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A federal judge dealt Otsuka a blow, dismissing claims that the FDA is precluded from approving generic versions of its blockbuster antipsychotic Abilify until its orphan exclusivity runs out in December 2021. Read More
The U.S. Supreme Court has declined to review a lower court ruling that upheld a California county ordinance requiring drugmakers to collect and dispose of unwanted drugs, in an outcome that could end up costing industry millions of dollars. Read More
Beleaguered Indian generics maker Wockhardt is recalling 93,393 bottles of its blood pressure medicine Captopril in the U.S., after discovering the tablets failed to meet specification for thickness. Read More
India’s Supreme Court has temporarily barred Glenmark Pharmaceuticals from making new copies of Merck’s diabetes drugs Januvia and Janumet, but the Mumbai-based company may continue to sell its existing stock. Read More
Endo International has agreed to buy Par Pharmaceutical from private equity firm TPG for $8 billion, in a deal the companies say will put them within the top five firms in the U.S. generics market. Read More
The former chairman of the Senate Veterans Affairs Committee is pressing the VA to invoke a wartime provision to break the patents on Gilead Sciences’ pricey hepatitis C drug Sovaldi, after the agency stopped treating veterans because it had exceeded the more than $400 million budgeted for hep C treatment. Read More
AbbVie has been sued over an alleged pay-for-delay scheme involving its blockbuster testosterone drug AndroGel, two days after a federal court in Pennsylvania dismissed some claims in a similar suit filed last year by the Federal Trade Commission. Read More