Recon: FDA rejects Aquestive’s allergy therapy over packaging concerns; Novo’s CagriSema tops Wegovy in Phase 3 diabetes study
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
New rule would force PBMs to disclose drug rebates and other fees (STAT)
FDA rejects Aquestive's allergy drug over packaging issues (Endpoints)
FDA opens submissions for PreCheck program to speed up US factory builds (Endpoints)
Pharming’s immunodeficiency drug gets CRL for use in younger patients (Endpoints)
Does America Still Know How to Spur Innovation? (Bloomberg)
Top 10 most anticipated drug launches of 2026 (Fierce Pharma)
In Focus: International
Sanofi is reprimanded by a U.K. trade group for misleading claims about a Pfizer vaccine (STAT)
European law changes mean drugmakers may have to grapple with generic competition sooner (Endpoints)
China’s Pampered Cats Spur Weight-Loss Drug Application (Bloomberg)
India to Spend $1.1 Billion to Make Biopharma Production Hub (Bloomberg)
A Quality Tax for Foreign Drug Makers? The Links Between National Security, Trade Deals, and Drug Quality. (FDA Law Blog)
Pharma & Biotech
Novo Nordisk's next-gen obesity drug outperforms Wegovy in late-stage diabetes trial (Reuters)
Obesity market sales potential tightens as Novo and Lilly enter new era (Reuters)
As male birth control gets closer to reality, men are lining up for clinical trials (STAT)
As its immunology work draws attention, Sanofi also pushes forward in rare disease (STAT)
GSK gives back rights to Wave Life Sciences' lead RNA editing program (Endpoints)
SanegeneBio licenses RNAi candidate to Genentech for $200M upfront (Endpoints)
Sanofi’s rare disease drug notches one win, one loss in a pair of Phase 3 trials (Endpoints)
Even Tech Skeptics Can Cheer AI’s Promise in Decoding the 'Dark Genome' (Bloomberg)
AstraZeneca Shares Start Trading in US After Listing Upgrade (Bloomberg)
Medtech
Boosting Your Brain With a Chip Carries a Price (Bloomberg)
Lawsuit challenges ethylene oxide exemptions for device sterilizers (MedTech Dive)
Grail files for FDA approval of multi-cancer early detection test (MedTech Dive)
At INBRAIN’s 5-Year Mark, BCI Experts Confront The Promise, Perils Of Brain-Computer Interfaces (MedTech Insight)
Thermo Fisher winds down Boston area plant (Fierce Pharma)
Food & Nutrition
France Lowers Limit for Toxin in Baby Formula, May Spark Recalls (Bloomberg)
EU body's advice on toxin limit in baby formula prompts more recalls (Reuters)
The food and beverage outlook for 2026 (Food Dive)
Government, Regulatory & Legal
Nine states challenge federal mandate that disabled people receive care in community (STAT)
Newsom files a civil rights complaint against CMS’ Oz in latest feud with the Trump administration (STAT)
The EPA just erased a century of public health progress (STAT)
How much should psychedelics researchers disclose about their personal use? (STAT)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
The US Food and Drug Administration (FDA) issued final guidance on 13 August regarding the types and timelines for formal meetings that sponsors can request during the development of new drugs and biological products.
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