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The FDA dinged generics maker Cipla’s quality unit for several lapses, including failing to properly investigate batch discrepancies or the impact of power outages on drug product, during a Feb. 6-17 inspection of the company’s Madhya, Pradesh, India plant. Read More
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). Read More
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) to traditional approval. Read More
Drugmakers and others in the pharmaceutical supply chain still have much overhauling of shipping and verification systems and processes to do if they are to meet the Nov. 27 deadline for Drug Supply Chain Security Act (DSCSA) compliance, a new report says. Read More
The bill would enable the FDA to immediately approve drugs instead of waiting out the normal 30-month approval stay if the only barrier to approval is a REMS patent. Read More
A new draft guidance from the FDA offers drug sponsors recommendations for developing potency assays for every stage of the lifecycle of monoclonal antibodies (mAbs) that directly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. Read More
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. Read More
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 the company. Read More
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 from Sen. Bernie Sanders (I-Vt.) calling on the two companies to follow suit. Read More