Twice-per-day dosing (rather than once) and an inhaler that patients already know how to use, along with strong efficacy, could give Pearl Therapeutics Inc.'s therapy for chronic obstructive pulmonary disease (COPD) an edge in the increasingly competitive therapeutic space. Read More
Hopes for a resubmitted Heplisav application by the end of this year were dashed Monday, after Dynavax Technologies Corp. said a recent meeting with the FDA indicated that an additional safety study would be required before the agency would consider approving the hepatitis B vaccine. Read More
After acknowledging in a conference call Friday that the FDA would not in all likelihood approve its lead product tivozanib for renal cell carcinoma (RCC), Aveo Pharmaceuticals Inc. said Monday it received a complete response letter (CRL) from the agency informing the biotech it will not approve in its present form the new drug application (NDA) for the product. Read More
DUBLIN, Ireland – Royalty Pharma's bitter and protracted takeover battle for Elan Corp. plc will, one way or another, reach a climax next Monday when Elan shareholders vote on the company's recent M&A deals. Read More
Acknowledging that the train may have already left the station for Glaxosmithkline plc's (GSK) Avandia, some advisory committee members and other experts looked down the track last week to give the FDA an earful on how to get more meaningful data about diabetes drugs and avoid the process that derailed the one-time blockbuster Avandia. Read More
Public biotechnology companies have represented one of the capital market's hottest sectors over the past several months. Due to this considerable growth, the Nasdaq OMX Group Inc., of New York, said it is modifying the methodology used to arrive at a valuation for the Nasdaq Biotechnology Index (NBI). Read More
• Clovis Oncology Inc., of Boulder, Colo., said it commenced a public offering to raise $170 million. The number of shares and share price was not disclosed. Underwriters J.P. Morgan Securities LLC, Credit Suisse Securities and Leerink Swann will have a 30-day option to purchase up to an additional 15 percent of the number of shares sold to cover overallotments. Read More
• Biolinerx Ltd., of Jerusalem, said it signed an out-licensing agreement with Jiagsu chia-tai Tianqing Pharmaceutical Co. Ltd. (CCTQ), of Jiangsu, China, for the development and commercialization of BL-8030, an oral treatment for hepatitis C virus. Read More
• Bioalliance Pharma SA, of Paris, started a Phase II trial evaluating the efficacy and safety of Validive (clonidine Lauriad) in the U.S. in patients with chemoradiation therapy-induced oral mucositis with head and neck cancer. Read More
• Sanofi Pasteur, the vaccines division of Sanofi SA, of Paris, said the FDA has approved the supplemental biologics license application (sBLA) for licensure of its four-strain influenza vaccine, Read More
• Boehringer Ingelheim GmbH, of Ingelheim, Germany, reported new findings presented during the APASL Liver Week in Singapore, highlighting the efficacy and safety of faldaprevir(+) plus pegylated interferon and ribavirin (PegIFN/RBV) in treatment-naïve patients with genotype-1 hepatitis C virus (HCV) in Asia. The post-hoc sub-analysis of the Phase III STARTVerso 1 and 2 trials showed that both doses of faldaprevir were associated with high viral cure rates and a shorter treatment duration in that particular patient group. Read More
