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Recon: EMA raises drug review fees; Pfizer adds to respiratory drug portfolio with purchase of RSV therapeutic biotech ReViral for $525M

ReconRecon | 07 April 2022 |  By 

Recon: EMA raises drug review fees; Pfizer adds to respiratory drug portfolio with purchase of RSV therapeutic biotech ReViral for $525M

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • U.S. FDA aims to decide on strain selection for COVID boosters by June (Reuters)
  • Quality metrics for pharma manufacturing is back in a big way, with FDA pledging to 'objectively rate' firms (Endpoints)
  • Proactive US FDA Propelled Review Of Genentech’s Actemra In Systemic Sclerosis Amid Evolving Regulatory Landscape (The Pink Sheet)
  • Inside a Campaign to Get Medicare Coverage for a New Alzheimer’s Drug (NYT)
  • Co-founder of Florida pharma indicted after multistate bacterial outbreak at children's hospitals (Endpoints)
  • Exiting Cancer Research Head Sees Hope in Moonshot Funding Plans (Bloomberg)
  • Many Medicare Part D beneficiaries don’t fill prescriptions for high-priced medicines (STAT)
  • Pharma IP in view as new USPTO director Kathi Vidal wins Senate confirmation (Endpoints)
 
In Focus: International  
Coronavirus Pandemic
  • Covid Raises Clotting Risks for Months After Even Mild Infection (Bloomberg)
  • Eight Hundred Million Africans Have Had Covid-19, WHO Says (Bloomberg)
  • German parliament rejects mandatory COVID shots for elderly in blow for Scholz (Reuters)
 
Pharma & Biotech
  • Pfizer to Pay up to $525 Million for Lung-Focused Biotech (Bloomberg) (Reuters) (Fierce)
  • In a one-two gut punch after kidney drug CRL, Akebia slapped with partial hold and will lay off 42% of staff (Endpoints)
  • Following $1.9B buyout, Sanofi shutters Kadmon's NY site and chops 25 staffers (Endpoints)
  • Catalent buys UK vaccine manufacturing centre (BioPharma Reporter)
  • After imploding three years ago, Aptinyx follows a painful setback with yet another PhII failure (Endpoints)
  • Seres quietly discloses it has once again altered plans in ulcerative colitis (Endpoints)
  • Mysterious Retro Biosciences Aims To Extend Human Lifespan By 10 Years With Cellular Anti-Aging Tech (Scrip)
 
Medtech
  • FDA sees 'appropriate' transition period for COVID-19 test EUAs when public health emergency ends (MedTech Dive)
  • FDA clarifies cybersecurity recommendations for device makers in new guidance (MedTech Dive) (Bloomberg)
  • EU Regulatory Output In 2022 To Support MDR And IVDR (MedTech Insight)
  • Aidoc locks down FDA OK for brain aneurysm-spotting AI, its 9th agency nod (Fierce)
  • Viz.AI collects $100M to spot more maladies in emergency CT scans (Fierce)
  • Minute Insight: OxfordVR’s Virtual Reality Program Treats Agoraphobia In Trial (MedTech Insight)
Government, Regulatory & Legal
 
  • Minnesota judge narrows charges in class action suit against Mylan, pharmacy benefit managers over EpiPen price hikes (Endpoints)
  • Bristol-Myers Sues MSN to Block Copies of Blockbuster Pomalyst (Bloomberg)
  • Integra LifeSciences Must Face Fraud Suit Over Off-Label Device (Bloomberg)
  • Balwani Jury Can See Evidence Theranos Used Pharma Logos (Law360)
 
 
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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