Recon: J&J halts COVID-19 vaccine trial; EU inks $1.2B deal for six-month supply of remdesivir

• J&J Covid-19 vaccine study paused due to unexplained illness in participant (STAT) (FT) (Reuters)
• J&J raises profit forecast as trial halt weighs (Reuters) (CNBC) (MedtechDive)
• Novavax to explore combined influenza/COVID-19 vaccine for use post pandemic (Reuters)
• Vaxart begins early-stage trial of oral COVID-19 vaccine candidate (Reuters)
• People Harmed by Coronavirus Vaccines Will Have Little Recourse (WSJ)

• EU makes one billion-euro bet on Gilead's COVID drug before trial results (Reuters)
• Russia approves trial of COVID-19 vaccine on group of over 60s – RIA (Reuters)
• France trials no-swab COVID test with results in 40 minutes (Reuters)
• Takeda group begins manufacturing COVID-19 plasma treatment ahead of approval (Reuters)
• Roche plans to sell COVID-19 antigen lab tests by end-2020 (Reuters)
• Mexico targets a group of Indian generics makers for homeland pharma hub (Fierce) (Economic Times)
• UK biotech companies raise over £1bn in record quarter (PharmaTimes) (Scrip)

• The Race for a Super-Antibody Against the Coronavirus (NYTimes)
• New Study Predicts Over 400,000 Pandemic-Related Deaths In The US This Year (NPR)
• A 25-year-old man becomes first in the U.S. to contract coronavirus twice, with second infection ‘more severe’ (CNBC)
• Black Doctors Work to Make Coronavirus Testing More Equitable (KHN)
• Norway to provide COVID-19 vaccine free of charge (Reuters)
• Mexico aims to vaccinate 116 million against coronavirus by end of 2021 (Reuters)
• Bangladesh will not co-fund Sinovac's vaccine trial - Health Minister (Reuters)
• Abbott gets emergency authorization for new COVID antibody test (The Hill)

• Selling stock like clockwork, Moderna’s top doctor gets $1 million richer every week (STAT)
• When off-label may mean off-target: How would doctors and insurers navigate demand for a new, narrow Alzheimer’s drug? (STAT)
• Voyager shares take a hit as FDA slaps a hold on the IND for Huntington's gene therapy — their #2 play in the pipeline (Endpoints)
• Bristol Myers Squibb hematology chief talks COVID challenges, opportunities in blood cancer therapies (Fierce)
• Takeda to transform into a 'cloud-first company' through Accenture, AWS partnership (Fierce)
• Bavencio, Imbruvica among latest SMC decisions (PharmaTimes)
• China Regulatory Express: New Cell Therapy, Gene Editing Guidelines Proposed (Pink Sheet)
• How To Host Onsite Drug GMP Inspections Without Spreading The Coronavirus (Pink Sheet)
• Real-World Evidence Uptake Is “Silver Lining” Of COVID-19 Response, USFDA’s Abernethy Says (Pink Sheet)
• Keytruda Filed for Triple Negative Breast Cancer in Japan: MSD (PharmaTimes)
• Regeneron/Sanofi post positive PhIII Dupixent data in pediatric asthma; Vineti scores $33M Series C extension (Endpoints)
• Riding a PhII success, a small French biotech lands a rare 'breakthrough' status in NASH (Endpoints)
• Gossamer shares take another beating as its lead drug fails 2 key clinical studies, highlighting harsh reviews for DP2 (Endpoints)
• Out to pioneer gene editing in China, EdiGene bags $67M to begin clinical testing for β-thalassemia therapy, universal CAR-T (Endpoints)
• Months after retiring from Genentech, Michael Varney brings his drug hunting eye to Frazier (Endpoints)
• A major new investor just arrived at the biotech party, as Evotec nets $295M from Mubadala and Novo (Endpoints)
• GSK's Emma Walmsley granted damehood by Queen Elizabeth II (Endpoints)

• De Novo-winning devices often lack effectiveness data, analysis shows (MedtechDive)
• Cancer testing drives 2020 medtech IPO surge after slow start (MedtechDive)
• EU Faces MDR Failure Unless It Adjusts To COVID-19 Crisis And Grows Notified Bodies (MedtechInsight)
• TCT 2020: Abbott devices, TAVR systems headline late breaker lineup (MedtechDive)
• Elective surgeries seen driving Q3 medtech comeback, but can it last? (MedtechDive)
• LivaNova study shows safer outcomes from its sutureless aortic heart valve (Fierce)

• Federal Trade Commission v. AbbVie Inc. (3d Cir. 2020) (Patent Docs)
• US CMS Issues ‘Cease And Desist’ Letters To Labs Running COVID-19 Tests Without CLIA Certification (MedtechInsight)
• New compliance dashboard for post-market medical device reviews (TGA)
• The TGA's approach to delays in medical device conformity assessment recertification (TGA)