INSM data due late March. ENDP FDA Approval. FLML offering + updates for TTPH SNSS ADHD PTCT

Mar 07, 2014 No Comments

Endo International plc (NASDAQ: ENDP) (TSX: ENL) announced the FDA approval of AVEED (testosterone undecanoate) injection for the treatment of adult men with hypogonadism (commonly known as Low-T) that is associated with a deficiency or absence of the male hormone testosterone. Flamel Technologies, S.A. (NASDAQ: FLML) announced that it is offering to sell American Depositary Shares (ADSs), […]

Read more

Pipeline updates for OPK CLDX ANAC CNAT ACRX GEVA. Offering news for ACAD BLRX

Mar 04, 2014 No Comments

Anacor Pharmaceuticals (NASDAQ:ANAC) announced that following an End-of-Phase 2 meeting with the FDA, a Phase 3 trial of AN2728 for the topical treatment of mild-to-moderate atopic dermatitis is scheduled to commence by the start of May 2014. Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) announced the initiation of a Phase 2 clinical trial of emricasan, in patients with nonalcoholic […]

Read more

NKTR Phase 3 data due early 2015.Offerings for INO SNSS + XLRN update

Feb 27, 2014 No Comments

Nektar Therapeutics (Nasdaq: NKTR) provided a pipeline update noting that topline data from the Phase 3 pivotal trial of NKTR-102 in advanced breast cancer are due in early 2015. Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) announced that it intends to offer and sell, subject to market and other conditions, shares of its common stock and warrants to purchase shares of its […]

Read more

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 […]

Read more

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 […]

Read more

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 […]

Read more

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 […]

Read more

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 […]

Read more

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 […]

Read more