Recon: Russia’s Sputnik V vaccine appears to be 92% effective; Novavax seeks authorization in Canada

• Biden administration to begin shipping vaccine doses directly to pharmacies (Politico)
• Biden Covid adviser tells providers to stop stockpiling vaccine (Politico)
• Pfizer expects $15bn in Covid vaccine revenue this year (FT) (Endpoints)
• Pfizer reports Q4 and full-year results (Press)
• Pfizer plans to deliver 200 million doses of Covid vaccine to US by May, sooner than expected (CNBC)
• Bristol Myers psoriasis drug succeeds in late-stage study (Reuters)
• Moderna Increases COVID-19 Vaccine Shipments While Pfizer Lags Behind (NPR)
• US health agency alarmed by slow vaccination of African-Americans (FT)
• PhRMA Slams 'Extreme' Call To Strip COVID-19 Patents (Law360)
• US promises undocumented migrants equal access to COVID-19 vaccines (Reuters)
• US Congress readies first steps toward $1.9 trillion COVID-19 relief bill (Reuters)

• Russia's Sputnik V vaccine has 92% efficacy in trial (BBC) (WSJ) (Reuters)
• Novavax submits COVID-19 vaccine for authorization in Canada (Reuters)
• Japan says EU export 'mechanism' already affecting vaccine supply schedule (Reuters)
• Top E.U. Official Comes Under Fire in Vaccine Wars (NYTimes)
• AstraZeneca's China partner expects to be able to make 400 million COVID-19 vaccine doses a year (Reuters)
• Russian drugmakers start production of generics without patent holder’s OK (PharmaLetter)
• Canada signs first deal for manufacture of foreign COVID-19 vaccine (Reuters)
• EMA starts rolling review of REGN-COV2 antibody combination (casirivimab / imdevimab) (EMA)
• Breast cancer overtakes lung as most common cancer-WHO (Reuters)
• WuXi STA snaps up Bristol Myers Squibb facility, plants feet in European CDMO marketplace (Endpoints) (Press)

• UK variant has mutated again, scientists say (BBC)
• Chinese syringe producers under pressure as vaccination programmes drive order surge (Reuters)
• WHO-led COVID-19 probe team in China visits animal health facility (Reuters)
• WHO team in Wuhan hold "good discussions" with Chinese counterparts (Reuters)
• Nigeria expects 41 million COVID-19 vaccine doses from African Union (Reuters)
• Tunisia, Palestinians to be among first COVAX recipients – WHO (Reuters)
• Mexico signs contract for millions of Russian Sputnik V vaccine doses (Reuters)
• BioNTech 'confident' it will meet Japan's COVID-19 vaccine demand (Reuters)
• Johnson & Johnson seeks Thai approval for COVID vaccine (Reuters)
• Verity Pharma and India's SII apply to distribute AstraZeneca vaccine in Canada (Reuters)

• If 2021 is to be the year of U.S. drug price controls, how should biopharma companies respond? (STAT)
• Pharmacy benefit managers take heavy criticism from a new source: local officials (STAT)
• Who will Vertex buy? How much will it spend? Deal questions dominate its earnings call (STAT)
• FDA lifts clinical hold on Mustang Bio's lentiviral gene therapy, paving the way for quick jump into pivotal trial (Endpoints)
• BioCryst surges 30% to a 5-year high as Redditors declare 'BioWar' against short-sellers (Insider)
• Eli Lilly's new cancer R&D chief has some things to say about drug discovery, the difficulty in finding new drugs to buy and the Venn dilemma (Endpoints)
• Durect's non-opioid painkiller brushes aside checkered past, gaining FDA approval in shoulder surgeries (Endpoints) (MarketWatch)
• Immunovant voluntarily halts studies on sole drug after surprise cholesterol findings, FcRn rival argenx surges (Endpoints)
• After rancorous threats and a clinical hold, Applied Therapeutics is set to resume pediatric galactosemia study (Endpoints)
• Blitz Of Biotechs Join Crowded IPO Lineup To Start February (Law360)
• 2020 report cards continue rolling in, with analysts detailing record-breaking fundraising for the UK (Endpoints)
• European Inspectors Spot GMP Deficiencies In India During ‘Virtual Tours’ (Pink Sheet)
• FDA approves new IM administration route for Biogen's MS drug Plegridy (Pharmafile)
• FDA Says 30 Websites Shuttered Over Illegal Opioid Sales (Law360)
• US FDA To Share Remote Assessment Findings And Mull Replies Before Issuing Complete Responses (Pink Sheet)
• BsUFA Suggestions From Sponsors Sound Easy, But Changes May Be Difficult For US FDA (Pink Sheet)
• Bayer’s Xarelto approved in the UK (PharmaTimes)
• EU approves Chiesi’s triple combination asthma therapy Trimbow (PharmaTimes)
• 'Hazardous' labeling mix-up prompts Meitheal to recall muscle relaxant cisatracurium (Fierce)
• Two years after flop, Verona gets a win as it preps for pivotal Phase III trials (Endpoints)
• James Sabry adds another weapon to Roche-Genentech arsenal; Daiichi Sankyo adds ADC #6 (Endpoints)
• Martin Shkreli’s old company touts PhIII win, guns for accelerated approval (Endpoints)
• An MS drug for ulcerative colitis? Bristol Myers steps in FDA fast lane to know the fate of Zeposia (Fierce)
• China Kicks Off Pharma Anti-Trust Push With Fine For DSM Partner Simcere (Scrip)
• Sangamo nabs new R&D lead from Lilly's 'special force' research unit (Fierce)
• Actimed hires ex-Bayer researcher to lead cachexia trials (Fierce)

• Top Medical Device Lobbyist On User-Fee Talks, Biden And New Congress, Implementing MCIT Rule (MedtechInsight)
• EU Notified Bodies Advise Manufacturers To Think Hard About Regulatory Strategy Timings (MedtechInsight)
• FDA approves Medtronic's diamond-laden heart ablation catheter (Fierce)
• Perspectum's liver-scanning software scores FDA clearance for planning cancer surgeries (Fierce)
• Blank Check Companies’ Hunt For Innovative Medtech Start-Ups To Heat Up Further, Experts Predict (MedtechInsight)
• From COVID-19 EUAs to 'insidious' remote care risks: ECRI's top 10 medtech hazards (MedtechDive)
• Siemens Q1 boosted by antigen tests, routine work normalizing (MedtechDive)
• Thermo Fisher Q4 fueled by COVID-19, but testing demand seen slowing in 2021 (MedtechDive)

• OIG PBM Rebate Rule Delayed – Twice (FDA Law Blog)
• Trustees of Columbia University v. Illumina, Inc. (Fed. Cir. 2021) (Patent Docs)
• Fed. Circ. Affirms Illumina PTAB Wins Axing Columbia DNA IP (Law360)
• Consulting Co. McKinsey Sued For Promoting OxyContin (Law360)
• CBD Industry Awaits Action From New Dem-Led Congress (Law360)
• 'Opioid Babies' Can't Get Class Certification In MDL (Law360)
• GSK Blasts Teva's Rehearing Bid In $235M Verdict Fight (Law360)
• Purdue Sues In Ch. 11 To Access $3.3B Insurance Funds (Law360)
• FTC Makes Double Reverse Payment Case Against Endo And Impax (Pink Sheet)