Ventrus Biosciences, Inc. (Nasdaq:VTUS) today reported positive results from its Phase 3 trial of diltiazem hydrochloride cream (VEN 307) in patients with anal fissures.  Both 4% and 2% diltiazem treatment arms demonstrated significant improvements compared to placebo in the primary endpoint of average of worst anal pain associated with or following defecation (pain score improvement 0.44, [...]

YM BioSciences Inc. (NYSE Amex: YMI, TSX: YM) provided an update today on CYT387 for the treatment of myelofibrosis. It intends to initiate its Phase 3 trial during 2H 2012. By the end of 2012 both final data from its Phase 1/2 Core trial and interim data from the Phase 1/2 Extension trial are expected to be reported. Interim [...]

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc. announced today that the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 18 to 4, with one abstention, to recommend approval of lorcaserin in patients with obesity. The current PDUFA date is June 27, 2012. However, this may be extended by three months if further data is provided by the company. A.P. Pharma, Inc.(OTCBB:APPA.OB) [...]

Ventrus Biosciences, Inc. (Nasdaq:VTUS) gave a pipeline update noting that initial top-line data from its Phase 3 trial of Diltiazem (VEN 307) in patients with Anal Fissures, is expected to be available in May 2012. Phase 3 data of Iferanserin (VEN 309) in patients with Hemorrhoidal Disease, is expected in late June or early July 2012. Aastrom Biosciences, Inc. (Nasdaq:ASTM) [...]

Delcath Systems (NASDAQ: DCTH) said that it intends to submit its NDA for its Hepatic CHEMOSAT delivery system in mid-August, 2012. GTx, Inc. (Nasdaq: GTXI) said that the clinical hold placed on Capesaris (GTx-758),for secondary hormonal therapy of advanced prostate cancer, has been lifted by the FDA. The Phase 2 trial will test three lower doses of Capesaris (125 mg, [...]

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) [...]

Vical Incorporated (Nasdaq: VICL) filed a mixed shelf allowing it to issue common stock and preferred stock, debt securities and/or warrants, either individually or in combination, with a total value of up to $150,000,000 from time to time. Gentium S.p.A. (Nasdaq:GENT) announced today that it has received the Day 180 List of Outstanding Issues (the “LoOIs”) [...]

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has received a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for ADASUVE. In its press release the company said the CRL was issued due to medical device deficiencies and plans to meet with the FDA to resolve the issues. Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) [...]