Donna Young

FDA Wants More Details on Dmab Before Giving Amgen a Go-Ahead

Oct. 20, 2009

The FDA needs more details from Amgen Inc. about its postmarketing safety surveillance study program before regulators will approve Prolia (denosumab) as a treatment for postmenopausal osteoporosis, the company said Monday. (BioWorld Today)

Senate Passes Bill to Outlaw Pay-to-Delay Generics Deals

Oct. 19, 2009

By Donna Young

Oxigene's VaxGen Grab Brings Cash; More May Be 'Emergent'

Oct. 16, 2009

By Donna Young

FDA Panel Backs Acorda MS Drug; Post-OK Trials Only

Oct. 15, 2009

By Donna Young

COLLEGE PARK, Md. — An FDA panel Wednesday voted 12 to 1 that Acorda Therapeutics Inc.'s Phase III trials provided substantial evidence that fampridine sustained-release was effective in improving the walking ability in patients with multiple sclerosis. (BioWorld Today)

Heed All FDA Compliance Efforts, Drugmakers Warned by Panelists

Oct. 14, 2009

By Donna Young

Berinert is the Victor in Race to the FDA's HAE Finish Line

Oct. 13, 2009

By Donna Young

PTO Scraps Would-be Limits on Patent Claims; GSK Happy

Oct. 12, 2009

By Donna Young

Acorda Staggers on FDA Word: MS Drug's Walk Data Below Par

Oct. 12, 2009

By Donna Young

Acorda Therapeutics Inc.'s stock plunged 21.4 percent after FDA drug reviewers raised concerns in briefing documents about the efficacy of Amaya (fampridine sustained-release) in improving the walking ability in patients with multiple sclerosis. (BioWorld Today)