Recon: Celltrion’s COVID antibody gets EMA rolling review; COVAX delivers first vaccine shipment to Ghana

• FDA scientists endorse J&J’s Covid vaccine, as new data shed light on efficacy (STAT) (Reuters) (NYTimes) (Boston Globe) (Politico)
• CVS Health to administer COVID-19 vaccines in six more states (Reuters)
• Biden to Address Chip Shortages, Supply-Chain Problems With Executive Action (WSJ)
• Novavax Nears Covid-19 Vaccine Game Changer—After Years of Failure (WSJ)
• Generic-Drug Labeling Strategy Likely to Survive Teva Rehearing (Bloomberg) (Law360)
• Silvis, chief of staff for former FDA Commissioner Gottlieb, joins Biden’s COVID response team (BioCentury)
• Republicans’ surprising Becerra attack: He’s not sympathetic enough to pharma (STAT) (NPR) (Pink Sheet)

• EU regulator says Celltrion's COVID-19 antibody drug under real-time review (Reuters) (EMA)
• AstraZeneca to miss second-quarter EU vaccine supply target by half (Reuters)
• EU 'catching up' with UK Covid vaccination rollout – Von der Leyen (The Guardian)
• British vaccine minister says confident in supply from manufacturers (Reuters) (The Guardian)
• Only 15% of AstraZeneca vaccine available in Germany has been used (Reuters)
• Takeda says first patient given Novavax COVID-19 vaccine in Japan clinical trial (Reuters)
• Sinopharm unit, CanSinoBIO apply in China for COVID-19 vaccines' public use approval (Reuters)
• COVAX delivers its first vaccine shots with shipment to Ghana (Reuters) (FT)

• Studies Examine Variant Surging in California, and the News Isn’t Good (NYTimes)
• High-End Medical Provider Let Ineligible People Skip COVID-19 Vaccine Line (NPR)
• Egypt registers Russia's Sputnik V COVID-19 vaccine (Reuters)
• Colombia approves emergency use of AstraZeneca coronavirus vaccine (Reuters)
• Vietnam's first batch of COVID-19 vaccine arrives from South Korea (Reuters)
• ACLA urges Biden to fund uninsured COVID-19 testing, close coverage loopholes (MedtechDive)

• With genome-editing companies’ stock booming, Beam Therapeutics seizes its moment (STAT)
• Opinion: Three steps can help companies speed FDA approval of new drugs (STAT)
• OpenBiome to wind down stool bank operations (STAT)
• Accelerated Approval: US FDA Review Of Expedited Program Could Bring More Withdrawals (Pink Sheet)
• It's official: FDA clamps a hold on bluebird's troubled LentiGlobin program while EMA considers new measures (Endpoints)
• Japan Pharma Market Shrinks 2.4% on COVID-19, Price Cuts: IQVIA (PharmaJapan)
• Xilio Therapeutics eyes the fast track to the clinic with $95M in investor cash to test redesigned IL-2, CTLA-4 meds (Endpoints)
• FDA Commissioner Race: Transparency Comes To Forefront With Study Of RTF Letters (Pink Sheet)
• UCB taps Microsoft to accelerate drug discovery, clinical trials (Fierce)
• Japan's SoftBank plots billions in biotech investments in move that could keep the valuation flood rising — report (Endpoints)
• Six years separated from a rabies vaccine scandal, China’s YishengBio grabs $130M to go big in infectious diseases, cancer (Endpoints)
• In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sciences to focus on decentralized clinical work (Endpoints)
• With Novavax vaccine deal under its belt, SK Bioscience plots out March IPO on the Korean exchange (Endpoints)
• EU Regulators Take A Practical Approach To Addressing Nitrosamine Contamination (Pink Sheet)
• Breaking Big Pharma's AI barrier: Insilico Medicine uncovers novel target, new drug for pulmonary fibrosis in 18 months (Fierce)
• Watch out, Novo Nordisk. Lilly's new dual action diabetes med could pressure Ozempic: analyst (Fierce)
• Kura tees up its lead drug with a 'breakthrough' at the FDA; NCI teams up with Cybrexa on peptide drug conjugate (Endpoints)
• Jeff Hatfield assembles a syndicate with some A-list public investors in the mix as Vividion adds $135M raise (Endpoints)
• Insilico preps first candidate for IND studies, hoping to launch trial in IPF by end of 2021 (Endpoints)
• Pfizer gets an FDA fast-pass for an old vaccine with potential military applications (Endpoints) (Press)

• Outpatient visits steady at end of 2020 but orthopaedics, cardiology remain down: report (MedtechDive)
• Update On EU Standardization: Will CEN/Cenelec Accept Commission’s Latest Request? (MedtechInsight)
• Medtronic sees capital equipment uptick despite latest coronavirus surge (MedtechDive)
• Truvian Sciences snares $105M for its many-in-one blood testing machine (Fierce)
• FDA Adds 7 New Tools To Its Regulatory Science Toolbox (MedtechInsight)
• Experts: COVID-19, Departure Of Key FDA Staff Likely Contributing Factors For Delayed AI/ML Action Plan (MedtechInsight)
• Indian regulators propose use of American Standard Test Methods for medical device conformance (Emergo)

• Elizabeth Holmes denies destroying evidence in Theranos case (CNBC)
• Plaintiff Cannot Escape Prior Pleadings to Avoid Statute of Limitations (Drug & Device Law)
• Distributor Gets Out of Gadolinium Failure to Warn Claim (Drug & Device Law)
• 7th Circ. To Crawl Into Humira 'Patent Thicket' Dispute (Law360)
• 10th Circ. Ruling Bolsters Medical Device Preemption Defense (Law360)
• Del. Justices Reverse Express Scripts' $82M Trial Loss (Law360)
• Justices Told Assignor Estoppel Is 'Uncommonly Lawless' (Law360)