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The FDA is worried that Biogen may take too long to complete a required confirmatory trial for Aduhelm (aducanumab), the high profile Alzheimer’s disease drug that just this week scored a historic FDA approval amidst doubts about its clinical trial data and criticisms of the agency’s close collaboration with Biogen. Read More
The company will now resume the studies and seek regulatory submissions for SCD and beta-thalassemia, said Andrew Obenshain, Bluebird Bio’s president of severe genetic diseases. Read More
The FDA has extended its review of Incyte’s Janus kinase (JAK) inhibitor Jakafi (ruxolitinib) for treating patients with steroid-refractory chronic graft-versus-host disease (GVHD). Read More
With a controversial bankruptcy settlement moving forward in the opioid lawsuit against Purdue Pharma, House Democrats and state attorneys general rallied Tuesday against the deal, calling for passage of legislation to ultimately hold its owners, the Sackler family, accountable. Read More
The FDA has lifted clinical holds on studies evaluating Bluebird Bio’s LentiGlobin gene therapy for sickle cell disease (SCD) as well as trials of a treatment for a blood disorder that uses the same viral vector. Read More
Novartis has become the latest pharma company to sue HHS over its threats to levy financial penalties against drugmakers who hold back 340B drug discounts from contract pharmacies, an effort that’s won a preliminary injunction against the fines for now. Read More
Drug safety surveillance, which saw a massive workload increase at the FDA’s Center for Drug Evaluation and Research (CDER) during the pandemic, hopes to pick up additional funding in the fiscal 2022 budget, said recently appointed center director Patrizia Cavazzoni. Read More
The FDA has finalized guidance on post-approval chemistry, manufacturing and control (CMC) changes developed in collaboration with the International Council for Harmonization (ICH). Read More
The FDA is still working out details of a regulatory pathway for bispecific antibodies, but the agency has issued a guidance for developers that says, generally, the manufacturing processes should follow “standard monoclonal antibody development practices.” Read More
In a revised guidance that will stay in effect until the end of the pandemic, the FDA explained how it will deal with drug applications when it is unable to conduct an inspection because of travel restrictions. Read More