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
This year has already witnessed a handful of memorable FDA approvals. But the race isn’t over yet. Looking to close out 2021 with FDA approvals stand four potential blockbusters from the likes of Argenx, UCB, Pfizer and Roche, according to Evaluate Pharma. Those meds combined are worth roughly $7.1 billion in sales cumulatively by 2026, according to Evaluate’s estimates.
Getting started is often the most difficult part—and that’s especially true in rare diseases and diagnoses. Patients and families often spend many years searching for their diagnosis starting point. For Horizon Therapeutics’ first innovation challenge, it took that struggle to heart and asked for technology-based rare disease solutions that result in faster or more accurate diagnoses.
Researchers from the Quadram Institute and the University of East Anglia (UEA) discovered that treating mice with broad-spectrum antibiotics increased the rate at which their breast cancer tumours grew.
