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An FDA advisory committee may have given its unanimous approval for a biosimilar application this month, but industry and patient groups contend the regulatory pathway still has many potholes and unanswered questions. 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
Unauthorized knock-offs of Gilead’s pricey blockbuster hepatitis C therapy, Sovaldi, may soon hit the market in India after the government refused to grant it patent protection. Read More
Mylan and Abbott have submitted proposed commitments to the European Commission’s competition oversight body to allay anti-competitive concerns over a proposed merger that would reincorporate Mylan in the Netherlands. Read More
Actavis must keep its Alzheimer’s drug Namenda on the market for now, but a recent agreement with the New York Attorney General will let the company avoid notifying more than half a million people of that fact. Read More
A federal appeals court is expected to rule next month in a dispute over Actavis’ plan to pull an older formulation of its blockbuster Alzheimer’s drug Namenda from the market and replace it with a newer version. Read More
India appears to be working somewhat on its reputation as being unfriendly to foreign drug patents, with a court temporarily blocking Cipla from marketing its own generic version of Novartis’ COPD therapy Onbrez. Read More
Hikma Pharmaceuticals will launch its gout treatment, Mitigare, after a federal court rejected Takeda’s arguments to block the product, which would compete with Takeda’s drug Colcrys. 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
The FDA this year aims to answer key questions on which quality metrics it will collect from drugmakers, how to develop biosimilars and how to use social media to promote products. Read More