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 $1.2B, ICER says (MedCity News )
The breast cancer drug market (Nature Reviews Drug Discovery )
Incyte lands priority review for PD-1 inhibitor in anal cancer (Fierce Biotech )
Medtech
Internet of Medical Things Market to Reach US$ 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.