Biopharma firms that are working on medical countermeasures (MCMs) to combat radiation exposure are looking to a joint FDA advisory committee meeting Friday to help define a path for development of treatments for use in radiological or nuclear events. Read More
SAN FRANCISCO – When AiCuris GmbH, of Wuppertal, Germany, analyzed the market for human cytomegalovirus therapies, it found a market with high medical need, neglected by big pharma, featuring a variety of disease manifestations. Read More
Much aging research has approached its subject by looking at the molecular processes that drive or slow down aging in individual cells. Sirtuin research is one example, as are investigations into telomeres or the aging marker p16ink4a. Read More
The slow pace of progress is wearing on the SEC's Advisory Committee on Small and Emerging Companies as it waits for the commission to move on recommendations it's suggested to help small companies get the capital they need to grow and create jobs. Read More
With a Phase III study on its lead investigational product, CPX-351 (cytarabine:daunorubicin) liposome Injection, currently enrolling patients, Princeton, N.J.-based Celator Pharmaceuticals Inc. said it raised $32.5 million to support the trial. Read More
• ViroPharma Inc., of Exton, Pa., reported net product sales of $107 million for the first quarter ended March 31, as compared to $136 million in the same period of 2012. Read More
• Actavis Inc., of Parsippany, N.J., and Valeant Pharmaceuticals International Inc., of Montreal, said Actavis Specialty Brands has acquired worldwide rights to Valeant's metronidazole 1.3 percent vaginal gel antibiotic, a topical antibiotic for the treatment of bacterial vaginosis. Read More
• OncoGenex Inc., of Bothell, Wash., said it plans to start a Phase II, investigator-sponsored study dubbed RANIER, to test OGX-427, a heat-shock protein 27 (Hsp27) inhibitor, in combination with Abraxane (nab-paclitaxel, Celgene Corp.) and gemcitabine in patients with previously untreated metastatic pancreatic cancer. Read More
• Janssen Research & Development LLC, of Raritan, N.J., a unit of Johnson & Johnson, said the FDA granted a breakthrough therapy designation for daratumumab for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and IMiD. Read More
• Almirall SA, of Barcelona, Spain, and Forest Laboratories Inc., of New York, reported positive topline results from AUGMENT COPD, the second six-month pivotal Phase III trial evaluating the efficacy and safety of investigational fixed-dose combinations of aclidinium bromide (LAMA) and formoterol fumarate (LABA), delivered in the Pressair (Genuairn outside the U.S.) inhaler. Read More
