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Recon: Record-shattering 2020 healthcare investment; BIO layoffs

Posted 22 January 2021 | By Kari Oakes 

Recon: Record-shattering 2020 healthcare investment; BIO layoffs

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Who’s who in Biden’s health care team (Medical Economics)
  • Biden begins presidency with aggressive healthcare agenda (Healthcare IT News)
  • Biden Inherits a Vaccine Supply Unlikely to Grow Before April (NYT)
  • Biden administration is trying to figure out what’s delaying Covid vaccine shots, CDC says (CNBC)
  • How To Fix The Covid-19 Vaccine Rollout (Forbes)
  • Biden’s plan for federally run mass vaccination sites takes shape (WaPo)
  • Woodcock Faces Maze Of Rules To Become Commissioner Nominee (Pink Sheet)
  • Biden’s planned actions on reproductive health care, explained (Vox)
  • Smiling Fauci Talks Variants, Vaccines at White House Briefing (MedPage Today)
  • Fauci, unchained (WaPo)
  • Fauci: Lack of facts 'likely did' cost lives in coronavirus fight (The Hill)
  • Special Report: How U.S. CDC missed chances to spot COVID's silent spread (Reuters)
  • Biden’s Covid-19 vaccine goal isn’t ambitious enough (Vox)
  • Covid Vaccine Rollout Leaves Most Older Adults Confused Where to Get Shots (KHN)
  • Dr. Rachel Levine’s historic appointment to the Biden administration, explained (Vox)
  • The Nation's Coronavirus Vaccine Rollout Plan Faces Another Obstacle (NPR)
  • Trump’s Pardons Included Health Care Execs Behind Massive Frauds (KHN)
  • Health Issues Carried Weight on the Campaign Trail. What Could Biden Do in His First 100 Days? (KHN)
  • Johnson & Johnson plans to have 100 million vaccines for Americans by spring, board member says (CNBC)
In Focus: International
  • Gavi to make 500,000 doses of Ebola vaccine available for outbreak response (EPR)
  • Japan Tries To Remain Optimistic As COVID-19 Threatens To Cancel Tokyo Olympics (NPR)
  • MHRA and vaccine makers in talks over new Covid variants (Guardian)
  • NICE no for BMS’ multiple sclerosis drug Zeposia (PharmaTimes)
  • Sorry, Europe: AstraZeneca follows Pfizer/BioNTech in cutting back EU vaccine delivery plans (Fierce Pharma)
  • Plenary highlights: vaccines, new US president, right to disconnect (European Parliament)
  • Generics applications under review by EMA – January 2021 (GaBI)
  • UK estimates COVID-19 infections falling, but warns cases still high (Reuters)
  • EU will seek clarification from Pfizer over new vaccine delays (Reuters)
  • E.U. leaders consider travel bans, faster vaccine rollout to contain coronavirus variants (WaPo)
Coronavirus Pandemic
  • Dr. Fauci says new data shows Covid vaccines appear to be less effective against some new strains (CNBC)
  • WHO Says Pfizer-BioNTech Covid-19 Vaccine Is Safe For The Elderly After Norway Questioned Its Role In Numerous Deaths (Forbes)
  • BioNTech to provide 50 million needles to extract more vaccine doses (Reuters)
  • Gap between COVID-19 shots may be stretched past recommended range in some cases: U.S. CDC (Reuters)
  • NCCN shares new guidance principles for vaccinating people with cancer against COVID-19 (EurekAlert)
  • Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine (JAMA)
  • Pfizer and BioNTech Reach Agreement with COVAX for Advance Purchase of Vaccine to Help Combat COVID-19 (Pfizer)
  • UPDATED: Gilead says remdesivir likely to be effective against new COVID-19 strains (PMLive)
  • World's poor need action, not Covid 'vaccine nationalism', say experts (Guardian)
  • U.S. alone won't fill COVAX funding gap, lead official says (Reuters)
  • After A Year Battling COVID-19, Drug Treatments Get A Mixed Report Card (NPR)
  • Pfizer's R&D president Dolsten: Not taking government cash made us more nimble for COVID-19 vaccine (Fierce Biotech)
  • With painstaking effort, Black doctors’ group takes aim at Covid-19 vaccine hesitancy (STAT)
Pharma & Biotech
  • Vaccine experts are excited about mRNA's success in COVID, but it's not time to 'walk away' from traditional shots: panel (Fierce Pharma)
  • BIO lays off staff to adapt to another year of virtual events (Fierce Biotech)
  • Civica Rx looks to break ground on first in-house manufacturing site (Endpoints)
  • Yale cancer specialist Charlie Fuchs tapped as new global development chief for Roche/Genentech (Endpoints)
  • Lupus drug prices in focus (Pharmaletter)
  • ICER takes hard line on new cholesterol drugs (Pharmaletter)
  • Tracking cancer metastasis with CRISPR opens new areas for drug development (Fierce Biotech) (Endpoints)
  • Neuvogen uncloaks with broad plan of attack for whole-cell cancer vaccines, clinical hopes within the year (Endpoints)
  • Servier and MiNA Target Neurodegenerative Disease With Novel RNA Therapy (Scrip)
  • GSK Ends Tough Week With Ulcerative Colitis Therapy Termination (Scrip)
  • Lilly Completes Acquisition of Prevail Therapeutics (Lilly)
  • Healthcare funding shatters records in 2020, helped by COVID-19 (MedTechDive)
  • Drug price hikes without new evidence upped spending by $1.2B, ICER says (MedCity News)
  • The breast cancer drug market (Nature Reviews Drug Discovery)
  • Incyte lands priority review for PD-1 inhibitor in anal cancer (Fierce Biotech)
  • Internet of Medical Things Market to Reach US$ 284.5 Billion by 2027 Globally (UnivDatos)
  • Boston Sci Wins Nod for 4th Gen. Vercise Genus DBS (MD+DI)
  • ACLA seeks lab reimbursement changes as need for COVID-19 testing surges (MedTechDive)
  • Boston Scientific bets on cardiac wearables with $925M Preventice buy (MedTechDive)

Government & Regulatory
  • SCOTUS Blog Friday round-up (SCOTUS blog)
  • Bill to Recategorize Cannabis Kicks Off Federal Pot Reform (Law360)
  • Most Favored Nation Drug Pricing Rule on Hold Awaiting Changes (FDA Law Blog)
  • The European Commission’s refusal to give public access to documents concerning the purchase of vaccines against COVID-19 (European Ombudsman) (Reuters)
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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