FDA

FDA pledges to work with medical entrepreneurs

Tuesday, July 19, 2011 01:02 PM

The head of the FDA pledged to work more closely with small medical technology companies, which have spent the last year alleging that the agency is needlessly slowing approvals of new drugs and devices, according to the Associated Press.

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Despite seeing benefits, industry awaits FDA final guidelines before adopting adaptive design trials

Monday, July 18, 2011 08:02 AM

The promise of adaptive design clinical trials exists, with increased ethical treatment of patients, greater likelihood of finding the optimal dose and shortened study duration. But a variety of sponsor and CRO barriers—lack of experienced personnel with the required skills and knowledge, misunderstood benefits and greater complexity of design and trial implementation—have slowed their widespread adoption.

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FDA names new deputy commissioner for medical products and tobacco

Friday, July 15, 2011 10:52 AM

The FDA has named former Dartmouth Medical School Dean Stephen Spielberg to the newly created position of deputy commissioner for medical products and tobacco, according to an internal letter sent to FDA employees obtained by Reuters.

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Inovio releases phase I flu vaccine results

Friday, July 15, 2011 10:27 AM

Inovio Pharmaceuticals, a developer of therapeutic and preventive vaccines against cancers and infectious diseases, announced that significant T cell and antibody responses were generated in its phase I clinical study of VGX-3400X, a SynCon DNA vaccine for the prevention of avian H5N1 influenza delivered using intramuscular (IM) electroporation.

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Chimerix launches AdV HALT trial

Friday, July 15, 2011 10:21 AM

Chimerix, a biotechnology company, has begun patient dosing in the AdV HALT trial.  The FDA has granted CMX001 Fast Track designation status for the development program for this indication.

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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.

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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.

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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.

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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.

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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.

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