The world's biggest biotech company Amgen Inc. will focus on recent results on a key experimental melanoma drug, testing of other drugs and revenue from its top-selling drugs when it reports first-quarter results after the stock market closes Tuesday.
Irish drugmaker Elan Corp. PLC said it had completed its "Dutch auction" stock repurchase, buying back $1 billion in stock for $11.25 per share. Under the modified Dutch auction, stockholders notify the company how many shares they'd like to sell and at what price within the announced range.
Federal health experts issued a split opinion on whether a long-acting testosterone injection from Endo Health Solutions is safe. A Food and Drug Administration panel voted 9-9 on the safety of Endo's Aveed, a drug designed to be injected once every 10 weeks to boost testosterone in men with abnormally low levels.
Viralytics Ltd. has finalized the clinical study report on the Phase 1 evaluation of Cavatak administered intravenously to late stage melanoma, prostate, breast, or colorectal cancer patients. Cavatak was well tolerated with some evidence of stable disease despite most patients only receiving a single dose of Cavatak.
Eli Lilly and Co. announced it has acquired two investigational positron emission tomography tracers from Siemens Medical Solutions USA Inc. The tracers are intended to image tau tangles in the brain, one of two known hallmarks of Alzheimer's disease.
A panel of respiratory experts voted in favor of approving an experimental inhaler drug from GlaxoSmithKline and Theravance for treating chronic lung disease. A majority of panelists felt that the Breo Ellipta inhaler is safe and effective for long-term use and to control flare ups in patients with COPD.
Acura Pharmaceuticals Inc. benefited greatly from a decision by federal regulators to block new painkillers that aren't designed to resist abuse. The company sells a decongestant called Nexafed and its abuse-deterring technology is used in Pfizer Inc.'s painkiller Oxecta.
Researchers have identified a molecule that prevents repair of some cancer cells, providing a potential new "genetic chemotherapy" approach to cancer treatment that could significantly reduce side effects and the development of treatment resistance compared with traditional chemotherapy.
Allergan Inc. said that the Food and Drug Administration isn't ready to approve its inhaled migraine treatment Levadex. Allergan said the FDA is concerned about elements of the manufacturing process for Levadex. The company said it is already responding to those concerns.
Federal health regulators will require generic versions of the best-selling painkiller OxyContin to include recent formulation changes designed to make the pill harder to abuse. The Food and Drug Administration said it would not approve any generic versions of OxyContin based on the original formulation.
Stem cells and tissue-specific cells can be grown in abundance from mature mammalian cells simply by blocking a certain membrane protein. Experiments show that the process doesn’t require other kinds of cells or agents to artificially support cell growth and doesn’t activate cancer genes.
The Justice Department said Amgen paid kickbacks to Omnicare Inc. and PharMerica Corp., which sell drugs to long-term care providers like nursing homes and hospitals, and Kindred Healthcare Inc., which runs long-term acute care hospitals and nursing and rehabilitation centers.
Actavis is once again selling a generic version of Bayer's oral contraceptive Yaz because a federal appeals court overturned one of the patents supporting the original. The company began selling it in January 2012, but took the drug off the market after a federal court in Nevada upheld the patent.
Researchers have discovered that rising temperature induces key changes in the dengue virus when it enters its human host, and the findings represent a new approach for designing vaccines against the aggressive mosquito-borne pathogen.
Eli Lilly and Company announced positive top-line results of two additional Phase 3 AWARD trials for dulaglutide, an investigational, long-acting glucagon-like peptide 1 receptor agonist being studied as a once-weekly treatment for type 2 diabetes.