With a label warning about weight loss that might actually help sales, Celgene Corp.’s oral phosphodieasterase-4 (PDE4) inhibitor Otezla (apremilast) was approved by the FDA on its Friday PDUFA date for adults with active psoriatic arthritis (PsA). Read More
LONDON – Horizon Discovery Group has raised £68.6 million (US$113 million) in an oversubscribed initial public offering (IPO) that priced at the top end of the valuation range, delivering an old-fashioned exit for the private backers who sold shares to the value of £28.6 million. Read More
LONDON – Adaptimmune Ltd. has been awarded a £2.1 million (US$3.5 million) government grant enabling it to launch its second T-cell cancer immunotherapy product into clinical development in the UK, in the treatment of triple negative breast cancer. Read More
Caught in the crossfire of an innovator drug company and the sponsor of a 505(b)(2) drug, the FDA is now facing a lawsuit for not assigning a therapeutic equivalence (TE) rating to Perrigo Israel Pharmaceuticals Ltd.’s testosterone gel 1 percent, which was approved more than a year ago based on its bioequivalence to Abbvie Inc.’s Androgel. Read More
Since launching in Tokyo in 2006, followed by the establishment of a U.S. subsidiary a year later, Regimmune Corp. has endured both financial and natural disasters: the meltdown of the global capital markets and the Tōhoku earthquake and tsunami. Read More
Researchers have identified a regulatory protein whose expression is important for protecting neurons from damage in the elderly. In doing so, they may have found an answer to one of the big puzzles in neurodegenerative disease: Many patients whose brains look like they should have Alzheimer’s disease at autopsy were, in fact, doing fine in terms of their cognitive functions and memory. Read More
CAP-CMV GmbH, of Cologne, Germany, said it raised a combined seed/start-up investment of €1.7 million (US$2.3 million) from Peppermint Venture Partners (PVP), NRW.Bank, Creathor Venture, KfW and other private investors. Read More
Provectus Biopharmaceuticals Inc., of Knoxville, Tenn., said it applied to the FDA for breakthrough therapy designation for PV-10 for the treatment of melanoma. PV-10, a solution developed from Rose Bengal, completed a phase II melanoma trial. Read More
Ariad Pharmaceuticals Inc., of Cambridge, Mass., said it started a pivotal phase II study of AP26113 in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) who previously were treated with Xalkori (crizotinib, Pfizer Inc.). Read More
Medivir AB, of Huddinge, Sweden, said the Russian Ministry of Health has approved Sovriad (simeprevir) for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adults with compensated liver disease (including cirrhosis) who are treatment naïve or who have failed previous interferon therapy (pegylated or non-pegylated) with or without ribavirin. Read More
