Archive for February, 2012

VVUS offering and MAA update. Pipeline updates for BDSI POZN ARIA

Feb 29, 2012 No Comments by

VIVUS,Inc. (Nasdaq:VVUS) announced it will offer 8.5m shares of its common stock in an underwritten public offering with an option to issue 1.275m additional shares of common stock to cover over-allotments, if any. It also noted that it received the 180-Day list of outstanding issues (LOI) from the Committee for Medicinal Products for Human Use (CHMP) for […]

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CBRX issued CRL. RPRX to meet FDA in May + TLON OPXA AFFY news

Feb 28, 2012 No Comments by

Watson Pharmaceuticals, Inc. (NYSE: WPI) and Columbia Laboratories, Inc. (Nasdaq: CBRX)  received a complete response letter (CRL) for its New Drug Application (NDA 22-139) for progesterone vaginal gel 8% for use in the reduction of risk of preterm birth in women with a singleton gestation and a short uterine cervical length in the mid-trimester of […]

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ASTM initiates Phase 3 CLI trial. YMI CLDX price offerings.

Feb 24, 2012 No Comments by

Aastrom Biosciences, Inc. (Nasdaq:ASTM) – According to the Phase 3 trial of  Ixmyelocel-T in patients with critical limb ischemia (CLI) (REVIVE) is open for enrolment. The primary endpoint is Amputation free survival (AFS) at 12 months post-injection. The trial is due to be completed in March 2015. YM BioSciences Inc.  (NYSE Amex: YMI; TSX: YM) priced its offering of […]

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CHTP positive Adcom vote. PDUFA date issued for IPXL + LGND YMI SGMO CLDX ISTA EXAS QLTI news

Feb 24, 2012 No Comments

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today announced that the FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 7-4 with 1 abstention and 1 non-vote to recommend approval of NORTHERA for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure (Parkinson’s disease, multiple system atrophy and pure autonomic failure), dopamine […]

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VVUS positive AdCom vote. Pipeline updates for SNTA AMLN DYAX + HZNP AVII news

Feb 23, 2012 No Comments

VIVUS, Inc. (NASDAQ: VVUS) today announced that the Endocrinologic and Metabolic Drugs Advisory Committee recommended Qnexa be granted marketing approval by the FDA for the treatment of obesity in adults. The Committee voted in favour by 20 to 2. The PDUFA date for Qnexa is April 17, 2012. Synta Pharmaceuticals Corp. (NASDAQ: SNTA) provided a pipeline update noting that it expects to complete enrolment […]

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GTXI Capesaris placed on clinical hold. RGEN PDUFA date. TRGT added to database + CHTP THLD ANTH GENT news

Feb 21, 2012 No Comments

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) briefing materials are now available HERE. The meeting will be held on Thursday, February 23, 2012 to review NORTHERA for the treatment of symptomatic neurogenic orthostatic hypotension. GTx, Inc. (Nasdaq: GTXI) announced that its clinical trials evaluating Capesaris (GTx-758) for primary (first line) androgen deprivation therapy for […]

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CORT FDA Approval. AMLN CTIC receive CHMP recommendations + CYTR GALE ALXA news

Feb 17, 2012 No Comments

Corcept Therapeutics Incorporated (NASDAQ: CORT – The FDA said in a press release that it has approved Korlym to control high blood sugar levels (hyperglycemia) in adults with endogenous Cushing’s syndrome. This drug was approved for use in patients with endogenous Cushing’s syndrome who have type 2 diabetes or glucose intolerance and are not candidates for […]

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ALXA offering. PLX prices offering. AEN now SYN + HZNP news

Feb 16, 2012 No Comments

Protalix BioTherapeutics, Inc. (NYSE Amex:PLX) (TASE:PLX), announced the pricing of its public offering of 4.5 million shares at a price to the public of $5.25 per share with an option to issue a further 675,000 additional shares to cover over-allotments. Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA), today announced that it intends to offer shares of its common stock and warrants to […]

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NPSP PDUFA date confirmed with BLA filing due end of 2012. PLX offering. INCY update

Feb 16, 2012 No Comments

NPS Pharmaceuticals, Inc.(NASDAQ: NPSP) confirmed that it has been assigned a PDUFA date of September 30, 2012 for Gattex for the treatment of adult short bowel syndrome or SBS. It also intends  to submit to the FDA a Biologics License Application (BLA) for Natpara toward the end of 2012 as the first replacement therapy for hypoparathyroidism. Protalix BioTherapeutics, Inc. (NYSE Amex:PLX) […]

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BPAX FDA Approval. SNTS NDA accepted. XNPT VNDA pipeline updates. ALNY prices offering

Feb 15, 2012 No Comments

BioSante Pharmaceuticals Inc. (NASDAQ: BPAX) – The FDA said today that it approved Bio-T-Gel, a once-daily transdermal testosterone gel in development for the treatment of male hypogonadism, or low testosterone levels. Santarus, Inc. (NASDAQ: SNTS) today announced the FDA has accepted for filing its New Drug Application (NDA) for UCERIS for the induction of remission of mild to moderate […]

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Feb 14, 2012 No Comments

Amarin Corporation plc (Nasdaq:AMRN) said that it has been informed by the FDA that no advisory committee meeting will be scheduled for its New Drug Application (NDA) of AMR101 in the treatment of patients with very high triglycerides, currently scheduled for review on July 26, 2012. Celsion Corporation (NASDAQ: CLSN) announced today that the first patient has been […]

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