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
Antibiotic resistance remains one of the biggest public health challenges. New drugs are still needed to tackle tough-to-treat bacteria. But finding new therapeutics to kill off pathogenic bacteria has been difficult.
Viral vectors are engineered viruses used to deliver gene therapies, gene-modified cell therapies and certain vaccines. And their shortage is already upon us, thanks to manufacturing approaches that simply haven’t kept pace with the advance of cell and gene therapies.
Beigene, a fast-growing drugmaker based in Cambridge, Massachusetts and Beijing, will partner with Shoreline Biosciences to develop cell therapies for cancer, expanding its research beyond the small molecule and antibody drugs.