Pink Sheet reporters and editors discuss the newly approved ALS drug Relyvrio, the promising data on the Alzheimer’s drug lecanemab, and CMS’s efforts to build the drug price negotiation program.

Pink Sheet reporters and editor discuss the impact of the long wait for a user fee deal to be negotiated, how the FDA will interpret President Biden’s statement that the COVID-19 pandemic is over, and concerns with the clinical development of the monkeypox treatment Tpoxx.

Pink Sheet reporters and editors discuss the role of real world evidence in US FDA product decisions, staffing and other problems that are limiting the agency’s ability to implement lessons from the pandemic, and updates to COVID-19 vaccine adverse event reporting requirements.

Pink Sheet reporters and editors discuss the positive advisory committee recommendation for Amylyx’s proposed ALS treatment, the striking drop in clinical trials conducted in Russia following the start of the war in Ukraine, and questions about Medicare price negotiations avoiding political influence.

Pink Sheet reporters and editor discuss the emergency use authorization for the updated COVID-19 vaccines, the new FDA Overdose Prevention Framework, and key decisions and deadlines upcoming in September.

Pink Sheet reporter reviews recent stories on US FDA concerns about the EU data protection regulation, the US enacting the Medicare price negotiation law, warning letters sent to Emergent BioSolutions and ImprimisRx, and Amylyx’s ALS drug going in front of the Institute for Clinical and Economic Review.

Pink Sheet reporters and editor discuss the new monkeypox vaccine EUA, the potential impact of drug pricing legislation, and how things may have been different if the FDA already had a desired technology upgrade.

Pink Sheet reporter looks at the biggest US FDA and pharma industry stories of the week, including the status of US FDA user fee renewal legislation, new real-time oncology review program guidance, Biogen’s ALS accelerated approval play, and Teva settling opioid litigation.