The FDA has granted priority review to Eisai’s and Biogen’s supplemental biologics license application (sBLA) for their Alzheimer’s treatment candidate Leqembi (lecanemab-irmb), supporting the biologic’s conversion from Accelerated Approval (AA)…
Intercept Pharmaceuticals has resolved patent litigation against Apotex Pharmaceuticals and MSN Laboratories over their alleged infringement on Intercept’s intellectual property protections for its liver disease drug Ocaliva (obeticholic acid). Source:…
Eisai pushed back yesterday against price cut recommendations by the Institute for Clinical and Evidence Review (ICER) for its Alzheimer’s treatment Leqembi (lecanemab), saying that the company had already reduced…
A new draft guidance from the FDA offers drug sponsors recommendations for developing potency assays for every stage of the lifecycle of monoclonal antibodies (mAbs) that directly target viral proteins.…
Novo Nordisk and Sanofi, the two largest makers of insulin in the U.S., seem unlikely to budge on pricing despite competitor Eli Lilly’s announcement of price cuts and subsequent letters…
The FDA has denied a citizen petition to grant a breakthrough therapy designation for Cassava Science’s investigational Alzheimer’s therapy, simufilam, because the petition was submitted by an individual rather than…
Catalyst Pharmaceuticals has filed a lawsuit against Lupin Pharmaceuticals alleging that Lupin’s proposed generic of Firdapse (amifampridine) runs afoul of patent rights for the Lambert-Eaton myasthenic syndrome (LEMS) drug. Source:…
The FDA has said no to Cytokinetics’ new drug application (NDA) for omecamtiv mecarbil, an investigational treatment for heart failure with reduced ejection fraction (HFrEF). Source: Drug Industry Daily
An international group of university students devoted to advancing health equity and access to therapies has filed a citizen’s petition seeking heightened efforts to improve compliance with clinical trial reporting…
In its latest annual report on drug safety priorities, the FDA’s Center for Drug Evaluation and Research (CDER) highlighted the agency’s continued focus on COVID-19 products and its commitment to…