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The European Medicines Agency released a comprehensive report detailing steps to better prevent and detect fraud and biased medical product reviews by 2016. Read More
Boehringer Ingelheim’s advanced lung cancer drug Vargatef is too expensive to justify the modest benefit it provides patients, according to the UK’s healthcare cost watchdog that recommended against coverage. Read More
The European Medicines Agency has chosen six drugs for initial review under its adaptive pathways pilot project, out of 34 potential candidates. Read More
European regulators approved Novartis’ eye drop drug Travatan to treat pediatric glaucoma patients, expanding patent protection for the treatment by another six months. Read More
The Federal Trade Commission counted 29 pay-for-delay deals in fiscal year 2013 out of a total of 145 patent litigation settlements between brand and generic drugmakers — a slight decline from 2012, but in line with the two previous years. Read More
Generics makers are pressing the FDA to expand its criteria for granting first-generic status to ANDAs, a move that would put more drugs in line for expedited review. Read More
The FDA will maintain its policy on determining when an orphan drug product is entitled to market exclusivity, saying a recent federal court ruling that overruled the agency’s policy applied to just one drug and established no precedent. Read More
BioCryst said it will start shipping its influenza drug Rapivab this week following FDA approval of the first new antiviral flu therapy in 15 years. Read More
The FDA approved Bristol-Myers Squibb’s melanoma treatment Opdivo through its breakthrough therapy pathway, the latest effort by the agency over the past three years to spur development of skin cancer drugs. Read More
China has agreed to streamline its regulatory processes and cut red tape for imports of new drugs, a move that should benefit the U.S. pharmaceutical industry, the U.S. Commerce Department says. Read More