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

• 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)

• EMA Hikes Pharma Industry Fees (The Pink Sheet) (EMA)
• Australian HTA Consults On Discount Rate (The Pink Sheet)
• Japan Lifts Decades-Old Bans On Somatropin In Diabetes, IFNβ In Pregnancy  (The Pink Sheet)
• Working groups to tackle regulatory and ethical issues around CGT expanded access (BioPharma Reporter)

• 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)

• 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)

• 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 9^th 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)

• 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)