The labeling change would drastically limit the drugs' FDA- approved indication to men who have abnormally low hormone levels due to disease or injury, instead of aging. For years companies like AbbVie and Eli Lilly have linked the condition to a variety of ailments in common in aging men, including sexual dysfunction and low mood.» Read More
WASHINGTON— The federal government says Bayer is making unsupported claims in advertisements for its dietary supplement designed to help with digestion, in violation of a federal court order.
The candidate Ebola vaccine is being co-developed by the United States National Institutes of Health and the British drugmaker GlaxoSmithKline. The trial will be led by Professor Adrian Hill of the Jenner Institute at Oxford University, which said on Friday the first shot is scheduled to be given to a human volunteer next week.
Sept 12- Eli Lilly and Co's Cyramza stomach-cancer drug prolonged survival of patients with advanced colon cancer in a late-stage study, the U.S. drugmaker said on Friday. The 1,000- patient global study, called RAISE, involved patients who had previously failed to adequately benefit from Roche Holding AG's Avastin and other standard treatments.
LONDON, Sept 12- New European Commission President Jean-Claude Juncker came under fire from health campaigners on Friday for his plan to shift responsibility for medicines to the Commission's industrial division from health.
The FDA first approved the drug, liraglutide, under the brand name Victoza in 2010 as a daily injection for type 2 diabetes, in which the body does not properly use insulin. Danish drugmaker Novo Nordisk now wants the FDA to approve the drug as an obesity treatment based on company studies showing significant weight loss in most patients.
NEW YORK, Sept 11- U.S. specialty drugmaker Akorn Inc is exploring a bid for Belgian drugmaker UCB SA's U.S. subsidiary, a deal that would allow the company to move its tax domicile overseas in a practice known as inversion, according to people familiar with the matter.
BOSTON, Sept 11- The first person to face criminal charges linked to a 2012 U.S. meningitis outbreak that killed 64 people and sickened 700 in 20 states pleaded not guilty on Thursday to claims that he knowingly shipped a tainted medication.
U.S. regulators are greenlighting a new weight-loss drug called Contrave, the third in a string of approvals for anti-obesity treatments.
The worst-ever Ebola outbreak, which has already killed at least 2,296 people in West Africa, has triggered a scramble to develop the first drug or vaccine for a deadly disease that was discovered nearly 40 years ago in the forests of central Africa.
JOHANNESBURG, Sept 10- Aspen Pharmacare is to sell the rights to market a blood clot drug in the United States to rival Mylan Inc for up to $300 million, it said on Wednesday, a move that would help Africa's top generic drugmaker pay down debt.
INDIANAPOLIS— European regulators have approved a long-lasting insulin from Eli Lilly and Co. and German drugmaker Boehringer Ingelheim that is the subject of patent infringement litigation with French rival Sanofi. That is subject to a stay of more than two years due to the Sanofi litigation.
NEW YORK, Sept 10- NPS Pharmaceuticals Inc rose sharply in premarket trading on Wednesday, after a preliminary review by the Food and Drug Administration said the company's hormone replacement therapy Natpara reduced the need for calcium and vitamin D supplements in clinical trials.
Sept 10- Eli Lilly and Co and Boehringer Ingelheim said on Wednesday that the European Commission approved their copycat version of Sanofi SA's blockbuster insulin, Lantus. The therapy received a positive recommendation from the European Medicine Agency in June.
BOSTON, Sept 9- After months of staying largely silent on a deal he is trying to broker, billionaire William Ackman on Tuesday criticized Allergan Inc' s board of directors, urging them to "wake up" and at least listen to what potential purchaser Valeant Pharmaceuticals has to offer the Botox maker.
Vamil Divan, Senior Analyst, U.S. Pharmaceuticals at Credit Suisse, discusses news that Bristol-Myers Squibb and Ono Pharmaceutical are suing Merck over the Keytruda cancer drug.
The FTC, which says AndroGel users paid hundreds of millions of dollars more than necessary because of the companies' actions, asked the U.S. District Court for the Eastern District of Pennsylvania to order AbbVie to refund users that money.
NEW YORK— The Federal Trade Commission is suing drugmakers AbbVie and Teva, saying they conspired to temporarily keep generic versions of AbbVie's low-testosterone drug AndroGel off the market.
CNBC's Meg Tirrell speaks to Johnson & Johnson chairman, Joaquin Duato, about J&J's partnership with the National Institutes of Health to fast track its Ebola vaccine program to begin human testing by early 2015.
CNBC's Andrea Day reports on a former convicted drug smuggler who has turned to selling diet supplements.
*Departure a "loss" for Roche- analyst. ZURICH, Sept 4- Swiss drugmaker Roche said on Thursday that Art Levinson had resigned from its board of directors with immediate effect, in order to avoid any conflict of interest given his role as chief executive at Google's Calico.