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Indian drugmaker Hetero has launched a biosimilar version of Roche’s Rituxan on the subcontinent, with plans to introduce it in key markets outside India through strategic partners. Read More
Pfizer has acquired exclusive rights to market potential generic versions of Teva’s multiple sclerosis drug Copaxone, under an agreement with Synthon. Read More
The Federal Circuit appeals court has denied AstraZeneca’s effort to block Mylan’s launch of a generic version of the acid reflux blockbuster Nexium, paving the way for additional competition for the drug. Read More
The Senate and House Appropriations Committees are calling on the FDA to issue guidance on biosimilars standards and work with industry to prevent drug shortages as part of their fiscal 2016 funding bills. Read More
Drugmakers want to know when changes to chemical, manufacturing and controls in ANDAs and other drug and biologics submissions must be reported to the FDA, saying draft guidance lacks clear criteria and examples. Read More
Indian generics maker Lupin is set to buy privately held U.S. generics maker Gavis Pharmaceuticals for $880 million, a move that expands Lupin’s share of the U.S. generics market. Read More
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