The Role Of RiskMAPs: Fentora Shows Shift From Post-Market To Pre-Market
Cephalon needs to improve the risk management plan for its breakthrough cancer pain drug Fentora regardless of whether it expands use to non-cancer pain patients, according to FDA and a joint Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committee
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Cholesterol Endpoints Draw Scrutiny At HoFH Panels
The Metabolic and Endocrinologic Advisory Committee accepts LDL lowering as endpoint for homozygous hypercholesterolemia drugs, backing approval of Aegerion’s lomitapide by 13-2 and Genzyme’s mipomersen by 9-6, but hones in on the need for better surrogates for cardiovascular morbidity and mortality.
Lone Wolfe: Drug Industry Critic Ends Tenure As Advisory Committee Member With Rare Decisive Vote
Sidney Wolfe’s stint as permanent member of the Drug Safety and Risk Management Advisory Committee ended May 31; his final meeting was the May 23 review of Xarelto for ACS. That gave him a second chance to vote against the product. A look back at Wolfe’s tenure shows he was a sure “no” vote when he sat on a panel—but that his service can hardly be construed as having damaged the industry.
Opioid Class REMS: FDA Wants Prescriber/Pharmacist Certification
Public meeting set for end of May: next step on the difficult road to a class-wide REMS. Important precedent in the making.