FDA refuses to file DCTH NDA. CLDA acquired. FURX SNTS INFI DVAX news

Feb 22, 2011 No Comments by

Furiex Pharmaceuticals, Inc. (Nasdaq: FURX) was added to the Clinical Database following release of 4Q 2010 results today. They initiated a Phase 2 proof-of-concept study in January for PPD-10558 for the treatment of dyslipidemia in patients who experience statin associated myalgia. FURX also recently obtained FDA Fast Track Designation of MuDelta for the treatment of diarrhea-predominant irritable bowel syndrome, currently in Phase 2 trials.

Santarus, Inc. (NASDAQ: SNTS) and Pharming Group NV (NYSE Euronext: PHARM) today announced that Pharming has begun a randomized, placebo-controlled Phase 3b clinical study evaluating RHUCIN (recombinant human C1 inhibitor) for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE). Pharming expects to enroll approximately 50 patients in the study, which may provide additional data, in support of an approval for RHUCIN at the 50 U/kg dose. The study is expected to be completed in 12 to 18 months. Their BLA was submitted in late December, 2010.

Delcath Systems, Inc. (Nasdaq: DCTH) announced today that the FDA has refused to file their NDA for treatment of patients with metastatic melanoma in the liver through the percutaneous intra-arterial administration of melphalan hydrochloride. They expect to submit a request to meet with the FDA this week and intend to resubmit the NDA by September 30, 2011. The FDA noted in their letter concerns regarding manufacturing plant inspection timing, product and sterilization validations and additional safety information which will be filed with our 120 day safety update in April, as well as additional statistical analysis clarification.

Forest Laboratories, Inc. (Forest) (NYSE: FRX) and Clinical Data, Inc. (Clinical Data) (NASDAQ: CLDA) today announced that Forest will acquire Clinical Data, for $30 per share in cash plus contingent consideration of up to $6 per share that may be paid upon achievement of certain commercial milestones related to Viibryd(TM). Forest will finance the transaction with existing cash. The transaction was approved by the boards of both companies and is expected to be completed in the second quarter of 2011, subject to customary closing conditions.

Infinity Pharmaceuticals, Inc. (Nasdaq:INFI) today announced the initiation of the randomized Phase 2 portion of the trial of IPI-926 in combination with gemcitabine (also known as Gemzar) in patients with previously untreated, metastatic, pancreatic cancer. The Phase 2 portion of the trial is a double-blind study that will compare treatment with IPI-926 in combination with gemcitabine to treatment with placebo and gemcitabine. The primary endpoint is overall survival. The trial is expected to enroll approximately 120 patients worldwide.

Dynavax Technologies Corporation (NASDAQ: DVAX) reported last Friday, new Phase 1a and Phase 1b safety and immunogenicity data for its universal flu candidate vaccine. Data from the Phase 1a and the Phase 1b study, initiated in September 2010, showed:

– N8295 alone or combined with H5N1 vaccine was very safe and generally well tolerated;
– The most common adverse events were mild, self-limited injection site reactions;
– There were no SAEs;
– All N8295 dose groups had an antibody response to M2e, and the placebo group did not;
– All N8295 dose groups had an antibody response to NP, and the placebo group did not;
– All N8295 dose groups had a cellular immune response to NP, and the placebo group did not;
– The addition of N8295 to a non-immunogenic dose of H5N1 vaccine resulted in H1 responses in all N8295 dose groups.

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About the author

Currently residing in New Zealand, Mr. A.Burden holds a Master of Commerce in International Business from the University of Sydney and used these skills together with his passion for investing to establish BioPharmCatalyst in June 2010 as a tool for investing decisions in the US pharmaceutical market. He spends much of his free time mountain biking, playing squash and hiking.
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