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Iceland-based biosimilar developer Alvotech has sued AbbVie in a U.S. federal court, seeking to have AbbVie’s patents for its blockbuster arthritis drug Humira (adalimumab) declared invalid. Read More
Attorneys representing more than 70,000 plaintiffs in multi-district litigation against Sanofi have accused the company of “widespread destruction” of company emails associated with a 2019 recall of its Zantac (ranitidine) heartburn medication and asked a federal court to allow more time to gather evidence. Read More
The Institute for Clinical and Economic Review (ICER) has assessed the clinical effectiveness and value of three new treatments targeting the B-cell maturation antigen for heavily pre-treated patients with triple-class refractory multiple myeloma who have completed many previous lines of therapy. Read More
A group of 10 moderate House Democrats have written to Speaker Nancy Pelosi (D-Calif.) urging her to embrace bipartisan drug pricing legislation, signaling a cooperative effort as a more realistic way to get a drug pricing bill to the Oval Office. Read More
The FDA has finalized guidance on qualified infectious disease product (QIDP) designations, drug designations that are meant to encourage the development of certain antibacterial and antifungal products for serious or life-threatening infections. Read More
The House on Tuesday failed to pass the Fairness in Orphan Drug Exclusivity Act, a bill that would have closed an orphan drug exclusivity loophole used to prevent competing drugs from hitting the market, with Republican opposition barring it from moving onwards to the Senate. Read More
The FDA has finalized guidance on post-approval chemistry, manufacturing and control (CMC) changes developed in collaboration with the International Council for Harmonization (ICH). Read More
The Department of Justice and the American Civil Liberties Union (ACLU) have filed a joint motion calling on a U.S. district court in to wait until December to decide on a high-profile case over the abortion pill, Mifeprex (mifepristone), while the FDA reviews the drug’s risk evaluation and mitigation strategy (REMS). Read More
AstraZeneca (AZ) may forgo seeking Emergency Use Authorization (EUA) from the FDA and instead go for full approval for its COVID-19 vaccine off the bat. Read More