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

• 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)

• 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)

• 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)

• 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)