Regulatory Focus™ > News Articles > 2021 > 8 > Recon: Sanofi to acquire Translate Bio for $3.2B; BMS withdraws Istodax indication after confirmator

Recon: Sanofi to acquire Translate Bio for $3.2B; BMS withdraws Istodax indication after confirmatory trial fails

Posted 03 August 2021 | By Michael Mezher 

Recon: Sanofi to acquire Translate Bio for $3.2B; BMS withdraws Istodax indication after confirmatory trial fails

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Abbott Labs to pay $160 mln over kickbacks, false diabetes claims to Medicare (Reuters) (DoJ)
  • Sanofi bets on mRNA vaccines beyond COVID in $3.2 bln Translate Bio deal (Reuters) (STAT) (Endpoints) (FT)
  • U.S. FDA gives priority review to Roche's Tecentriq lung cancer drug (Reuters)
  • Rare disease drugmakers to Congress: Don't gut the accelerated approval pathway (Endpoints)
  • Bristol Myers pulls lymphoma indication for Istodax after confirmatory trial falls flat (Endpoints) (Fierce)
  • CytoDyn faces DOJ, SEC subpoenas after promoting failed Covid-19 drug (Endpoints)
  • Novartis to launch new Zolgensma trial after FDA lifts restriction (Reuters) (Endpoints) (Press)
  • Eli Lilly bets on Alzheimer's disease drug data as it chases Biogen (Reuters)
In Focus: International
  • Germany to offer booster against COVID-19, vaccines for children (Reuters)
  • Analysis: Tougher terms: why the EU is paying more for new COVID shots (Reuters)
  • Where a Vast Global Vaccination Program Went Wrong (NYTimes)
  • Medical opium industry on brink of collapse, warn UK poppy farmers (FT)
Coronavirus Pandemic
  • U.S. donates more than 110 mln COVID-19 vaccine doses abroad -White House (Reuters)
  • The Army’s buying 500 million COVID vaccine doses, but they’re not for soldiers (Army Times) (DoD)
  • Amid A Vast Need For Vaccinates Worldwide, Millions Of Doses In The U.S. Are Expiring (NPR)
  • Wuhan: Chinese city to test entire population after virus resurfaces (BBC)
  • Lilly and Incyte's baricitinib reduced deaths among patients with COVID-19 receiving invasive mechanical ventilation (Press)
  • MHLW’s COVID-19 Guide Adds Chugai’s Cocktail Therapy (PharmaJapan)
Pharma & Biotech
  • 'Erratic' FDA and inconsistent drug decisions put doctors off new meds: survey (Fierce)
  • Amylyx is breaking all of biotech’s unwritten rules — and still raising impressive sums (STAT)
  • FDA to importer: keep your active pharma ingredients away from weed killer and antifreeze (STAT)
  • FDA’s New Orphan Products Director Brings Industry, Legal, Academic, Regulatory Background (Pink Sheet)
  • Lilly Delivers Strong Second-Quarter 2021 Financial Results, Updates 2021 Financial Guidance (Press)
  • Bristol Myers Squibb Completes Sale of Manufacturing Facility in Couvet, Switzerland (Press)
  • Sage Therapeutics axes 2 zuranolone trials deemed unnecessary for approval in depression (Fierce)
  • J&J, GV back a new single-cell approach for tackling inflammatory diseases and hacking the tumor microenvironment (Endpoints)
  • After struggling with its sole drug for years, Marinus rides positive data to a commercialization deal in Europe (Endpoints)
  • LEO Pharma, Norgine, Daiichi-Sankyo, Novartis, Sanofi, Consilient, and Pharmasure have been named in advertisements for breaches of the ABPI Code (PMCPA)
  • BD to Begin Remediation for BD Alaris™ System Software (FDA)
  • Abbott's FreeStyle Libre 2 app snags FDA clearance to help users manage diabetes (mobihealthnews)
  • Volpara Health lands additional FDA clearance for breast cancer detection product (mobihealthnews)
  • Boston Scientific, Stryker get extra year of add-on payments as CMS adjusts to pandemic (MedtechDive)
  • Hillrom reverses course, will finalize $375M BardyDx acquisition (MedtechDive)
Government, Regulatory & Legal
  • Senate Infrastructure Legislation ‘Pay Fors’ Not So Bad For Pharma But Real Threat is Ahead (Pink Sheet)
  • WSJ Publisher Asks To Unseal Elizabeth Holmes Docs (Law360)
  • Takeda Kept Generic Drug Off Shelves For 6 Years, Suit Says (Law360)
  • Teva's Opioid Order Monitoring On Hot Seat In NY Trial (Law360)
  • PTAB Axes Patent Claims For Nektar Hemophilia Drug (Law360)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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