Recon: Russia claims Sputnik COVID vaccine is 92% effective; EU approves contract for Pfizer-BioNTech vaccine

• Moderna on track to report COVID-19 vaccine data later this month (Reuters)
• Cold storage challenges could hamper distribution of Pfizer, Moderna COVID-19 vaccines, Fauci says (Reuters)
• Health officials to begin distribution of Eli Lilly antibody drug this week (The Hill)
• For Eli Lilly’s newly authorized Covid-19 treatment, a dosing discrepancy causes confusion (STAT)
• Biden pledges Americans won't lose health coverage during pandemic (Politico)
• Warren wants answers on suspension of FDA inspections of overseas drug manufacturing facilities (CNBC) (Letter)
• Democratic Senators Object to ‘Rebranding’ of Purdue as a Public Asset (WSJ)

• Russia says its Sputnik V COVID-19 vaccine is 92% effective (Reuters)
• China's Sinopharm says data 'better than expected" from unit's COVID-19 vaccine trials (Reuters)
• Brazil says Chinese vaccine trial can resume (Reuters)
• BioNTech/Pfizer and Commission reach coronavirus vaccine deal (Politico) (EC)
• Europe to pay less than US for Pfizer vaccine under initial deal (Reuters)
• GSK says flu shot shortage not linked to COVID-19 vaccine ramp up (Reuters)
• In blow to WHO, EU seeks powers to declare health emergencies (Reuters) (EC)

• The husband-and-wife team behind the leading vaccine to solve COVID-19 (NYTimes) (FT)
• US reports more than 100,000 COVID-19 cases for seventh day in a row (Reuters)
• Europe COVID death toll tops 300,000 as winter looms and infections surge (Reuters)
• 'Two-way street': CDC report says masks protect wearers and everyone else (NBC)
• New Type of Test May Better Discern Immunity to the Coronavirus (NYTimes)
• The Children Never Had the Coronavirus. So Why Did They Have Antibodies? (NYTimes)
• Government gears for unprecedented challenge of Eli Lilly antibody rollout as efficacy questions linger (Endpoints)
• UK ready to roll out COVID-19 vaccine once regulator gives safety all clear (Reuters)
• Swiss boost COVID-19 vaccine reservations with shots from Pfizer, WHO-led programme (Reuters)
• Switzerland boosts COVID-19 vaccine fund to 400 million Swiss francs (Reuters)
• Russia set to start post-registration trials for second COVID-19 shot (Reuters)
• China's Rhodiola set to sell and test Russia's Sputnik-V vaccine (Reuters)
• Uzbekistan to carry out late-stage trial of Chinese COVID-19 vaccine candidate (Reuters)
• Pandemic-Affected Trials Will Need Same Exploratory Analyses That US FDA Used To Save Aducanumab (Pink Sheet)

• Final Revisions Should Ease Global Use Of EU GMP Annex I Sterile Drugs Guidance, Associations Say (Pink Sheet)
• Impact of COVID-19 on pharmaceutical external innovation sourcing (Nature)
• Top analyst sizes up windfall billions for Pfizer, Regeneron and Eli Lilly in a big week for the Covid-19 R&D race (Endpoints)
• Optimizing Therapeutic Production by Taking a Quality-by-Design Approach (GEN)
• A cancer vaccine that might work? Moderna posts 'promising' early snapshot for Merck-partnered program and raids Bristol Myers for a new cancer R&D chief (Endpoints)
• Merck scraps Keytruda lung cancer trial adding Bristol Myers' Yervoy. What about the Opdivo combo? (Fierce)
• Pfizer, still chasing Dupixent, releases fifth round of data for eczema JAK inhibitor abrocitinib (Endpoints)
• Small biotech Inipharm lands $35M to take new NASH approach, diverging from RNAi competitors (Endpoints)
• Citing toxicity concerns, Boehringer Ingelheim drops short-lived IPF pact — keeping $1B+ in its pocket (Endpoints)
• Gates Foundation backs a new sickle cell CRISPR approach; Siddhartha Mukherjee's Vor adds a new CAR-T (Endpoints)
• Five Prime claims a big win in topline data for their comeback gastric cancer drug as shares skyrocket (Endpoints)
• Silverback files to go public, potentially adding to this year's record-high biotech IPO raise (Endpoints)

• UK Updates Medtech Industry On National Regulatory System Progress (MedtechInsight)
• Abbott begins U.S. rollout of its radiofrequency ablation device for chronic pain (Fierce)
• Making The Leap From EU MDD To MDR Clinical Evidence (Part 1): Practical Advice (MedtechInsight)
• Remote trials, US-Israel device partnership among pitches in FDA, HHS funding bills (MedtechInsight)

• FTC Probes Illumina's $8B Deal For Cancer Detection Biz (Law360)
• GSK Says FDA Rejected Zofran Label Change (Law360)
• Bard Gets Fed. Circ. To Revive $68M Infringement Trial (Law360)
• Boehringer To Settle 3K Pradaxa Bleeding Risk Cases (Law360)
• Edwards Lifesciences Bolsters Tech's Attack On PTAB Denials (Law360)
• 4 Key Moments As Justices Debate ACA's Fate (Law360)
• Boehringer To Settle 3K Pradaxa Bleeding Risk Cases (Law360)