Recon: J&J, Novavax COVID vaccine readouts; FDA delays decision on Biogen’s Alzheimer’s drug

• FDA extends review period for Biogen's Alzheimer's drug to June (Reuters) (WSJ) (STAT)
• J&J adds to COVID-19 vaccine armoury with 66% efficacy in global trial (Reuters) (STAT) (NYTimes)
• J&J Covid Vaccine Supply to Start at 2 Million Doses, GAO Says (Bloomberg)
• US COVID vaccine hopeful using Gates Foundation cash to prepare for human trial (Reuters)
• Eli Lilly Profit Rises, Helped by Covid-19 Drug Sales (WSJ) (Press)
• McKinsey in advanced talks with US states to settle opioid claims (FT) (WSJ)
• States Move Ahead With Canada Drug Importation While Awaiting Signal From Biden (KHN)
• National drug shortage crisis hits Covid vaccine rollout (CNBC)
• ‘A milestone in oncology’: Amgen’s KRAS-blocking drug proves effective for lung cancer patients in clinical trial (STAT)

• Novavax CEO Sees U.K. Vaccine Approval First; in Talks With FDA (Bloomberg)
• Novavax says COVID-19 vaccine 89% effective in UK trial, less in South Africa, shares jump (Reuters) (NYTimes) (Politico) (STAT)
• Novartis to help Pfizer-Biontech produce COVID-19 vaccine (Reuters) (Press)
• European regulator gives green light for Astra-Oxford COVID-19 vaccine (Reuters) (BBC) (EMA)
• Behind AstraZeneca’s Covid-19 Vaccine Stumble (WSJ)
• EU stands its ground in vaccine row, says AZ contract 'crystal clear' (Reuters 1, 2 (Politico) (BBC)
• EU warned by business group on plan to curb Covid vaccine exports (FT)
• Scotland to publish vaccine supply data amid EU row with AstraZeneca (Reuters)
• EU holds out for more after AstraZeneca offered 8 million extra COVID-19 shots (Reuters)
• WHO hopes to have EUL for AstraZeneca COVID-19 vaccine within two weeks (Reuters)
• Moderna cuts deliveries to Italy and France in new blow to EU vaccination plans (FT) (Reuters 1,
• AstraZeneca to seek Japan's approval of COVID-19 vaccine as early as mid-February – Yomiuri (Reuters)

• Drugmakers rush to adapt Covid treatments to mutant strains (FT)
• Pregnant Women Get Conflicting Advice on Covid-19 Vaccines (NYTimes)
• Shortfall in jabs pushes EU vaccine drive to crisis point (FT)
• White House releases 'previously hidden' state COVID-19 data (The Hill)
• FEMA asks Pentagon for help administering COVID-19 vaccines (The Hill)
• WHO shepherds $2.50-per-test deal to support rapid COVID-19 screening in low-resource countries (Fierce)
• New York undercounted nursing home deaths by as much 50 percent, report finds (Politico) (ProPublica)
• Hungary approves Chinese Sinopharm's COVID vaccine, first in European Union (Reuters)
• Early Data Shows Striking Racial Disparities In Who's Getting The COVID-19 Vaccine (NPR)
• COVAX to ship enough shots for 3% of poor countries' populations in H1 – WHO (Reuters)
• Analysis: "Russian roulette" in Europe as needle shortages hamper COVID-19 shots (Reuters)
• Russia's RDIF says it could ship 100 million doses of vaccine to EU in second quarter (Reuters)
• Russia to launch 'Sputnik-Light' COVID vaccine in Feb - Sputnik V Twitter (Reuters)
• Ukraine bans use of Russian COVID-19 vaccines (Reuters)
• India's Serum applies to conduct local trial for Novavax vaccine – CEO (Reuters)
• WHO team in Wuhan visits hospital that treated early COVID cases (Reuters)

• From 9/11 to COVID-19: A Brief History of FDA Emergency Use Authorization (Harvard Bill of Health)
• Conducting Virtual Inspections: EMA and MHRA do it, CMOs do it, why won’t FDA do it? (FDA Law Blog)
• J&J pushes new amivantamab data for NSCLC subset, trying to bolster case for quick FDA approval (Endpoints)
• FDA blasts Lonza facility in Form 483 that derailed Bristol Myers' plan of liso-cel nod by 2020 (Fierce)
• One Prediction For US FDA Under Biden: More Advisory Committees (Pink Sheet)
• Ultragenyx earns 2 rare disease drug approvals—and a validated commercial strategy (Fierce)
• When Drug Development for Rare Disease Hit Setback, Parents Were Stung (WSJ)
• WCLC: AstraZeneca builds case for growing ADC pipeline with double wins in advanced lung cancer (Endpoints)
• Though still struggling, Bellicum can resume trial on CAR-T hopeful after FDA lifts clinical hold (Endpoints)
• Catabasis Pharmaceuticals snaps up HAE antibody in buyout; Gladstone, UCSF scientist spearhead launch of neuro research center (Endpoints)
• The diabetes 'cure' Vertex acquired in its 2019 Semma buyout? It's headed to the clinic (Endpoints)
• Illumina co-founder Mark Chee moves from the genome to the proteome with upstart Encodia (Endpoints)
• Roche taps into quantum computing software for Alzheimer's disease research (Fierce)
• EMA begins review of GBT's sickle cell treatment Oxbryta (PharmaTimes)
• England’s New Innovative Medicines Fund ‘Must Be Future Proof’ (Pink Sheet)
• Gene therapy for hemophilia: So close, yet so far away (BioPharmaDive)

• 4 key trends for medtech in 2021 (MedtechDive)
• 3 big predictions for digital health in 2021 (MedtechDive)
• Mammoth Biosciences teams with Agilent to deliver CRISPR-based coronavirus tests (Fierce)
• FDA Updates Labeling Requirement In Emergency Blood Clot Detection Device Guidance (MedtechInsight)
• FDA Eyeballs Handful Of Emerging Tech Topics For New Medical Device Development Tools (MedtechInsight)

• 4 Highlights As Biden Starts Scrubbing Trump's Health Legacy (Law360)
• US Merck Seeks To Upend Pfizer Pneumonia Vaccine Again (Law360)
• House Panel Probes $79M In Ventilator Deals For Abuse (Law360)
• Mallinckrodt Seeks To Move Acthar Cases To Delaware (Law360)
• Feds Can't Dodge Gilead HIV Patent Counterclaims (Law360)