Regulatory Focus™ > News Articles > 2021 > 11 > Recon: Novo Nordisk to buy Dicerna for $3.3B; US signs deal for $5.3B worth of Pfizer's COVID antivi

Recon: Novo Nordisk to buy Dicerna for $3.3B; US signs deal for $5.3B worth of Pfizer's COVID antiviral drug

Posted 18 November 2021 | By Michael Mezher 

Recon: Novo Nordisk to buy Dicerna for $3.3B; US signs deal for $5.3B worth of Pfizer's COVID antiviral drug

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • FDA approves Merck's Keytruda as first immunotherapy for early kidney cancer (BioPharmaDive) (FDA)
  • Pfizer signs $5.3 billion U.S. deal to supply COVID-19 antiviral pills (Reuters)
  • J&J sees potential for 14 new multibillion-dollar drugs by 2025 (Reuters)
  • White House Plans Major Expansion of Covid Vaccine Production (NYTimes)
  • Gilead pays up to retain rights to Arcus cancer drugs (BioPharmaDive) (STAT)
  • By selling bonds tied to drug access and climate goals, Teva takes pharma in a new direction (STAT)
  • SEC Investigating Cassava Sciences, Developer of Experimental Alzheimer’s Drug (WSJ)
In Focus: International
  • AstraZeneca's preventative COVID-19 shot shown to work longer-term (Reuters)
  • AstraZeneca says to seek commercial price for preventive antibody cocktail (Reuters)
  • EU assesses GSK-Vir COVID-19 antibody therapy for authorisation (Reuters) (EMA)
  • European Antibiotic Awareness Day: Fighting the silent pandemic (EMA)
  • Monkey-brain study with link to China's military roils top European university (Reuters)
  • Novartis Has a Big Pile of Cash and Investors Are Demanding Action (Bloomberg) (Fierce)
  • Denmark's Novo Nordisk to buy Dicerna Pharma for $3.3 billion (Reuters) (Fierce)
  • ‘Can’t get much worse’: What a European rejection of an Alzheimer’s drug would mean for Biogen (STAT)
Coronavirus Pandemic
  • Phasing Out of the COVID MyStudies Application (App) (FDA)
  • Germany recommends booster shots for all adult population (Reuters)
  • Covid : Children told to delay jab for 12 weeks after infection (BBC)
Pharma & Biotech
  • Misuse of antibiotics in pandemic building resistant bacteria, health agency warns (Reuters)
  • Companies make progress tackling drug-resistant infections, foundation says (Reuters)
  • Flagship's machine learning startup Generate bags $370M in latest round with plans for a big hiring spree (Endpoints) (STAT)
  • Public Opinion Is Unified on Lowering Drug Prices. Why Are Leaders Settling for Less? (KHN)
  • Eli Lilly, under pressure from Biohaven, launches head-to-head migraine trial between Emgality and Nurtec (Fierce)
  • Endo partners up with US government on $120M infusion into the national stockpile (Endpoints)
  • Sanofi ‘Strongly Disagrees’ With EMA Rejection Of NAS Status For Nexviadyme (Pink Sheet)
  • FDA+ roundup: ALS bill would provide $100m annually to access potential drugs; FDA needs to better enforce reporting, researchers say (Endpoints)
  • Sanofi inks major AI deal to improve clinical development odds with $270M cash investment (Endpoints)
  • BridgeBio borrows $750M ahead of key PhIII readout, as it looks to wrap up buzzy 2021 (Endpoints)
  • TAVR uptake in US cities tied to race, ethnicity and income: JAMA study (MedtechDive)
  • After High-Risk Recall And Scathing Inspection Report, Is FDA Warning Letter Next For Philips? (MedtechInsight)
  • Blackrock Neurotech nabs FDA breakthrough nod for system that uses thoughts to control devices (Fierce)
Government, Regulatory & Legal
  • Former Theranos patient testifies that a blood test at Walgreens came back with false positive for HIV (CNBC)
  • Teva, Cooper Cos. Must Face All Claims In Paragard IUD MDL (Law360)
  • Teva Says Dr. Reddy's Broke Deal Over Birth Control Device (Law360)
  • Pfizer's $2.3B Trillium Deal Closes Without FTC Challenge (Law360)
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.


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.