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
Hybrid closed-loop systems rely on an algorithm to first analyze real-time blood sugar readings from a continuous glucose monitor, then use the results to adjust an insulin pump’s output as needed throughout the day. In this case, the algorithm was developed by Diabeloop, the CGM is a Dexcom G6 sensor, and the insulin pump comes from ViCentra.
Boehringer Ingelheim has acquired bacterial cancer therapy company T3 Pharmaceuticals in a deal that could be worth up to 450 million Swiss francs ($508 million). The addition of Allschwil, Switzerland-based T3 will “significantly expand” the German drugmaker’s immuno-oncology pipeline and aligns with some of the company’s existing R&D programs.
EuroAPI has completed the acquisition of BianoGMP, a contract development and manufacturing organization (CDMO) specializing in oligonucleotides. The acquisition, announced in August, further differentiates its value proposition to support a broader client base across the whole oligonucleotide development continuum, from research to commercialization, EuroAPI said.