One month after reporting enhanced overall survival (OS) in a pivotal study and one day before its PDUFA date, Genentech Inc.'s cobimetinib, branded Cotellic, was approved by the FDA for use in combination with Roche AG's Zelboraf (vemurafenib) to treat locally advanced or metastatic melanoma carrying a BRAF V600E or V600K mutation – subtypes that account for roughly half of the population of patients with melanoma.
Glaxosmithkline plc (GSK) and Avalon Ventures shook hands on the seventh deal in their 2-year-old build-to-buy translational medicine collaboration by establishing Iron Horse Therapeutics Inc., which will seek to advance treatments for amyotrophic lateral sclerosis (ALS), commonly known as Lou Gehrig’s disease, by modulating the activity of the protein EphA4.
Days after luring Sanofi SA to a potential multi-billion-dollar diabetes deal, the pipeline of metabolic assets at Hanmi Pharmaceuticals Co. Ltd. caught the eye of another big pharma. Janssen Pharmaceuticals Inc., a unit of Johnson & Johnson, of New Brunswick, N.J., gained exclusive global rights outside Korea and China to develop and commercialize Hanmi’s oxyntomodulin-based therapies, including HM12525A (LAPSGLP/GCG), a GLP-1/glucagon receptor dual agonist.
As abstracts from next month's meeting of the American Society of Hematology (ASH) in Orlando poured out Thursday morning, analysts keyed in on interim data reported by Bluebird Bio Inc., which included the first bifurcated results from the treatment of beta-thalassemia patients with Lentiglobin BB305.
Hanmi Pharmaceutical Co. Ltd. picked up its biggest partnership yet in a potential €3.9 billion (US$4.25 billion) global deal with Sanofi SA to develop a portfolio of long-acting diabetes treatments.
Gilead Sciences Inc. continued to raise the bar in treatments for HIV-1 infection with the FDA approval of its once-daily single-tablet regimen branded Genvoya.
Atreca Inc. played its hot cancer immunotherapy hand to amass an oversubscribed $56 million series A, enabling the company to exploit its Immune Repertoire Capture (IRC) technology in a ploy to advance therapies that optimize antitumor immune responses in concert with the use of checkpoint inhibitors and immune activators.
Bristol-Myers Squibb Co. (BMS) sought to up the ante in the heart failure market with its acquisition of Cardioxyl Pharmaceuticals Inc., providing the New York-based pharma with global rights to the second-generation nitroxyl (HNO) donor prodrug, CXL-1427, which is being readied for a phase IIb study in acute decompensated heart failure (ADHF).
Repros Therapeutics Inc. should be preparing for an advisory committee meeting with a panel from the FDA's Division of Bone, Reproductive and Urologic Products, scheduled for Tuesday, to review the new drug application (NDA) for enclomiphene (formerly Androxal) to treat secondary hypogonadism (HG).
