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AbbVie and Eli Lilly have pulled out of a voluntary UK drug pricing agreement for the National Health Service (NHS) — a move that could leave NHS patients with curtailed access to their therapies. Read More
Oncology drug trials should consider a wide range of dosages and how they impact a wide variety of participants, rather than immediately titrating patients up to the maximum tolerated dose (MTD), the FDA said in a new draft guidance. Read More
Reforms in orphan drug exclusivity will see significant movement in 2023, according to Andi Fristedt, the FDA’s deputy commissioner for policy, legislation, and international affairs. Read More
The European Medicines Agency (EMA)’s safety committee has recommended measures to reduce the serious side effects linked with Janus kinase (JAK) inhibitors used to treat chronic inflammatory disorders. Read More
California is taking to the courts to challenge insulin pricing, charging that Eli Lilly, Novo Nordisk, Sanofi and three pharmacy benefit managers (PBMs) have conspired to set the price of insulin and to keep it on an ever-increasing trajectory. Read More
The FDA’s new pilot, the Biosimilar Regulatory Science Program, has gotten off the ground and has awarded grants for five projects that will explore ways to enhance biosimilar and interchangeable biosimilar product development and regulatory science. Read More
A new draft guidance from the FDA provides a variety of recommendations for the content of drug dosage and administration labeling, including information on dosage range, risks related to drug handling, concomitant treatments, specific populations and missed doses. Read More
A nonprofit physicians’ group has issued a statement calling for a full vetting of Eisai’s Alzheimer’s disease drug Leqembi (lecanemab) in an FDA advisory committee meeting before the agency makes any decision on full approval. Read More
Sandoz received bad news Tuesday when a federal appeals court affirmed the FDA’s decision to deny its challenge and grant Sanofi the exclusive right to market the blockbuster multiple sclerosis drug Aubagio. Read More