Archive for July 2022

Avadel Pharmaceuticals has sued the FDA and HHS for holding up review and approval of its Lumryz narcolepsy drug after making administrative errors in the approval process, including delaying the review 10 months beyond the legal limit and requiring an unneeded patent certification. Source: Drug Industry Daily

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. Source: Drug Industry Daily

Sandoz’s biosimilar of Biogen’s blockbuster multiple sclerosis drug Tysabri (natalizumab) has gained new regulatory footholds with both the FDA and the European Medicines Agency (EMA). Source: Drug Industry Daily

Boise, Idaho-based Episciences was issued an 8-observation Form 483 for missing testing procedures, deficient cleaning and other quality lapses. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily