FDA

Elan cuts 104 jobs

Friday, July 15, 2011 10:13 AM

Following the recent decision to sell its drug manufacturing unit to Alkermes for $960 million, Elan is eliminating 104 jobs from a Pennsylvania facility that is part of the deal, according to a notice filed with the Pennsylvania Department of Labor.

More... »

FDA proposes targeted drug testing guidelines

Wednesday, July 13, 2011 10:53 AM

Targeted drugs or therapies up for regulatory approval would have to be reviewed simultaneously with the diagnostic devices they rely on, according to a proposed policy issued by the FDA, according to Reuters.

More... »

Tarsa to advance clinical programs with $24.5M financing

Wednesday, July 13, 2011 10:02 AM

Tarsa Therapeutics reported progress in its two ongoing clinical development programs for its oral recombinant salmon calcitonin for the treatment and prevention of postmenopausal osteoporosis. Patient enrollment in the phase II osteoporosis prevention trial has been completed, and the full set of data from the phase III ORACAL trial has been accepted for an oral presentation at the American Society for Bone and Mineral Research (ASBMR) 2011 annual meeting in September. Separately, Tarsa also said it has closed an additional financing round that raised a total of $24.5 million.

More... »

FDA eases rules for Alzheimer’s experiments to speed new treatments for dementia

Tuesday, July 12, 2011 12:35 PM

The FDA is making it easier to test new Alzheimer’s drugs, hoping to speed progress toward new treatments for the mind-robbing disease, according to an Associated Press report.

More... »

FDA approves Whooping Cough vaccine

Monday, July 11, 2011 12:24 PM

The FDA has approved GlaxoSmithKline’s BOOSTRIXR [Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine, Adsorbed (Tdap)] for use in adults 65 years of age and older for active booster immunization against tetanus, diphtheria and pertussis (whooping cough). This approval makes BOOSTRIX the first Tdap vaccine approved for use in this age group.

More... »

Examination of cancer drug approvals shows FDA is faster than EMA, disproving an ‘urban myth’

Monday, July 11, 2011 08:00 AM

It has been a long-held belief that European regulators are willing to take more innovative approaches to ushering drugs through the regulatory process. And several recent reports have criticized the FDA for being inefficient in its approval process for medical devices compared to the European Medicines Agency (EMA). Complaints about cancer drugs being held up in the U.S. regulatory process are particularly widespread.

More... »

FDA says drug approvals highest in two decades

Friday, July 8, 2011 02:15 PM

Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, testified before the U.S. House Energy and Commerce's health subcommittee that first-cycle drug approvals are at a 20-year high, and more than two-thirds of new treatments are being cleared within the time frames given to new drug applications.

More... »

Study results support BYDUREON’s NDA

Friday, July 8, 2011 12:21 PM

Amylin Pharmaceuticals, Eli Lilly and Alkermes announced results from QT (tQT) study of exenatide to increase the QT interval across a wide range of plasma concentrations. The study was conducted to satisfy a requirement by the FDA in support of the New Drug Application (NDA) for BYDUREON (exenatide extended-release for injectable suspension), an investigational medication for type 2 diabetes.

More... »

Medivir receives Fast Track designation from FDA

Wednesday, July 6, 2011 01:21 PM

Medivir’s investigational protease inhibitor TMC435 has received Fast Track designation from the FDA for treatment of chronic hepatitis C (CHC) genotype-1 infection, based on its potential to address medical needs in CHC infection compared to currently approved therapies.

More... »

FDA approves first LazandaR nasal spray

Wednesday, July 6, 2011 10:03 AM

Archimedes Pharma and its subsidiary, Archimedes Pharma U.S., have won FDA approval of LazandaR (fentanyl) nasal spray for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and are tolerant to opioid therapy for their underlying persistent cancer pain.

More... »