Supply Chain Council of European Union |

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)


  • 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.

Related posts

Small Businesses May Take Over $1B Supply Chain Recompete


Growers Fresh Farms LLC Joins The Movement to Build The World’s Safest Food Supply Chain Adopting The Free iTrade Traceability Campaign


Boohoo to Investigate Supply Chain Practices After Health Report | News & Analysis