FDA Approves BTG's Biologics License Application (BLA) for Voraxaze
Saturday January 28, 2012
Chemotherapy patient. Image: NCI Clinical Center/Mathews Media Group
The FDA has approved BTG International's Biologics License Application (BLA) for Voraxaze (glucarpidase), a treatment that helps cancer patients expel toxic levels of ... Read More
Viibryd and Bystolic Help Forest Labs Exceed Sales Projections
Saturday January 28, 2012
Viibryd, Forest Labs' drug for treating major depression launched in August 2011, and its next-generation blood pressure drug, Bystolic, both exceeded industry analysts' sales projections for the last quarter.
Viibryd sales ... Read More
Pharma Whistleblower Story Gets Picked up by Film Producer
Monday January 23, 2012
Film production house New Regency has optioned the rights to the book "Blood Feud: The Man Who Blew the Whistle on One of the Deadliest Prescription Drugs Ever" based on ... Read More
CDC: Fatal Prescription Drug Overdose Rate Tripled Since 1990
Saturday January 14, 2012
Image: Morguefile
Prescription drug abuse is the fastest growing drug problem in the United States, according to a report issued by the Centers for Disease Control and Prevention (CDC).
In 2007, there ... Read More
FDA: Cancer Drug Shortages, Price Tags Encourage Counterfeits
Friday January 13, 2012
Counterfeit or other unauthorized versions of Faslodex, an injectable cancer drug for breast cancer, have been promoted in the United States, according to the FDA.
The FDA warned health care ... Read More
Fast-Tracked Cancer Drug Implicated in Brain Inflammation in 3 Patients
Friday January 13, 2012
Adcetris (brentuximab vedotin), the new cancer drug approved last August for the treatment of two types of lymphoma, was touted as one of the FDA's speediest reviews and approvals of ... Read More
Dissecting FDA's Draft Guidance on Mobile Medical Apps
Friday January 13, 2012
The FDA's Draft Guidance on Mobile Medical Applications has been out for a few months, providing developers with recommendations on how they can develop medical apps on different platforms while ... Read More
National Academy of Sciences Calls for Limited Use of Chimpanzees in Research
Wednesday January 11, 2012
Morguefile photo
Last month, the Institute of Medicine and the National Research Council completed a comprehensive analysis of the scientific necessity of chimpanzees for National Institutes of Health-funded biomedical and behavioral ... Read More
FDA to Send Recommendations on Biosimilar User Fees to Congress
Tuesday January 10, 2012
Photo: thinkpanama/Flickr
The FDA is expected to send its recommendations on biosimilar user fees to Congress this week. The fees are an integral part of establishing an approval pathway for biosimilars.
The ... Read More
No Dissipation of Controversy Over HHS Decision on Plan B
Monday January 9, 2012
Photo: Teva Pharmaceuticals
Health and Human Services Secretary Kathleen Sebelius is the target of continuing criticism for her decision to overrule the Food and Drug Administration's recommendation to make Plan B ... Read More
FDA Drug Approvals Up in 2011
Monday January 9, 2012
The FDA approved 35 novel drugs during fiscal year 2011, reversing a decade-long trend of declining approvals.
Calling 2011 "a remarkable year for innovative drug approvals," FDA commissioner Margaret Hamburg, ... Read More
Study: Newly Identified Compound Could Prevent Sudden Heat Stroke
Monday January 9, 2012
Researchers at Baylor College of Medicine may have identified a molecule that could reduce an individual's sensitivity to heat and prevent heat stroke, according to a study published January 8 ... Read More
Novartis Recalls Some Popular OTC Drugs
Monday January 9, 2012
Swiss drug manufacturer Novartis announced Sun., Jan. 8, that it is voluntarily recalling some lots of Excedrin, Bufferin, Gas-X and NoDoz from U.S. markets after receiving consumer complaints of chipped ... Read More