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Latest From Covis Pharma
The company offered to stipulate that findings from the PROLONG trial do not verify clinical benefit of the preterm birth prevention drug; the US FDA’s drugs center opposed a stipulation, saying failure of a confirmatory trial to verify clinical benefit is an independent ground for withdrawing accelerated approval and an advisory committee should vote on the question.
Company is coming into its second panel meeting with new data analyses from the CENTAUR trial, advisory committee experience under its belt, and a recent Health Canada approval. In an interview with the Pink Sheet, co-CEOs Cohen and Klee highlight clinical outcomes data with AMX0035 and say they are not too worried about the lack of effect on neurofilament biomarker.
Teva has appointed a new general manager in Canada following the departure of Christine Poulin to Covis Pharma. At the same time, Amneal’s associate general counsel, Meredith Cook, has taken up a role at ANI Pharmaceuticals, while Alvotech has appointed several new directors to its board as part of its transition to being a publicly-listed company.
Pink Sheet reporters and editors discuss new changes to the Senate drug pricing bill, the FDA’s decision to call a second advisory committee meeting for Amylyx’s ALS drug, and Covis’ request to skip a vote during the hearing on Makena’s withdrawal.