AstraZeneca News – Recon: Pfizer withdraws application for COVID vaccine in India; AstraZeneca’s Imfinzi fails in head

• Biden health team hatches new vaccine strategy as variant threat builds (Politico) (Reuters)

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• 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)

In Focus: International

• 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)

Coronavirus Pandemic

• 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)

Pharma & Biotech

• Merck CFO Brings Corporate Strategy Experience to CEO Role (Fintech Zoom)
• 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)

Medtech

• 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)

Government, Regulatory & Legal

• 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)

Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
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