. Met one of three co-primary endpoints in NI-AC301 trial. Met all endpoints in NI-AC302 trial.
NRBO
Gemcabene - COBALT-1
Homozygous Familial Hypercholesterolemia (HoFH)
Phase 2b
01/30/2017
Phase 2b interim data released January 30, 2017.
TENX
Levosimendan
Reduce the incidence of low cardiac output syndrome during cardiac surgery
Phase 3
01/31/2017
Phase 3 top line data released January 31, 2017 - primary endpoints not met.
CATB
Edasalonexent (CAT-1004)
Duchenne muscular dystrophy (DMD)
Phase 1/2
01/31/2017
Phase 1/2 top-line data released January 31 - primary endpoint not met.
AMGN
Parsabiv
Secondary hyperparathyroidism (SHPT)
Approved
02/07/2017
Approved February 7, 2017.
GWPH
Sativex (Nabiximols)
Spasticity due multiple sclerosis
Phase 2
02/07/2017
Phase 2 trial did not meet primary endpoint - noted February 7, 2017.
JNJ
XARELTO (rivaroxaban)
Coronary Artery Disease or Peripheral Artery Disease
Phase 3
02/08/2017
Phase 3 trial stopped early due to positive efficacy - February 8, 2017.
ACOR
INBRIJA (CVT-301)
OFF episodes of Parkinson’s disease (PD)
Phase 3
02/09/2017
Phase 3 data released February 9, 2017 - primary endpoint met.
TCON
TRC105 and Avastin
Glioblastoma - cancer
Phase 2
02/09/2017
Phase 2 data released February 9, 2017 - primary endpoint not met.
ZSAN
M207
Migraine
Phase 3
02/13/2017
Phase 3 trial data due released February 13, 2017 - primary endpoints met.
SAGE
SAGE-217 - MOUNTAIN
Major Depressive Disorder (MDD)
Phase 2
02/13/2017
Phase 2 top-line data from open-label trial released February 13, 2017
MRK
MK-8931 (017) - Verubecestat
Mild-to-moderate Alzheimer's
Phase 3
02/14/2017
Phase 3 trial stopped due to lack of efficacy - February 14, 2017.
BHC
Brodalumab
Psoriasis
Approved
02/15/2017
Approved February 15, 2017.
ARDX
Tenapanor
Serum phosphorus - chronic kidney disease (CKD) on dialysis
Phase 3
02/15/2017
Phase 3 released February 15, 2017 - primary endpoint met.
AZN
Lynparza
Breast cancer
Phase 3
02/17/2017
Phase 3 data released February 17, 2016 - primary endpoint met.
MRK
Lynparza
Breast cancer
Phase 3
02/17/2017
Phase 3 data released February 17, 2016 - primary endpoint met.
TRVN
Oliceridine (TRV130)
Moderate to severe acute pain
Phase 3
02/21/2017
Phase 3 APOLLO-1 and APOLLO-2 data released February 21, 2017 - primary endpoints met but commercial doubts raised.
CDTX
CD101 Topical - RADIANT
Vulvovaginal candidiasis (VVC)
Phase 2
02/21/2017
Phase 2 data released February 21, 2017 - efficacy not evident, Development to be discontinued.
AMPH
Naloxone Intranasal
Opioid overdose
CRL
02/21/2017
CRL announced February 21, 2017.
BMY
REVLIMID
Multiple myeloma (MM) - autologous stem cell transplant (ASCT)
Approved
02/22/2017
Approved February 22, 2017.
CMRX
Brincidofovir - Advise trial
Adenovirus Infection
Phase 3
02/22/2017
Phase 3 interim analysis released May 2016. Final data released February 22, 2017.
BCRX
Berotralstat BCX7353
Reduce or eliminate attacks in HAE patients
Phase 2
02/27/2017
Phase 2 interim data released February 27, 2017.
LJPC
GiaprezaTM (angiotensin II)
Increase blood pressure in adults with septic or other distributive shock
Phase 3
02/27/2017
Phase 3 data released February 27, 2016 - primary endpoint hit. Secondary endpoints not mentioned. NDA filing due 2H 2017.
AZN
Saxagliptin and dapagliflozin
Type-2 diabetes
Approved
02/28/2017
Approval announced February 28, 2017.
AUPH
Voclosporin - AURORA
Lupus
Phase 2b
03/01/2017
Phase 2b data released August 2016. Primary endpoint met but with high number of deaths. Further data released March 1, 2017 - no additional deaths and endpoints met.
MRK
Odactra (MK-8237)
House dust mite allergies
Approved
03/01/2017
Approved March 1, 2017.
PTCT
Translarna
Nonsense mutation cystic fibrosis
Phase 3
03/02/2017
Phase 3 data released March 2, 2017 - endpoints not met. Development to be discontinued.
KPTI
Selinexor SOPRA
Cancer - Relapsed/Refractory Acute Myeloid Leukemia (AML)
Phase 2
03/02/2017
Data Safety Monitoring Board (DSMB) noted March 2, 2017 that trial will not meet primary endpoint.
IONS
Volanesorsen - APPROACH
Familial chylomicronemia syndrome (FCS)
Phase 3
03/06/2017
Phase 3 data released March 6, 2017 - primary endpoint met. Relative safety concerns noted.
KURA
Tipifarnib - (AIM-HN/SEQ-HN)
Head and neck squamous cell carcinomas (HNSCC)
Phase 2
03/06/2017
Phase 2 ongoing data released March 6, 2017 - further data due 2H 2017.
TGTX
TG-1101 and IMBRUVICA (GENUINE trial)
Chronic Lymphocytic Leukemia (CLL) cancer
Phase 3
03/06/2017
Phase 3 trial met primary endpoint - March 6, 2017, meeting with FDA in 2H 2017.
ACOR
Ampyra
Improve walking in patients with multiple sclerosis
-
03/09/2017
Decision on Inter Partes Review (IPR) released March 10, 2017 - patents upheld.
NVS
LEE011
HR+/HER2- advanced breast cancer
Approved
03/13/2017
Priority review granted November 1, 2016. Approval announced March 13, 2017.
MRK
KEYTRUDA
Relapsed or Refractory Classical Hodgkin Lymphoma
Approved
03/14/2017
Approval announced March 14, 2017.
AZN
Lynparza - SOLO 2
Second-line ovarian cancer
Phase 3
03/14/2017
Data presented March 14, 2017 showed significant PFS benefit.
ENDP
OPANA ER
Management of pain
-
03/14/2017
Advisory Committee Meeting March 14, 2017 voted 18 to eight that the benefits of reformulated OPANA ER no longer outweigh its risks.
CPRX
Firdapse
MuSK-antibody positive myasthenia gravis (MuSK-MG)
Phase 2
03/15/2017
Phase 2 top-line data met endpoints - March 15, 2017. Pivotal trial planned.
AZN
Lokelma (ZS-9)
Hyperkalaemia
CRL
03/17/2017
Second CRL issued March 17, 2017.
AMGN
Repatha
Cardiovascular disease
Phase 3
03/17/2017
Phase 3 cardiovascular outcomes study data released March 17, 2017 - endpoints met but down on expectations.
LLY
Abemaciclib - MONARCH 1 and 2
Second-line hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer and HR+, HER2- breast cancer
Phase 3
03/20/2017
Phase 3 data released March 20, 2017 - PFS primary endpoint met.
BLRX
BL-8040 GENESIS
Stem-cell mobilization for autologous transplantation
Phase 2
03/20/2017
Phase 2 trial initiated March 2016. Partial data released March 20, 2017.
JAZZ
JZP-110
Excessive sleepiness associated with obstructive sleep apnea
Phase 3
03/20/2017
Phase 3 data released March 20, 2017 - primary endpoints met.
NVS
RELAX-AHF-2 (RLX030)
Acute heart failure
Phase 3
03/22/2017
Phase 3 data released March 22, 2017 - primary endpoints not met.
PFE
Avelumab
Metastatic Merkel cell carcinoma
Approved
03/23/2017
Priority review announced November 29, 2016. Approval announced March 23, 2017.
XENE
XEN801
Acne
Phase 2
03/24/2017
Phase 2 data released March 24 2017 - endpoints not met.
GSK
Niraparib - NOVA (Niraparib Ovarian)
Cancer - ovarian
Approved
03/27/2017
PDUFA date under priority review was June 30, 2017. Approved March 27, 2017.
MNLO
FMX101
Acne
Phase 3
03/27/2017
Phase 3 data released March 27, 2017 - three of four primary endpoints met across two trials.
