Concerns about biopharma executives profiting from stock sales aligned with releases of promising COVID-19 vaccine results could result in Congress requiring a cooling-off period for executives’ 10b5-1 plans that provide a safe harbor to insider trading.

The question of whether the U.S. FDA will review emergency use authorizations (EUAs) for lab-developed tests (LDTs) for the COVID-19 pandemic has bounced around frequently in recent weeks, and Brett Giroir of the Department of Health and Human Services has resurrected the issue.

The European Commission has awarded the CE mark to Hologic Inc. for its Genius Digital Diagnostics system for cervical cancer screening. According to the company, it is the first digital cytology platform to combine a new artificial intelligence (AI) algorithm with advanced digital imaging to assist cytotechnologists and pathologists in detecting precancerous lesions and malignant cells in women.

Even as Alkermes plc works to resolve the complete response letter (CRL) sent by the FDA regarding ALKS-3831, labeling talks are underway for the compound, an oral therapy for schizophrenia and bipolar I disorder in adults. Regulators reviewed manufacturing records and said the Dublin-based firm needs to supply documents related to making the tablet’s coating at the Wilmington, Ohio, facility. No clinical or non-clinical concerns were raised, the firm said, and shares (NASDAQ:ALKS) hardly moved, closing Nov. 17 at $18.30, up 45 cents.

BOGOTA, Colombia and VANCOUVER, Canada – Anvisa, Brazil’s health care surveillance agency, re-started phase III trials for Coronavac, the COVID-19 vaccine candidate developed by China-based Sinovac Biotech Ltd., after a suspension of just two days. “Anvisa understands that it has sufficient subsidies to allow the resumption of vaccination,” the regulator said on Nov. 11. Anvisa said it plans to continue monitoring “the possible relationship of causality” between an unexpected serious adverse event and the vaccine.