BDSI receives FDA Approval for BUNAVAIL

Jun 07, 2014 No Comments

BioDelivery Sciences International, Inc. (BDSI) (NASDAQ: BDSI) announced that the FDA has granted approval for BUNAVAIL (buprenorphine and naloxone) buccal film (CIII) for the maintenance treatment of opioid dependence. BDSI expects to launch BUNAVAIL late 3Q 2014. Tweet

Read more

FLML to resubmit NDA +MDGN news.

Jun 06, 2014 No Comments

Flamel Technologies (NASDAQ: FLML) announced that it intends to resubmit their second New Drug Application (NDA), which was given a Complete Response Letter (CRL) on April 28, 2014. This follows notice from their supplier that their facility has been classified as acceptable by the FDA. They expect to make an announcement prior to the end of June 2014 […]

Read more

NVAX offering. HALO clinical hold lifted.

Jun 05, 2014 No Comments

Novavax, Inc. (Nasdaq: NVAX) announced that it intends to offer to sell $100 million of its common stock in an underwritten public offering. Halozyme Therapeutics, Inc. (NASDAQ: HALO) announced that the FDA has removed the clinical hold on patient enrollment and dosing of PEGPH20 in the ongoing Phase 2 trial (Study 202) evaluating PEGPH20 in patients with pancreatic cancer permitting […]

Read more

OREX PDUFA date change. HRTX to delay NDA resubmission. OMER FDA Approval + ALKS update.

Jun 03, 2014 No Comments

Orexigen Therapeutics, Inc. (Nasdaq: OREX) announced that the FDA has delayed the PDUFA date of the NB32 New Drug Application to June 11, 2014, one day beyond the original assignment. The delay is due to a FDA administrative error, miscalculating the correct PDUFA date. Heron Therapeutics, Inc. (NASDAQ: HRTX) provided an update regarding their NDA (new drug application) re-submission of SUSTOL, for the […]

Read more

ADMP files NDA. INO reverse split update. CTIC name change. AKBA update.

May 30, 2014 No Comments

Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) announced the submission of a 505(b)(2) New Drug Application (NDA) to the FDA for its epinephrine pre-filled single dose syringe (PFS) product, for the emergency treatment of allergic reactions (Type I) including anaphylaxis. Akebia Therapeutics, Inc. (NASDAQ:AKBA) maintained guidance that Phase 2b data of AKB-6548, for the treatment of anemia related to chronic kidney disease (CKD) […]

Read more

FDA approves TRLPF’s Natesto. ICPT NDA due to be filed 1H 2015 + SPPI update.

May 29, 2014 No Comments

Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept) noted that they are on track to file their New Drug Application (NDA) of obeticholic acid (OCA) for the treatment of patients with primary biliary cirrhosis (PBC), during 1H 2015.   Trimel Pharmaceuticals Corporation (TSX: TRL) announced that the FDA has approved Natesto (testosterone), formerly CompleoTRT, a nasal gel for replacement therapy in adult males […]

Read more

QRXPY CRL. ITMN resubmits NDA. AVNR data due Sept-Oct + BCRX BMRN updates

May 28, 2014 No Comments

QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced that the FDA has issued a Complete Response Letter (CRL) regarding the Moxduo New Drug Application (NDA) for the treatment of moderate to severe acute pain. InterMune, Inc. (Nasdaq: ITMN) announced that it has resubmitted its pirfenidone NDA to the FDA in response to a Complete Response Letter (CRL) […]

Read more

AUXL Phase 2 cellulite data expected later this year.

May 06, 2014 No Comments

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) noted that its Phase 2b trial of XIAFLEX for Frozen Shoulder Syndrome, is on track for anticipated data in 1Q 2015, while its Phase 2a trial for cellulite is ahead of schedule with data now expected in 4Q 2014.   Tweet

Read more

ECYT Phase 3 trial halted + pipeline updates for ACOR MACK TRVN ITMN NBY VTL

May 04, 2014 No Comments

Merck (NYSE:MRK) and Endocyte, Inc. (NASDAQ:ECYT) announced that the Data Safety Monitoring Board (DSMB) of the PROCEED trial has recommended that the trial be stopped because vintafolide did not demonstrate efficacy on the pre-specified outcome of Progression-Free Survival (PFS) in patients with platinum-resistant ovarian cancer. Acorda Therapeutics, Inc. (Nasdaq:ACOR) announced that the FDA has issued […]

Read more