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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
The FDA late Friday approved Cubist Pharmaceuticals’ antibiotic Zerbaxa to treat complicated intra-abdominal infections and urinary tract infections, the latest approval granted through an initiative to encourage antibiotic development. Read More
Drug industry groups are urging the European Commission to invest more in research and development, streamline regulatory systems and accelerate recently approved clinical trial reforms as ways to bolster the EU’s pharmaceutical industry. Read More
Apotex’s application for a biosimilar version of Amgen’s chemotherapy Neulasta has been accepted by the FDA, one of several recent signs that regulatory movement on approving the therapies is gaining momentum. Read More
The FDA is considering employing unmanned aerial drones to aid in facility inspections, although it’s unclear whether that would encompass drug manufacturing plants. Read More
Addressing the ANDA backlog, setting up the pharmaceutical quality office, and issuing final guidance on abuse-deterrent opioids are among the roughly dozen top priorities for CDER in 2015. Read More