The thin thread suspending Damocles' sword inches from federal budgets snapped Friday as Congress and the president threw up their hands on averting a sequester that will bring across-the-board cuts to most government programs, including those at the FDA and National Institutes of Health. Read More
Although they hoped it wouldn't come to this, the FDA and National Institutes of Health (NIH) are preparing for the reality of the sequester sword. Read More
Briefing documents released ahead of Tuesday's FDA advisory meeting to discuss the risk-benefit profile of calcitonin-containing drugs in osteoporosis said that the cancer risk associated with the polypeptide hormone "appears plausible" and "cannot be ignored," signaling another potential blow to the drug class, which has seen its share of the osteoporosis market decline over the past decade. Read More
By targeting one specific type of inhibitory brain receptor, researchers have been able to improve neural function and memory in a mouse model of Down syndrome. The findings give additional support to the idea that some neurodevelopmental disorders can be reversed, at least partially, after they are established. Read More
The Senate added its stamp of approval to H.R. 307, the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), agreeing by unanimous vote to reauthorize the Biomedical Advanced Research and Development Authority (BARDA) and Project BioShield. The move followed strong bipartisan support for the bill in the House, which passed its version in January by a 395-29 vote. Read More
• Salix Pharmaceuticals Ltd., of Raleigh, N.C., reported a GAAP net income of $17.6 million, or $0.28 per share, fully diluted, for the fourth quarter of 2012 and $64.2 million, or $1.01 per share, fully diluted, for the full year ended Dec. 31, 2012. Read More
• EntreMed Inc., of Rockville, Md., said it has received commitments from investors to purchase approximately $10.7 million of securities in a registered direct offering. Read More
• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., said "a significant number" of shares have not yet been voted on its proposed merger with ANI Pharmaceuticals Inc., of Baudette, Minn., but that 84.2 percent of votes cast favor the proposal and 80.6 percent favor the reverse split proposal required to maintain the merged company's Nasdaq Global Market listing. Read More
• Anacor Pharmaceuticals Inc., of Palo Alto, Calif., reported positive preliminary results from the second of two Phase III trials of tavaborole (known as Study 302). Tavaborole is a topical anti-fungal for the treatment of onychomycosis, a fungal infection of the nail and nail bed that affects approximately 35 million people in the U.S. Read More
• H. Lundbeck A/S, of Copenhagen, Denmark, and Otsuka Pharmaceutical Co., Ltd., of Tokyo, said the FDA approved Abilify Maintena (aripiprazole) for extended-release injectable suspension, an intramuscular depot formulation for the treatment of schizophrenia. Read More
Scientists from the Japanese Shiga University of Medical Sciences have discovered that brain-derived neurotrophic factor, or BDNF, influences appetite. Read More
