Recon: Sino, Boehringer ink cancer drug deal worth $7B; CVS to split pharmacy business from insurance
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- Another midterm wave coming? FDA chief counsel announces departure (Pink Sheet)
- FDA acting chief of staff sees stable user fee path despite Democrats’ Capitol Hill takeover (Pink Sheet)
- FDA grants priority review to BeOne’s Brukinsa-rituximab regimen in first-line MCL (The Pharma Letter)
- Vanda drives straight into FDA trouble with fast-paced Nereus ad (Fierce Pharma)
- Botox court defeat prompts CMS to seek legal clarity on price negotiation authority (Pink Sheet)
- A push for speedier drug approvals doesn’t promise smooth market sailing (PharmaVoice)
- Oncology PRO assessment timing may need to evolve, FDA says (Pink Sheet)
In Focus: International
- China proposes market exclusivity for rare disease, pediatric medicines (Pink Sheet)
- Australia proposes broader trial disclosures and greater GCP transparency (Pink Sheet)
- EMA considers faster route for smaller drug development questions (Pink Sheet)
- New Korea guidance streamlines biosimilar data requirements (Pink Sheet)
- Indian drugmaker Dr Reddy's gets Brazil regulator nod to sell generic Ozempic (Reuters)
- Swiss pharma industry behind in technology and clinical trials, index shows (Reuters)
- India proposes instant manufacturing license suspension for drugs failing quality tests (Reuters)
- In China, a flood of controversial clinical trials slows to a trickle (STAT)
- Patients continue missing out in UK industry clinical trial recruitment (The Pharma Letter)
- Chinese drugmaker Ganzhou Hemay delays Hong Kong listing on market conditions (Reuters)
Pharma & Biotech
- Sino Biopharmaceutical, Boehringer ink cancer drug deal worth $7 billion in milestones (Reuters) (BioSpace)
- CVS to break up, splitting pharmacy business from insurance (Endpoints) (STAT)
- AstraZeneca made $10 billion offer for obesity drugmaker Rhythm, sources say (Reuters) (Wall Street Journal)
- Former Madrigal Pharmaceuticals executive alleges coverup of safety issues tied to its drug (STAT)
- Evommune licenses Hinova autoimmune drug in up to $1.1 billion deal (Reuters) (Fierce Biotech)
- Servier's $1.5B bet on Edgewise drug fails five months in (Endpoints)
- AbbVie bets up to $1.47B on Nxera's gut-targeting IBD program (Endpoints) (BioSpace)
- China's Qyuns Therapeutics licenses antibody program to Caldera in up to $780 million deal (Reuters)
- J&J's trispecific, Tibsovo's AML win and Calquence's CLL letdown as first ASH abstracts land (Endpoints)
- Sanofi ends development of Nurix's STAT6 degrader (Endpoints) (BioPharma Dive)
Medtech
- Siemens Healthineers begins carve-out of diagnostics unit amid China weakness (Reuters)
- Boston Scientific, Blackstone agree to $455M deal to co-fund heart pump development (MedTech Dive)
- FDA cites Next Medical for contamination controls and unapproved ultrasound gel changes (Medtech Insight)
- Zimmer raises sales forecast despite slower knee business (MedTech Dive) (Medtech Insight)
- Smith+Nephew cuts outlook after failed orthopaedics deal talks with J&J (Reuters) (Medtech Insight)
- Edwards pushes TAVR into moderate aortic stenosis; Medtronic touts renal denervation data (Medtech Insight)
- Philips’s diagnosis, treatment orders jump close to 20%, but ultrasound delays keep sales flat (Medtech Insight)
- Abbott’s Amulet 360 hits 96.3% complete LAA closure at 1 year in pivotal VERITAS study (Medtech Insight)
- In 2027, international regulatory reliance could become the rule, not the exception (Medtech Insight)
- Abbott expects H1 2027 FDA approval of SonicForce IVL after successful TECTONIC trial (Medtech Insight)
Food & Nutrition
- FDA closes investigation into romaine outbreak (Food Safety News)
- Congresswoman has concerns about sale of infant formula company (Food Safety News)
- WHO proposes food profiling model to inform regulation of ultra-processed foods (Food Safety Magazine)
Government & Legal
- Albertsons must pay $900 million for fueling opioid epidemic in Washington state, judge rules (Reuters)
- Democratic wins in Congress will fuel MFN, FDA oversight, may advance bipartisan legislation (Pink Sheet)
- A looming deadline to fund the government will shape Congress’ unusual lame duck session (STAT)
- Closing loopholes: US Labor Department PBM fee transparency rule aims to prevent gaming (Pink Sheet)
- Pharma critic Bernie Sanders is set to hold major sway over FDA funding bill (STAT)
- What the midterms could mean for the future of health AI (STAT)
- Democratic doctors and scientists ride the blue wave (STAT)
- Where does MAHA go from here? Three possible futures (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.