Recon: FDA declines to review Soligenix’s lymphoma drug; GSK pulls out of COVID deal with Vir

• FDA Rejects Soligenix’s Lymphoma Candidate (BioSpace) (Reuters) (Endpoints) (Fierce)
• OTC Naloxone In US Could Limit Access Due To Costs, Comments On Emergent Switch NDA Argue (Pink Sheet)
• FDA rejects Biocon and Viatris' Avastin biosimilar after inspection question marks (Endpoints)
• Scientific institutions must embrace antiracist policies, National Academies report urges (STAT)
• House GOP Seeks Fauci Testimony in Probe of Covid-19 Origins (Bloomberg)
• House readies first GOP-led COVID vaccine probe (Axios)
• Drug Price Negotiations Need ‘Nimble’ Approach, Official Says (Bloomberg) (Pink Sheet)
• Johnson & Johnson names ex-Sanofi executive as pharma, R&D vice president (Reuters)

• NYT sues European Commission over failure to reveal text messages with Pfizer CEO Albert Bourla (Fierce)
• Germany proposes to fix shortages in certain medicines (Reuters)
• Freezing UK Statutory Scheme Rebate Could Cost UK Government Over £15m (Pink Sheet)
• WHO increasing health surveillance after Equatorial Guinea finds Marburg virus (Reuters) (Washington Post)
• Eli Lilly strikes 2^nd deal to boost affordable insulin access, this time in Bangladesh (Fierce)

• GSK nixes next-gen COVID-19 antibody collaboration, leaving Vir to fly solo, seek new partners (Fierce) (Biospace) (Endpoints)
• With $520 million in hand, two entrepreneurs try to upend the biotech funding model (STAT)
• Korea Q4 Roundup: International Growth A Key Factor For Major Firms (Scrip)
• Viz.ai Collaborates with Johns Hopkins to Expedite Enrollment in Brain Injury Trial (BioSpace)

• When Is An IVD A CDx? EU IVDR Guidance Updated To Include Flowchart (MedTech Insight)
• Diagnostics Industry Helps MHRA Shape IVDs Roadmap As Part Of Future UK Regulation (MedTech Insight)
• Alcon to pay J&J $199M to settle dispute over patents for laser eye surgery device (MedTech Dive) (Fierce)
• Vicarious Surgical lays off 14% of workers to get its VR-powered robotics ‘out the door fast’ (Fierce)

• Judge indicates intention to dismiss J&J talc unit faces bankruptcy bid (Reuters)
• US government, Pfizer and others side with Sanofi and Regeneron in Supreme Court patent case (Endpoints)
• Merck, Glenmark headed to trial after judge scraps early dismissal bid in Zetia antitrust case (Fierce) (Bloomberg)
• Spacelabs Reaches Settlement Over Allegedly Overcharging VA, DOD (Bloomberg)