Recon: FDA grants priority review to Pfizer’s RSV vaccine; Merck’s COVID pill falls short in preventing infection

ReconRecon | 21 February 2023 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Pfizer’s maternal RSV vaccine filing gets priority review, setting up showdown with AstraZeneca, Sanofi (Fierce) (BioPharma Reporter) (BioSpace)
  • Icosavax Granted FDA Fast Track Designation for IVX-A12 (BioSpace) (Yahoo Finance) (Precision Vaccinations)
  • Akebia’s Appeal for Anemia in CKD Drug Delayed Again (BioSpace)
  • Pharmalittle: Cystic fibrosis patients caught in battle between pharma and insurers; Merck Covid pill fails to prevent infection among household members (STAT)
  • Why and How Innovators are Leaving Academia for Industry (BioSpace)
  • HIV patient cured after bone marrow transplant in rare case, research shows (Washington Post)
  • How a depression test devised by a Zoloft marketer became a crutch for a failing mental health system (STAT)
In Focus: International
  • EU Issues More Q&As To Support Compliance With Clinical Trials Regulation (Pink Sheet)
  • EU Decision Time For Zejula/Zytiga Combo Therapy, Vadadustat & Other Drugs (Pink Sheet)
  • Develop vaccines for all animal influenza strain, says incoming WHO chief scientist (Reuters)
  • Three COVID-19 Drugs Clear UK Funding Hurdle But Olumiant No Longer In The Running (Pink Sheet)
  • World’s Failure to Wipe Out Covid Bodes Badly for Next Pandemic (Bloomberg)
  • UK Launches Inquiry Into Its Clinical Trials Problems After Pharma Outcry (Scrip)
  • Beijing signs MoU to import some drugs from Merck (Reuters)
  • Maternal Infection May Play Role in Child’s Leukemia (MedPage Today)
Pharma & Biotech
  • Executive chairman of Spanish pharma company Grifols resigns (Reuters)
  • 2022’s 10 top clinical trial flops (Fierce)
  • Merck’s COVID pill fails to prevent infection among household members (Reuters) (Endpoints)
  • En route to BLA filing, Actinium details PhIII win for targeted radiotherapy in acute myeloid leukemia (Endpoints)
  • Genentech’s California biologics facility will support launches in cancer, neuroscience and more: exec (Fierce)
  • Cancer biotech ends trial, searches for sale or other route (Endpoints)
  • Updated: Resilience to shut down Massachusetts manufacturing plant (Endpoints)
  • Hemab Secures $135M for Neglected Bleeding Disorders (BioSpace) (BioPharma Reporter)
  • S. African drugmaker Adcock warns of margin pressure in coming months (Reuters)
  • Potential preeclampsia treatment uses LMPs to deliver mRNA to the placenta (Fierce)
  • Bridge holds firm despite placebo beating drug in midphase ulcerative colitis trial (Fierce)
  • Implementing The EU MDR Amendment: “Messy” And “A Lot To Figure Out On The Hoof” (MedTech Insight)
  • Medtech SMEs Set Out Regulatory Needs As UK Advances Post-EU System (MedTech Insight)
  • Perfuze Millipede Catheter Gains FDA Clearance for Treating Ischemic Stroke (FDAnews)
  • Medtronic beats quarterly profit estimates on strong heart device sales (Reuters)
  • Philips management will not receive bonuses for 2022 (Reuters)
  • Smith & Nephew’s 2022 performance weighed down by inflation and currency headwinds (MedWatch)
  • Thermo Fisher Scientific Selected to Support National Institute of Health’s Blueprint MedTech program (BioSpace)
  • A device restored hand movement for two stroke survivors. Researchers want to take it mainstream (STAT) (MedTech Dive)
Government, Regulatory and Legal
  • J&J $302 Million Pelvic Mesh Fine a Skip for Supreme Court (Bloomberg) (Reuters)
  • Maryland Law Ending State Retiree Drug Benefits Upheld on Appeal (Bloomberg)
  • Disgraced Doctor Who Gene Edited Babies Gets Hong Kong Visa (Bloomberg)
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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