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4 February 2025
by Jason Scott

Recon: FDA approves Supernus’ Parkinson’s drug-device combo; Uganda launches vaccine trial for Sudan Ebola strain

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • FDA approves Supernus’ Parkinson’s drug-device after two rejections (Endpoints)
  • He ruled the operating room and then daytime TV. Now, Dr. Oz is set to take over a $1.5 trillion health agency (STAT)
  • A crucial moment for RFK Jr. And for Bill Cassidy (STAT)
  • RFK Jr.’s nomination clears a major hurdle as key GOP senator assents (STAT)
  • The first shot taken at Medicaid, and Optum’s wellness visit ad (STAT)
  • FDA Communications In Flux As HHS Assesses Mission-Critical Activities (Pink Sheet)
  • Pfizer shows profit growth from cost cuts and steadier COVID sales (Reuters)
In Focus: International                                                                                                       
  • A new Ebola Sudan vaccine trial is underway (STAT)
  • Smooth Transition To EU Clinical Trials Regulation With Only A ‘Few Hundred’ Left Behind (Pink Sheet)
  • Indian Startups Look To Fill The Void Left By The Refurbished Medical Device Ban (MedTech Insight)
  • Angle Shares Up After New Research Released In Partnership With Illumina (MedTech Insight)
  • UN warns maternal deaths in Afghanistan may rise after US funding pause (Reuters)
  • Merck’s 2025 guidance hit by Gardasil pause in China (STAT)
  • Stada CEO Sees Strong Investor Demand Ahead of Top European IPO (Bloomberg)
Pharma & Biotech
  • CAR-T cells can arm other immune cells with engineered proteins to fight cancer, study says (STAT)
  • New study will try to stop Alzheimer’s decades before it begins, using experimental Eli Lilly drug (Endpoints)
  • Flagship spinout Omega is days away from bankruptcy, filing shows (Endpoints)
  • Turnstone stops TIL studies; GH Research’s $150M offering (Endpoints)
  • Bavarian Nordic’s stock sinks after 2024 revenues underwhelm (Endpoints)
  • Astellas shakes up management despite impressive nine-month earnings (Endpoints)
  • Novo Nordisk's next-gen obesity drug Cagrisema: investors seek answers (Reuters)
  • Regeneron's Libtayo reaches blockbuster status and has potential for more growth: execs (Fierce Pharma)
  • Arcutis drafts NFL star Odell Beckham Jr. to raise awareness of seborrheic dermatitis, Zoryve treatment (Fierce Pharma)
Medtech
  • Scoop: Sword teases AI mental health expansion (STAT)
  • How opioid addiction treatment startup Bicycle Health reached a profit (Endpoints)
  • Advamed pushes for medical device exemption from Trump tariffs (MedTech Dive)
  • GE Healthcare invests $138M to expand contrast media production at Ireland site (MedTech Dive)
  • FDA labels recall of discontinued Olympus endoscope part as Class I (MedTech Dive)
  • Baxter CEO José Almeida retires (MedTech Dive)
Government, Regulatory & Legal
  • National Science Foundation restores payments after five-day pause, but worries over science funding persist (STAT)
  • Kennedy Would Issue Trial Diversity Guidance, But Not Necessarily Roll Back All Anti-DEI Actions (Pink Sheet)
  • US FDA Hiring: Growth Continued During The Quarter That Included Presidential Election (Pink Sheet)
  • No, Bernie Sanders and Elizabeth Warren aren’t top recipients of pharmaceutical industry donations (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.