NICE Doubtful On Cost-Effectiveness Of Tarceva The U.K.'s National Institute for Health and Clinical Excellence is asking for a further cost-effectiveness analysis of Roche's Tarceva to weigh against the cost effectiveness of AstraZeneca's Iressa.
EU's CHMP Warns About Boceprevir In HIV, Aliskiren In Diabetes, But Clears Orlistat And Reinstates Trasylol The EU's scientific advisory panel, the CHMP, recommends prescribing information changes for drug/drug interactions with Merck's Victrelis and adverse events with Novartis' aliskiren, but clears obesity therapy orlistat of causing liver injury and reverses its 2007 negative opinion on Bayer's Trasylol.
A Setback In Its High-Profile "Nuc" Trial Creates An Overhang For Gilead's HCV Pipeline Gilead concedes that 12 weeks of treatment with ribavirin and GS-7977, the high-profile "nuc" asset it obtained when it bought Pharmasset late in 2011 is suboptimal for genotype 1 null responders; general expectation is that longer duration of therapy might suffice.
FDA Says Qnexa Needs CV Outcome Trial, Asks Cmte. To Consider Pre- Or Post-Approval Timeframe Endocrinologic and Metabolic Drugs Advisory Committee also will weigh in on a teratogenicity risk management strategy for Vivus' weight-loss drug during a Feb. 22 meeting.
Corcept's Voluntary Central Distribution Helps Korlym Evade REMS FDA required no REMS, though Korlym (mifepristone), also known as RU-486, will carry a boxed warning that the therapy for Cushing's syndrome will terminate pregnancy; Corcept has set up distribution through a central pharmacy.
A Closer Look: Alogliptin's Delay Accelerated Takeda's Pursuit Of Nycomed Takeda found itself desperate to fill gaps with Actos LOE looming and alogliptin faltering, hastening a 10-year conversation with Nycomed.
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