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United Therapeutics has filed suit in federal court in New Jersey, claiming Allergan’s Paragraph IV ANDA for a generic version of its hypertension drug Tyvaso violates three of the drug’s patents. Read More
A U.S. district court in Maryland has let stand the FDA’s November 2014 decision to revoke Mallinckrodt’s equivalence rating for its generic version of Janssen’s ADHD drug Concerta. Read More
GlaxoSmithKline, which last year paid Chinese authorities $483 million to settle corruption charges, is facing similar allegations in Romania. Read More
Pfizer has terminated its over-the-counter Lipitor program in the U.S. after a Phase 3 clinical trial showed that patients required a physician’s help to take the cholesterol-lowering drug correctly. Read More
The European Commission is suspending sales and distribution of 700 formulations of more than four dozen generic drugs after determining that the bioequivalence testing on which their approvals were based included manipulated echocardiogram data. Read More
Drugmakers doing business in India should prepare for price caps on more drugs as the National Pharmaceutical Pricing Authority rushes to complete price fixes on 98 essential drugs. Read More
Hikma Pharmaceuticals is purchasing Boehringer Ingelheim’s Roxane generics unit for $2.65 billion, in a deal that will make the Jordanian drugmaker the sixth largest provider of generics by revenue in the U.S. Read More