Recon: FDA approves Daiichi’s Enhertu for certain gastric adenocarcinomas; Norway says advice on Pfizer vaccine unchanged

• AstraZeneca, Daiichi's breast cancer drug gets broader US approval (Reuters) (FDA)
• Biden will keep Dr. Francis Collins as National Institutes of Health director: statement (Reuters)
• Biden warns of challenges ahead as he rolls out new vaccine plan (Politico)
• Biden Administration Will Rename 'Operation Warp Speed,' Citing Trump 'Failures’ (NPR) (Politico)
• COVID-19 Supply Deal Lets Vaccine Maker Earmark Doses For Employees And Their Families (NPR)
• Biden to Elevate Science Adviser to His Cabinet (NYTimes) (Science)
• Trump admin enlists private firm to review some Covid-19 tests (Politico)
• Health officials confident Biden will deliver on promise of 100 million vaccines in 100 days (Politico)
• The Trump administration bailed out prominent anti-vaccine groups during a pandemic (Washington Post)

• WHO hopes poorer nations can access Pfizer vaccine 'very soon' (Reuters)
• Chinese and Russian vaccines in high demand as world scrambles for doses (FT)
• Norway says advice on use of Pfizer vaccine is unchanged (Reuters)
• Israel sharing COVID-19 data with Pfizer to help fine-tune vaccine rollout (Reuters)
• UK says vaccine manufacturing is 'lumpy' but still on course for targets (Reuters)
• Sinovac says its COVID-19 vaccine more effective with longer dosing interval (Reuters)
• A Mix of Pride and Doubts as Modi Launches India’s Covid-19 Vaccine Drive (NYTimes)
• Scientists tackle vaccine safety, efficacy and access at global R&D forum (WHO)
• Emergency Committee on COVID-19 advises on variants, vaccines (WHO)
• Vaccine nationalism puts world on brink of 'catastrophic moral failure' - WHO chief (Reuters)

• Black Americans Are Getting Vaccinated at Lower Rates Than White Americans (KHN)
• US and China clash at WHO over scientific mission in Wuhan (Reuters)
• EU works to plug large gap in virus sequencing as COVID variants spread (Reuters)
• Swiss to get Moderna vaccine in tranches until mid-year: Blick (Reuters)
• Swiss set to approve AstraZeneca COVID vaccine this month: NZZ (Reuters)
• Pakistan approves AstraZeneca COVID-19 vaccine for emergency use (Reuters)
• Pfizer delays Jan. vaccine delivery to Bahrain - health ministry (Reuters)
• Valneva says UK rollout of COVID-19 vaccine could start in July-Sept – report (Reuters)
• Bayer aims to help CureVac with COVID-19 vaccine output, says CEO (Reuters)
• Lebanon inks final deal for 2.1 million doses of Pfizer-BioNTech vaccine (Reuters)
• Brazilian approval of Sputnik V vaccine delayed by missing data (Reuters)
• Brazil clears emergency use of Sinovac, AstraZeneca vaccines, shots begin (Reuters)
• Priority strategies to optimize testing and screening for COVID-19 in Canada: Report (Health Canada)

• The limits of acceptable political influence over the FDA (Nature)
• Accelerating the Adoption of Advanced Manufacturing Technologies to Strengthen Our Public Health Infrastructure (FDA)
• Thermo Fisher Shells Out $876M For Viral Vector Maker (Law360)
• Health data firm Target RWE buys NoviSci in Amgen-backed deal (Reuters)
• Janssen Files Imbruvica for Post-Transplant GVHD in Japan (PharmaJapan)
• Xalkori bags FDA green light for rare paediatric non-Hodgkin lymphomac (PharmaTimes)
• FDA approves Janssen's AL amyloidosis drug (Pharmafile)

• EU Notified Body Association Takes Steps To Allay EC’s Virtual Audit Fears (MedtechInsight)
• ‘Slippery slope territory’: Health officials propose waiving regulatory review of medical AI tools (STAT)
• Consultation on proposed changes to the Medical Devices Directorate’s Draft Guidance Document - List of Recognized Standards for Medical Devices (Health Canada)
• Neuromod portfolios advance at Medtronic, Boston Scientific, Abbott (MedtechDive)
• NANS 2021: Boston Scientific Advances New Personalized Pain Therapy (MedtechInsight)
• Liquid Biopsy Company Delfi Diagnostics Raised $100M For New Class of Early Cancer Detection Test (MedtechInsight)
• Pear Therapeutics inks deal with digital pill company etectRx (mobihealthnews)
• EU Rule Presents New Medical Device Compliance Hurdles (Law360)

• Government Report Outlines Costs, Savings Of Major Regs (MedtechInsight)
• Supporting a Budget Increase for FDA for FY 22 (Alliance for a Stronger FDA)
• Maryland Senate overrides governor’s veto of prescription drug affordability board (STAT)
• Compounding Pharmacy Mogul Sentenced for Multimillion-Dollar Health Care Fraud Scheme (DOJ)
• Rite Aid Must Face Trial For Inflated Drug Price Claims (Law360)
• Sanofi Prevails Over Mylan At Fed. Circ. On Jevtana Patent (Law360)
• Novo Joins Challenge To HHS Pharma Discount Opinion (Law360)
• Fed. Circ. Sticks With Ruling In Bard's $68M Patent Fight (Law360)