PRTK
Sarecycline
Severe acne vulgaris
Phase 3
03/27/2017
Phase 3 data released March 27 2017 - primary endpoints met. NDA filing due 2H 2017.
VRTX
Tezacaftor / ivacaftor
Cystic fibrosis - Two Copies of the F508del Mutation
Phase 3
03/28/2017
Phase 3 data released March 28, 2017 - primary endpoint met. NDA filing due 3Q 2017.
QLGN
RP-G28
Lactose intolerance
Phase 2/3
03/28/2017
Phase 2/3 top-line data released March 28, 2017. Primary endpoint met. End of Phase 2 meeting with FDA planned.
REGN
Dupixent (dupilumab)
Atopic dermatitis
Approved
03/28/2017
Approved under priority review - March 28, 2017.
SNY
Dupixent (dupilumab)
Atopic dermatitis
Approved
03/28/2017
Approved under priority review - March 28, 2017.
LNTH
Azedra
Pheochromocytoma
Phase 2b
03/30/2017
Pivotal Phase 2 trial resumed January 2015 following suspension of trial in 2010 due to lack of funding. Primary endpoint met - March 30, 2017. NDA filing due mid-2017.
CRBP
Lenabasum
Cystic Fibrosis
Phase 2
03/30/2017
Phase 2 data released March 30, 2017 - primary endpoint met but some concerns regarding efficacy.
AZN
Tagrisso
Epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC)
Approved
03/31/2017
Approval announced March 31, 2017.
NVCR
Tumor Treating Fields (TTFields) - INNOVATE-3
Ovarian cancer
Phase 2
03/31/2017
Phase 2 data presented December 12, 2016. Further promising PFS data released March 31, 2017.
PFE
IBRANCE (palbociclib)
HR+, HER2- Metastatic Breast Cancer
Approved
03/31/2017
sNDA acceptance announced December 21, 2016. Approval announced March 31, 2017.
PRTK
Omadacycline
Community-acquired bacterial pneumonia (CABP)
Phase 3
04/03/2017
Phase 3 data released April 3, 2017 - all endpoints met.
KPTI
Selinexor
Diffuse Large B-Cell Lymphoma (DLBCL)
Phase 2b
04/04/2017
Phase 2b additional interim data released April 4, 2017 at AACR. Final top-line data due mid-2018.
NKTR
Cipro DPI
Bronchiectasis
Phase 3
04/05/2017
Phase 3 second trial did not meet endpoint - April 5, 2017.
SUPN
Trokendi
Migraine
Approved
04/05/2017
Tentative approval August 19 2016, subject to the pediatric exclusivity which expires March 28, 2017. Final approval announced April 6, 2017.
MRK
Januvia (Sitagliptin)
Type 2 Diabetes
CRL
04/07/2017
CRL issued April 7 2017. sNDA for approved drug requested to include data on cardiovascular effects
GERN
Imetelstat (IMpactMF)
Myelofibrosis
Phase 2/3
04/10/2017
Phase 2 clinical hold lifted Nov 2014. Phase 2 initiated September 2015. Internal review conducted September 2016. Low dose discontinued, high dose enrollment suspended. Further review conducted April 2017 - further development pending FDA feedback and longer term data.
MESO
Rexlemestrocel
Heart failure
Phase 3
04/10/2017
Noted April 10, 2017 that interim analysis has been completed - trial to continue as planned.
NBIX
INGREZZA
Tardive dyskinesia
Approved
04/11/2017
Approved April 11, 2017.
NOVN
SB208
Fungal infections
Phase 2
04/12/2017
Phase 2 data released April 12, 2017. Primary endpoint met.
INCY
Baricitinib
Rheumatoid arthritis
CRL
04/14/2017
Announced January 19 2016 that NDA Filing had been submitted. Three month delay announced January 13, 2017. CRL received April 14, 2017.
LLY
Baricitinib
Rheumatoid arthritis
CRL
04/14/2017
Announced January 19 2016 that NDA Filing had been submitted. Three month delay announced January 13, 2017. CRL received April 14, 2017.
RARE
Crysvita (Burosumab)
X-Linked Hypophosphatemia (XLH)
Phase 3
04/18/2017
Phase 3 data released April 18, 2017 - primary endpoint met, two of three secondary endpoints met (missed on pain).
ABBV
Veliparib
Squamous non-small cell lung cancer (NSCLC) and triple negative breast cancer (TNBC)
Phase 3
04/19/2017
Phase 3 trial did not meet primary endpoints - April 19, 2017.
MRK
RENFLEXIS - SB2 (infliximab biosimilar)
Biosimilar candidate of Remicade
Approved
04/21/2017
BLA acceptance announced May 23, 2016 by partner Samsung Bioepis. Approval annuonced April 21, 2017.
EIGR
Lonafarnib - D-LIVR
Chronic hepatitis delta virus (HDV)
Phase 2
04/21/2017
Phase 2 end of trial data released April 21, 2017. Meeting with FDA scheduled for 4Q 2017.
LLY
Abemaciclib - MONARCH 3
HR+, HER2-locoregionally recurrent or metastatic breast cancer (MBC)
Phase 3
04/24/2017
Phase 3 interim analysis April 24, 2017 met primary endpoint. Detailed data due 2H 2017 with regulatory filings due 3Q 2017.
JAZZ
Xyrem
Pediatric narcolepsy patients with cataplexy
Phase 2/3
04/24/2017
Phase 2/3 positive data released April 24, 2017. sNDA filing due 4Q 2017.
XOMA
XOMA 213
Hyperprolactinemia
Phase 2
04/24/2017
Phase 2 proof-of-concept results released April 24, 2017.
AKTX
Nomacopan
Paroxysmal nocturnal hemoglobinuria (PNH)
Phase 2
04/24/2017
Phase 2 interim data released April 24, 2017. Phase 3 program to commence 4Q 2017 with initial data due 1Q 2019.
REGN
Praluent (alirocumab)
High low-density lipoprotein (LDL) cholesterol
Approved
04/25/2017
sBLA Approval announced April 25, 2017.
SNY
Praluent (alirocumab)
High low-density lipoprotein (LDL) cholesterol
Approved
04/25/2017
sBLA Approval announced April 25, 2017.
JAZZ
Solriamfetol (JZP-110)
Excessive sleepiness associated with narcolepsy
Phase 3
04/26/2017
Phase 3 data released April 26, 2017. NDA to be filed late 2017.
BMRN
Cerliponase alfa
Batten Disease
Approved
04/27/2017
PDUFA date extended by three months to April 27 2017. Approval announced April 27, 2017.
NVS
Rydapt (Midostaurin - PKC412)
Acute myeloid leukemia (AML)
Approved
04/28/2017
Priority review granted November 14, 2016. Approval announced April 28, 2017.
TGTX
TG-1101 - ULTIMATE I
Multiple Sclerosis
Phase 2
04/28/2017
Phase 2 preliminary results presented at American Academy of Neurology (AAN) annual meeting April 28, 2017.
RDUS
TYMLOS (Abaloparatide)
Osteoporosis
Approved
04/28/2017
PDUFA date originally scheduled for March 30 2017 delayed by three months to June 30, 2017. Approval announced April 28, 2017.
AEZS
Zoptrex
Endometrial cancer
Phase 3
05/01/2017
Phase 3 trial did not meet primary endpoint - May 1, 2017.
AZN
Urothelial carcinoma - Bladder cancer
Bladder cancer
Approved
05/01/2017
BLA acceptance announced December 9, 2017. PDUFA under priority review. Approval announced May 1, 2017.
AMAG
Feraheme
Adults with iron deficiency anemia (IDA)
Phase 3
05/02/2017
Phase 3 trial completion announced May 2, 2017 - endpoints met. sNDA due mid-2017.
REGN
Dupixent (dupilumab)
Eosinophilic esophagitis
Phase 2
05/04/2017
Phase 2 data released May 4, 2017.
SNY
Dupixent (dupilumab)
Eosinophilic esophagitis
Phase 2
05/04/2017
Phase 2 data released May 4, 2017.
TXMD
Yuvvexy - TX-004HR
Moderate-to-severe vaginal pain
CRL
05/08/2017
CRL announced May 8, 2017. Company noted that FDA cited a lack of long-term endometrial safety data.
LCTX
OpRegen
Dry age-related macular degeneration (AMD)
Phase 2
05/09/2017
Phase 2 second cohort underway. Interim data presented at May 8, 2017 at ARVO conference.
