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

• 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)

• 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)

• 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)

• 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)