Many Accelerated Approval Drug Labels Lack Required Marketing Information
More than 10 percent of drugs marketed with an Accelerated Approval (AA) failed to include mention of the AA on the label, a new study has found. Source: Drug Industry…
As DSCSA Deadline Looms, Manufacturers’ Supply Chains Still Have Far to Go
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…
FDA Grants Leqembi Priority Review for Full Approval
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 Settles Ocaliva Lawsuits With Apotex, MSN Labs
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 Defends Leqembi Pricing in Face of ICER Recommended Cuts
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…
FDA Offers Guidance on Potency Assays for Antibodies That Target Viral Proteins
A new draft guidance from the FDA offers drug sponsors recommendations for developing potency assays for every stage of the lifecycle of monoclonal antibodies (mAbs) that directly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, Sanofi Unlikely to Cut Insulin Prices Despite Pressure From Senator
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…
FDA Denies Petition by Cassava Investor to Grant Simufilam Breakthrough Designation
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 Launches Patent Suit Against Lupin Over Firdapse Generic
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:…
CDER Prioritized Safety of COVID-19 Products, Opioids in 2022, Report Says
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…
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