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
Source: biopharmadive.com
“There’s no better place to meet our industry partners in person and get a first-hand feel for the state of the pharma industry than at CPHI,” says Borderless Partner Rosalie Harrison, who leads the firm’s life sciences practice.
On Sep. 25, German biopharma company Boehringer Ingelheim opened its new 11,000 sqm Angelika Amon Research Building at its site in Vienna, Austria. According to Boehringer Ingelheim, the investment of around €60 million is further proof of the company’s commitment to cancer research.
Eli Lilly and Company (Lilly) recently announced a $4.5 billion (€4.07 billion) investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The facility will enable Lilly to research new methods of producing medicines and scale up manufacturing for clinical trials.
