We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Teva Pharmaceuticals has agreed to a proposed $4.25 billion settlement to resolve lawsuits brought by more than 2,500 U.S. cities, counties, states and Native American tribes over the company’s alleged role in the opioid crisis. Read More
The defendants are barred from seeking or accepting reimbursement for any Gilead medication dispensed to individuals enrolled in the programs. Read More
A three-judge panel has rejected Pfizer’s plan to help Medicare patients pay for one of its most expensive drugs, citing the federal anti-kickback statute. Read More
The FDA has granted priority review status to Biogen’s New Drug Application for tofersen, giving the drugmaker an early win in its battle for an amyotrophic lateral sclerosis (ALS) therapy. Read More
Sens. Cory Booker (D-N.J.) and Rand Paul (R-Ky.) introduced a bill yesterday seeking to update the Right to Try Act to permit terminally ill patients to access Schedule I drugs that have completed a phase 1 trial — including MDMA and psilocybin. Read More
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended 11 new medicines for EU marketing authorizations at its July 18-21 meeting. Read More
Several cancer organizations have voiced strong support for the Biden administration’s apparent pick for National Cancer Institute (NCI) director, Monica Bertagnolli, a distinguished surgical oncologist with a long career in clinical research. Read More
The International Coalition of Medicines Regulatory Authorities (ICMRA) has published a call to bring stakeholders together in a discussion about using real-world evidence (RWE) and real-world data (RWD) in bringing new medicines to market. Read More
Sponsors of cancer drugs can apply for real-time review of their trial data if their investigational products demonstrate substantial improvements over available therapy and use straightforward study designs and endpoints that can be easily interpreted, according to a new FDA draft guidance. Read More