Recon: Pfizer, BioNTech say vaccine safe, protective in children; FDA approves first biosimilar to Roche's Lucentis

• US to buy millions of Pfizer vaccine doses to donate to world (Washington Post) (Reuters)
• CDC study finds Moderna vaccine is best at preventing Covid-19 hospitalization (Politico)
• Pfizer/BioNTech say data show COVID-19 vaccine safe and protective in kids (Reuters) (STAT)
• Regulators expected to OK Pfizer boosters for older Americans this week (Reuters)
• Key data on U.S. J&J, Moderna COVID-19 boosters weeks away, Fauci says (Reuters)
• FDA approves first biosimilar rival to Roche's blockbuster eye drug (Reuters)
• Sinema tells White House she’s opposed to current prescription drug plan (Politico)
• ‘A solid black eye’: Drug pricing reform advocates scramble to reset after setback in Congress (STAT)
• Senate proposes expanding pharma penalties for hiking drug prices (STAT)
• Mirati drug combination shrinks tumors in 39% of colon cancer patients in study (Reuters) (Endpoints) (STAT)

• Biden to Push Global Plan to Battle Covid as National Gaps Widen (NYTimes)
• Vietnam approves Abdala vaccine as president visits Cuba (Reuters)
• U.K. government launches a new system to monitor clinical trial reporting (STAT)
• Brazil police raid pharmaceutical firm amid Senate vaccine probe (Euronews)
• World’s largest vaccine maker optimistic on India easing export restrictions (FT)
• Ministers told to bar EU from UK trial data in vaccines row (The Guardian)
• End of ‘super profits’? Shares of top medical glove maker fall as Covid-induced demand eases (CNBC)

• COVID creates shortages of an array of U.S. medical supplies (Reuters)
• Confusion over Biden's booster plan riles governors (Politico)
• U.S. will re-open to international travelers with vaccine requirements (Reuters)
• They Shunned Covid Vaccines but Embraced Antibody Treatment (NYTimes)

• AstraZeneca, Daiichi Sankyo's ADC Enhertu blows away Roche's Kadcyla in second-line advanced breast cancer (Endpoints)
• A PDUFA First: Pre-Approval Inspection Notice Goal Will Be Created (Pink Sheetz)
• The best of the rest: Highlights from the below-the-fold presentations at #ESMO21 (Endpoints)
• Months after a mammoth raise, Ventyx Biosciences dips back into venture well (Endpoints)
• Is a Beyondspring drug helping lung cancer patients live longer? Study results trigger debate (STAT)
• Fresh off FerGene's meltdown, David Meek takes over at Mirati with lead KRAS drug racing to an approval (Endpoints)
• Zolgensma patent spat brews between Novartis and Regenxbio as top Novartis gene therapy exec departs (Endpoints)       
• ESMO: Exelixis lays out promising early Cabometyx combo data in prostate cancer, but key discrepancies persist (Fierce)
• As Bayer, Novartis stack up their radiopharmaceutical data at #ESMO21, a key debate takes shape (Endpoints)
• Exelixis pulls a surprise win in thyroid cancer just days ahead of final Cabometyx readout (Endpoints)
• Time for round 2: Illumina-backed VC snags $325M for its next fund (Endpoints)
• Denmark's Gubra to collaborate with Bayer on peptides; Samsung and Biogen receive FDA approval for Lucentis biosimilar (Endpoints)

• Boston Scientific adds colorectal cancer survival boost to list of wins for tumor-targeting microbeads (Fierce)
• AstraZeneca’s Alexion taps DNA profiler Genomenon for rare disease diagnoses (Fierce)
• Thermo Fisher COVID-19 testing forecast tops estimates, crushes 2022 guidance (MedtechDive)
• FDA warns of false positive risk of Abbott COVID-19 tests (MedtechDive)
• China's Medtech Regulatory Update Does Not Go Far Enough For Overseas Innovators (MedtechInsight)
• FTC warns app makers fall under breach notification rule (MedtechDive)

• Ex-Mylan employee pleads guilty to insider trading, illegally dealing on FDA approvals, earnings and Upjohn merger (Endpoints) (STAT)
• Biden adds measles to list of diseases that could require quarantine (Reuters)
• Former Theranos scientist says Elizabeth Holmes pushed her to validate tests for Walgreens rollout (CNBC)
• Two men plead guilty in a personal injury scheme involving pelvic mesh implants. (NYTimes)