Acelrx Pharmaceuticals Inc. didn't have to wait for its Sunday PDUFA date for Zalviso, but the company also didn't receive the FDA approval it sought and analysts largely expected. Instead, the FDA late Friday issued a complete response letter (CRL) for the pain management product, seeking more information about the device to ensure proper use. Read More
Word that a pair of pharmacy benefit managers (PBMs) may drop two nonsteroidal anti-inflammatory drugs (NSAIDs) from their formularies sent Horizon Pharma Inc. shares into a tailspin and caused onlookers to speculate about further pushbacks from payers and their agents against high drug prices. Read More
In a two-step scheme, specialty vaccine developer Paxvax Inc. acquired the FDA-approved oral typhoid vaccine Vivotif from Crucell Switzerland AG and financed the deal with $50 million in secured debt from an investment fund managed by Pharmakon Advisors and $12 million in an extension of its series B preferred stock. The Redwood City, Calif.-based company, whose lead product is a single-dose cholera vaccine in a phase III program, now takes up the challenge of transforming from a small biotech to a commercial venture. Read More
LONDON – The EMA added an eighth product to the roster of biosimilar versions of Amgen Inc.’s Neupogen it has approved, giving the nod to Accofil from Accord Healthcare Ltd., of Haverhill, UK. Read More
Zealand Pharma A/S could earn up to €295 million (US$396 million) in milestone payments arising from a second drug development deal in diabetes with Boehringer Ingelheim GmbH. It will bank €5.6 million during 2014. Read More
HONG KONG – A multidisciplinary research team from Singapore has made a significant breakthrough in the understanding of the molecular basis of benign fibroadenomas, one of the most common breast tumors in women, which could have important implications for the diagnosis and treatment of malignant breast cancers. Read More
Lumena Pharmaceuticals Inc. hit the ground running when it was founded three years ago and in-licensed programs aimed at rare liver diseases. Read More
Responding to citizen petitions filed by Abbvie Inc., of North Chicago, and Auxilium Pharmaceuticals Inc., of Chesterbrook, Pa., the FDA said it doesn't need to do a rulemaking to assign a therapeutic equivalency (TE) rating to testosterone drugs approved on the 505(b)(2) path. Read More
Morphosys AG, of Martinsried, Germany, provided an update on its candidate portfolio, placing a priority on phase II data in non-Hodgkin's lymphoma by the end of this year with MOR208, an anti-CD19 antibody. Read More
Tetraphase Pharmaceuticals Inc., of Watertown, Mass., said it completed patient enrollment in IGNITE 1, its phase III trial evaluating the safety and efficacy of eravacycline in the treatment of complicated intra-abdominal infections (cIAIs). Read More
Aqua Pharmaceuticals, of West Chester, Pa., a subsidiary of Almirall SA, said the FDA approved Acticlate (doxycycline hyclate USP) tablets, 150 mg and 75 mg. Read More
Janssen R&D Ireland, of Cork, Ireland, and Medivir AB, of Huddinge, Sweden, said results from the phase II COSMOS study were published in The Lancet, demonstrating that 92 percent of genotype 1 chronic hepatitis C virus adult patients treated with simeprevir, an NS3/4A protease inhibitor, in combination with sofosbuvir (Gilead Sciences Inc.), achieved sustained virologic response 12 weeks after the end of treatment, including those patients with compensated cirrhosis and prior null response to treatment with pegylated interferon and ribavirin. Read More
