The 11-member committee voted nearly unanimously in November that Biogen’s drug should not be approved. The FDA approved it anyway.

Two members of the U.S. Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory Committee resigned after the agency’s approved the controversial Alzheimer’s drug aducanumab (Aduhelm, Biogen/Eisai), against the committee’s recommendation. The 11-member committee voted nearly unanimously in November that Biogen’s drug should not be approved. The FDA approved it anyway. Price forContinue reading “The 11-member committee voted nearly unanimously in November that Biogen’s drug should not be approved. The FDA approved it anyway.”

Teva Pharmaceutical Industries Ltd. indicted on fixed prices on generic drugs

Teva Pharmaceutical Industries Ltd. has been indicted on charges the drugmaker fixed prices on generic drugs. WASHINGTON—The U.S. business of Teva Pharmaceutical Industries Ltd. was indicted Tuesday on charges the generic drugmaker fixed prices on cholesterol medication and other drugs. The Justice Department’s antitrust division brought the case in a Pennsylvania federal court, alleging TevaContinue reading “Teva Pharmaceutical Industries Ltd. indicted on fixed prices on generic drugs”

Are you Practicing GCP?

You probably heard news or stories such as Misconduct Delayed Drug Approval or Duke Settles Negligence Suit. The Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safetyContinue reading “Are you Practicing GCP?”