Recon: CDC clears fourth COVID-19 vaccine; Merck’s Keytruda hit with setback after failed head and neck cancer trial

| 20 July 2022 | By Joanne S. Eglovitch 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • A fourth Covid vaccine is cleared for use in the United States. (NYT) (STAT) (Reuters)
  • ACIP Nod For Novavax’s COVID Vaccine Comes With Criticism On Lack Of Expiration Date Packaging (The Pink Sheet)
  • FDA carryover funds to pay staff to last until November, Burr says (Politico)
  • FDA slaps ImprimisRx with a warning letter over sponsored articles in medical journals (Endpoints)
  • PhRMA and BIO descend on D.C. & unpacking the Senate’s FDA funding drama (STAT)
  • With new CEO, Invitae lays off more than 1,000 employees, slims international footprint (Fierce)
  • An abundance of CAR-Ts: $37B cell therapy cancer market can’t support ‘congested’ pipeline, report says (Fierce)
  • Soaring Overdose Rates in the Pandemic Reflected Widening Racial Disparities (NYT)
  • FDA announces external review of food safety and tobacco regulatory offices (Politico)
In Focus: International
  • CTIS: EU Member States Seek Advance ‘Warning’ On Lead Assessor Requests (The Pink Sheet)
  • EU Health Emergency Response Authority Calls On Off-Patent Sector (The Pink Sheet)
  • High-Stake Meetings With EMA In Store For Sponsors Of EU Filings (The Pink Sheet)
  • EU signs COVID drug procurement deal with Gilead (Reuters)
  • llumina fails to block EU antitrust review of $8B Grail merger (MedTech Dive) (Bloomberg)
  • WHO reports 14,000 cases of monkeypox globally, five deaths in Africa (Reuters)
  • With monkeypox spreading globally, many experts believe the virus can’t be contained (STAT)
  • Japan health panel delays emergency approval of Shionogi COVID-19 pill (Reuters)
  • China Compliance Risks In Focus As Digital Tools Spread (The Pink Sheet)
  • Policies That Could Lead To Korean Biopharma Growth And Competitiveness (The Pink Sheet)
  • Pharma's new 'Berlin Declaration' seeks to reserve vaccines, therapeutics in production for low-income countries (Endpoints)
  • MDMA psychotherapy trial put on pause after Health Canada inspection (Endpoints)
  • Vaccine group invites African states to apply for malaria shot support (Reuters)
Pharma & Biotech
  • WuXi Biologics serves up $1.4B expansion of research and manufacturing center in Singapore (Endpoints)
  • Keytruda hit with second PhIII setback this year as Merck's blockbuster flops certain head and neck trial (Endpoints) (Biospace) (Fierce) (Reuters)
  • BioMarin Eyes European Market for Gene Therapy After US Setback (Bloomberg)
  • Clinical Trial Diversity: PhRMA, Academia Lay Foundation For Network Of Community-Based Sites (The Pink Sheet) (PhRMA)
  • Biogen Axes Schizophrenia Program, Touts Potential of Next Alzheimer’s Drug (Biospace) (Endpoints)
  • San Francisco cell therapy player lays off 94 staffers as it awaits data on lead candidate (Endpoints)
  • Top 10 game-changing biotech layoffs in H1 (Fierce)
  • Novartis scraps key PD-1 submission, while touting 'significant bolt-on M&A firepower' (Endpoints)
  • Growing demand for organ-on-a-chip services prompt CN Bio expansion (Fierce)
  • Neuronetics Receives FDA Clearance For Transcranial Magnetic Stimulation System For Depression (MedTech Insight)
  • Abbott’s Plan For DBS Depression Therapy Wins FDA’s Breakthrough Designation (MedTech Insight)
  • Tunbridge: Global CABs Are Vital For Global Device Regulation (MedTech Insight)
  • Defibrillators, chest drains added to FDA’s list of device shortages (MedTech Dive)
  • Diagnostic sector faces a ‘challenging set-up’ amid economic slowdown: analysts (MedTech Dive)
  • AbbVie agrees to pay $60M for rights to acquire implantable glaucoma device (MedTech Dive)
  • J&J lowers full-year sales forecast amid rising inflation, currency pressures (MedTech Dive)
Government, Regulatory & Legal
  • U.S. announces $1.2 bln healthcare crackdown tied to telehealth, cardiovascular tests (Reuters)
  • Biogen pays $900M to resolve whistleblower’s MS kickback as competition drags on sales (Fierce)
  • Amgen, GSK, Regenxbio and others urge SCOTUS to review 'damaging' decision on biomedical patents (Endpoints)
  • Daiichi Sankyo willfully infringed Seagen patent in creating Enhertu, court rules (Fierce)
  • (Bloomberg)
  • Clinical Labs Group Wins Appeal In Medicare Payment Case (MedTech Insight)
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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