Recon: Judge orders Pfizer to give Moderna COVID-19 vaccine formulation details; Artificial wombs on the horizon pending FDA review

• Pfizer Ordered to Give Moderna Key Vaccine-Making Details (Bloomberg Law)
• Artificial wombs, after years in development, reach FDA review for human trials (STAT)
• FDA Accepts Orchard’s BLA for Rare Disease Gene Therapy Behind EU Approval (BioSpace)
• Bankrupt Drugmaker Mallinckrodt Considers Sale of Opioid Business (The Wall Street Journal)
• FDA is changing the therapeutic equivalence rating for Accord Healthcare Inc.’s generics of Prograf (tacrolimus) oral capsules (FDA)
• How one company profited while delaying Narcan’s drugstore debut (Washington Post)
• Boston Scientific to buy chronic back pain therapy maker Relievant (Reuters)

• European Commission authorizes GSK's HIV prevention drug (Reuters)
• After a high-profile pressure campaign, Cepheid agrees to sell a TB test at cost (STAT)
• Novo Nordisk contracts Aspen to produce insulin for Africa (Reuters)
• EU antitrust regulators raid cardiovascular medical device company (Reuters)
• Lack of Adequate Study Plan Prompts EMA Review Of Cardiovascular Risk With Mysimba (Pink Sheet)
• MedTech Europe says MDR, IVDR framework needs ‘structural reform’ (MedTech Dive)
• Finland’s Eurofins Becomes EU’s 11th Notified Body Designated Under the IVDR (MedTech Insight)
• New Swiss Database To Cut Costs Of GMP/GDP Certification (Pink Sheet)

• BeiGene to go solo with cancer drug after Novartis deal termination (Reuters) (BioSpace)
• 60 Degrees Pharma withdraws mid-stage study application for COVID drug (Reuters)
• Iveric, Astellas eye US label expansion for geographic atrophy drug after positive two-year data (Endpoints)
• RNA editing startup launches with $30M based on Stanford and University of Tübingen research (Endpoints)
• Biosimilars making inroads into Humira sales, but docs still cautious on switching: Spherix (Fierce Pharma)
• With covalent meds abuzz, RA Capital and Novartis lead $56M seed round for new startup (Endpoints)
• MRM open to partnerships after lead candidate impresses in PhIIa ulcerative colitis trial (Endpoints)
• Kinnate lays off 70% of employees, shaves pipeline to focus on CDK4 and pan-RAF inhibitor (Endpoints)
• Exclusive: Backed by former Google CEO’s VC, a Colorado biotech hatches platform to evolve degraders (Endpoints)
• PharmaEssentia, trying to activate patients, shares rare blood cancer stories in video series (Fierce Pharma)

• Beacon Biosignals receives FDA clearance for sleep tracking headband (MedTech Dive)
• A popular breast cancer genomic test underestimates risks for Black women (STAT)
• David Liu startup to focus on getting CRISPR therapy to hard-to-reach cells (STAT)
• AlphaFold, meet AlphaMissense: Google DeepMind's AI successor predicts how 71M mutations cause disease (Endpoints)
• Gates Foundation grants GE HealthCare $44M for AI ultrasound tech (MedTech Dive)

• Novo, Lilly's 'paradigm shifting' obesity drugs suffer from cost and coverage issues: docs' survey (Fierce Pharma)
• Pharmacy Middlemen Altering Business Models, PhRMA Report Says (Bloomberg)
• Are Fees The New Rebates? PhRMA Highlights Shifts In PBM Practices As House Tees Up Reform Vote (Pink Sheet)