Recon: EU orders additional 300M doses of Pfizer-BioNTech vaccine; France steps up aid to boost pharma manufacturing

• Joe Biden’s big FDA decision (Vox) (Politico)
• Woodcock vs. Sharfstein: A head-to-head comparison of Biden’s top choices for FDA commissioner (STAT)
• Eli Lilly says CFO resigns after 'inappropriate communication' with staff (NBC) (Endpoints)
• Democratic lawmakers push FDA to lift restrictions on abortion pill (Politico)
• Democrats push temporary Obamacare expansion in Covid bill (Politico)
• CDC plans national Covid vaccination forum to reassert federal leadership (NBC)
• An Illegal Dietary Supplement Named Tianeptine Is Being Sold to Americans, and the FDA Knows It (Consumer Reports)

• EU finalises second deal with Pfizer for 300 million vaccine doses (Reuters)
• France Increases Aid for Pharmaceutical Industry in Covid Fight (Bloomberg)
• Berlin earmarks 9 billion euros to buy COVID-19 shots for Germans and EU (Reuters)
• India says J&J interested in making COVID-19 vaccine in country (Reuters)
• WHO expected to back use of Oxford-AstraZeneca vaccine in adults (Reuters)
• Valneva open to partners for COVID-19 vaccine as it looks beyond Europe (Reuters)
• Does the world need new COVID vaccines? 'Jury is out', Oxford's Pollard says (Reuters)
• US joins WHO programme aimed at boosting COVID-19 fight (Reuters 1, 2)
• Hong Kong biotech sector booms on buoyant markets and pandemic (FT)
• A move to crack down on human rights, environmental abuses puts European pharma on notice (STAT)

• WHO team: Coronavirus unlikely to have leaked from Chinese lab (Politico) (NBC) (NYTimes) (NPR)
• A Few Covid Vaccine Recipients Developed a Rare Blood Disorder (NYTimes)
• Facebook says it plans to remove posts with false vaccine claims. (NYTimes)
• Dermapharm aims to start making Pfizer shot at second site by May (WHTC)
• Japan minister: EU approved first shipment of Pfizer COVID-19 vaccine to Japan (Reuters)
• India backs AstraZeneca shot despite South Africa halt (Reuters)
• Pakistan approves Russia's Sputnik-V COVID-19 vaccine for emergency use (Reuters)
• Sinovac's Ukrainian partner seeks to delay COVID-19 vaccine shipments (Reuters)
• Hungary to start vaccinations with Russian COVID-19 shot (Reuters)
• Reference Pricing Clauses In US COVID-19 Contracts Leave Drug Industry Vulnerable (Pink Sheet)

• In mid-stage study, KalVista pill halts swelling attacks caused by rare, genetic disease (STAT)
• BMS finally gets FDA OK for liso-cel, sets $410k launch price (PharmaPhorum)
• Glaxo’s growth problem (Evaluate)
• US FDA's Presubmission Expedited Regulatory Programs Eyed For Streamlining (Pink Sheet)
• We Still Can’t Hear You: 11 Months Into Pandemic, Virtual US FDA Meetings Still Challenging (Pink Sheet)
• US FDA’s Potential Class Of 2021 By The Numbers (Pink Sheet)
• Lonza offloads specialty ingredients unit in $4.7B sale to Bain Capital, Cinven in consolidation around biopharma (Endpoints)
• Janssen's esketamine nasal spray gets Europe approval for new indication (Pharmafile)
• SMC approves funding for four new medicines on the NHS (PharmaTImes)
• ViiV's HIV drug Rukobia gets EC marketing authorisation (Pharmafile)
• Freeline Therapeutics slams the brakes on gene therapy trial plans as FDA seeks more clarity on manufacturing (Endpoints)
• J&J's Erleada/Zytiga combo hits PhIII endpoint — but what about OS?; Targovax loses prostate cancer partner after enrollment struggles (Endpoints)
• Nautilus set to go public in reverse merger with Perceptive SPAC, aims to test proteomics platform with big-name backers (Endpoints)
• One of the giant vaccine players pushes back against a ‘fundamental shift’ spurred by mRNA. But is the CEO just whistling past the graveyard? (Endpoints)
• Months after shocking house arrest, Legend co-founder Frank Zhang is out on bail — though the CAR-T player has moved on (Endpoints)
• Learning from others' mistakes, low-profile microRNA biotech looks to prove itself in the clinic (Endpoints)
• Bristol Myers Squibb pulls the curtain on PhIII data to back Opdivo in the adjuvant setting (Endpoints) (Press)
• BMS and Exelixis’ Opdivo/Cabometyx shows continued benefit in kidney cancer (PMLive)
• BMS Buoyed By EU Approval Of Myelofibrosis Drug (Scrip) (Press)
• FDA Announces New Resource for Veterinarians and Pet Owners Interested in Clinical Field Studies of Animal Cells, Tissues, and Cell- and Tissue-Based Products (FDA)

• Analysts Applaud Zimmer Biomet’s Dental And Spine Spin-Off, Focus On Orthopedics (MedtechInsight)
• Mightier scores $2M from NIH to study impact of biofeedback video game on children with ADHD (MobiHealthNews)
• Verily links with Janssen for at-home COVID-19 immune system study (Fierce)
• Dexcom's first Super Bowl ad sparks social media buzz with celebrity Nick Jonas—and price concerns (Fierce)

• 8th Circ. Won't Revive Suit Over Teva's ParaGard Risks (Law360)
• Whistleblower Gets $3.6M In FCA Deal With Roche, Humana (Law360)
• Catalent Hit With Patent Suit Over Epilepsy Drug Vimpat (Law360)
• Novelion Therapeutics Seeks Ch. 15 To Wind Up Liquidation (Law360)
• MDL Court Predicts Expansion of Illinois Law (Drug & Device Law)