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October 9, 2025
by Jason Scott

Recon: Novo to purchase Akero for up to $5.2B; Indian police make arrest in cough syrup deaths case

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

In Focus: US
  • The limits of FDA flexibility are tested as a controversial Biohaven drug decision nears (STAT)
  • Trump Excludes Generics From Big Pharma Tariff Plan (The Wall Street Journal)
  • Updated COVID shot led to less severe illness, fewer hospitalizations last year, US study finds (Reuters)
  • Key US vaccine panel meeting delayed, agenda unclear (Reuters)
  • US Shutdown Drags On With Republicans and Democrats Trading Blame (Bloomberg)
  • Five Questions for Ex-NIH Official Who Says RFK Jr. Tried to Censor Him (Bloomberg)
In Focus: International                                                                                                       
  • Indian police arrest owner of cough syrup company linked to deaths of 19 children (Reuters)
  • In China, a low-cost push to rival a life-saving, $2M medicine (Endpoints)
  • Novo Nordisk to Acquire Akero Therapeutics for Up to $5.2B (WSJ) (STAT) (Reuters)
  • Akero CEO is named chair of Expedition, which raised $165M for COPD drug from China (Endpoints)
  • Finnish researchers report success in mid-stage study of heart disease gene therapy (Endpoints)
  • Pakistan’s Ijara Buys Sindlab, Expands Health Care Business (Bloomberg)
Pharma & Biotech
  • Parents of children with rare diseases ask: How long until our CRISPR miracle? (STAT)
  • Novo CEO Says Risk-Taking, Deals Are Needed to Win Obesity Race (Bloomberg)
  • Pharma’s shift away from infectious disease research could spell disaster for the world’s poorest people (STAT)
  • Startups supporting Parkinson’s care pick up new investments and key hospital partnerships (STAT)
  • Monopar resurrects a shelved Wilson disease drug. Spotting a possible math problem helped (STAT)
  • Expedition Therapeutics, a biotech company scouring China for drug candidates, raises $165 million (STAT)
  • In biotech, Boston reigns supreme, but its competitive edge is being challenged in new ways (STAT)
  • Former Moderna leaders raise $325M for biotech venture firm Ascenta Capital (Endpoints)
  • AviadoBio, UgeneX Therapeutics ink up to $413M deal; Apogee’s $300M stock sale (Endpoints)
Medtech
  • Harvard Medical School licenses consumer health content to Microsoft (Reuters)
  • Exclusive: Otsuka Precision Health buys maternal meditation platform Mindful Mamas (Endpoints)
  • World’s Largest Glove Maker Eyes US Growth as China Rivals Surge (Bloomberg)
  • FDA’s presence at AdvaMed conference shrinks amid shutdown (MedTech Dive)
Food & Nutrition
  • PepsiCo Sees Signs of Turnaround in US Beverages, Driven by Soda (Bloomberg)
  • SNAP restrictions may cost $1.6B for retailers to implement: report (Food Dive)
Government, Regulatory & Legal  
  • Blue Cross of Mass. offers buyouts to hundreds of employees amid financial struggles (STAT)
  • US Republicans and Democrats split on party lines on Trump's Tylenol-autism claim, KFF poll finds (Reuters)
  • What's behind Amazon’s in-person pharmacy play (Endpoints)
  • Xspray gets CRL over third-party production issues; Oxford Biomedica buys site from Resilience subsidiary (Endpoints)
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.
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