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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A new draft guidance from the FDA offers drug sponsors recommendations for developing potency assays for every stage of the lifecycle of monoclonal antibodies (mAbs) that directly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
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 the drug’s price below what its own models indicated to be a fair price. Read More
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 requirements — yet another call for the FDA to step up enforcement in this area. Read More