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) [...]

Geron Corporation (Nasdaq: GERN) today announced that it has completed enrollment of its Phase 2 trial of imetelstat, as maintenance therapy following platinum-based induction therapy for patients with advanced non-small cell lung cancer (NSCLC). Top-line results are expected by before the end of 4Q 2012. Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today provided an update on its Phase [...]

The following is a list of some companies with upcoming meetings (May – June 2012) where shareholders will be asked to vote to give permission to enforce a reverse split and/or change (usually increase) the number of authorised shares. REVERSE SPLIT VOTES: BIONOVO INC (BNVI):  May 3 – Reverse Split vote at a ratio of 1-for-250. [...]

Zogenix, Inc. (NASDAQ: ZGNX) announced that it has submitted a New Drug Application (NDA) to the FDA for Zohydro for the treatment of chronic pain. AVEO Pharmaceuticals Inc.(NASDAQ: AVEO) announced preliminary data from its Phase 2 trial comparing the combination of ficlatuzumab and gefitinib to gefitinib monotherapy in previously untreated Asian subjects with non-small cell lung [...]

Pfizer Inc.(NYSE:PFE) and Protalix BioTherapeutics, Inc. (NYSE-AMEX:PLX, TASE:PLX) announced today that the FDA has approved ELELYSO (taliglucerase alfa) for the long-term treatment of adults with a confirmed diagnosis of type 1 Gaucher disease. The label is available HERE. Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today gave an update on its Complete Response Letter (CRL) received in March [...]

Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced that interim, topline results of the Phase 2b EMERGE study of CDX-011 in patients with advanced breast cancer will be presented in a webcast on May 23, 2012. The company had planned to present these data at the American Society of Clinical Oncology(ASCO) 2012 Annual Meeting. However, due to a clerical error [...]