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The surge of opposition to Zogenix’s controversial painkiller Zohydro ER shows no signs of abating, with state officials joining congressional critics in calling for a reversal of the single-entity hydrocodone product’s approval. Read More
The FDA has rejected Avedro’s NDA for its riboflavin ophthalmic solution/KXL System, saying additional data supporting the drug-device combo’s efficacy and safety are required for approval. Read More
The FDA has extended by three months the PDUFA-review date for Biogen Idec’s Plegridy, a drug candidate proposed to treat relapsing multiple sclerosis (MS), the drugmaker said Tuesday. Read More
Pierre Fabre has received FDA approval for its oral drug Hemangeol, indicated to treat proliferating infantile hemangioma (IH) requiring systemic therapy. Read More
UK regulators have created a pathway to speed life-saving drugs to patients under an early-access program, which officials liken to the FDA’s popular breakthrough therapy initiative. Read More
The UK’s healthcare costs watchdog has once more rejected Celgene’s blockbuster cancer drug Revlimid for a new indication. This time, the National Institute for Health and Care Excellence (NICE) says the drug failed to show clear efficacy and cost-effectiveness as a second-line treatment for multiple myeloma. Read More
A court battle is heating up between PhRMA and the Federal Trade Commission over the FTC’s new rule expanding antitrust reviews of post-merger patent transfers, and the fees associated with the expanded reviews. Read More
The FDA has placed clinical trials for California-based biotech Geron’s blood cancer candidate, imetelstat, on hold after liver abnormalities were found in study subjects. Read More
Purdue Pharma is reporting positive results for an investigational once-daily analgesic that could compete with Zogenix’s controversial painkiller Zohydro ER, which, unlike Purdue’s candidate, lacks abuse-deterrent properties. Read More