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Pennsylvania compounder Summit Health Pharmacy has petitioned the FDA to include oxitriptan on the agency’s 503A bulk substances list—and says the agency should also allow it for compounding in the meantime. Read More
Pfizer is calling on the FDA to retroactively assign four-letter suffixes to biologics that act as reference products for innovative biosimilars. Read More
PhRMA will back “responsible” drug patent reforms, but lawmakers would do well to remember how essential patent protections are to getting life-saving medicines to patients, one of the group’s executives told a Senate panel Tuesday. Read More
The designers of a single-payer system “would need to consider whether a substantial reduction in drug prices would reduce manufacturers incentive to develop new drugs,” the report states. Read More
A dispute between Amgen and generics maker Cipla is headed to appellate court after a federal judge turned aside Amgen’s effort to get Cipla to stop making generics of the blockbuster Sensipar while the two companies litigate over rights. Read More
Acacia Pharma’s anti-nausea drug Barhemsys has stalled again, with the FDA issuing a second complete response letter in less than a year over problems at the plant that makes the drug’s main ingredient. Read More