Regulatory Focus™ > News Articles > 2021 > 4 > Recon: ThermoFisher acquires PPD for $17.4B; First chimeric human-monkey embryos

Recon: ThermoFisher acquires PPD for $17.4B; First chimeric human-monkey embryos

Posted 15 April 2021 | By Kari Oakes 

Recon: ThermoFisher acquires PPD for $17.4B; First chimeric human-monkey embryos

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Daily U.S. Covid cases remain above 70,000 amid Johnson & Johnson vaccine pause (CNBC)
  • Fauci, Jim Jordan spar over pandemic restrictions (The Hill)
  • What’s behind the wait on a J&J vaccine verdict (Politico) (NYT) (WSJ)
  • The J&J Vaccine Pause Is Science Working Like It’s Supposed To (Slate)
  • Why the Johnson & Johnson pause may not matter for America’s Covid-19 vaccine rollout (VOX)
  • Inside the puzzling delay in naming a new FDA commissioner (MMM Online)
  • U.S. preparing for 1-year COVID-19 booster shots; Pfizer chief sees need (Reuters)
  • FDA is urged to move faster to list medicines withdrawn over safety concerns (STAT)
  • Hints emerge about a key Senate committee’s plans for health care (STAT)
  • FDA inspection of Emergent’s Baltimore site in 2020 raises new questions (Endpoints)
  • FDA wants more data on promising ALS drug, frustrating patients seeking faster access (STAT)
  • US FDA Oncology Center Wants Trial Datasets Flagged As Remote Or In-Person Assessments (Pink Sheet)
  • U.S. Prescription Drug Prices Are 2.5 Times Those in Other OECD Countries (RAND)
  • Woodcock: COVID Is Not The Time For Structural Changes At US FDA (Pink Sheet)
  • NIH funds new influenza research network (NIH)
In Focus: International
  • EU leaders want 'Digital Green Certificates' ready by summer (Healthcare IT News)
  • Global officials urge rich countries to donate excess COVID-19 vaccines, money to help end pandemic (Reuters)
  • Changing Strategy, E.U. Bets Big on Pfizer to Battle Covid (NYT)
  • Antibiotics in development not enough to tackle 'superbugs'- WHO (Reuters) (Financial Times)
  • Russia seeks to distance Sputnik V from blood clotting cases (Pharmaletter)
  • Brazil's COVID-19 response cost thousands of lives, says humanitarian group (Reuters)
  • WTO head urges movement on controversial Covid-19 vaccine proposal, but objections remain (STAT)
Coronavirus Pandemic
  • UK scientists find higher risk of brain clots from COVID-19 compared with vaccines (Reuters)
  • One year of SARS-CoV-2 evolution (EurekAlert)
  • CDC finds less than 1 percent of fully vaccinated people got COVID-19 (The Hill)
  • Vax Passports Are a Bad Idea (Medpage Today)
  • CureVac hopes to win regulatory approval for its Covid vaccine by June (Financial Times)
  • Record-breaking sales of $24.8bn by 2021 predicted for Pfizer/BioNTech’s vaccine (Pharmaletter)
  • Oxford/AstraZeneca Covid vaccine research ‘was 97% publicly funded’ (Guardian)
  • Moderna eyes beefed-up vaccine production with the help of U.S.-brokered manufacturing talks: report (Fierce)
  • Two to a bed in Delhi hospital as India's COVID crisis spirals (Reuters) (CNBC)
  • Penn study suggests those who had COVID-19 may only need one vaccine dose (EurekAlert)
  • GeNeuro To Tackle Long COVID By Targeting Ancestor Viral Gene Activation (Scrip)
  • Novartis agrees to help produce Roche’s repurposed COVID-19 drug (PMLive)
  • Pfizer CEO: Third dose of COVID-19 vaccine 'likely' needed within 1 year  (CNBC) (The Hill)
Pharma & Biotech
  • International team creates first chimeric human-monkey embryos (STAT)
  • Vaccines that can protect against many coronaviruses could prevent another pandemic (Science)
  • GSK discontinues two feladilimab trials in head and neck cancer (PMLive)
  • Activist investor Elliott takes ‘significant’ stake in GlaxoSmithKline amid string of setbacks: report (Fierce)
  • New name, new board, new focus: AltruBio relaunches with $63M series A (Fierce)
  • Abzena picks North Carolina as the home for its 6th manufacturing site, plans to add 325 jobs in Sanford (Endpoints)
  • Genechem’s bispecifics deal with I-Mab marks debut for a global strategy 20 years in the making (Biocentury)
  • Designing better antibody drugs with artificial intelligence (EurekAlert)
  • Next-generation DNA damage response programs at AACR (Biocentury)
  • GSK stops Keytruda combo trials after ICOS drug falls short (Biopharma Reporter)
  • Merck ends development of Covid drug it acquired from OncoImmune (CNBC)
  • Roche’s Evrysdi drug for SMA shown to significantly increase survival (Pharmafile)
  • With a new method to synthesize DNA, San Diego's Molecular Assemblies notches $24M Series A (Endpoints)
  • Long-term survival rates for immunotherapies could be misinterpreted (EurekAlert)
  • Eli Lilly axes 163 Dermira staffers, shutters Menlo Park site (Endpoints)
  • NICE backs Ultomiris for adult patients with PNH (Pharmaletter)
  • European Commission approves Opdivo plus Cambometyx for advanced kidney cancer (PMLive)
  • The world of Wnt heads to Nasdaq as Surrozen announces a $212M SPAC deal (Endpoints)
  • Call it a pandemic reckoning: New ESG expectations spur surge of pharma good deeds (Fierce)
  • Investment in Rare Disease Drug Development Continues to Surge (Global Genes)
  • Another big CRO deal has landed as Thermo Fisher acquires PPD for $17.4B (Endpoints)
  • 6 medtechs to watch when earnings kick off next week (Medtech Dive)
  • Medtronic Recalls Several Heart Devices Due to a Battery Problem (MD+DI)
  • Glucose monitors revolutionized diabetes care. Now digital health startups want to bring them to the masses (STAT)
  • Fitbit looks to close diversity gap in research with new Health Equity Research Initiative (Mobi Health News)
  • Samsung upcycles older phones to diagnose eye diseases in impoverished communities (Mobi Health News)
  • Anthem, K Health, Blackstone launch digital health company (MedCity News)
Government & Regulatory
  • Drone-Enabled Pharmaceutical Delivery: Navigating Regulatory Turbulence (Harvard Bill of Health)
  • Ask and Ye Shall Receive, But Don’t Ask FDA for a Virtual Inspection (FDA Law Blog)
  • Genentech and Centus Notify Court of Settlement of Bevacizumab Litigation (Goodwin)
  • The FDA Seeks a New Way to Review Old Drugs Without Causing Prices to Soar (KHN)
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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