Recon: Biogen to acquire RayThera for $1B; FDA approves first generic version Roche flu drug
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- FDA approves first generic version of Roche's flu drug (Reuters)
- Following dispute with FDA, UniQure is cleared to submit Huntington’s treatment for approval (STAT)
- Senate Democrats demand HHS provide records on federal vaccine policy (STAT)
- IRA's $2,000 out-of-pocket cap helped Medicare patients access expensive drugs, study finds (Endpoints)
In Focus: International
- RA, Forbion and Sanofi Ventures appear to back new eye drug from Korea (Endpoints)
- Exclusive: KKR eyes at least $1 billion stake in Medicover's India hospital arm, source says (Reuters)
- Congo Ebola response strained a month after WHO declares international emergency (Reuters)
- Penumbra wins CE mark for Thunderbolt clot removal tech (MedTech Dive)
Pharma & Biotech
- Innoviva revives Lyndra's long-acting oral drug platform, with Langer and Woodcock as advisors (Endpoints)
- What’s next for GLP-1 weight loss drugs? (STAT)
- Novocure’s electric fields therapy fails key glioblastoma study (Endpoints)
- Pfizer CFO Dave Denton to leave company in August (Reuters)
- Biogen targets immunology growth with $1 billion RayThera deal (Reuters)
- Eli Lilly cuts 340B discounts for hospitals resisting its claims data submission policy (Fierce Pharma)
Medtech
- ‘Putting the body back together’ with MMI’s microsurgery robot (MedTech Dive)
- FDA warns breast biopsy needle shortage to continue into 2027 (MedTech Dive)
- Medtech M&A maintains momentum following decade-high 2025: PwC (MedTech Dive)
- Clue-SDK Deal Opens A Parallel Route For Femtech Into Insured Care, Bypassing Germany’s DiGA (MedTech Insight)
- Draft CMS TAVR Memo ‘Clear Win’ For Edwards But Leaves Regurgitation Players Waiting (MedTech Insight)
- Solius Labs Launches Solius Pro, The First FDA-Cleared OTC UVB Therapy Device (MedTech Insight)
- Cardiac Monitor Maker iRhythm Hit By Data Breach And Extortion Demand (MedTech Insight)
- New Maggot Species Cleared For Wound Care (MedTech Insight)
Food & Nutrition
- New infant botulism outbreak puts fancy formulas under scrutiny (STAT)
- Better together: Hershey’s combined sweets and snacks business pays off for retailers, consumers (Food Dive)
Government, Regulatory & Legal
- How many Americans can afford high-quality health care? A new poll finds the number has fallen (STAT)
- Congress should embrace strategic health diplomacy (STAT)
- RFK Jr. presents $700 million in mental health funding, but experts say grants aren’t new (STAT)
- DOJ’s swift win in OhioHealth case should have hospitals studying their contracts, experts say (STAT)
- Super-potent synthetic opioids called nitazenes are spreading across the U.S. (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.
