Regulatory Focus™ > News Articles > 2021 > 1 > Recon: J&J, Novavax COVID vaccine readouts; FDA delays decision on Biogen’s Alzheimer’s drug

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

Posted 29 January 2021 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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)
In Focus: International
  • 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)
Coronavirus Pandemic
  • 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)
Pharma & Biotech
  • 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)
Government, Regulatory & Legal
  • 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)
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.
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS

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