Recon: Pfizer withdraws application for COVID vaccine in India; AstraZeneca’s Imfinzi fails in head and neck cancer trial

• Biden health team hatches new vaccine strategy as variant threat builds (Politico) (Reuters)
• J&J files COVID-19 vaccine application with FDA (Reuters) (Politico)
• AstraZeneca expects US trial results in next 4-6 weeks, research chief says (Reuters)
• Op-Ed: The right leader for the FDA in a time of crisis (LA Times)
• Merck warns against using anti-parasite drug to treat COVID-19 (Reuters)
• FDA cites litany of errors at Lonza Houston plant at the center of BMS CVR debacle (Endpoints)
• Gilead’s Covid drug delivers $2bn boost to revenue in Q4 (FT) (Fierce)
• ‘A waste of money’: The home Covid-19 test funded by the Biden administration is too costly and complex, critics say (STAT)
• Biden to use DPA to boost production of COVID-19 tests, gloves, vaccine supplies (The Hill)
• How Pfizer And Moderna Are Working To Vaccinate Young People By The Summer (NPR)

• Oxford says COVID-19 vaccine with AstraZeneca works against UK variant (Reuters)
• UK regulators say extra AstraZeneca vaccine data highlights efficacy in elderly (Reuters)
• Britain to work with Germany's CureVac on vaccines against coronavirus variants (Reuters) (NYTimes)
• Countdown to 'catastrophe:' Inside Europe's fight for COVID shots (Reuters)
• Under pressure to deliver COVID shot, Sanofi seeks more cost cuts (Reuters) (FT)
• Pfizer drops India vaccine application after regulator seeks local trial (Reuters)
• Korea in talks with Moderna over $200 mln investment to build vaccine factory (Reuters)
• South Korea grants conditional approval for Celltrion’s COVID-19 antibody treatment (Reuters)
• WHO chief says drug firms should share vaccine-making capacity (Reuters)
• AstraZeneca files for Japan approval of COVID-19 vaccine, second after Pfizer treatment (Reuters)
• AstraZeneca's Imfinzi drug fails in head and neck cancer trial (Reuters)
• Rich countries block India, South Africa's bid to ban COVID vaccine patents (DW)
• NICE launches public consultation for process review (PharmaTimes) (Pink Sheet)

• Understanding COVID-19 origins will take years, says WHO team member (Reuters)
• Exclusive: Brazil to buy 20 million more doses of China's CoronaVac, governor says (Reuters)
• UK orders 50m doses of Covid vaccines in fight against variants (The Guardian)
• South Korea advises caution on AstraZeneca's COVID-19 vaccine for elderly (Reuters)
• WHO's COVAX initiative aims to start shipping 90 million COVID-19 vaccine doses to Africa in Feb (Reuters)
• Canada to shrug off 'momentary disruptions' in vaccine supply, working closely with US (Reuters)
• Takeda to Begin Japan Trial for Novavax Vaccine as Early as Feb. 20 (PharmaJapan)
• Gilead Mulling Japan Entry into PIII Study for Inhaled Version of Veklury (PharmaJapan)

• Merck CFO Brings Corporate Strategy Experience to CEO Role (WSJ)
• How will the Biden administration affect funding for life science research? (Endpoints)
• FDA weighs tighter restrictions for Pfizer's Xeljanz on the heels of safety red flags (Fierce)
• Bayer’s Lampit Has Unique Status: US FDA’s Most ‘Critical’ Approval In 2020 (Pink Sheet)
• How To Use The EU’s New Clinical Trial Submission System (Pink Sheet)
• UCB’s bimekizumab data in plaque psoriasis published in The Lancet (PharmaTimes)
• Keytruda recommended for routine NHS use in lung cancer (PharmaTimes)
• Sanofi flunks Parkinson's Phase II, axes handful of mid-stage programs in Q4 earnings (Endpoints)
• Prescription medicines: registration of new chemical entities in Australia, 2020 (TGA)
• Prescription medicines: new or extended uses, or new combinations of registered medicines, 2020 (TGA)
• Bolt Biotherapeutics strikes a major upsized $230M IPO for next-gen cancer work (Fierce)
• PTC whiffs on another Duchenne study, plans to go to FDA again anyway (Endpoints)
• Merck KGaA expands its deal with Pfizer/BioNTech with an eye on a key vaccine manufacturing bottleneck (Endpoints)
• FDA slaps clinical hold on antibiotics trial after deaths in monkey trial spurred concerns (Endpoints)
• FDA blasts Merck's bid for adjuvant Keytruda in TNBC before adcomm, calling late-stage data 'questionable' (Endpoints)
• Regeneron has a winner in Dupixent and big sales hopes. So why are so few patients taking it? (Endpoints)
• Former GlaxoSmithKline CEO Andrew Witty takes the helm at UnitedHealth; After more than a decade, Daniel Chung is back on a familiar project (Endpoints)
• Vor leads a new pack of IPOs to price, continuing steady stream of companies making leap to the Nasdaq (Endpoints)
• Apotex pulls pair of injectable anticoagulant batches thanks to syringe measurement mix-up (Fierce)

• BD posts better-than-expected COVID-19 test sales, but flagship Veritor revenues to slow (MedtechDive)
• Roche's COVID-19 diagnostics boosted 2020 sales despite other testing losses (Fierce)
• Report: US Customs Agency Seized Millions Of Counterfeit COVID-19 Products In 2020 (MedtechInsight)

• CBO’s Model of Drug Price Negotiations Under the Elijah E. Cummings Lower Drug Costs Now Act: Working Paper 2021-01 (CBO)
• Coalition Says Bayh-Dole Not For Cutting Drug Costs (Law360)
• McKinsey Deal Renews Friction Among AGs And Opioid Attys (Law360)
• McKinsey’s Push For Class-Wide Opioid REMS Among Actions Targeted In Opioid Settlement (Pink Sheet)