PFE
Avelumab
Urothelial Carcinoma
Approved
05/09/2017
Approval announced May 9, 2017.
MRK
Keytruda
First-Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer
Approved
05/10/2017
Approved May 10, 2017.
GSK
Mepolizumab
Chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype
Phase 3
05/10/2017
Phase 3 METREX trial met primary endpoint. Phase 3 METREO failed to meet endpoint.
AZN
Tralokinumab (STRATOS1)
Severe, uncontrolled asthma
Phase 3
05/10/2017
Phase 3 trial did not meet primary endpoint - May 10, 2017.
LLY
Galcanezumab - EVOLVE-1, EVOLVE-2 and REGAIN
Migraine prevention
Phase 3
05/12/2017
Phase 3 data released May 12, 2017 - primary endpoints hit in all trials. BLA filing due 2H 2017.
CAPR
CAP-1002 ALLSTAR
Myocardial infarction (heart attack)
Phase 2
05/12/2017
Phase 2 data released May 12, 2017 - primary endpoint unlikely to be met.
AZN
Durvalumab (PACIFIC)
Lung cancer
Phase 3
05/12/2017
Phase 3 interim analysis released May 12, 2017 - PFS primary endpoint already met. OS endpoint to be assessed.
ARDX
Tenapanor (T3MPO-1)
Constipation-predominant irritable bowel syndrome (IBS-C)
Phase 3
05/12/2017
Phase 3 data released May 12, 2017. Primary endpoint met - however, competitive concerns raised.
IONS
Inotersen (IONIS-TTRRx)
NEURO-TTR - familial amyloid polyneuropathy (FAP).
Phase 3
05/15/2017
Phase 3 data released May 15, 2017 - primary endpoint met but with safety concerns.
RVNC
DAXI (RT002) - ASPEN
Cervical dystonia
Phase 2
05/18/2017
Phase 2 additional data released May 18, 2017 with oral presentation June 7, 2017 at International Congress of Parkinson's Disease and Movement Disorders.
MRK
KEYTRUDA
First and Second line locally advanced or metastatic urothelial cancer - bladder cancer
Approved
05/18/2017
Approved May 18, 2017.
BMY
ZEPOSIA (Ozanimod)
Relapsing Multiple Sclerosis
Phase 3
05/22/2017
Phase 3 data due released May 22, 2017 - primary endpoint met, disability endpoint not met.
AMGN
EVENITY (Romosozumab)
Osteoporosis
Phase 3
05/22/2017
PDUFA date July 19, 2017. However, likely to be delayed due to safety data from ARCH trial released May 22, 2017.
SNY
Sarilumab
Rheumatoid arthritis
Approved
05/22/2017
CRL October 28, 2016. Resubmitted with FDA Approval announced May 22, 2017.
REGN
Sarilumab
Rheumatoid arthritis
Approved
05/22/2017
CRL October 28, 2016. Resubmitted with FDA Approval announced May 22, 2017.
LJPC
GiaprezaTM (angiotensin II)
Increase blood pressure in adults with septic or other distributive shock
Phase 3
05/22/2017
Phase 3 data released February 27, 2016 - primary endpoint hit. Secondary endpoints not mentioned. Data released May 22, 2017 confirmed primary endpoint was met but with lack of mortality improvement.
MRK
KEYTRUDA
Microsatellite Instability-High Cancer
Approved
05/23/2017
PDUFA date March 8, 2017 extended to June 9, 2017 due to submission of extra data. Approved May 23, 2017.
NBIX
INGREZZA - T-Force GOLD
Tourette syndrome - juvenile
Phase 2
05/23/2017
Phase 2 data released May 23 - primary endpoint not met.
AERI
Roclatan
Glaucoma
Phase 3
05/24/2017
Phase 3 Mercury 1 data released September 14, 2016. Primary endpoint met. Mercury 2 trial data released may 24, 2017 - primary endpoint also hit with NDA filing due 1H 2018.
PBYI
Neratinib (NERLYNX)
Extended adjuvant HER2-positive early stage breast cancer
-
05/24/2017
Announced acceptance of NDA Filing September 20, 2016. PDUFA estimate July 20, 2017. Advisory Committee Meeting May 24, 2017 voted 12-4 in favor of recommending approval.
BCRX
Berotralstat BCX7353
Reduce or eliminate attacks in HAE patients
Phase 2
05/25/2017
Phase 2 interim data released February 27, 2017. Top-line data released May 25, 2017.
NVS
Zykadia
First-line use in patients with ALK+ metastatic NSCLC
Approved
05/26/2017
Priority review granted February 22, 2017. Approval announced May 26, 2017.
MRK
ISENTRESS
HIV-1
Approved
05/30/2017
Approval announced May 30, 2017.
GILD
Bictegravir/F/TAF
HIV
Phase 3
05/30/2017
Phase 3 data released May 30 - primary endpoint met. NDA filing due 2Q 2017.
NVO
Nonacog beta pegol
haemophilia B
Approved
05/31/2017
Approval announced May 31, 2017.
RETA
Omaveloxolone
Friedreich’s ataxia (FA)
Phase 2
06/01/2017
Phase 2 initial data released June 1, 2017. Primary endpoint not met.
LLY
Larotrectinib (LOXO-101)
Solid tumors that harbor a TRK fusion.
Phase 2
06/03/2017
Announced 76% ORR at ASCO - June 3, 2017. Primary analysis by the end of 2017 with NDA filing late 2017 or early 2018.
JNJ
ZYTIGA (abiraterone acetate) - LATITUDE
metastatic hormone-naïve prostate cancer (mHNPC)
Phase 3
06/03/2017
Phase 3 data presented at ASCO June 3, 2017 - PFS 33 months.
TGTX
TG-1101 and IMBRUVICA (GENUINE trial)
Chronic Lymphocytic Leukemia (CLL) cancer
Phase 3
06/03/2017
Phase 3 trial met primary endpoint - March 6, 2017. Data presented at ASCO 2017. Meeting with FDA in 2H 2017.
HALO
HALO-301
Pancreatic cancer
Phase 2
06/04/2017
Phase 2 data released January 5, 2017. Oral presentation of Phase 2 data at ASCO June 4, 2017 showed ORR of 45%.
AZN
Lynparza
Breast cancer
Phase 3
06/04/2017
Phase 3 data released February 17, 2016 - primary endpoint met. Late breaker at ASCO June 4, 2017 showed HR of 0.58 (42% reduction of risk of disease progression or death).
MRK
Lynparza
Breast cancer
Phase 3
06/04/2017
Phase 3 data released February 17, 2016 - primary endpoint met. Late breaker at ASCO June 4, 2017 showed HR of 0.58 (42% reduction of risk of disease progression or death).
FPRX
Cabiralizumab (FPA008)
Pigmented Villonodular Synovitis (PVNS)
Phase 1/2
06/04/2017
Phase 1/2 initial data released at ASCO June 4, 2017.
PIRS
PRS-080
Anemia of chronic disease
Phase 1b
06/04/2017
Phase 1b data released at ERA-EDTA June 4, 2017.
BLUE
ide-cel bb2121 - KarMMa
Relapsed/refractory multiple myeloma
Phase 1
06/05/2017
Phase 1 interim data released November 30, 2016 - 78% ORR. Pivotal trial to be initiated 2017. Updated data at ASCO June 5, 2017 - ORR 89%.
BMY
ide-cel bb2121 - KarMMa
Relapsed/refractory multiple myeloma
Phase 1
06/05/2017
Phase 1 interim data released November 30, 2016 - 78% ORR. Pivotal trial to be initiated 2017. Updated data at ASCO June 5, 2017 - ORR 89%.
BMY
liso-cel (JCAR017)
Relapsed or refractory (R/R) large B-cell lymphoma
Phase 1/2
06/05/2017
Pivotal trial to be initiated in 2017. ASCO Poster Session June 5, 2017 - ORR 86%.
GILD
Axicabtagene ciloleucel - (ZUMA-3)
Adult patients with r/r ALL - cancer
Phase 1
06/05/2017
Phase 2 data due 2018. Phase 1 data released at ASCO June 5, 2017. Complete remission 73%.
IOVA
LN-144 - lifileucel
Refractory metastatic melanoma
Phase 2
06/05/2017
Phase 2 second cohort commenced enrollment - May 19, 2017. Initial data presented at ASCO June 5, 2017.
CLSN
GEN-1 OVATION 2
Ovarian cancer
Phase 1b
06/05/2017
Phase 1b interim data released at ASCO 2017 - ORR 86%.
