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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)