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A federal appeals court last month affirmed a lower court order preventing Actavis from replacing an older formulation of Namenda ahead of generic versions of the Alzheimer’s drug hitting the market in July. Read More
The FDA is clarifying its definition of “established conditions” to ensure drugmakers properly report postapproval chemistry, manufacturing and control changes in NDAs, ANDAs and BLAs. Read More
If the FDA were to implement a quality metrics program similar to the collection of 16 metrics used in ISPE’s Quality Metric Pilot Program, the cost would be about $75,000 annually per company, or $35 million across the industry, ISPE says. Read More
Cephalon has agreed to pay the federal government $1.2 billion to settle antitrust allegations that it illegally blocked competition to Provigil by paying generics makers to hold off on their versions of the blockbuster narcolepsy drug. Read More
For the second time in two days, the FDA has recommended approval of a PCSK9 inhibitor as an effective and relatively safe means of lowering bad LDL cholesterol. Read More
The Goldwater Institute is suing the FDA after it denied the group’s Freedom of Information Act request for information on the process the agency used in allowing two Americans to be treated with an investigational anti-Ebola drug. Read More
The European Medicines Agency Wednesday released final guidance on the primary and secondary endpoints sponsors should use to evaluate drugs to treat acute heart failure — along with recommendations on designing and conducting such studies in children. Read More
The FDA has granted breakthrough therapy status for Genentech's scleroderma treatment Actemra, guaranteeing the drug a six-month review rather than the usual 10 months. Read More
The Australian government has developed a framework for measuring the performance of its regulatory agencies, in an effort to increase transparency and cut down on practices that impede the operations of regulated industries. Read More