CRVS
CPI-444
Solid tumors - cancer
Phase 1b
06/05/2017
Phase 1/1b preliminary data released November 2016. Further update at ASCO June 5, 2017.
GLYC
Uproleselan (GMI-1271)
Acute myeloid leukemia (AML) newly diagnosed and refractory - cancer
Phase 2
06/05/2017
Phase 2 enrollment completed - announced May 31, 2017. Data updates at ASCO June 5, 2017.
ALKS
Aristada
Schizophrenia
Approved
06/06/2017
Approved October 5 2015. sNDA filed for 2-month option with approval announced June 6, 2017.
NVS
Kymriah (CTL019 )- JULIET
Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)
Phase 2
06/07/2017
Phase 2 pivotal primary analysis due International Conference on Malignant Lymphoma (ICML) on June 14, 2017. Abstract released June 7, 2017. ORR 45%.
LXRX
Sotagliflozin
Type 1 Diabetes
Phase 3
06/09/2017
Phase 3 data released September 9, 2016 met primary endpoint. Secondary endpoint data due May 2017. Data from second trial released December 21, 2016 - primary endpoint met. Data from third trial also met primary endpoint - June 9, 2017.
JNJ
INVOKANA CANVAS
Type 2 diabetes
Phase 3
06/12/2017
Cardiovascular Outcomes trial data released June 12, 2017 - 14% reduction in the risk of the composite primary endpoint of CV mortality.
XLRN
Dalantercept - DART Study
Renal Cell Carcinoma (RCC) - cancer
Phase 2
06/12/2017
Phase 2 data released June 12, 2017 - primary endpoint not met.
CHRS
CHS-1701
Pegfilgrastim biosimilar
CRL
06/12/2017
CRL announced June 12, 2017.
EPZM
Tazemetostat
Follicular lymphoma
Phase 2
06/14/2017
Phase 2 data released June 14, 2017 - DLBCL ORR 29%.
ALDX
Reproxalap (ADX-102)
Allergic conjunctivitis
Phase 2b
06/14/2017
Phase 2b data released June 14 2017 - primary endpoint not met. However, Phase 3 trial is planned.
RDHL
BEKINDA
Gastroenteritis
Phase 3
06/14/2017
Phase 3 top-line data released June 14, 2017 - primary endpoint met.
KURA
Tipifarnib
Relapsed or refractory peripheral T-cell lymphoma
Phase 2
06/14/2017
Phase 2 data presented at ICML conference on June 14, 2017 - 3/18 partial responses.
ADMP
Epinephrine Pre-filled Syringe (PFS)
Emergency treatment of anaphylaxis.
Approved
06/15/2017
CRL issued March 27 2015. CRL issued again June 6, 2016. Approval announced June 15, 2017 following third submission.
SELB
SEL-212 (COMPARE) - Head to head trial vs Krystexxa
Tophaceous gout
Phase 2
06/15/2017
Phase 2 dosing commenced late October 2016. Initial data released at EULAR June 15, 2017.
ALXN
Cerdulatinib (PRT2070)
Refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia - cancer
Phase 2
06/15/2017
Phase 2 enrollment commenced May 2016. Interim data released June 15, 2017 - noted CLL/SLL 67% partial responese rate + two patient deaths.
JNJ
DARZALEX (Daratumumab) + pomalidomide and dexamethasone
Relapsed or refractory multiple myeloma
Approved
06/16/2017
Approval announced June 16, 2017 - note: submitted by Janssen Biotech, Inc.
GMAB
DARZALEX (Daratumumab) + pomalidomide and dexamethasone
Relapsed or refractory multiple myeloma
Approved
06/16/2017
Approval announced June 16, 2017 - note: submitted by Janssen Biotech, Inc.
CLVS
Rucaparib ARIEL3
Ovarian cancer patients with a BRCA-like mutation
Phase 3
06/19/2017
Phase 3 data released June 20 2017 - primary endpoint met. sNDA filing due 3Q or early 4Q 2017.
LPCN
TLANDO - LPCN 1021
Men with low testosterone (Low T)
-
06/19/2017
CRL issued June 2016. Flexibility trial data announced June 19, 2017 - primary endpoint met with NDA fiing due 3Q 2017.
SGEN
Vadastuximab Talirine (CASCADE)
Acute myeloid leukemia (AML) - cancer
Phase 3
06/19/2017
Phase 3 trial discontinued due to higher rate of deaths - June 19, 2017.
NEOS
Cotempla XR-ODT
Attention deficit hyperactivity disorder (ADHD)
Approved
06/19/2017
Approval announced June 19, 2017.
NVS
RTH258 (brolucizumab)
Wet age-related macular degeneration (AMD)
Phase 3
06/20/2017
Phase 3 data released June 20, 2017 - primary and key secondary endpoints met.
CARA
IV CR845
Acute pain
Phase 3
06/21/2017
Interim conditional power analysis conducted June 21, 2017 - trial completion due 4Q 2017.
PFE
Epoetin alfa biosimilar
CRL
06/22/2017
CRL issued June 22, 2017.
NVS
Tafinlar (dabrafenib) and Mekinist (trametinib)
Non-small cell lung cancer (NSCLC) with BRAF V600E mutation
Approved
06/22/2017
FDA Approval announced June 22, 2017.
HALO
Subcutaneous rituximab
Various blood cancers
Approved
06/22/2017
Approval announced June 22, 2017.
XOMA
ACZ885 (canakinumab)
CV risk reduction
Phase 3
06/22/2017
Phase 3 trial met primary endpoint - data to be presented later in 2017 at a medical congress.
NVS
ACZ885 (canakinumab)
CV risk reduction
Phase 3
06/22/2017
Phase 3 trial met primary endpoint - data to be presented later in 2017 at a medical congress.
GBT
GBT440 HOPE-KIDS 1
Sickle cell disease - children age 6-17.
Phase 1/2
06/23/2017
Phase 2a initiated June 2016. Preliminary data released at European Hematology Association (EHA) - June 23, 2017.
BLCM
BPX-501 Rivo-cel
Adjunct T-cell therapy administered after allogeneic HSCT - (hematopoietic stem cell transplantation) - cancer
Phase 1/2
06/23/2017
Phase 1/2 update June 23, 2017.
BLUE
LentiGlobin - HGB-207 Northstar-2
non-β0/β0 transfusion-dependent thalassemia (TDT)
Phase 3
06/23/2017
Phase 3 early data released at EHA June 23, 2017.
ALXN
Bevyxxa (betrixaban)
Venous thromboembolism (VTE) Prevention
Approved
06/23/2017
FDA Approval noted June 23, 2017.
AGIO
AG-348 (ACTIVATE-T)
Pyruvate kinase deficiency
Phase 1/2
06/24/2017
Phase 2 updated data released at EHA June 24, 2017.
AMAG
Makena - auto injector
Reduce the risk of preterm birth in women with a singleton pregnancy
Phase 2
06/26/2017
sNDA filing announced April 17, 2017. PDUFA date February 14, 2018. 10-month review despite initial expectations of a 6-month review.
ATRS
Makena - auto injector
Reduce the risk of preterm birth in women with a singleton pregnancy
Phase 2
06/26/2017
sNDA filing announced April 17, 2017. PDUFA date February 14, 2018. 10-month review despite initial expectations of a 6-month review.
SGEN
ADCETRIS in combination with chemotherapy ECHELON-1
Frontline Hodgkin lymphoma
Phase 3
06/26/2017
Phase 3 data released June 26, 2017 - primary endpoint met.
TAK
ADCETRIS in combination with chemotherapy ECHELON-1
Frontline Hodgkin lymphoma
Phase 3
06/26/2017
Phase 3 data released June 26, 2017 - primary endpoint met.
XENE
TV-45070
Postherpetic neuralgia
Phase 2b
06/27/2017
Phase 2b data released June 27, 2017. Endpoints not met.
NRBO
Gemcabene - COBALT-1
Homozygous Familial Hypercholesterolemia (HoFH)
Phase 2b
06/28/2017
Phase 2b data released June 28, 2017 - primary endpoint met.
AMGN
Vectibix (Panitumumab)
Wild-Type RAS Metastatic Colorectal Cancer
Approved
06/29/2017
sBLA approval announced June 29, 2017.
ALKS
ALKS 3831 - ENLIGHTEN-1
Schizophrenia
Phase 3
06/29/2017
Phase 3 preliminary data released June 30, 2017. Primary endpoint met - adverse events included weight gain.
