STAT+: Pharmalittle: FDA rejects Merck cough medicine; Sanofi abandons an ADC for lung cancer
The FDA rejected Merck's treatment for chronic cough, saying the application "did not meet substantial evidence of effectiveness," the company said.
Good morning, everyone. Damian Garde here, filling in for Ed Silverman in a week customarily devoted to deciding just which tasks one can get away with putting off until next year. Here’s hoping you’re firmly on the downslope of doing actual work for the remainder of 2023. In the meantime, here are a few tidbits to start your day. And, as always, do let us know if you hear anything interesting out there. …
The Food and Drug Administration rejected Merck’s treatment for chronic cough, the company said. The application “did not meet substantial evidence of effectiveness” refractory chronic cough or unexplained chronic cough, according to Merck. The company said it’s reviewing the FDA’s feedback to determine next steps for the medicine.
BioMarin Pharmaceutical signed a deal with activist investor Elliott Management that will likely prevent a proxy challenge, the company announced. Under the agreement, BioMarin will add three members to its board, conduct a review of its business strategy, and host an investor day in 2024. Elliott, famous for its successful disputes with management teams, had taken up a stake in BioMarin and reportedly urged the company to change course.
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