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A European Medicines Agency committee on Friday recommended approval of GlaxoSmithKline’s melanoma drug Mekinist, the first of its kind treatment that selectively targets the MEK protein kinase. Read More
Drugmakers are enthusiastic supporters of the FDA’s plans to offer five years of market exclusivity for more fixed-dose combination products — but they want the agency to broaden its new policy so it will cover products already under review. Read More
FDA drug approval times vary widely depending on which division is conducting an application’s review, with approvals for Alzheimer’s and Parkinson’s drugs taking three to four times longer than cancer drugs. Read More
The EU’s primary biotech lobbying group is pushing back against same-name biosimilars, arguing that physicians would find such a system confusing. Read More
Switzerland’s medicines authority said last month that it will not accept marketing authorization applications for biosimilars of low-molecular-weight heparin products already approved there. Read More
The UK’s health cost-benefit watchdog is developing new “burden of illness” and “societal impact” measurements to use when assessing new drugs for government reimbursement. Read More
The UK’s Medicines and Healthcare products Regulatory Agency has created a pathway to speed life-saving drugs to patients via an early-access program similar to the U.S. Food and Drug Administration’s popular breakthrough therapy initiative. Read More
The European Medicines Agency has launched a pilot program to speed new therapies to patients by authorizing products in stages for targeted populations. Read More
Manufacturers of influenza vaccine in the EU must file strain variation applications for next year’s flu season by June 16, the European Medicines Agency says. Read More
Actavis and Pfizer say they have settled all patent litigation over the generic version of painkiller Celebrex, which may clear the way for Actavis to start marketing its version of the drug before the end of the year. Read More
OncoGenex Pharmaceuticals Wednesday said the FDA has granted fast-track designation for the drugmaker’s investigational drug custirsen as a second line treatment for men with metastatic castrate-resistant prostate cancer (CRPC) and non-small cell lung cancer. Read More