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