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 [...]
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 [...]
Aastrom Biosciences, Inc. (Nasdaq:ASTM) – According to clinicaltrials.gov 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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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) [...]
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 [...]
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 [...]
Dear BioPharmCatalyst reader, I am pleased to announce that the chatroom has had a complete revamp for the benefit of all users of BioPharmCatalyst. The previous chatroom was admittedly poorly designed and as a result received little attention. It was not user-friendly and in fact most readers were unaware it existed. However, as of today [...]
Spectrum Pharmaceuticals (NasdaqGS: SPPI) announced the initiation of a Phase 2 trial of ZEVALIN for intravenous use + rituximab in combination with motexafin gadolinium (MGd) in patients with rituximab-refractory low-grade or follicular B-cell non-Hodgkin’s lymphoma (NHL). Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced efficacy and safety results from its Phase 2 trial of urocortin 2 in 53 patients [...]
Earlier today abstracts to next month’s ASCO meeting were released. Approximately 75 of those abstracts can now be found in the BioPharmCatalyst ASCO Calendar, which can be found HERE. Session times and other information can also be found to give you a one-stop resource provided to save you much time in searching for abstracts.
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