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Recon: Lawmakers grill Califf on response to infant formula crisis; Supply chain, China lockdowns cl

Posted 26 May 2022 | By Michael Mezher 

Recon: Lawmakers grill Califf on response to infant formula crisis; Supply chain, China lockdowns cloud Medtronic’s outlook

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US

  • Lawmakers grill U.S. FDA on response to Abbott baby formula safety (Reuters) (NYTimes)
  • The next U.S. abortion battle is over pills, and it’s already begun (Reuters)
  • Novavax Missed Its Global Moonshot but Is Angling to Win Over mRNA Defectors (KHN)
  • A no good, very bad week for the FDA (STAT)
  • Eli Lilly set to invest $2.1B in home state manufacturing boost (Endpoints) (PharmaPhorum)
  • McKesson, Walgreens, Drug Distributors Dodge Price-Fixing Claims (Bloomberg Law)
  • US sees spike in Paxlovid usage as Merck’s molnupiravir and AstraZeneca’s Evusheld are slower off the shelf (Endpoints)
  • NIH’s new, independent breakthrough drug accelerator ARPA-H gets its first employee (Endpoints)
  • CMS turning attention to hospitals with Covid outbreaks (Politico)

In Focus: International

  • Cancer treatments may benefit from lessons of pandemic set-backs -AstraZeneca executive (Reuters)
  • Medtronic posts downbeat results on supply chain issues, China hit (Reuters) (MedtechDive)
  • NICE recommends Sanofi and Regeneron’s Libtayo for advanced CSCC (PMLive)
  • Vaccines hold potential to curb antibiotic resistance (FT)
  • Diagnostic tests a crucial tool in fight against antibiotic resistance (FT)
  • Happy IVDR day! (MedicalDevicesLegal)

Pharma & Biotech

  • Flagship’s latest startup launches with bold claim: the discovery of thousands of new human proteins (STAT) (Endpoints)
  • Taking another shot at mRNA glory, CureVac inks oncology pact while keeping up with Covid work (Endpoints)
  • Bristol’s Abecma, Amgen’s Lumakras headline record-setting oncology launch class as costs continue to balloon: IQVIA (Fierce)
  • Former Editas CEO Katrine Bosley goes the VC route, joining early-stage investor (Endpoints)
  • Covaxin clinical trials to resume in the US as FDA lifts halt (Live Mint)
  • Avadel’s shares crumble as narcolepsy drug delayed yet again, this time on patent issue (Fierce)
  • This time around, Lyrica’s inventor is developing his Northwestern discoveries at his own biotech (Endpoints)
  • Pfizer and CDMOs ramp up Paxlovid manufacturing with Kalamazoo plant expansion leading the way (Endpoints)
  • PK Evaluation In Pregnancy: Can HIV Show A Way Forward? (Pink Sheet)
  • Zydus Pivots To Multivariant COVID-19 Vaccine, Looks To Revlimid Opportunity (Scrip)

Medtech

  • Baxter raises forecasts for Hillrom synergies, allaying concerns over $10.5B takeover (MedtechDive)
  • How a Dexcom-Insulet combination would shake up the diabetes treatment industry (MedtechDive)
  • FDA’s QMSR: 3 Experts Read Draft Rule Comments So You Don’t Have To. Here’s What They Saw (MedtechInsight)
  • Pew Responds To Draft Legislation Creating Regulatory Oversight Of Lab Developed Diagnostics (MedtechInsight)
  • Proposed LDT regulations has diagnostics industry, consumer groups at odds (MedtechDive)
  • Roche unveils three new monkeypox tests as cases rise (Endpoints)
  • Abbott Medical Recalls Dragonfly OpStar Imaging Catheter for Potential Loose Catheter Marker Band That May Cause Patient Harm (FDA)

Government, Regulatory & Legal

  • Biotech Founder Arrested in Murder-for-Hire Scheme (WSJ)
  • Generic Distributors Slip Indirect Reseller Price-Fixing Claims (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.

 

© 2022 Regulatory Affairs Professionals Society.


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