CARA
CR845
Osteoarthritis (OA)
Phase 2b
06/29/2017
Phase 2b data released June 29, 2017 - trial failed.
BMY
ORENCIA
Psoriatic Arthritis (PsA)
Approved
07/06/2017
Approval announced July 6, 2017.
RCKT
Trabodenoson and latanoprost
Glaucoma
Phase 2
07/07/2017
Phase 2 trial failed - noted July 7, 2017.
UTHR
Ralinepag ADVANCE OUTCOMES
Pulmonary Arterial Hypertension
Phase 2
07/10/2017
Phase 2 data released July 10, 2017. Primary endpoint met. Secondary missed.
IMRN
IMM-124E
Nonalcoholic steatohepatitis (NASH)
Phase 2
07/10/2017
Phase 2 top-line data due 4Q 2017. Interim analysis July 10, 2017 showed no statistical difference with placebo.
PFE
Mylotarg (gemtuzumab ozogamicin)
Acute myeloid leukemia (AML)
-
07/11/2017
Advisory Committee Meeting July 11, 2017 voted in favor 6-1 of a favorable risk:benefit profile.
AMGN
BLINCYTO
Ph+ R/R ALL
Approved
07/11/2017
PDUFA date under priority review August 14, 2017. Approval announced July 11, 2017.
BMRN
Valoctocogene roxaparvovec (BMN 270) - GENEr8-1
Hemophilia A
Phase 1/2
07/11/2017
Phase 1/2 updated data released July 11, 2017. 97% reduction in Annualized Bleed Rate (ABR).
OCUL
DEXTENZA
Ocular inflammation and pain following cataract surgery
CRL
07/11/2017
CRL July 25 2016 - due to manufacturing deficiencies. NDA resubmitted, PDUFA date July 19, 2017. Further CRL issued July 11, 2017 with FDA noting deficiencies in manufacturing processes and analytical testing.
KDMN
KD025
Chronic graft-versus-host disease (cGVHD)
Phase 2
07/11/2017
Phase 2 interim data presented July 11, 2017. ORR 71%.
SVRA
Aironite - INDIE
Heart failure with preserved ejection fraction (HFpEF)
Phase 2
07/11/2017
Phase 2 interim data released July 11, 2017.
AMGN
KYPROLIS (ASPIRE)
Relapsed Multiple Myeloma
Phase 3
07/12/2017
Phase 3 trial met primary endpoint. HR 79%.
LGND
KYPROLIS (ASPIRE)
Relapsed Multiple Myeloma
Phase 3
07/12/2017
Phase 3 trial met primary endpoint. HR 79%.
NVS
Kymriah (CTL019)
Relapsed/Refractory B-Cell Acute lymphoblastic leukemia
-
07/12/2017
Advisory Committee Meeting July 12, 2017 voted 10-0 recommending approval.
JNJ
Guselkumab
Plaque psoriasis
Approved
07/13/2017
Approval announced July 13, 2017.
AMGN
EVENITY (Romosozumab)
Osteoporosis
CRL
07/16/2017
CRL issued July 16, 2017.
PBYI
Neratinib (NERLYNX)
Extended adjuvant HER2-positive early stage breast cancer
Approved
07/17/2017
Approval announced July 17, 2017.
PRTK
Omadacycline - oral
Acute bacterial skin and skin structure infections (ABSSSI)
Phase 3
07/17/2017
Phase 3 data released July 17, 2017 - all endpoints met.
CBAY
Seladelpar (RESPONSE)
Primary biliary cholangitis (PBC)
Phase 2
07/17/2017
Phase 2 top-line data released late May 2016. Positive interim data from second trial data released July 17, 2017.
GILD
Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir)
Hepatitis C virus (HCV)
Approved
07/18/2017
Approval announced July 18, 2017.
TBPH
Revefenacin
COPD
Phase 3
07/19/2017
12 month safety trial data released July 19, 2017 with NDA filing due 4Q 2017.
IRWD
IW-3718
Gastroesophageal reflux disease (GERD)
Phase 2b
07/20/2017
Phase 2b data released July 20, 2017. Primary endpoint met but data below expectations.
BVXV
M-001
Universal flu vaccine
Phase 2b
07/20/2017
Phase 2b data released July 20, 2017 - endpoints met.
GSK
Benlysta (belimumab) - subcutaneous
Systemic lupus erythematosus (SLE)
Approved
07/21/2017
Approval announced July 21, 2017.
GNCA
GEN-003
Genital herpes
Phase 2b
07/24/2017
Phase 2b data released January 6, 2017. 12-month data released July 24, 2017. Phase 3 to commence 4Q 2017.
RETA
Bardoxolone methyl - CARDINAL
Alport Syndrome
Phase 2
07/24/2017
Phase 2/3 trial initiation announced February 23, 2017. Data from Phase 2 part of trial released July 24, 2017.
MRK
KEYNOTE-040 KEYTRUDA
Recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)
Phase 3
07/24/2017
Phase 3 trial did not meet primary endpoint - July 24, 2017. Awarded accelerated approval in 2016.
LJPC
Eravacycline (TP-434) - IGNITE4
cIAI (complicated intra-abdominal infections)
Phase 3
07/25/2017
Phase 3 data released July 25, 2017 - primary endpoint met. NDA filing due 1Q 2018.
PCRX
EXPAREL
Post surgical pain
Phase 3
07/25/2017
Phase 3 data released July 25, 2017. Upper extremity met primary endpoint, lower extremity trial missed endpoint.
EGRX
Ryanodex
Exertional heat stroke (EHS)
CRL
07/26/2017
CRL issued July 26, 2017. Additional trial required.
AZN
Durvalumab +/- tremelimumab (MYSTIC)
Lung cancer
Phase 3
07/27/2017
Phase 3 data released July 27, 2017 - primary endpoint not met.
DVAX
HEPLISAV-B
Hepatitis B
-
07/28/2017
Advisory Committee Meeting July 28, 2017 voted 11 -1 in favor of recommending approval.
NVIV
Neuro-Spinal Scaffold: INSPIRE 2.0
Complete Thoracic AIS A Spinal Cord Injury
Phase 3
07/31/2017
Noted July 31, 2017 that enrollment has been temporarily halted as it discusses potential changes to patient enrollment criteria due to patient deaths - enrollment now due to be completed 1H 2018 with Humanitarian Device Exemption (HDE) application due 2H 2018.
RDHL
RHB-104 MAP
Crohn’s disease
Phase 3
07/31/2017
Phase 3 DSMB safety analysis released December 13, 2016 - trial to continue as planned. Further analysis July 31, 2017 recommended trial continue as planned.
ICPT
Obeticholic acid (OCA) AESOP
Primary Sclerosing Cholangitis (PSC)
Phase 2
07/31/2017
Phase 2 data released July 31, 2017 - primary endpoint met.
ICPT
Obeticholic acid (OCA) - CONTROL
NASH patients taking statins
Phase 2
07/31/2017
Phase 2 primary endpoint met - July 31, 2017. One patient death noted but DSMB noted unlikely to be related to OCA (company unsure).
BMY
CM-142 – Opdivo
(dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer (CRC)
Approved
08/01/2017
Approval announced August 1, 2017.
AGIO
IDHIFA (enasidenib) - AG-221
Advanced hematologic malignancies with an IDH2 mutation
Approved
08/01/2017
Approval announced August 1, 2017.
BMY
IDHIFA (enasidenib) - AG-221
Advanced hematologic malignancies with an IDH2 mutation
Approved
08/01/2017
Approval announced August 1, 2017.
ACRX
Zalviso
Post-operative pain following open abdominal surgery and hip or knee replacement surgery
Phase 3
08/01/2017
Phase 2 data released August 1, 2017.
JNJ
Sirukumab
Rheumatoid arthritis
-
08/02/2017
BLA filing announced September 23, 2016. PDUFA estimate September 23, 2017. Advisory Committee Meeting August 2, 2017 voted 12-1 against that safety data is adequate to support approval. 13-0 in favor of efficacy.
ABBV
Imbruvica
Second-line Chronic graft-versus-host disease (GVHD)
Approved
08/02/2017
Approval announced August 2, 2017.
TBPH
Velusetrag (TD-5108)
Gastroparesis
Phase 2b
08/02/2017
Phase 2b data released August 2, 2017. Primary endpoint not met.
JNJ
Imbruvica
Second-line Chronic graft-versus-host disease (GVHD)
Approved
08/02/2017
Approval announced August 2, 2017.
