BCRX PDUFA date set. ITMN Phase 3 IPF trial meets endpoints. NBIX offering + ANIK approval.

Feb 26, 2014 No Comments

BioCryst Pharmaceuticals, Inc.(Nasdaq:BCRX) announced that the FDA has accepted for review the New Drug Application (NDA) for intravenous (i.v.) peramivir, with a PDUFA date of December 23, 2014. No Advisory Committee review is planned at this stage. Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced that it is offering to sell 7,000,000 shares of its common stock in an underwritten public […]

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ECYT – key data due March. AMPE offering. SLXP PDUFA delay. AUXL sNDA PDUFA set

Feb 25, 2014 No Comments

Salix Pharmaceuticals, Ltd.  (NASDAQ:SLXP) and Pharming Group NV (NYSE Euronext:PHARM) announced that the FDA has extended the PDUFA Date to July 16, 2014 for their Biologics License Application (BLA) for RUCONEST for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE). Celsion Corporation (NASDAQ: CLSN) maintained previous guidance that their Phase 3 trial […]

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CHTP FDA decision delayed until Tuesday. BMRN FDA Approval. STEM offering

Feb 16, 2014 No Comments

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP $4.73) announced that as a result of severe weather conditions leading to an office closure, the FDA today notified the company that the goal date for their NORTHERA NDA has been extended to the next business day, or Tuesday, February 18, 2014. BioMarin Pharmaceutical Inc. (Nasdaq:BMRN $75.81) announced that the FDA […]

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ETRM Adcom date set. DRRX CRL. PCYC FDA Approval. MDCO negative Adcom opinion. DARA OXGN offerings. INCY STEM updates

Feb 13, 2014 No Comments

EnteroMedics Inc. (NASDAQ: ETRM $2.11) announced that the FDA Office of Device Evaluation has scheduled a meeting of the Center for Devices and Radiologic Health’s (CDRH) Advisory Committee on Thursday, May 29, 2014 to review the Maestro System delivering VBLOC vagal blocking therapy as a treatment for morbid obesity.  The Medicines Company (NASDAQ: MDCO $30.00) announced that the U.S. Food and Drug Administration (FDA) Cardiovascular and Renal […]

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DRTX CBST Adcom dates set. CPRX Phase 3 data due 3Q. OGXI Phase 3 data due mid-year + SGEN SGMO updates

Feb 12, 2014 No Comments

Durata Therapeutics Inc (NASDAQ:DRTX $12.71) – The Anti-Infective Drugs Advisory Committee will meet on March 31, 2014, to discuss the NDA of dalbavancin hydrochloride for intravenous injection, for the proposed indication of treatment of acute bacterial skin and skin structure infections. Cubist Pharmaceuticals, Inc. (NASDAQ: CBST $74.29) – The Anti-Infective Drugs Advisory Committee will meet on March 31, 2014, to discuss the NDA of tedizolid […]

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SNSS Phase 3 data delay. SYN data due at AAN. Offerings galore for MGNX BDSI AMAG IRWD MSTX OPHT PTCT + INSM TRGT updates

Feb 11, 2014 No Comments

Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS)  announced that the unblinding of the pivotal, Phase 3 VALOR trial of vosaroxin plus cytarabine in first relapsed or refractory acute myeloid leukemia (AML) is now expected in 3Q 2014. Insmed Incorporated (NASDAQ: INSM) remains on track to report top-line data from a Phase 2 trial of ARIKACE in the U.S. and Canada to treat NTM lung […]

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PGNX Adcom postponed. SPPI PDUFA date set. CYTK data due next quarter. DARA reverse split + RPRX NBIX THRX updates

Feb 07, 2014 No Comments

Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX) and Salix Pharmaceuticals, Inc. (NASDAQ:SLXP) have been informed by the that the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) meeting proposed to occur on March 10-11, 2014, regarding the RELISTOR  sNDA for opioid induced constipation in patients taking opioids who suffer from chronic pain, has been postponed to a date in […]

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GWPH pipeline update + offering news for PPHM and PDLI

Feb 06, 2014 No Comments

PDL BioPharma, Inc. (PDL) (NASDAQ: PDLI) announced that it intends to offer $250 million of new convertible senior notes due February 1, 2018. Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM) announced that it intends to sell preferred stock in an underwritten public offering. GW Pharmaceuticals plc (NASDAQ: GWPH) provided a pipeline update noting that Phase 3 data from their trial […]

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IGXT receives CRL. FURX Phase 3 eluxadoline meets endpoints. AGEN offering + ARRY update

Feb 05, 2014 No Comments

IntelGenx Corp. (TSXV: IGX) (OTCQX: IGXT) and RedHill Biopharma Ltd. (NASDAQ: RDHL) announced that they received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) for their VersaFilm Oral Film Product for the treatment of acute migraines. According to the company, the concerns raised in the CRL “primarily relate to […]

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