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Regulatory Focus™ > News Articles > 2020 > 2 > Recon: Sanofi/BARDA Team Up on Coronavirus Vaccine; NHS Starts Luxturna Gene Therapy

Recon: Sanofi/BARDA Team Up on Coronavirus Vaccine; NHS Starts Luxturna Gene Therapy

Posted 18 February 2020 | By Michael Mezher 

Recon: Sanofi/BARDA Team Up on Coronavirus Vaccine; NHS Starts Luxturna Gene Therapy

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Sanofi announces it will work with HHS to develop coronavirus vaccine (STAT) (Reuters) (Press)
  • The top 100 biopharma venture investors at the megabillions deal table (Endpoints)
  • ‘Pharma doesn’t like fish oil’: Wall Street funds sold Amarin after big win with heart drug (STAT)
  • FDA goes on high alert as coronavirus raises threat to drug manufacturing and clinical trials grind to a halt (Endpoints)
  • Payout From a National Opioids Settlement Won’t Be as Big as Hoped (NYTimes)
  • Unregulated sales of insulin common on Craigslist (Reuters)
In Focus: International
  • Europe braces for coronavirus-induced drug shortages (Politico)
  • China sees fall in coronavirus deaths but WHO urges caution (Reuters)
  • Japan plans HIV drug trials to fight coronavirus as Diamond Princess cases rise (Reuters)
  • Gilead’s Coronavirus Drug Trial Slowed by Lack of Eligible Recruits (WSJ)
  • First patient undergoes Luxturna gene therapy on NHS (PharmaTimes) (BBC)
  • Beovu bags EU approval in wet AMD (PharmaTimes) (PMLive)
  • Experts call on NICE to recommended a ban on OTC codeine sales (Pharmafile)
  • Grifols to help Saudi Arabia produce blood plasma medicines (Reuters)
Pharmaceuticals & Biotechnology
  • FDA calls states’ bluffs on drug importation (STAT)
  • A Global Look at Cancer Genomes (NIH)
  • New Meds Set to Reshape US CNS and oncology Markets (Xconomy)
  • Young cancer survivors have higher risk of severe health problems later (Reuters)
  • RA joins global syndicate to back a $98M round for CANbridge (Endpoints)
  • Breakthrough Therapy Designations: Phase II Data Is Sweet Spot For US FDA Award (Pink Sheet-$)
  • Crossover round, check. New team of biopharma execs, check. Now, Imara wants an IPO (Fierce)
  • As sickle cell patients find new options, NEA-founded Imara pitches mid-stage alternative for $86M IPO (Endpoints)
  • ReNeuron set for recovery after Woodford stake sale (PMLive)
  • Pfizer Warns Doctors About Blood Clot Risk With Xeljanz (Pink Sheet-$)
  • Warren Buffett gets a double take as the investment powerhouse settles on its first biotech investment (Endpoints)
  • DNX Biopharmaceuticals Announces Collaboration With Lung Cancer Initiative at Johnson & Johnson (Press)
  • Drug discovery in HD: Oxford spinoff's mass spectrometry approach scores fresh funding (Endpoints)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • Two fast track designations for Corey Goodman's new startup; Vifor/Akebia secure priority review voucher (Endpoints)
  • ALX Oncology’s ALX148 Receives Two Fast Track Designations from FDA for the Treatment of Patients with Head and Neck Squamous Cell Carcinoma and Patients with Gastric or Gastroesophageal Junction Adenocarcinoma (Press)
  • Alnylam Completes Enrollment of HELIOS-A Phase 3 Study of Vutrisiran for the Treatment of hATTR Amyloidosis with Polyneuropathy (Press)
  • Five Prime Therapeutics Provides Update on Phase 2 Trial of Cabiralizumab Combined with Opdivo® in Pancreatic Cancer (Press)
  • Horizon Therapeutics plc Announces U.S. FDA Approval of New Dosage Form for PROCYSBI® (Cysteamine Bitartrate) Delayed-Release Oral Granules (Press)
  • The First Patient Included in Japan in Isofol's Phase 3 AGENT Study (Press)
  • Arrevus Receives FDA Orphan Drug Designation for ARV-1801 (sodium fusidate) (Press)
  • Ra Pharmaceuticals Announces Publication of Zilucoplan Phase 2 gMG Trial Results in JAMA Neurology (Press)
  • FDA Approves Additional Molybdenum-99 (Mo-99) Filling Lines at NorthStar Medical Radioisotopes’ Columbia, Mo. Facility (Press)
Medical Devices
  • BD warns on some Alaris extension sets (MassDevice)
  • Grail Hits Another Milestone by Initiating PATHFINDER Study (MDDI)
  • ClinOne brings medical-grade remote monitoring to clinical trials with the BioIntelliSense FDA-cleared BioSticker™ device (Press)
  • Guided Therapeutics Files Pre-Submission Document with U.S. FDA Detailing Clinical Plan to Support Approval (Press)
  • Human factors terminology breakdown (Emergo)
US: Assorted & Government
  • Another Gadolinium Win for Defendants (Drug & Device Law)
  • Paw Shucks: Court Defers to FDA’s Request for Additional Animal Studies (FDA Law Blog)
Upcoming Meetings & Events Europe
  • European Commission Approves VYNDAQEL®, the First Treatment in the EU for Transthyretin Amyloid Cardiomyopathy (Press)
India
  • India Proposes Tiered Approach To Oversee Genome Editing (Pink Sheet-$)
  • NITI Ayog to hold emergency meeting on Feb 19 with drug industry to discuss API supply (Pharmabiz)
  • Dr. Reddy's sterile plant now meets at least minimal compliance, FDA says (Fierce)
  • Lupin denies quality is a company-wide issue despite run ins with FDA (InPharmaTechnologist)
  • India update: Expanded scope of medical device regulations, plus new expedited registration route (Emergo)
Australia
  • Multi-level marketing company fined $37,800 for alleged advertising breaches (TGA)
Canada
  • Summary Safety Review - Direct-acting antivirals (DAAs) – (Health Canada)
Coronavirus Outbreak
  • Officials amp up coronavirus warnings (Politico)
  • China approves flu drug being touted as a potential coronavirus treatment amid a rush of clinical studies (Endpoints)
  • Gottlieb: Japan is ‘on the cusp’ of coronavirus epidemic, could indicate pandemic is nearing (CNBC)
  • U.S. State Dept tracks 60 U.S. citizens in Japan following coronavirus outbreak (Reuters)
  • Hospital director dies in China's Wuhan, epicenter of coronavirus outbreak (Reuters)
  • Chinese doctors using plasma therapy on coronavirus, WHO says 'very valid' approach (Reuters)
  • EMA to support development of vaccines and treatments for novel coronavirus disease (COVID-19) (EMA)
  • He built a MERS treatment in 6 months and then the best Ebola drug. Now Christos Kyratsous turns his sights on Covid-19 (Endpoints)
  • How a Pharmacy Handles Mask Hoarders and Coronavirus Fears (NYTimes)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
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