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FDA won’t review Novo diabetes drug in latest case of regulatory pushback

March 27, 2021
Life sciences

The FDA’s letter to Novo is the latest example in a series of regulatory pushbacks that some analysts view as signs of tougher oversight from the agency.

In recent weeks, the FDA has surprised Acadia Pharmaceuticals with an unexpected notice of “deficiencies” in the company’s drug application and FibroGen with the unexpected scheduling of an advisory committee meeting. Reviews of drugs from AbbVie and Kadmon, meanwhile, have been extended past scheduled decision dates.

More broadly, the agency is in the midst of an “industry-wide” review of accelerated approvals for cancer immunotherapies, and appears to be enforcing a tough line on manufacturing with cell and gene therapy developers. READ MORE

by Ned Pagliarulo


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