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FDA slaps hold on Finch’s C. diff med to get info on COVID-19 screening for donor-derived therapy (Fierce) (Endpoints)
FDA quickly follows a voluntary pause for CAR-T 2.0 with a clinical hold to investigate 2 patient deaths (Endpoints)
Pfizer's bacterial infection vaccine fails main goal in study (Reuters)
NIH orders sweeping review of potentially risky experiments on viruses and other pathogens (The Washington Post)
How Operation Warp Speed clashed with Pfizer in the early days of the pandemic (Endpoints)
Progressives Press for More Changes to Medicare Payment Program (Bloomberg)
In Focus: International
EMA Begins Setting Up New Bodies To Tackle Drug Shortages (The Pink Sheet)
UK Offers To Help ‘Innovation Passport’ Holders Tackle Market Access Challenges (The Pink Sheet)
Europe's Generics Industry Takes Action To Maintain Medicines Access In Ukraine (The Pink Sheet)
In Difficult Times For AAV Gene Therapies, AbbVie Boosts Regenxbio’s Ambitions (Scrip)
Coronavirus Pandemic
Weaker Omicron variant is great news for the world, but bad news for Covid-related clinical trials (Endpoints)
CDC data suggest Pfizer vaccine protection holds up in kids 5-11, raising questions on earlier study (STAT)
Nerve damage may explain some cases of long COVID -U.S. study (Reuters)
White House unveils new plan to move America past covid crisis, says shutdowns, school closures no longer necessary (Washington Post)
Pfizer to provide 10 mln courses of COVID pill to developing countries -the Global Fund (Reuters)
Pharma & Biotech
Pfizer joins Sanofi on the C. difficile failure train after its vaccine flopped a PhIII study (Endpoints)
Sanofi enlists Adagene and its 'masking' tech to develop new I/O drugs, in a deal potentially worth $2.5B (Endpoints)
3 burning questions spurred by the big CRISPR patent ruling (STAT) (Biopharma Dive)
The Family Dollar Inspection Report: How Not To Handle A Rodent Problem (The Pink Sheet)
As GSK is forced to slam the brakes, Pfizer cruises ahead with a ‘breakthrough’ on RSV (Endpoints)
Vesalius Therapeutics launches to develop treatments for common diseases (STAT)
That bullish stance Karyopharm took on its subgroup cancer study data? The FDA wasn't impressed (Endpoints)
Flagship's latest boast? A startup that will 'revolutionize treatment' for 'ninety percent of human illness' (Endpoints)
SEC jumps into the FibroGen fiasco with a subpoena, probing cardio data manipulation (Endpoints)
Medtech
IVD Expert Panel: First 15 Reviews Performed With Many Requests For Additional Information (MedTech Insight)
FDA approves J&J’s allergy-fighting contact lens infused with an antihistamine (Fierce)
QMSR Quick Take: Medtech Consultant Steve Silverman (MedTech Insight)
FDA Warns Against Use Of 3 Unapproved COVID-19 Tests (MedTech Insight)
Sanofi strikes $30M strategic agreement with digital health company DarioHealth (MedTech Dive)
Quanterix links up with Eli Lilly for Alzheimer’s blood biomarker testing collaboration (Endpoints)
Zimmer Biomet completes spinoff of ZimVie spine, dental business (Fierce)
Government, Regulatory & Legal
Tennessee judge sanctions Endo for withholding opioid documents, refuses to recuse himself from case (STAT)
Purdue Pharma mediator extends talks to resolve Sackler liability for opioid epidemic (Reuters)
3 Product Liability Highlights from The State of The Union (Law360)
High Court Poised to Make DOJ's Job Harder in Opioid Cases (Law360)
Supreme Court debates exactly when a doctor’s misprescribing becomes criminal (STAT)
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.
Three major pharmaceutical industry groups—two in the US and one in India—have called for changes to the US Food and Drug Administration's (FDA) Scale-Up and Post-Approval Changes (SUPAC) guidelines. They believe these guidelines should be updated to reflect more modern manufacturing methods and better align with International Council for Harmonisation (ICH) standards.
Patients with breast cancer said faster approval times for oncology products, as a trade-off for evidentiary certainty, is most permissible in situations where there are no treatment alternatives, the results from a recent qualitative study suggest.