Strategies & Technologies Driving Drug Discovery to Market
Amgen Earnings Report Due Tuesday
April 19, 2013 6:26 am | by Linda A. Johnson | News | CommentsThe 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.
Elan Buys Back $1B in Own Shares
April 18, 2013 5:02 pm | News | CommentsIrish 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.
Panel Issues Split Decision on Aveed
April 18, 2013 4:46 pm | by Matthew Perrone | News | CommentsFederal 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.
Positive Results from Cancer Trial
April 18, 2013 12:33 pm | News | CommentsViralytics 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.
Lilly Acquires Tau Diagnostic Program
April 18, 2013 12:18 pm | News | CommentsEli 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.
FDA Panel Backs Breo Ellipta
April 17, 2013 4:14 pm | News | CommentsA 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.
Decision A Boon for Abuse-Resistant Pills
April 17, 2013 1:16 pm | News | CommentsAcura 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.
DIDS Molecule Blocks DNA Repair in Leukemia
April 17, 2013 12:21 pm | News | CommentsResearchers 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.
Levadex Approval on Hold
April 17, 2013 12:06 pm | News | CommentsAllergan 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.
FDA Blocks Generic OxyContin
April 17, 2013 10:09 am | by Matthew Perrone | News | CommentsFederal 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.
Researchers Churn Out Stem Cells
April 17, 2013 12:00 am | News | CommentsStem 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.
Amgen Paying $25M To End Kickback Case
April 16, 2013 6:37 pm | News | CommentsThe 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 Resumes Generic Yaz Sales
April 16, 2013 6:16 pm | News | CommentsActavis 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.
New Approach to Fighting Dengue
April 16, 2013 12:15 pm | News | CommentsResearchers 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.
Lilly Releases Positive Phase 3 Data
April 16, 2013 11:50 am | News | CommentsEli 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.
