Recon: BMS’ Opdivo wins full FDA approval for resected esophageal or GEJ cancer; Japan authorizes Moderna, AZ COVID vaccines

• Full OK for Covid Shots Will Take Months, FDA Vaccine Chief Says (Bloomberg)
• FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung Cancer (FDA)
• FDA recommends not using syringes from Chinese firm after safety issues with vaccine injections (Reuters) (FDA)
• BMS’ Opdivo wins FDA approval for resected esophageal or GEJ cancer (Endpoints) (Press) (FDA)
• As Mallinckrodt sells rare disease drug, parents worry about access (STAT)
• Prescription drug price fight gets a funding infusion (Axios)
• What Becerra’s senior team says about HHS’ priorities (Politico)
• Biden orders Software Bill of Materials to boost cybersecurity. AdvaMed wants uniform standards. (MedtechDive)

• EU advises against second AstraZeneca shot for people with blood clots (Reuters)
• EU regulator backs extending approval for remdesivir for another year (Reuters)
• EU regulator backs use of GSK-Vir antibody to treat COVID-19 (Reuters) (EMA)
• Bluebird’s new gene therapy among three new EMA OKs ahead of FDA (Endpoints) (EMA)
• Japan approves more COVID-19 vaccines, expands state of emergency (Reuters) (PharmaJapan)
• S.Korea approves Moderna's COVID-19 vaccine (Reuters)
• ‘Share dollars and doses’: rich world tries to tackle vaccine inequalities (Reuters)
• India and Pfizer hit impasse over vaccine indemnity demand -sources (Reuters)
• Australia seeks domestic capability to produce mRNA vaccines (Reuters)

• Get Ready for the Next Wave of Covid Vaccines (Bloomberg)
• Britain to work with WHO on 'pandemic radar' to track diseases (Reuters)
• Pfizer to deliver through COVAX some vaccines pledged to poorer nations (Reuters 1, 2)
• GAVI signs COVID-19 vaccine supply deal with J&J (Reuters)
• EU to invest 1 billion euros to build vaccine production hubs in Africa (Reuters)
• Latin America poised to benefit as U.S. raises exports of COVID-19 shots (Reuters)
• Total death toll from COVID-19 could be at least 6-8 million: WHO (Reuters)
• Two AstraZeneca shots could be 85-90% effective, UK data suggests (Reuters)
• White House partners Tinder parent in hopes users swipe right on vaccinations (Reuters)
• COVID vaccines possibly less effective against Indian variant -German health official (Reuters)
• COVID fight could return ‘to square one’: experts sound vaccines alarm (Reuters)
• India's vaccine output likely to fall short of target, sources say (Reuters)
• India's Bharat Biotech ramps up vaccine production, 'black fungus' cases add to COVID-19 woes (Reuters)
• India faces antifungal drug shortage as rare complication adds to COVID-19 woes (Reuters)
• UK regulator says Pfizer COVID vaccine can be stored 31 days in fridge (Reuters)
• Inside the race to find a COVID-19 treatment pill (Reuters)

• Beigene's cancer therapy meets late-stage study goal (Reuters)
• FDA revises and expands draft guidance on adjusting for covariates in RCTs (Endpoints)
• Regenerative Medicine Designation More Useful 'Tool' Than CBER’s Marks Initially Anticipated (Pink Sheet)
• NICE rejects Janssen's prostate cancer drug Erleada (Pharmafile)
• Stinging from a proxy loss and hungry for cash, GlaxoSmithKline bails on equity stake in Innoviva for a tidy $392M (Endpoints)
• Novartis' Sandoz reshuffles antibiotic supply chain in EU as field faces a shortage of investment (Endpoints)
• In tight next-gen pneumococcal vaccine race with Pfizer, Merck reads out topline pediatric data (Endpoints)
• Takeda tees up priority review for storied CMV drug from its $62B Shire buyout (Endpoints)
• Arie Belldegrun's vision for Ginkgo comes into view, as the now $15B company teams with Biogen on gene therapy (Endpoints)
• Months after bursting into the bispecific scene out of nowhere, Janux follows the Merck hype to an IPO (Endpoints)
• Annovis Bio claims wins in Alzheimer's and Parkinson's, shares skyrocket; FDA delays decision for Omeros' narsoplimab (Endpoints)
• BioTheryX collects $92M in Series E round; WuXi Biologics ups its stake in an emerging ADC player (Endpoints)
• A new RNA startup looks to reimagine heart treatments, with eyes set on Entresto (Endpoints)
• Resilience has caught the eye of the Canadian government, which will invest $163M to boost mRNA production (Endpoints)
• ASCO: Boehringer, OSE offer promising glimpse of the immuno-oncology drug at the heart of their $1.4B deal (Fierce)
• #ASCO21: Watch out Bristol Myers, J&J is back at ASCO with some competitive BCMA CAR-T data (Endpoints)
• I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2) (FDA Law Blog)

• FDA 'working around the clock' with COVID-19 workload, all reviews impacted: CDRH chief (MedtechDive)
• FDA Warns Industry: We’re Looking ‘Closely And More In-Depth At Class II Recalls’ (MedtechInsight)
• Notified Body Liability: TÜV Rheinland Considers Next Move In PIP Scandal Saga (MedtechInsight)
• Heru sets sights on virtual reality eye tests and therapies with $30M round (Fierce)
• FDA seeks feedback on device ingredient labeling requirements (MedtechDive)
• Medtronic's Evolut TAVR system holds up to open heart surgery in 2-year study of low-risk patients (Fierce)
• New Brain-Controlled Robotic Arm Gives Wearer The Sense Of Touch (NPR)
• Overjet nets FDA clearance for gum-disease-spotting deep learning software (Fierce)
• Tasso's at-home blood sampling device for virtual clinical trials snags European approval (Fierce)
• Higher Medtech Regulatory Salaries In The EU, Longer Recruitment Times And A Candidate-Driven Market (MedtechDive)

• Pharma Resisting Efforts To Send Drug Pricing Savings To US Budget ‘Black Hole’ – Pfizer’s Bourla (Pink Sheet)
• Eli Lilly sues HHS to halt any 340B-related monetary penalties (Endpoints)
• Trade Groups Urge Justices To Review $600M NY Opioid Tax (Law360)
• Ex-Insys CEO Escapes FCA Suit Over Opioid Bribes, For Now (Law360)
• Cigna Defeats Class Cert. Bid In ERISA Suit Over Drug Prices (Law360)
• FTC To Focus On In-House Challenge Of Illumina Deal (Law360)
• Maryland U.S. Attorney’s Office Seizes Domain Name Falsely Purporting to Provide COVID-19 Vaccines (FDA)
• Pacific Biosciences of California, Inc. v. Oxford Nanopore Technologies, Inc. (Fed. Cir. 2021) (Patent Docs)