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Regulatory Focus™ > News Articles > 2020 > 9 > Recon: Moderna releases COVID vaccine trial blueprint; BioNTech buys Novartis’ site to boost EU vacc

Recon: Moderna releases COVID vaccine trial blueprint; BioNTech buys Novartis’ site to boost EU vaccine production

Posted 17 September 2020 | By Michael Mezher 

Recon: Moderna releases COVID vaccine trial blueprint; BioNTech buys Novartis’ site to boost EU vaccine production

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Moderna would seek limited emergency use of COVID-19 vaccine based on early data (Reuters) (Boston Globe)
  • Moderna Shares the Blueprint for Its Coronavirus Vaccine Trial (NYTimes)
  • Moderna to develop seasonal flu vaccine (Reuters)
  • Biden-aligned group outlines potential Day 1 drug pricing actions (STAT)
  • US plans for hundreds of millions of cheap, fast COVID-19 tests (Reuters)
  • Lilly, Amgen partner to manufacture potential COVID-19 drugs (Reuters)
  • NIH launches trial of Rigel drug for severe COVID-19 (Reuters)
  • Trump contradicts CDC director on vaccine, masks: 'He was confused' (Reuters)
  • New York charges Johnson & Johnson with insurance fraud over opioid claims (Reuters)
  • Independent review clears Kodak chiefs of insider trading (FT)
In Focus: International
  • AstraZeneca's trial illnesses may not be due to COVID-19 shot, Oxford University says (Reuters)
  • WHO says safety comes first as over 170 nations join COVID-19 vaccine plan (Reuters)
  • BioNTech CEO expects vaccine can be fridge-stored for two weeks (Reuters)
  • BioNTech buys German site from Novartis to boost vaccine output (Reuters) (FT)
  • China's Sinovac to test coronavirus vaccine candidate in teenagers, children (Reuters)
  • Takeda-led COVID-19 plasma product to begin trial this month (Reuters)
  • South Korea approves Phase 2/3 trials of Celltrion COVID-19 antibody drug (Reuters)
  • Japan Pharma Groups Stepping Up Lobbying on FY2021 Budget, Tax Reform (PharmaJapan)
  • Opdivo scores NICE recommendation in two non-small cell lung cancer indications (Pharmafile)
  • WHO prequalifies first clofazimine, ivermectin and Sandoz’ rituximab biosimilar (WHO 1, 2, 3)
Coronavirus Pandemic
  • Sorrento Therapeutics soars 27% after FDA green-lights COVID-19 antibody trial (BI)
  • Vaccines Europe Statement on the safety of COVID-19 vaccines (Efpia)
  • CVS Health plans to double COVID-19 drive-thru test sites to over 4,000 (Reuters)
  • Why Can't America Make Enough N95 Masks? 6 Months Into Pandemic, Shortages Persist (NPR)
  • Nixed Philips, Hamilton, Vyaire ventilator contracts subject of expanding House probe (MedtechDive)
  • Trials 'unable to bounce back' after COVID-19 chaos: report (Fierce)
  • Detection of SARS-CoV-2 with SHERLOCK One-Pot Testing (NEJM)
  • New COVID-19 Vaccines May Be Accelerated By Using Existing Manufacturing Platforms, US FDA's Marks Says (Pink Sheet)
Pharma & Biotech
  • The cost of Gilead’s HIV prevention pill thwarted widespread use, study finds (STAT)
  • A longtime CytomX exec re-emerges at Synthekine, an $82M Stanford spinout (Endpoints)
  • Rare Pediatric Disease Designation Requests Skyrocket Ahead Of Voucher Program’s Sunset (Pink Sheet)
  • Arrowhead shares soar on liver disease data from four patients (BioPharmaDive)
  • New Designations Set To Speed Hemlibra, CAR-T In China (Scrip)
  • Amgen Files Erenumab for Migraine Prevention in Japan (PharmaJapan)
  • Moderna lands $100M upfront in deals with Vertex, Chiesi (Fierce)
  • Novo, Sanofi VC units lead Lava's $83M series C to fund gamma delta T-cell trials (Fierce)
  • Past a turning point, Finch scores $90M to complete the final stretch for oral microbiome therapy (Endpoints)
  • Sarepta faces another gene therapy hiccup as Regenxbio sues over Jim Wilson's patent (Endpoints)
  • Sean Bohen's break from biopharma is over. The ex-AstraZeneca CMO has retired his Big Pharma jersey and is now — happily — running a little biotech (Endpoints)
  • 'The biggest inflection point ever': On R&D day, Moderna CEO Stéphane Bancel doubles down on vaccines and lays out a vision for a '40, 50'-drug biotech (Endpoints)
  • One month after $115M megaround, muscle disease-focused Dyne goes public with $233M IPO (Endpoints)
  • After leading Celgene buyout, Matthew Roden leaves Bristol Myers Squibb for venture capital firm (Endpoints)
  • Jim Broderick reels in a $100M Series B to explore a 'new and big' angle of immune regulation (Endpoints)
  • Lava breaks prolonged silence with an $83M Series C and two I/O programs set for the clinic (Endpoints)
  • Two-Year, Randomized, Controlled Trial of Belimumab in Lupus Nephritis (NEJM)
Medtech
  • FDA Approves Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test (FDA)
  • Medtronic, Stryker among CEOs weighing in on COVID-19 recovery (MedtechDive)
Government, Regulatory & Legal
  • GAO report finds brokers offered false info on coverage for pre-existing conditions (The Hill)
  • Therapeutic goods advertising compliance: 2019-20 Annual Report (TGA)
  • W.Va. Ax Of Biogen MS Drug Patent Binds Del. Litigation (Law360)
  • USPTO Defers Fees On COVID-19 Provisional Applications (Law360)
  • Natera Fights Illumina's Bid To Invalidate DNA Testing Patent (Law360)
  • Bristol Myers Squibb Announces Settlement of U.S. Patent Litigation for REVLIMID® (lenalidomide) With Dr. Reddy’s (Press)
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.

Tags: US, worldwide

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