CRIS
Fimepinostat (CUDC-907) and venetoclax
Diffuse-large B-cell lymphoma (DLBCL)
Phase 2
08/03/2017
Phase 2 initial data released August 3, 2017 - ORR 19%.
JAZZ
Vyxeos
Acute myeloid leukemia
Approved
08/03/2017
Approval announced August 3, 2017.
PFE
Xeljanz
Psoriatic arthritis
-
08/03/2017
PDUFA date December 2017. No exact date given. December 31, 2017 noted as last possible date using guidance of "December 31". Advisory Committee Meeting August 3, 2017 voted 10-1 in favor of recommending approval.
ENTA
Glecaprevir/Pibrentasvir (G/P)
Hepatitis C virus (HCV)
Approved
08/03/2017
Approval announced August 3, 2017.
ABBV
Glecaprevir/Pibrentasvir (G/P)
Hepatitis C virus (HCV)
Approved
08/03/2017
Approval announced August 3, 2017.
LLY
Lasmiditan
Migraine
Phase 3
08/04/2017
Phase 3 data released August 4, 2017 - endpoints met. NDA filing due 2H 2018.
FGEN
Pamrevlumab (FG-3019) - ZEPHYRUS
Idiopathic pulmonary fibrosis
Phase 2
08/07/2017
Phase 2 data released August 7, 2017 - primary endpoint met.
BMY
Mavacamten (MYK-461) - EXPLORER-HCM
Hypertrophic cardiomyopathy (HCM)
Phase 2
08/07/2017
Phase 2 data released August 7, 2017 - primary endpoint met.
BHC
Latanoprostene bunod
Open angle glaucoma (OAG) or ocular hypertension (OHT)
CRL
08/07/2017
CRL issued August 7, 2017.
ZYNE
ZYN002
Adult Epilepsy Patients with Refractory Focal Seizures
Phase 2
08/07/2017
Phase 2 data released August 7, 2017 - endpoints not met.
ESPR
Bempedoic Acid/ Ezetimibe
Hypercholesterolemia
Phase 2
08/08/2017
Phase 2 data released August 8, 2017. Primary endpoint met.
ABIO
Gencaro
Chronic Heart Failure
Phase 2b
08/09/2017
Phase 2b interim analysis August 9, 2018 - trial to continue to completion. Data 1Q 2018.
GLPG
ISABELA - Ziritaxestat GLPG1690
Idiopathic pulmonary fibrosis
Phase 2a
08/09/2017
Phase 2a top-line data released August 10, 2017. Disease progression halted. Further trials planned.
GILD
ISABELA - Ziritaxestat GLPG1690
Idiopathic pulmonary fibrosis
Phase 2a
08/09/2017
Phase 2a top-line data released August 10, 2017. Disease progression halted. Further trials planned.
TGTX
Umbralisib (UNITY-NHL)
Follicular lymphoma (FL)
Phase 2b
08/10/2017
Phase 2b enrollment commenced June 2016. First interim analysis August 10, 2017 determined that enrollment in TGR-1202 arm will stop but continue in TG-1101 + TGR-1202 arm. TGR-1202 arm replaced by combo of TG-1101, TGR-1202, and bendamustine.
ISEE
Fovista
Wet age-related macular degeneration (Wet-AMD)
Phase 3
08/14/2017
Phase 3 data released December 12, 2016 - primary endpoint not met. Data from third trial released August 14, 2017- primary endpoint not met.
CVM
Multikine
Head and Neck cancer
Phase 3
08/14/2017
Initiated Dec 2010. Announced partial clinical hold September 27, 2016. Full clinical hold noted May 2017. Clinical hold released - August 14, 2017.
REGN
REGN2222
Respiratory syncytial virus (RSV)
Phase 3
08/14/2017
Phase 3 data released August 14, 2017 - primary endpoint not met.
ZYNE
ZYN002 - STOP
Osteoarthritis
Phase 2
08/14/2017
Phase 2 data released August 14, 2017 - primary endpoint not met. However, company still intends to initiate Phase 3 trial pending discussions with FDA.
BMY
CM-214 – Opdivo + Yervoy
First-line Renal cell carcinoma (RCC)
Phase 3
08/15/2017
Phase 3 data released August 15, 2017 - one of two co-primary endpoints met.
AZN
Lynparza - SOLO 2
Second-line ovarian cancer
Approved
08/17/2017
Approval announced August 17, 2017.
PFE
Inotuzumab Ozogamicin
Relapsed or Refractory Acute Lymphoblastic Leukemia in Adults
Approved
08/17/2017
Approval announced August 17, 2017.
IRWD
DUZALLO (LESINURAD AND ALLOPURINOL)
Hyperuricemia associated with gout
Approved
08/21/2017
Approval announced August 21, 2017.
RARE
Aceneuramic acid extended release (Ace-ER)
GNE Myopathy
Phase 3
08/22/2017
Phase 3 data released August 22, 2017 - endpoints not met.
ADMS
GOCOVRI (ADS-5102)
Levodopa-Induced Dyskinesia + Parkinson's disease patients receiving levodopa and experiencing OFF episodes
Approved
08/24/2017
Approval announced August 24, 2017.
NVO
Victoza (liraglutide)
Type 2 diabetes
Approved
08/25/2017
Approval announced August 25, 2017.
KMDA
KamRAB
Prophylaxis of rabies disease
Approved
08/25/2017
Approval announced August 25, 2017.
XOMA
ACZ885 (canakinumab)
CV risk reduction
Phase 3
08/27/2017
Data presented August 27, 2017 showed a 77% reduction in lung cancer mortality.
NVS
ACZ885 (canakinumab)
CV risk reduction
Phase 3
08/27/2017
Data presented August 27, 2017 showed a 77% reduction in lung cancer mortality.
AZN
Faslodex (fulvestrant)
Monotherapy for expanded use in women with HR+, HER2- advanced breast cancer
Approved
08/28/2017
Expanded approval announced August 28, 2017.
NVS
Meropenem-vaborbactam
Complicated urinary tract infections (cUTI)
Approved
08/29/2017
Approved August 29, 2017.
OTIC
OTO-104 AVERTS-1
Meniere's disease
Phase 3
08/30/2017
Phase 3 data released August 30 failed to meet primary and key secondary endpoints.
OTIC
OTIVIDEX
Ménière's disease
Phase 3
08/30/2017
Phase 3 development suspended following failure of AVERTS-1 trial - August 30, 2017.
NVS
Kymriah (CTL019)
Relapsed/Refractory B-Cell Acute lymphoblastic leukemia
Approved
08/30/2017
PDUFA date under priority review announced March 29, 2017. Approval announced early - August 30, 2017.
UTHR
Trevyent
Pulmonary Arterial Hypertension (PAH)
-
08/31/2017
Refusal to file Letter (RTF) issued August 31, 2017 in response to NDA filing.
PFE
Mylotarg (gemtuzumab ozogamicin)
Acute myeloid leukemia (AML)
Approved
09/01/2017
Approval announced September 1, 2017.
CLLS
UCART123 - AMELI-01
Acute myeloid leukemia (AML)
Phase 1
09/04/2017
Clinical hold announced September 4, 2017 following one fatality in the BPDCN clinical trial (ABC study).
NVS
Fingolimod
Multiple Sclerosis (MS)
Phase 3
09/05/2017
Phase 3 trial met primary endpoint.
VSTM
Duvelisib - DUO
Chronic lymphocytic leukemia (CLL)//Small Lymphocytic Lymphoma (SLL)/Follicular Lymphoma
Phase 3
09/06/2017
Phase 3 data released September 6, 2017 - primary endpoint met.
SRPT
Golodirsen - Exon 53
Duchenne muscular dystrophy
Phase 1/2
09/06/2017
Phase 1/2 data released September 6, 2017 - endpoints met.
AMGN
Tezepelumab - NAVIGATOR
Asthma
Phase 2b
09/07/2017
Phase 2b data released September 7, 2017 - primary endpoint met.
AZN
Tezepelumab - NAVIGATOR
Asthma
Phase 2b
09/07/2017
Phase 2b data released September 7, 2017 - primary endpoint met.
VRNA
RPL554
COPD
Phase 2a
09/07/2017
Phase 2a positive data released September 7, 2017.
BMY
CM-214 – Opdivo + Yervoy
First-line Renal cell carcinoma (RCC)
Phase 3
09/07/2017
Phase 3 trial stopped early due to clear efficacy.
