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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. Read More
Genentech has filed a complaint against Biogen seeking patent royalties from a manufacturing process Biogen allegedly used to produce its multiple sclerosis (MS) drug Tysabri (natalizumab). Read More
The FDA and the Federal Trade Commission (FTC) have launched a campaign against false or misleading information about biosimilars that “may constitute unfair or deceptive practices” leading to decreased confidence in biosimilars. Read More
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