CooperSurgical is hit with second letter for misleading promotion of its copper-containing intrauterine contraceptive. Video lacked any safety information, agency says in request for corrective communication.

Pfizer and Moderna execs note they have sufficient resources with their partners to meet their vaccine production commitments. J&J, which has a manufacturing arrangement with Sanofi, is ready to ship four million doses of its vaccine upon receiving authorization from FDA.

Pfizer and Genentech execs describe steps they’ve taken to increase diversity in clinical trials from moving trial sites into new neighborhoods to modifying protocols and holding others accountable for diversity.

From biomarkers to treatment effect size, agency officials respond to some of more than a hundred questions that poured in during a webinar on development of drugs to treat the liver disease.

Federal Circuit panel to reconsider whether Teva induced infringement of GSK Coreg patent despite label carve-out. Biologics and biosimilars could be particularly hurt if ruling stands given FDA’s recent guidance requiring reference to branded product.

Sanofi R&D head John Reed says company has kept 95% of patients on its nearly 400 clinical trials and started 59 studies. Company has also stepped up collaborations and closed acquisitions, integrating employees remotely.