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)
- 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)
- 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)
- 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)
- 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)
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