Recon: Independent review critical of delayed pandemic response; US Supreme Court rejects Merck hep C patent appeal

• Small biotech launches human trials of a potential ‘backstop’ for Covid-19 vaccines (STAT)
• Will the FTC get tougher on pharma business practices under the Biden administration? (STAT)
• Supreme Court rebuffs Merck appeal in hepatitis C patent fight with Gilead (Reuters) (Law360)
• Mylan loses bid to dismiss EpiPen antitrust claims (Reuters)
• How Operation Warp Speed Created Vaccination Chaos (ProPublica)
• Lilly gives $60M to Merus, ties in $1.6B in biobucks for next-gen cancer research pact (Fierce)

• Independent pandemic review panel critical of China, WHO delays (Reuters) (NYTimes)
• European countries struggle to make most of Pfizer COVID-19 vaccine doses (Reuters)
• Brussels recommends vaccinating at least 70% of EU adults by summer (Reuters)
• India to start COVID-19 vaccine exports as soon as Wednesday (Reuters)
• France to ensure there will be no layoffs at Sanofi – minister (Reuters)
• AbbVie brings ‘precautionary’ High Court action over €587m tax bill (The Irish Times)
• Sputnik-AstraZeneca vaccine trials to start in February, says R-Pharm (Reuters)
• Russia's second vaccine '100% effective', watchdog tells media (Reuters)

• What we now know — and don’t know — about the coronavirus variants (STAT)
• 3 Questions And The Emerging Answers About COVID-19 Vaccine Protection (NPR)
• Suspicion and tech glitches blight India’s vaccination campaign (FT)
• After repeated delays, Trump’s HHS punts on oversight of a massive Covid-19 response fund for hospitals (STAT)
• Valneva set to begin commercial manufacturing of COVID-19 vaccine within days (PMLive)
• Philippines to buy 20 million Moderna vaccine doses as COVID-19 cases rise (Reuters)
• Mexico plans to administer 7.4 million doses of Sputnik V vaccine by end-March (Endpoints)
• Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19) (FDA)

• The IPO queue adds 5 more biotechs hoping to ring in 2021 by blitzing Nasdaq (Endpoints)
• Family medicine residents don’t interact with pharma as much as they once did (STAT)
• Ineos gives Oxford £100m to set up antibiotic research institute (FT)
• GSK Aims To Launch 13 Blockbusters In Five Years (Scrip)
• News briefing: Beam cobbles together $260M private placement; miRagen rebrands to Viridian Therapeutics (Endpoints)
• Samsung eyes manufacturing expansions into U.S. and beyond as work on Korean 'Super Plant' plows ahead (Fierce)
• 2020 Sees Sharp Rise In EU New Drug Approvals (Pink Sheet)
• Tecartus wins NICE recommendation for mantle cell lymphoma (PharmaTimes)
• SMC kicks of the new year by accepting five new medicines for NHS use (PharmaTimes)
• Breakthroughs, Orphans Hit High Notes As US FDA’s 2020 Novel Approvals Play A Familiar Tune (Pink Sheet)
• 2020 In Review: US FDA New Drug Office’s COVID-19 Response Aided By Reorganization (Pink Sheet)
• Oxford gets £100M to seize a 'breakthrough moment' in fighting superbugs (Endpoints)
• Novartis' Cosentyx available on NHS in Scotland (Pharmafile)
• MHRA grants Promising Innovative Medicine Designation to Sanofi's RSV drug (Pharmafile)
• GSK’s PD-1 inhibitor dostarlimab shows updated promise in dMMR solid tumours (PMLive)
• MHLW Eyes 1st Revision of Drug Industry Vision in 8 Years as Off-Year Re-Pricing Takes Shape: Official (PharmaJapan)
• Ex-Gilead execs bag $80M to trial drug licensed from Merck KGaA (Fierce)
• Gilead's Kite Pharma unit nabs Marincola to head up its cell therapy research (Fierce)
• Lonza hits the exit on gel and liquid capsules, offloading 2 production sites to NextPharma (Endpoints)
• 'Bluest of blue-chip investors' pump $94M into Sekar Kathiresan's quest to bring CRISPR to the heart (Endpoints)
• Pssst: That big Biohaven Alzheimer's study? It was a bust. Even the subgroup analysis execs touted was a flop (Endpoints)
• An ambitious GV-backed gene editing upstart re-emerges as a one-drug kidney company (Endpoints)
• Poll: Should Joshua Sharfstein or Janet Woodcock lead the FDA from here? (Endpoints)
• A cardiovascular cell therapy player grabs $54M for a new beginning — where next-gen CAR-T approach features prominently (Endpoints)
• As coronavirus variants trigger new alarms, the NIH is putting an under-the-radar ‘next-gen’ vaccine into PhI (Endpoints)
• Eli Lilly tees up discovery pact worth more than $1.6B with Merus for T cell-focused bispecific antibodies (Endpoints)

• Canada Proposes 14 New Entries To List Of Recognized Device Standards (Reuters)
• UK Responsible Person, EU ARs and Northern Ireland: The View From MedTech Europe (MedtechInsight)
• Researches Show Efficacy Of Personalized Brain Stimulation In Psychiatric Treatments (NPR)
• DARPA to Fund CRISPR Diagnostics Using Mammoth, IDbyDNA Technologies (GEN)

• Biden HHS pick Rachel Levine would make history as first openly transgender Senate-confirmed federal official (The Hill)