ABBV
Upadacitinib
Atopic Dermatitis
Phase 2b
09/07/2017
Phase 2b data released September 7, 2017 - primary endpoint met.
KURA
Tipifarnib - (AIM-HN/SEQ-HN)
Head and neck squamous cell carcinomas (HNSCC)
Phase 2
09/07/2017
Phase 2 trial met primary endpoint prior to completion of enrollment.
SGEN
Tisotumab Vedotin (innovaTV 301)
Cervical Cancer
Phase 1/2
09/08/2017
Phase 1/2 data presented at ESMO 2017. Response rate 32%.
GMAB
Tisotumab Vedotin (innovaTV 301)
Cervical Cancer
Phase 1/2
09/08/2017
Phase 1/2 data presented at ESMO 2017. Response rate 32%.
UTHR
Orenitram
Pulmonary arterial hypertension (PAH)
Phase 3
09/08/2017
Phase 3 data due 2H 2018. Independent data monitoring committee (DMC) noted September 8, 2017 that the trial should continue following its interim analysis.
LLY
KEYTRUDA + chemo (KEYNOTE-021)
First-Line Nonsquamous Non-small cell lung cancer (NSCLC)
Phase 2
09/08/2017
Phase 2 data presented at ESMO 2017 - ORR 57%, PFS 19 months, HR 0.54
MRK
KEYTRUDA + chemo (KEYNOTE-021)
First-Line Nonsquamous Non-small cell lung cancer (NSCLC)
Phase 2
09/08/2017
Phase 2 data presented at ESMO 2017 - ORR 57%, PFS 19 months, HR 0.54
AZN
Durvalumab (PACIFIC)
Lung cancer
Phase 3
09/09/2017
Late breaker at ESMO September 9, 2017 showed PFS 16.8 months v 5.6 months for placebo.
EXEL
Cabozantinib - CABOSUN
First-Line RCC - cancer
Phase 2
09/09/2017
Late breaker at ESMO September 2017 showed PFS 8.6 months versus 5.3 months for sunitinib. HR 0.48
BMY
CM-238 – Opdivo (Adjuvant)
Melanoma
Phase 3
09/10/2017
Phase 3 interim data released June 6, 2017 - primary endpoint met. Data presented at ESMO September 10, 2017 - HR 0.65 compared to Yervoy.
MRNS
Ganaxolone - Marigold
CDKL5 Deficiency Disorder (CDD)
Phase 2
09/11/2017
Phase 2 top-line data released September 11, 2017.
REGN
Dupixent (dupilumab)
Asthma
Phase 3
09/11/2017
Phase 3 data released September 11, 2017 - primary endpoints met. 46% improvement after 52 weeks in 300 mg group. sBLA filing due by end of 2017.
SNY
Dupixent (dupilumab)
Asthma
Phase 3
09/11/2017
Phase 3 data released September 11, 2017 - primary endpoints met. 46% improvement after 52 weeks in 300 mg group. sBLA filing due by end of 2017.
SAGE
SAGE-547
SRSE
Phase 3
09/12/2017
Phase 3 data released September 12, 2017 - primary endpoint not met.
ALDX
Reproxalap (TRANQUILITY)
Dry eye syndrome
Phase 2a
09/12/2017
Phase 2a data released September 11, 2017 - noted statistically and clinically significant activity.
GSK
Shingrix
Shingles
-
09/13/2017
Advisory Committee Meeting September 13, 2017 voted 11-0 in favor. PDUFA estimate October 24, 2017.
VNDA
Tradipitant - EPIONE 1
Atopic dermatitis
Phase 2
09/13/2017
Phase 2 data released September 13, 2017 - primary endpoint not met.
AGEN
Shingrix
Shingles
-
09/13/2017
Advisory Committee Meeting September 13, 2017 voted 11-0 in favor. Shingrix, containing Agenus' adjuvant, QS-21 Stimulon.
FOLD
SD-101
Epidermolysis Bullosa (EB)
Phase 3
09/13/2017
Phase 3 top-line data released September 13, 2017 - endpoints not met.
ABBV
MVASITM (bevacizumab-awwb)
Biosimilar candidate to Avastin (bevacizumab)
Approved
09/14/2017
Approved September 14, 2017.
AZN
Bydureon
Type 2 Diabetes
Phase 3
09/14/2017
Phase 3 Cardiovascular Outcome trial data released September 14, 2017 - primary efficacy objective of a superior reduction in MACE missed statistical significance (p=0.061).
AMGN
MVASITM (bevacizumab-awwb)
Biosimilar candidate to Avastin (bevacizumab)
Approved
09/14/2017
Approved September 14, 2017.
PFE
XTANDI (PROSPER)
Non-metastatic high risk hormone-sensitive prostate cancer
Phase 3
09/14/2017
Phase 3 data released September 14, 2017 - primary endpoint met.
NEOS
NT-0201
Attention deficit hyperactivity disorder (ADHD)
Approved
09/15/2017
Approval announced September 15, 2017.
OPTN
XHANCE
Nasal polyps
Approved
09/17/2017
Approval announced September 18, 2017 (prior to IPO).
GSK
Trelegy Ellipta (FF/UMEC/VI)
Chronic obstructive pulmonary disease (COPD)
Approved
09/18/2017
Approval announced September 18, 2017.
INVA
Trelegy Ellipta (FF/UMEC/VI)
Chronic obstructive pulmonary disease (COPD)
Approved
09/18/2017
Approval announced September 18, 2017.
SUPN
SPN-810
Impulsive Aggression in ADHD
Phase 3
09/18/2017
Noted September 18, 2017 that the lower of the two doses will be discontinued following interim analysis.
ABBV
Venclexta (MURANO)
Relapsed or refractory Chronic Lymphocytic Leukemia (CLL)
Phase 3
09/18/2017
Phase 3 data released September 18, 2017 - PFS primary endpoint met.
RHHBY
Venclexta (MURANO)
Relapsed or refractory Chronic Lymphocytic Leukemia (CLL)
Phase 3
09/18/2017
Phase 3 data released September 18, 2017 - PFS primary endpoint met.
NBRV
Lefamulin - Intravenous and Oral
Moderate to severe Community Acquired Bacterial Pneumonia (CABP)
Phase 3
09/18/2017
Phase 3 data released September 18, 2017 - primary endpoints met.
PFE
Sutent (Sunitinib)
Renal cell carcinoma (RCC)
-
09/19/2017
Advisory Committee Meeting September 19, 2017 voted 6-6 the benefits outweigh risks.
KPTI
Selinexor - SEAL
Dedifferentiated liposarcoma
Phase 2/3
09/20/2017
Phase 2/3 trial initiated January 2016.Topline data for the Phase 2 portion released September 20, 2017 - PFS HR 0.60. Phase 3 data due 2019.
ALNY
Patisiran
Familial Amyloidotic Polyneuropathy (FAP) in Patients with ATTR
Phase 3
09/20/2017
Phase 3 top-line data released September 20, 2017 - all endpoints met. NDA filing due by end of 2017.
SNY
Patisiran
Familial Amyloidotic Polyneuropathy (FAP) in Patients with ATTR
Phase 3
09/20/2017
Phase 3 top-line data released September 20, 2017 - all endpoints met. NDA filing due by end of 2017.
ARAV
VRS-317 VELOCITY
Growth hormone deficiency, or GHD - pediatric
Phase 3
09/21/2017
Phase 3 top-line data released September 21, 2017 - primary endpoint not met.
BCRX
RAPIVAB (peramivir injection)
Acute uncomplicated influenza to pediatric patients
Approved
09/21/2017
Approved September 21, 2017.
MRK
Keytruda
Cancer - Third-line Gastric or Gastroesophageal Junction Adenocarcinoma
Approved
09/22/2017
Approved September 22, 2017 - under priority review.
JNJ
Sirukumab
Rheumatoid arthritis
CRL
09/22/2017
CRL issued September 22, 2017. Advisory Committee Meeting August 2, 2017 voted 12-1 against that safety data is adequate to support approval. 13-0 in favor of efficacy.
BMY
Opdivo and Yervoy
Previously Treated Hepatocellular Carcinoma
Approved
09/22/2017
Approved under priority review September 22, 2017.
GNCA
GEN-003
Genital herpes
-
09/25/2017
Announced September 25, 2017 that development will be ceased.
PRQR
QR-010
Cystic Fibrosis
Phase 1b
09/25/2017
Phase 1b top-line data released September 25, 2017. FEV levels not significant across four doses. One of four doses showed significance in subgroup.
