As is so often the case with gastrointestinal disease, Index Pharmaceuticals AB obtained phase III results with its topical ulcerative colitis drug Kappaproct that were neither black nor white but a distinct shade of gray. Read More
On its third try before the FDA, Mannkind Corp.'s inhaled insulin Afrezza (insulin human [rDNA origin]) finally won approval Friday, capping nearly eight years of dogged pursuit in the wake of the spectacular commercial failure of first-generation inhaled insulin Exubera, but an FDA nod is only the first battle; the Valencia, Calif.-based firm still faces challenges of proving the drug's worth in the marketplace. Read More
SAN DIEGO – With an untested approval pathway for biosimilars in the U.S., industry intellectual property experts well versed in the world of small-molecule generics told BIO 2014 attendees that the best path for bringing follow-on biologics to market remains muddy. Read More
SAN DIEGO – What's the value equation for the cost of cancer therapy, and what portion of that cost should public and private payers bear? The topic – an important one for patients and drug developers alike – was the intriguing premise of a session on the final day of the BIO International Convention. Read More
SAN DIEGO – The U.S. tops most lists in biotech, but studying data from other international players can provide lessons for the front-runner and everyone else. Such intent is motivating Scientific American Worldview, in its sixth year of rankings that were detailed during a session on the final day of the BIO International Convention. Read More
HONG KONG – Researchers from the Riken Center for Life Science Technologies in Japan said they have gained new insights into the role of a chemokine protein in the enhancement of stem cell pluripotency, an improved understanding that could lead to the development of more stable and clinically useful stem cells. Read More
LONDON – The EMA published the conclusions of a first attempt to bring its pan-European assessments of absolute efficacy into line with the needs of national health technology assessment (HTA) bodies that are responsible for making judgements on relative efficacy of drugs, to feed into reimbursement decisions at a member state level. Read More
Karyopharm Therapeutics Inc., of Natick, Mass., priced its public offering of about 2.6 million shares at $42.50 apiece, a slight discount to Thursday's closing price. Read More
Gilead Sciences Inc., of Foster City, Calif., said it submitted a new drug application to Japan's Pharmaceutical and Medical Devices Agency for approval of sofosbuvir, a once-daily nucleotide analogue polymerase inhibitor, for the treatment of chronic hepatitis C virus (HCV) infection. Read More
Essentialis Inc., of Carlsbad, Calif., said it dosed the first patient in study PC025, which is designed to evaluate the safety and efficacy of diazoxide choline controlled-release (DCCR) tablets in obese Prader-Willi syndrome (PWS) patients. Read More
Eli Lilly and Co., of Indianapolis, and Boehringer Ingelheim GmbH, of Ingelheim, Germany, said the Committee for Medicinal Products for Human Use issued a positive opinion recommending approval of LY2963016, an insulin glargine product. Read More
Researchers from the Israeli Hebrew University have gained new insights into one way in which bacteria learn to live with antibiotics. Resistance is the ability to survive antibiotic treatment, as long as the concentrations of antibiotics are not too high. Read More
Icon Bioscience Inc. has kept development of its pipeline of drugs targeting ophthalmic indications largely under wraps. That posture may change as lead candidate IBI-10090, designed to treat inflammation associated with cataract surgery, moves through a pivotal phase III trial that completed enrollment four months ahead of schedule. Read More
