FDA advisors mostly agree that Acadia’s Nuplazid isn't effective at treating Alzheimer’s-related psychosis (Endpoints)
In Focus: International
Pfizer to buy 8.1 percent stake in French vaccines company Valneva (Reuters)
EU drugs watchdog begins review of Moderna's variant COVID vaccine (Reuters)
WHO panel backs use of Omicron-adapted vaccine as booster dose (Reuters)
Greece Files Graft Lawsuit Against Novartis: Minister (Barron’s)
FTC could sanction AstraZeneca over alleged collusion (The Korea Herald)
China Tweaks On-Site Inspection Priorities As Registration Filings Soar (Endpoints)
BioNTech chief calls for speedy ruling on Covid vaccines that target latest strains (FT)
Global regulators work towards strengthening collaboration on observational research beyond COVID-19 pandemic (EMA)
EMA Management Board: highlights of June 2022 meeting (EMA)
Pharma & Biotech
Never forget that early vaccines came from testing on enslaved people (STAT)
WTO's IP waiver for vaccines is out and the response is generally negative — from all sides (Endpoints)
J&J inks clinical trial deal with Stand Up To Cancer, latest pharma to join cancer nonprofit study efforts (Endpoints)
Pushing for top spot in Big Pharma, AbbVie lands a key approval for its blockbuster Skyrizi (Endpoints)
More drug, fewer jabs: Novartis' Sandoz eyes EMA nod for high-concentration Humira copy (Fierce)
Teetering on the brink, Clovis abandons an early approval for Rubraca (Endpoints)
EU Proposes Changes To Labeling Of Investigational Drugs Under Clinical Trial Regulation (Pink Sheet)
Medtech
Morcellation Containment System Guidance Stresses Leak Detection, Prevention (MedtechInsight)
The Pace Of Cyberattacks Is Accelerating. Can Regulators Keep Up? (MedtechInsight)
MDR And IVDR – Similar Step Ups, Varying Commercial Impacts (MedtechInsight)
Government, Regulatory & Legal
Bristol Myers petitions the Supreme Court in a final bid to prove Gilead's Kite infringed on CAR-T patents (Endpoints)
Generic Co. Asks Fed. Circ. To Undo Loss In Takeda IP Fight (Law360)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported that the agency has approved 17 pharmaceuticals that utilize continuous manufacturing in their production.
The European Medicines Agency (EMA), in partnership with the European Commission (EC) and the Heads of Medicines Agencies (HMA), has published the first quarterly report on the state of clinical trials conducted in the EU and the European Economic Area (EEA). The report is intended to shed light on the progress being made to attract more clinical trials to the region and increase access to new treatments as part of the targets set by the EU in 2025.
An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to secure approval for their products.