INSM clinical hold lifted. VVUS MAA decision due 2Q. Updates for ANX BCRX KERX PSDV SGEN TZYM PBTH

May 07, 2012 No Comments by

Insmed Incorporated (Nasdaq CM: INSM) today announced the FDA lifted the clinical hold previously placed on ARIKACE in Cystic Fibrosis (CF) patients with Pseudomonas lung infections.

ADVENTRX Pharmaceuticals, Inc.(NYSE Amex: ANX) today said that its product ANX-188 is expected to be initiated in a Phase 3 trial in patients with sickle cell disease, later in 2012.

VIVUS, Inc. (NASDAQ: VVUS) maintained today that it expects a response from the Committee for Medicinal Products for Human Use (CHMP) for the Qnexa Marketing Authorization Application (MAA), in 2Q 2012.

BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) said it is hoping to finalise partnership details later in 2012 for its pending Phase 3 trial of  BCX4208, in patients with gout. During 3Q 2012, it expects to complete the extension phase through 52-weeks of its randomized Phase 2b clinical trial of BCX4208 added to allopurinol in patients with gout who had failed to reach the sUA goal of < 6 mg/dL on allopurinol alone. It also hopes to complete its Phase 2 BCX4208 clinical trial in patients with moderate renal impairment during 3Q 2012.

Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that KRX-0401 (perifosine) will have its license rights returned back to Aeterna Zentaris (AEZS). AEZS plans to continue the Phase 3 study in relapsed/refractory multiple myeloma. KERX will be entitled to low single-digit royalties on future net sales of perifosine in the U.S., Canada and Mexico.

pSivida Corp.(NASDAQ:PSDV) today announced the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA) has granted marketing authorization for ILUVIEN for the treatment of vision impairment associated with chronic diabetic macular edema (DME).

Seattle Genetics, Inc. (Nasdaq: SGEN) and Millennium: The Takeda Oncology Company, today announced the initiation of a Phase 3 trial of  ADCETRIS (brentuximab vedotin) in patients with CD30-expressing cutaneous T-cell lymphoma (CTCL) who received at least one prior systemic therapy. They also expect to initiate Phase 3 trials for front-line Hodgkin lymphoma (HL) and front-line mature T-cell lymphomas expected by late 2012 or early 2013.

Tranzyme, Inc.  (Nasdaq: TZYM) filed a mixed shelf that will allow the company, from time to time, issue up to $100m of a combination of common stock, preferred stock, debt securities, warrants and/or units.

PROLOR Biotech, Inc. (NYSE Amex: PBTH) today reported today it expects to initiate Phase 3 trials following its release of top-line results from its Phase 2 trial of hGH-CTP, in growth hormone deficient adults.


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About the author

Currently residing in New Zealand and employed in the education industry, Mr. A. Burden holds a M.Com 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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