rf-fullcolor.png

 

August 17, 2020
by Michael Mezher

Recon: Sanofi to acquire Principia for $3.7B; FDA approves Roche’s NMOSD drug Enspryng

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Trump eyes new unproven coronavirus "cure" (Axios)
  • Roche gets US approval for Enspryng, takes on Alexion's Soliris (Reuters) (Press)
  • Trump Administration picks McKesson for coronavirus vaccine distribution (Reuters)
  • Unity Biotechnology fails early test, raising doubts its ability to develop drugs to reverse aging symptoms (STAT)
  • Bristol Myers Squibb pens $475M Dragonfly pact for IL-12 program (Fierce)
  • FDA clears saliva test for Covid-19, opening door to wider testing (STAT) (FDA)
  • CDC's chief of staff, deputy chief of staff jointly depart (Politico)
  • Clinical Trials of Coronavirus Drugs Are Taking Longer Than Expected (NYTimes)
In Focus: International
  • Sanofi in hunt for specialty drugs with $3.7 billion deal for U.S.-based Principia (Reuters) (Bloomberg) (STAT) (Endpoints) (FT) (Press)
  • CureVac vows ‘ethical margin’ on price of Covid-19 vaccine (Financial Times)
  • CureVac doesn't rule out accelerated approval for COVID-19 vaccine (Reuters)
  • Russia produces first batch of COVID-19 vaccine: Interfax (Reuters)
  • Russia vaccine thrusts little-known state research unit into spotlight (FT)
  • Testing of CanSino's COVID-19 candidate vaccine begins in Russia (Reuters)
  • Novavax begins mid-stage study of COVID-19 vaccine in South Africa (Reuters)
  • China grants country's first COVID-19 vaccine patent to CanSino: state media (Reuters)
  • NICE publishes guidance on Astellas' Xospata (PharmaTimes)
  • Juno joint venture seeks IPO haul to bring CAR-Ts to China (Fierce) (Endpoints)
Coronavirus Pandemic
  • Scientists See Signs of Lasting Immunity to Covid-19, Even After Mild Infections (NYTimes)
  • PPE Shortage Could Last Years Without Strategic Plan, Experts Warn (KHN)
  • Politics Slows Flow of US Pandemic Relief Funds to Public Health Agencies (KHN)
  • Trust, Fear and Solidarity Will Determine the Success of a COVID Vaccine (KHN)
  • U.S. Deaths Top 170,000 As Coronavirus Pandemic Continues To Take Its Toll (NPR)
  • Trump elevates Scott Atlas, a doctor with a rosier coronavirus outlook (Politico)
  • Coronavirus Crisis Has Made Brazil an Ideal Vaccine Laboratory (Politico)
  • Japan's AGC to expand vaccine agent production for Novavax (Nikkei)
Pharma & Biotech
  • Q&A: Sanofi CEO Paul Hudson on a major acquisition, long-term strategy, and Covid-19 vaccines (STAT)
  • EU To Coordinate Assessment Of Clinical Trial Safety Data (Pink Sheet)
  • Ned Sharpless' 'brainchild' nabs a speedy FDA review for small cell lung cancer drug (Endpoints)
  • Blackstone finalizes R&D pact with Alnylam as part of earlier $2 billion investment (Endpoints)
  • FDA slaps clinical hold on Applied Therapeutics after savage fight over short attack (Endpoints)
  • Trevena preps low-key launch, responsible marketing for long-awaited opioid Olinvyk (Fierce)
  • Bristol Myers bets $475M cash on a blockbuster shot at breaking the mold in immuno-oncology — with a potential IL-12 game-changer (Endpoints)
  • KKR healthcare vet Jim Momtazee jump starts a new investment firm; Bayer signs up a top China biotech player to $645M deal (Endpoints)
  • Taysha buys clinic-ready gene therapy from Abeona, bringing Steven Gray's portfolio back in one place (Endpoints)
  • Q&A: BIO CEO Michelle McMurry-Heath Outlines Diversity Goals (Pink Sheet)
  • An RNA vaccine for advanced melanoma (Nature)
  • Zooming in on What Matters! (LifeSciVC)
Medtech
  • MedTech 100 roundup: Up-and-down week for industry (MassDevice)
  • NIH study shows multifocal contact lenses can slow down childhood nearsightedness (Fierce)
  • Surgical robots, early cancer tests top CB Insights digital health startup list (MedtechDive)
  • Designation Of EU Notified Bodies: Is There Evidence Of Bias? (MedtechInsight)
  • Baxter Obtains U.S. FDA Emergency Use Authorization for Regiocit Replacement Solution Used in CRRT (Press)
Government, Regulatory & Legal
  • Hancock axes ‘failing’ Public Health England (The Telegraph)
  • Ohio’s lawsuit against drug distributors over opioid crisis set to go before a judge and jury this October (Cleveland)
  • Ex-Insys Sales Rep Evades Prison Over Opioid Bribe Ploy (Law360)
  • Ex-FDA Head Says He Didn't Ask NY Docs About Opioid Rx's (Law360)
  • 3M Inks Deal To End Mask Suit Against Amazon Vendor (Law360)
  • Mallinckrodt Must Face Antitrust Claims Over Seizure Drug (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.
×

Welcome to the new RAPS Digital Experience

We have completed our migration to a new platform and are pleased to introduce the updated site.

What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.

We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.

We welcome your feedback. Please let us know how we can continue to improve your experience.