Archive for Daily News

OTIC misses endpoint in Ménière’s disease trial + updates for AFMD BIOD GNCA

May 22, 2015 1 Comment by

Latest updates to the Company Pipeline Database for May 20 and 21 2015. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary AFMD 9.10 AFM13 Hodgkin Lymphoma Phase 2 Phase 2a initial data due late 2015. Final data due 2H 2016 BIOD 1.14 BIOD-531 Type 2 diabetes Phase 2b Phase 2b initiated mid May […]

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May 18 and 19 updates + 100+ updates made over weekend

May 20, 2015 2 Comments by

Latest updates to the Company Pipeline Database for May 18 and 19, 2015. Refer to the FDA Calendar for upcoming catalysts: In addition, over 100 updates were made over the weekend as companies continued with their reporting season. You can find the updates from last week by clicking the “updated” column on the far right of the Company Pipeline Database. […]

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61 pipeline updates for 42 companies from May 7 and 8

May 09, 2015 1 Comment by

Latest updates to the Company Pipeline Database for May 7 and 8, 2015. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ACHN 9.43 ACH-3422 in combination with ACH-3102 HCV Hepatitis C – treatment durations of 6, 8 and 12 weeks Phase 2 Phase 2 to be initiated 2Q 2015. SVR4 results are expected […]

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Pipeline updates for ADHD ALXA ANAC ARQL CCXI CERU CLVS CTIC GWPH INFI MGNX PGNX PTLA RDUS SCMP TRLPF TTPH VNDA VSAR XNPT

May 07, 2015 No Comments

Latest updates to the Company Pipeline Database for May 6 2015. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ADHD 5.53 MDX (Metadoxine Extended Release (MG01CI)) Fragile X Syndrome Phase 2b Phase 2b enrolment due to be completed 1Q 2015. Data due 2Q 2015 ADHD 5.53 MDX (Metadoxine Extended Release (MG01CI)) Adult […]

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Updates for ACRX ALDR AQXP ARDX IRWD KERX MACK MDWD RCPT

May 06, 2015 No Comments

Latest updates to the Company Pipeline Database for May 4 and 5 2015. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ACRX 3.04 Zalviso Post-operative pain following open abdominal surgery and hip or knee replacement surgery CRL CRL Jul 26 2014. NDA resubmission was due 1Q 2015 but announced in early March 2015 that […]

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Latest updates for INCY PCYC SGEN BMRN CEMP CYTK CYTR EBIO EXEL KYTH LPCN LXRX MDCO NBIX NBS OCRX OGXI OPK THLD THRX TSRO

May 02, 2015 No Comments

Latest updates to the Company Pipeline Database for April 29-May 1 2015. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary INCY 98.28 Ruxolitinib – JANUS 1 and JANUS 2 Cancer – Pancreatic Phase 3 Phase 3 data for JANUS 1 due 2016. JANUS 2 due at a later date PCYC 254.51 IMBRUVICA […]

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OTIC NDA accepted by FDA. MACK and BMRN complete rolling NDA filings

Apr 29, 2015 No Comments

Latest updates to the Company Pipeline Database for April 27 and 28 2015. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary MACK 12.15 MM-398 NAPOLI-1 Cancer – second line pancreatic Phase 3 Rolling NDA completed on or about April 27 2015. Priority review requested OTIC 27.58 AuriPro Ear Tube Placement Surgery NDA […]

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CLDN fails Phase 2b trial + updates for week ending April 26 – AERI CNAT GNCA AMPE GWPH MDWD ONTX OTIC SGEN ATHX DSCO

Apr 26, 2015 No Comments

Latest updates to the Company Pipeline Database for week ending April 26 2015. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary AERI 12.87 Rhopressa Glaucoma Phase 3 Phase 3 Rocket 1 trial data released April 2015 did not meet endpoint. Rocket 2 data due 3Q 2015 CLDN 13.68 MYDICAR – CUPID […]

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FDA approves Generic Copaxone – MNTA. MDCO thumbs up from Adcom. RPRX PDUFA date set + ALIOF CLSN EBIO PVCT STEM TRGT updates

Apr 16, 2015 No Comments

Latest updates to the Company Pipeline Database for April 15 and 16. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ALIOF 124.28 Ponesimod Relapsing multiple sclerosis Phase 3 Phase 3 initiated mid-April 2015 CLSN 2.94 ThermoDox Recurrent Chest Wall Breast Cancer (RCWBC) Phase 2 Phase 2 enrolment to be completed 3Q […]

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Latest calendar updates for AEZS GALE NEOT

Apr 15, 2015 No Comments

Latest updates to the Company Pipeline Database. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary AEZS 0.58 Macimorelin Acetate – Macrilen Adult Growth Deficiency CRL CRL Nov 5 2014. Announced mid-April 2015 plans to initiate a Phase 3 trial GALE 1.45 NeuVax (E75) – PRESENT Cancer – low-to-intermediate HER2+ breast […]

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SHPG PDUFA date set. EXEL data due 2H 2015. DERM initiates Phase 2 acne trial.

Apr 10, 2015 No Comments

Latest updates to the Company Pipeline Database for April 9. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary DERM 15.15 DRM01 Acne Phase 2b Phase 2b initiated April 2015. Data due 1H 2016 EXEL 3.01 Cabozantinib – (METEOR) Cancer – metastatic renal cell cancer (RCC) Phase 3 Data due 2Q 2015 […]

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