Recon: Moderna announces more than $6B in revenue in first quarter; Valneva to trial booster of its COVID vaccine

ReconRecon | 04 May 2022 | By

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • AstraZeneca poised to snag fast approval for a frontline use of Imfinzi, adding to its growing oncology portfolio (Endpoints) (AstraZeneca)
  • FDA grants Prothena fast track designation for Alzheimer’s disease therapy (Biopharma Reporter)
  • FDA hits Miami University in Ohio with a warning letter over falsified data (Endpoints) (STAT)
  • FDA Approves Phathom’s Voquezna Triple and Dual PAK (Bloomberg)
  • COVID-19 Vaccines: Spikevax Review Reflected Changing Realities Of Omicron In US (The Pink Sheet)
  • Mifepristone Access Imperiled By Supreme Court’s Draft Decision Overturning Abortion Rights (The Pink Sheet) (Bloomberg)
In Focus: International
  • Vaccines Effective Against New Omicron Variants, WHO Chief Says (Bloomberg)
  • A compromise on patent waivers for Covid-19 vaccines takes a key step at the WTO (STAT)
  • Valneva to launch trial for booster use of its COVID-19 vaccine candidate (Reuters)
  • Novartis' compassionate use requests worldwide: Just 0.5% came from lower-middle- and low-income countries (Endpoints)
  • Australian Regulator On The Highs & Lows Of Project Orbis (Pink Sheet)
  • Biosimilars ‘Policy Salad’ Setting Back Sector, Canadian Study Says (Pink Sheet)
  • Canada Pulls Controversial Pricing Measures (The Pink Sheet)
  • Fresenius warns of bigger Ukraine war impact after Q1 profit beat (Reuters)
  • Regeneron's COVID drug sales outside U.S. help revenue beat (Reuters)
  • COVID worsens asthma in children; booster after infection not as beneficial vs Omicron (Reuters)
  • Pfizer Says Patients Who Relapse After Covid Pill Can Repeat (Bloomberg)
Pharma & Biotech
  • Moderna Highlights More than $6B in Revenue, Talks Boosters (Biospace) (Reuters)
  • Biogen shoves Aduhelm to the side. It’s time for lecanemab (Fierce)
  • All Takeda wants for its billion-dollar gene therapy spending spree is functional cures (Fierce)
  • Chasing Bristol Myers and Pfizer, Connect fails phase 2 ulcerative colitis trial but spies path forward (Fierce)
  • Novartis’ Kisqali Adds Years to Breast Cancer Patients’ Lives (Biospace)
  • Record-breaking 2021 revenue shows there’s more to Swiss biotech sector than Roche, Novartis (Fierce)
  • BMS, Merck KGaA push protein degrader ambitions with $2.3B Amphista partnership (Fierce)
  • An upstart protein degradation contender adds Merck KGaA and Bristol Myers to its list of Big Pharma backers (Endpoints)
  • AstraZeneca’s Alexion to get new Boston headquarters (Biopharma Reporter)
  • Biogen CEO Vounatsos, board and top execs formally agreed to keep the breakup civil (Endpoints)
Medtech
  • Biden should send ‘clear’ message to semiconductor industry on prioritizing medtech, AdvaMed says (MedTech Dive)
  • Mirvie Granted Breakthrough Device Designation For Test To Identify Risk Of Preeclampsia (MedTech Insight)
Government, Regulatory & Legal
  • HHS Allocates $55 Million for Tribal Opioid Response Program (Bloomberg)
  • Wash. AG, Distributors Cut $518M Deal Ending Opioid Trial (Law360)
  • Opioid Charges Filed by DOJ Against 12 Medical Professionals (Bloomberg)
  • Amazon subsidiary PillPack reaches a settlement with US government and will have to shell out over $5.6M (Endpoints)
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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