A 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.
Hypoactive 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.
Johnson & 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.
Screening for mitochondrial RNA Polymerase (POLRMT) toxicity just got easier and more reliable. INDIGO Biosciences, Inc. offers a unique set of products designed to evaluate potential for POLRMT inhibition by anti-viral drugs. Mitochondrial gene expression studies are also available.
GlaxoSmithKline 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.
Moody’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.