Recon: Moderna to study COVID vaccine in babies 3 to 6 months of age; Walgreens enters clinical trial business

| 16 June 2022 | By Michael Mezher 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • US FDA Commissioner Admonishes Health Care Stakeholders To Know Agency Better, Help More (MedtechInsight)
  • Moderna to Study Its Covid-19 Vaccine in Babies as Young as 3 Months (WSJ)
  • FDA Panel Recommends Pfizer and Moderna Vaccines for Youngest Children (NYTimes) (STAT)
  • Abbott Baby Formula Plant Again Stops Production, This Time Because of Flooding (NYTimes)
  • Bidenworld: We won the Covid battle, lost the political war (Politico)
  • Walgreens enters clinical trials business through new unit (Reuters)
  • OxyContin Decision Involved FDA ‘Miscalculation,’ Woodcock Says (Bloomberg)
  • A ‘veritable playground’: CVS whistleblower details how patients were charged higher drug prices (STAT)
In Focus: International
  • Japan’s Kyowa Kirin Eying $1 Billion Sale of Pharma Assets (Bloomberg)
  • Minutes of the 115th meeting of the Management Board (EMA)
  • Nations urged to waive vaccine patents while drugmakers say rules are fair (FT)
  • WHO getting monkeypox tests for Africa, urges vaccine readiness (Reuters)
  • A Roche treatment fails to slow cognitive decline in patients with inherited form of Alzheimer’s disease (STAT) (Reuters)
  • MHRA joins international partnerships to set global standards for medicines and medical devices regulation (MHRA)
Pharma & Biotech
  • As FTC cracks down on pharma M&A, analyst sees a potential 'chilling' effect on large deals (Fierce)
  • Exelixis signs on $25M to check out 3 drug targets from BioInvent's antibody library (Fierce)
  • Covis' controversial Makena gets FDA hearing date in bid to stay on the market (Fierce)
  • Boehringer extends cancer dealmaking with right to buy biotech partner (BioPharmaDive)
  • Popular drug may have new benefit in men with diabetes, but not women, study shows (STAT)
  • Verily co-founder lays out vision for how real-world data can transform health care (STAT)
  • Bavarian Nordic to test its Covid-19 booster against Pfizer/BioNTech shot in pivotal study (Endpoints)
  • Amidst large investment from parent company, Samsung Biologics seeks to ramp up biotech funding (Endpoints)
  • Pfizer's digital therapeutics partner is back, this time in a new collab with Eli Lilly (Endpoints)
  • NASH-focused Akero Therapeutics extends its runway by another year with Pfizer's help (Endpoints)
  • As PD-(L)1 disruptors suffer setbacks, Checkpoint touts another win (Endpoints)
  • Exelixis taps into cancer antibody discoverer out of Sweden (Endpoints)
  • One year after wrapping PhI, Biogen drops ALS drug it bought from Karyopharm for $10M cash (Endpoints)
  • Biogen Foundation doubles down on next generation STEM neuroscience to kick off its next decade (Endpoints)
  • Medtronic’s Martha says supply chain woes may ease in second half (MedtechDive)
  • FDA clears augmented reality system to help navigate spine surgery (Fierce)
  • Boston Scientific inks $230M deal to buy majority stake in M.I.Tech (MedtechDive)
  • EU Project Findings To ‘Instil Confidence’ In Using Patient Preference Studies (MedtechInsight)
  • FDA Update On Heater-Cooler Devices Seeks New Designs To Reduce Infections (MedtechInsight)
  • Breast Implant Patient Preferences Topic Of New FDA Study (MedtechInsight)
  • Goldman Sachs leads a $300M round into a China biotech unicorn boasting of its AI/robotics prowess (Endpoints)
Government, Regulatory & Legal
  • Zydus Blasts Takeda's Patent Abuse 'Blueprint' At 3rd Circ. (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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