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July 28, 2020
by Michael Mezher

Recon: Pfizer, BioNTech begin pivotal COVID-19 vaccine trial; Drugmakers skip out on White House meeting

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Drugmakers refuse to attend White House meeting after Trump issues executive orders on costs (Politico) (Reuters)
  • Moderna, Pfizer start decisive COVID-19 vaccine trials, eye year-end launches (Reuters) (NYTimes)
  • Pfizer-BioNTech begin late-stage study of lead COVID-19 vaccine candidate (Reuters) (STAT) (Endpoints) (Press)
  • Pfizer shares rise after better-than-expected earnings and higher 2020 outlook (CNBC) (Press)
  • Coronavirus Stimulus: How the Republican and Democratic Plans Compare (WSJ)
  • Covid-19 relief package likely to include billions more for vaccines, testing (STAT)
  • Trump alleges pharmaceutical industry is running false ads on his drug price plan (Reuters)
  • Kodak Shifts Into Drug Production With Help of a $765 Million U.S. Loan (WSJ)
  • Japan's Fujifilm gets $265 million U.S. contract to boost output of potential virus vaccine (Reuters)
In Focus: International
  • Vaccine alliance eyes range of prices for COVID shots, says $40 would be maximum (Reuters)
  • Pfizer will not charge developed countries less than US for similar vaccine order (Reuters)
  • Canada gives conditional approval to Gilead's remdesivir for COVID-19 (Reuters)
  • After early hype, Japan's homegrown COVID-19 drug hope Avigan faces rocky future (Reuters)
  • EMA Wants Panexcell-Tested Generics Suspended; Spares Yondelis (Pink Sheet)
Coronavirus Pandemic
  • WHO says COVID-19 pandemic is 'one big wave', not seasonal (Reuters)
  • Masks May Reduce Viral Dose, Some Experts Say (NYTimes)
  • The Doctor Behind the Disputed Covid Data (NYTimes)
  • Vaccines are 'one of the safest interventions we have,' thanks to ongoing FDA monitoring (NBCI thi)
  • Humanigen momentum barges on as Covid-19 candidate is selected for NIAID trial (Endpoints)
  • Serum Institute conducting phase III clinical trial of tuberculosis vaccine: DBT (Economic Times)
  • Coronavirus (COVID-19) Update: Daily Roundup July 27, 2020 (FDA)
  • Pfizer could earn $15B-plus in COVID-19 vaccine sales: analyst (Fierce)
Pharma & Biotech
  • New York panel seeks extra Medicaid rebates from Biogen for pricey rare disease drug (STAT)
  • After stopping Farxiga trial early, AstraZeneca declares success in CKD treatment (Endpoints) (Fierce)
  • Praxis raises $110 million to target CNS disease with Phase II drugs (Endpoints)
  • After down year, 2020 brings new cash into Massachusetts biotech (Endpoints)
  • mRNA vaccines: intellectual property landscape (Nature)
  • EU’s Joint Regulatory/HTA System Praised, But Improvements Needed (Pink Sheet)
  • US FDA Expediting ANDA Postapproval Manufacturing Changes Due To COVID-19 Impacts (Pink Sheet)
  • Early API Momentum At Indian Firms: Not Just A Quarterly Bump? (Scrip)
  • PRIME status for Adaptimmune's synovial sarcoma drug (PharmaTimes)
  • AbbVie helps autoimmune startup Enthera to €28M A round (Fierce)
  • Distanced from a pricing controversy, Jeff Aronin steers one of his biotechs to Nasdaq — with a familiar regulatory strategy tied to a big bet (Endpoints)
  • AbbVie backs an Italian startup focused on autoimmune diseases; BioTheryX advances AML drug with $35M D round (Endpoints)
  • A protein engineering platform spawns a new IL-2 player out of Basel, with human trials looming next summer (Endpoints)
Medtech
  • Diagnostics makers must plan for EUA products to have post-pandemic future (MedtechDive)
  • Unprecedented Number Of EU Medtech Guidance Documents Now Available On New Commission Website (MedtechInsight)
  • 3M dips on missed Q2 projections (MassDevice)
Government & Regulatory
  • Gilead Slams HHS' 'Perverse' Requests In HIV Drug IP Battle (Law360)
  • FTC, AbbVie Don't Want Spat Paused Amid Justices' Review (Law360)
  • U.S. judge rejects imposing attorney fee levy on opioid lawsuit settlements (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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