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)
- 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)
- 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)
- '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)
- 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)
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