Strategies & Technologies Driving Drug Discovery to Market
SIGA Liable In Contract Row
May 26, 2013 6:17 pm | News | CommentsThe Delaware Supreme Court has upheld a finding that SIGA Technologies is liable for breaching contractual obligations to negotiate in good faith with rival biodefense company PharmAthene. But the court also remanded the case back to the Delaware Court of the Chancery to reconsider the damages it awarded.
Guilty Plea Entered in Xibrom Case
May 24, 2013 5:30 pm | by Carolyn Thompson | News | CommentsISTA Pharmaceuticals has pleaded guilty in a federal case involving its eye drug Xibrom, admitting it promoted the drug for unapproved uses and agreeing to pay $33.5 million in fines and fees. ISTA also pleaded guilty to violating anti-kickback laws by sponsoring outings intended to persuade doctors to prescribe the drug.
Court Blocks Generic Pulmicort
May 24, 2013 4:56 pm | News | CommentsActavis Inc. said a federal appeals court granted an injection that blocks it from selling a generic version of AstraZeneca PLC's asthma treatment Pulmicort Respules. The injunction bars Actavis from selling its generic until the litigation with AstraZeneca is resolved.
Merck Ends Preladenant Development
May 23, 2013 5:31 pm | News | CommentsAn initial review of data from three separate Phase 3 trials did not provide evidence of efficacy for preladenant compared with placebo. Based on these results, Merck is taking steps to discontinue the extension phases of these studies and no longer plans to pursue regulatory filings for preladenant.
Long-Time Forest CEO to Retire
May 23, 2013 3:58 pm | News | CommentsForest Laboratories Inc. announced that Howard Solomon, its CEO for the last 36 years, will retire at the end of 2013. Solomon, 85, will step down as president and CEO on Dec. 31, and will resign as chairman at the time of the company's annual shareholder meeting in 2014.
Alkermes Posts 4Q Profit As Royalty Payments Rise
May 23, 2013 12:44 pm | by The Associated Press | News | CommentsAlkermes said that it was profitable in its fiscal fourth quarter as it received bigger royalty payments and more revenue for drug manufacturing. The Irish company said revenue from manufacturing and royalty payments climbed 33% during the quarter, and its total revenue rose 25%.
A Potential Treatment for Hypoactive Sexual Desire Disorder
May 23, 2013 11:44 am | by Robert E. Pyke, MD, PhD, Chief Medical Officer; S1 Biopharma, Inc., Jersey City, NJ | Articles | CommentsHypoactive sexual desire disorder affects 10% of women in the United States and significantly higher percentages of women who have undergone surgical menopause.There are no U.S. Food and Drug Administration-approved treatments for this large, unmet medical need.
Heartburn May Be Predictive of Cancer
May 23, 2013 10:00 am | News | CommentsResearchers have found that a history of frequent heartburn was linked to a 78% increased risk for cancers of the throat and vocal cord. They also found that among those who had frequent heartburn, taking antacids—but not prescription medications or home remedies—had a protective effect.
J&J Forecasts 10 NDAs by 2017
May 23, 2013 8:31 am | by Linda A. Johnson | News | CommentsJohnson & Johnson plans to submit more than 10 new treatments to regulators for approval and 25 applications for additional uses of approved drugs by 2017. The company's pipeline of late-stage drugs include a hepatitis C treatment, a long-lasting version of Invega, and several vaccines.
Does Cancer Drug Reverse Alzheimer’s?
May 23, 2013 12:00 am | News | CommentsResearchers have verified that the lymphoma treatment bexarotene can significantly improve cognitive deficits in mice expressing gene mutations linked to human Alzheimer’s disease, but did not find any evidence that the drug cleared away amyloid plaques from the brains.
Despite Concerns, Panel Backs Insomnia Drug
May 22, 2013 5:46 pm | by Matthew Perrone | News | CommentsA majority of medical experts on a U.S. Food and Drug Administration panel said that an experimental insomnia drug from Merck & Co. Inc. appears safe and effective, in spite of evidence from company trials that the pill can cause daytime sleepiness and difficulty driving.
Moody's Reviewing Hospira Debt Rating
May 22, 2013 3:11 pm | News | CommentsMoody's Investors Service has placed Hospira Inc.'s long-term debt rating under review for possible downgrade. The move was based on a concern that the company's performance over the next few years remains uncertain as a result of costs related to its new product strategy and possible regulatory issues.
Glaxo, U.S. Partnering on Antibiotics
May 22, 2013 2:26 pm | News | CommentsGlaxoSmithKline is beginning starting an unusual collaboration with the U.S. government to develop several antibiotics for both bioterrorism threats and drug-resistant bacteria. Glaxo's partnership will bring the British drugmaker $40 million over the first 18 months.
Pfizer Reducing Stake in Zoetis
May 22, 2013 10:01 am | News | CommentsPfizer Inc. plans to start selling its remaining stake in the animal health business Zoetis Inc. through a voluntary exchange offer with its shareholders. Shareholders will be able to trade their Pfizer holdings for Zoetis shares at a discount, depending on the number of shares exchanged.
Immunotherapy Brightens BMS Future
May 22, 2013 8:35 am | News | CommentsBristol-Myers Squibb could be a big winner with a portfolio of cancer treatments under development that use a patient's own immune system to attack the disease. Citi analyst Andrew Baum expects that within 10 years, immunotherapy will form the backbone of 60% of all cancer treatment plans in the developed world.