PTCT
Translarna
Duchenne muscular dystrophy caused by nonsense mutations (nmDMD)
-
09/28/2017
Received a Refusal to File letter for their NDA Filing - February 23 2016. Appeal rejected October 17, 2016. Decision made to resubmit NDA during 1Q 2017 under protest. New PDUFA date October 24, 2017. Advisory Committee Meeting September 28, 2017 voted that although it is possible that ataluren may be effective, the data are inconclusive, and more work would be needed to establish whether ataluren is effective.
ZYNE
Zygel ZYN002
Fragile X syndrome
Phase 2
09/28/2017
Phase 2 data released September 28, 2017. Company noted data were positive with primary endpoint met. Note though that trial was uncontrolled/open-label.
PRTA
PRX003
Psoriatic Arthritis
Phase 1b
09/28/2017
Phase 1b data released September 28, 2017 - insufficient meaningful clinical effect for further development.
ZGNX
FINTEPLA (ZX008)
Dravet syndrom
Phase 3
09/29/2017
Phase 3 data released September 29, 2017 - primary endpoint met.
NVO
Fiasp (fast-acting insulin aspart)
Type 1 and type 2 diabetes
Phase 3
09/29/2017
Approved September 29, 2017.
MCRB
SER-287
Mild-to-Moderate Ulcerative Colitis
Phase 1b
10/02/2017
Phase 1b data released October 2, 2017 - did not perform better than placebo.
ABBV
Botox
Forehead lines
Approved
10/03/2017
Approval (third indication) announced October 3, 2017.
RIGL
Fostamatinib
Warm Autoimmune hemolytic anemia (WAIHA)
Phase 2
10/03/2017
Phase 2 data from Stage 1 of trial released October 3, 2017 - sufficient efficacy shown to progress to Stage 2.
RDHL
BEKINDA
IBS-D
Phase 2
10/03/2017
Phase 2 top-line data released October 3, 2017 - primary endpoint met (borderline) - p=0.05.
LLY
Abemaciclib - MONARCH 1 and 2
Second-line hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer and HR+, HER2- breast cancer
Approved
10/04/2017
Approved October 4, 2017.
BLUE
Lenti-D - ALD-102
Childhood cerebral adrenoleukodystrophy (CCALD)
Phase 2/3
10/04/2017
Phase 2/3 trial initiated October 2013. Interim top-line data released June 26, 2017. Further data released October 4, 2017 - 88% free of free of major functional disabilities.
CATB
Edasalonexent (CAT-1004)
Duchenne muscular dystrophy (DMD)
Phase 1/2
10/04/2017
Phase 1/2 data from open-label extension trial presented October 4, 2017 - deemed sufficient to proceed to Phase 3 development.
VTRS
Glatiramer Acetate Injection - Generic for Copaxone
Multiple sclerosis (MS)
Approved
10/04/2017
Approval announced October 4, 2017.
NBIX
INGREZZA
Tardive dyskinesia
Approved
10/05/2017
Approval for sNDA 80 mg capsules announced October 5, 2017.
FLXN
Zilretta - FX006
Osteoarthritis of the knee
Approved
10/06/2017
Approval announced October 6, 2017.
SRPT
Golodirsen - Exon 53
Duchenne muscular dystrophy
Phase 1/2
10/07/2017
Phase 1/2 late breaking poster presented at World Muscle Society October 7, 2017.
LLY
Abemaciclib - JUNIPER
Thrid line KRAS mutation positive Non-small cell lung cancer (NSCLC)
Phase 3
10/10/2017
Phase 3 data released October 10, 2017 - primary endpoint not met
ANAB
ANB020 - etokimab
Moderate-to-severe adult atopic dermatitis
Phase 2a
10/10/2017
Phase 2a positive data released October 10, 2017
VTRS
MYL-1401H
Neulasta biosimilar
CRL
10/10/2017
CRL issued October 10, 2017.
ARDX
Tenapanor (T3MPO-2)
Constipation-predominant irritable bowel syndrome (IBS-C)
Phase 3
10/11/2017
Phase 3 data released October 11, 2017. Primary endpoint met but with relatively high rates of diarrhea.
ACRX
DSUVIA (ARX-04)
Moderate-to-severe acute pain following a surgical procedure
CRL
10/12/2017
CRL issued October 12, 2017.
PFE
LYRICA (pregabalin)
Postherpetic neuralgia (PHN)
Approved
10/12/2017
Approval announced October 12, 2017.
ATRS
XYOSTED (testosterone enanthate)
Testosterone deficiency
-
10/12/2017
PDUFA date October 20, 2017. Noted October 12, 2017 that the FDA has identified deficiencies with the NDA.
JNJ
STELARA (USTEKINUMAB)
Plaque psoriasis
Approved
10/13/2017
Approval announced October 13, 2017.
AERI
Rhopressa
Glaucoma
-
10/13/2017
PDUFA date February 28, 2018. Advisory Committee meeting October 13, 2017 voted 9-1 in favor that efficacy outweighs safety risks,
EXEL
Cabozantinib (CELESTIAL)
Advanced hepatocellular cancer (HCC)
Phase 3
10/16/2017
Phase 3 data released October 16, 2017 - primary endpoint met. sNDA filing due 1Q 2018.
TAK
Cabozantinib (CELESTIAL)
Advanced hepatocellular cancer (HCC)
Phase 3
10/16/2017
Phase 3 data released October 16, 2017 - primary endpoint met. sNDA filing due 1Q 2018.
FENC
Pedmark (sodium thiosulfate)
Cisplatin-Induced Hearing Loss
Phase 3
10/16/2017
Phase 3 trial met primary endpoint - full data released October 16, 2017.
NVO
Semaglutide
Type 2 diabetes
-
10/18/2017
Advisory Committee Meeting October 18, 2017 voted 16-0 in favor.
RHHBY
Entrectinib
Solid tumors and ROS1-positive non-small cell lung cancer (NSCLC)
Phase 2
10/18/2017
Updated promising data released October 18, 2017.ORR 69%, PFS 29.6 months.
DRRX
POSIMIR
Post-operative pain relief
Phase 3
10/19/2017
CRL Feb 12 2014. Phase 3 commenced November 2015 in response to CRL. Noted October 19, 2017 that primary endpoint was not met.
CRBP
Lenabasum (resunab) - DETERMINE
Dermatomyositis
Phase 2
10/19/2017
Phase 2 data released October 19, 2017 - primary endpoint met.
JNJ
SIMPONI ARIA
Psoriatic arthritis (PsA)
Approved
10/20/2017
Approval announced October 20, 2017.
JNJ
SIMPONI ARIA
Ankylosing Spondylitis
Approved
10/20/2017
Approval announced October 20, 2017.
GSK
Shingrix
Shingles
Approved
10/20/2017
Approval announced October 20, 2017.
ATRS
XYOSTED (testosterone enanthate)
Testosterone deficiency
CRL
10/20/2017
CRL issued October 20, 2017.
AGEN
Shingrix
Shingles
Approved
10/20/2017
Approval announced October 20, 2017.
DBVT
Viaskin Peanut
Peanut allergy - ages 4 to 11 years
Phase 3
10/20/2017
Phase 3 top-line data released October 20, 2017 - primary endpoint not met.
ALXN
Eculizumab
Refractory generalized myasthenia gravis (gMG)
Approved
10/23/2017
Approval announced October 23, 2017.
ENTA
EDP-305 ARGON-2
Non-alcoholic steatohepatitis (NASH)
Phase 1
10/23/2017
Phase 1 data at AASLD meeting - October 23, 2017.
GBT
GBT440
Hypoxemia in patients with idiopathic pulmonary fibrosis (IPF) who are on supplemental oxygen at rest
Phase 2a
10/23/2017
Phase 2a discontinuation announced October 23, 2017 due to lack of efficacy.
VRTX
Tezacaftor (VX-661) / ivacaftor
Cystic fibrosis - one copy of the F508del mutation and a second mutation that results in a gating mutation
Phase 3
10/25/2017
Phase 3 data released October 25, 2017 - primary endpoint not met.
PTCT
Translarna
Duchenne muscular dystrophy caused by nonsense mutations (nmDMD)
CRL
10/25/2017
CRL issued October 25, 2017.
ABBV
Risankizumab
Psoriasis
Phase 3
10/26/2017
Phase 3 data released October 26, 2017 - primary endpoints met.
GSK
Rolapitant - intravenous (IV)
Prevention of chemotherapy induced nausea and vomitin