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The U.S. Court of Appeals for the Federal Circuit found that a district court was overly broad in its interpretation of patents in a lawsuit by a Teva subsidiary accusing Apotex of infringing its patents for the coating on a muscle relaxant pill. Read More
A new FDA draft guidance recommends sponsors include new class labeling and prescribing information for combined hormonal contraceptives containing estrogen and progestin. Read More
The trial results showed the combinations did not significantly increase the risk of asthma-related hospitalizations, intubations or asthma-related deaths. Read More
The PTO’s Patent Trial and Appeal Board dismissed a patent owner’s claims of sovereign immunity from the proceedings — in a move that might have implications for Allergan’s Restasis patent case involving a Native American tribe that is currently pending before the board. Read More
The FDA is requesting all NDA and ANDA holders to submit a one-time, written status report to the agency after reviewing the information published in the Orange Book. Read More