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
Thermo Fisher Scientific plans to buy PPD for $17.4 billion to bolster its clinical research service offerings to pharmaceutical and biotech companies.
Nestlé Research has linked a specific blend of myo-inositol (a type of sugar), probiotics, riboflavin, zinc and vitamins D, B6 and B12 to the decreased incidence of preterm birth when consumed before and during pregnancy.
Eli Lilly hired a new digital chief from Apple in another consumer switch for pharma and as the industry speeds up its shift to online strategies.