Regulatory Focus™ > News Articles > 2021 > 6 > Recon: Pfizer to start large pediatric trial of COVID-19 vaccine; FDA pushes back decision on Incyte

Recon: Pfizer to start large pediatric trial of COVID-19 vaccine; FDA pushes back decision on Incyte’s Jakafi

Posted 08 June 2021 | By Michael Mezher 

Recon: Pfizer to start large pediatric trial of COVID-19 vaccine; FDA pushes back decision on Incyte’s Jakafi

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Pfizer to start large study to test COVID-19 vaccine in children below 12 (Reuters)
  • Inovio expands partnership with Advaccine for COVID-19 vaccine study (Reuters)
  • Incyte the latest to fall victim to JAK scrutiny as FDA pushes back Jakafi review in GVHD (Fierce)
  • FDA rejects Google's push to add virtual exam for Parkinson’s disease to its smartwatch (Endpoints)
  • White House lays out sprawling new plan to shore up pharma and API manufacturing (Endpoints)
  • Becerra to defend Biden’s budget blueprint (Politico)
  • Amazon Pharmacy offers half-yearly prescriptions starting at $6 (Reuters)
In Focus: International
  • EMA evaluating the use of COVID-19 Vaccine Moderna in young people aged 12 to 17 (EMA)
  • EU regulator does not expect approval for CureVac vaccine before August – source (Reuters)
  • Over 3 million medicines and devices seized in UK as part of global crackdown (MHRA)
  • A UN Declaration on Ending AIDS Should Have Been Easy. It Wasn’t. (NYTimes)
  • Aspirin does not improve survival in COVID-19 patients - UK study (Reuters)
  • Some Russian drugmakers focus on export-oriented Sputnik Light shot (Reuters)
  • Kuwait approves Johnson & Johnson Covid vaccine (Reuters)
  • Boyu, Sinopharm among bidders shortlisted for Mundipharma China -sources (Reuters)
Coronavirus Pandemic
  • U.S. Report Found It Plausible Covid-19 Leaked From Wuhan Lab (WSJ) (Reuters)
  • US reports fewer than 15,000 Covid cases per day, averaging about 1 million daily vaccinations (CNBC)
  • Florida, Alabama discontinue daily Covid data reporting in shift to ‘next phase’ of pandemic (CNBC)
  • Boeing Tested Air Purifiers Like Those Widely Used in Schools. It Decided Not to Use Them in Planes. (KHN)
  • A ‘landmark’ trial to test mRNA vaccines against COVID-19 in Africa can’t get the coveted shots (Science)
  • Thailand starts Covid vaccine drive using jabs made by king’s firm (The Guardian)
Pharma & Biotech
  • Alzheimer’s Drug Is Bonanza for Biogen, Most Likely at Taxpayer Expense (NYTimes) (CNBC) (FT) (STAT)
  • An extra twist in the FDA’s Alzheimer’s decision: no limits on which patients can get the drug (STAT)
  • Biogen to start shipping Alzheimer's drug in about two weeks (Reuters)
  • By approving Biogen’s Alzheimer’s drug, the FDA is shifting its rules. That is a giant risk (STAT)
  • Elation, pride, and a slew of questions: Clinical trial participants reflect on their own complicated reactions to Aduhelm approval (STAT)
  • Bayer's billon-dollar Parkinson's disease bets land in the clinic (Fierce)
  • Plans For EU Electronic Product Information Move Up A Gear (Pink Sheet)
  • Denmark Outlines Vision For Decentralized Trials Beyond COVID-19 (Pink Sheet)
  • Cipaglucosidase alfa with miglustat in the treatment of late-onset Pompe disease (MHRA)
  • NICE recommends Tecentriq for first-line NSCLC (PharmaTimes)
  • MHRA approves venetoclax as acute myeloid leukemia treatment (Pharmafile)
  • SMC backs five new medicines for NHS use (PharmaTimes)
  • New NICE recommendation for Astellas prostate cancer drug (Pharmafile)
  • Roche, Pfizer and Novartis earn top marks from cancer patient groups during pandemic: survey (Fierce)
  • Keen to turn a new page, Indivior branches out, picking up an option for cannabis addiction drug (Endpoints)
  • Trailing the Big Pharma players, a lesser known BCMA CAR-T candidate comes into the spotlight (Endpoints)
  • Hoping to challenge blockbuster breast cancer franchises, a small Dutch biotech says its ADC passed a PhIII test (Endpoints)
  • SpringWorks and Seagen team up in multiple myeloma; Merck and Eisai build out Keytruda/Lenvima data (Endpoints)
  • From protein degradation to 'toad venom': Another five biotechs will make the Nasdaq shuffle after filing SEC paperwork (Endpoints)
  • #ASCO21: AstraZeneca takes a swing at J&J and AbbVie's Imbruvica with long-term data from head-to-head trial (Endpoints)
Medtech
  • US FDA Announces Trial-Focused Spinal Devices Workshop (MedtechInsight)
  • Commission’s eIFU Draft Unleashes Diametrically Opposed Views Among Device Users (MedtechInsight)
  • How The EU’s Device Nomenclature Operates: Free Of Charge And Accessible To All (MedtechInsight)
  • How Compliance With International UDI Rules Can Help Under New EU Rules (MedtechInsight)
  • Medtronic Announces FDA Approval Of SenSight Directional Lead System For Treating Movement Disorders (MedtechInsight)
  • Israeli startup receives CE Mark for synthetic corneal implant (mobihealthnews)
Government, Regulatory & Legal
  • Teva Fights To Invalidate Astellas' Urinary Drug Patent (Law360)
  • JPML Sends McKinsey Opioid Cases To New MDL (Law360)
  • Justices Won't Hear Challenge To FDA Regulation Of E-Cigs (Law360)
  • Fed. Circ. Mulls Mixed PTAB Rulings In Teva Antibody IP Fight (Law360)
  • Panel Rules Pfizer Can't Get New MDL Over Cancer Drug IP (Law360)
  • Becton, Dickinson & Co. v. Baxter Corp. Englewood (Fed. Cir. 2021) (Patent Docs)
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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