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

Posted 20 September 2021 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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)
In Focus: International
  • 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)
Coronavirus Pandemic
  • 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)
Pharma & Biotech                                                                                                     
  • 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)
Government, Regulatory & Legal
  • 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)
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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