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)
- 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)
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