The Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
Regulatory Focus™ > News Articles > 2020 > 7 > Recon: Moderna plans to start Phase 3 coronavirus vaccine study on 27 July; Roche, Blueprint partner

Recon: Moderna plans to start Phase 3 coronavirus vaccine study on 27 July; Roche, Blueprint partner on targeted cancer drug

Posted 14 July 2020 | By Michael Mezher 

Recon: Moderna plans to start Phase 3 coronavirus vaccine study on 27 July; Roche, Blueprint partner on targeted cancer drug

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Vaccine-makers’ ‘no profit’ pledge stirs doubts in Congress (Politico)
  • Moderna will begin late-stage coronavirus vaccine trial on July 27 (CNBC) (Reuters)
  • US COVID-19 vaccine program to start manufacturing by late summer, says official (Reuters) (Endpoints) (CNBC)
  • Hospitals Stock Up on Covid-19 Drugs to Prepare for Second Wave in Fall (WSJ)
  • Blueprint Medicines partners with Roche to develop and sell genetically targeted cancer drug (STAT)
  • FDA rejects Verrica’s skin warts pitch, a month after flagging application ‘deficiencies’ (Endpoints)
  • Ohio sues Express Scripts for ‘egregiously’ overcharging for medicines (STAT)
In Focus: International
  • Global vaccine plan may allow rich countries to buy more (AP)
  • Covid Shot Derived From Tobacco-Like Plant Tested in Humans (Bloomberg)
  • Pharmas restart drug trials after pandemic-related declines, Medidata finds (Reuters)
  • Lupin shuts manufacturing drug plant after 17 employees test positive for Covid-19 (Economic Times)
  • Merck KGaA's manufacturing group could see billions from COVID-19 work: analyst (Fierce)
  • Pharma trade group scolds Gilead again for misleading information about a rival HIV drug (STAT)
  • Cytokinetics nabs Chinese partner, up to $450M as CV becomes company focus (Endpoints)
  • European Parliament backs WHO effort to create a Covid-19 technology access pool (STAT)
  • NICE links with Colombia’s Institute of Health Technology Assessment (PharmaTimes)
Coronavirus Pandemic
  • Immunity to the coronavirus may last only a few months, UK study finds (CNBC)
  • Mulvaney calls U.S. coronavirus testing abilities 'inexcusable,' breaking from Trump (Politico)
  • TimesFauci says US local public healthcare is ‘in tatters’ (Financial Times)
  • Coronavirus Sparks New Interest In Using Ultraviolet Light To Disinfect Indoor Air (NPR)
  • 3M partners with MIT researchers to develop U.S.-backed rapid coronavirus antigen test (CNBC)
  • Joined-Up EU Approach Is Key To Continuing COVID-19 Fight (Pink Sheet)
  • AstraZeneca taps IQVIA to 'warp speed' its US pandemic vaccine research (Fierce)
  • Coronavirus (COVID-19) Update: Daily Roundup July 13, 2020 (FDA)
Pharma & Biotech
  • Biotech Properties Draw Billions of Dollars as Other Real Estate Languishes (WSJ)
  • Sanofi and MD Anderson team up to accelerate cancer drug testing (STAT) (Endpoints)
  • Biogen, Eisai take Alzheimer’s candidate BAN2401 into phase 3 (PMLive)
  • Generic Drug User Fee Program Sees First-Ever Fee Spending Decrease, FTE Decline (Pink Sheet)
  • Massachusetts biotech Revitope scores first collaboration thanks to dual-engaging T cell platform (Endpoints)
  • Billions of dollars worth of SPACs are riding on the biotech IPO boom (Endpoints)
  • Junshi taps Revitope for next-gen anticancer bispecifics (Fierce)
  • Digital cancer pathology player Paige adds investments from Goldman Sachs, others (Fierce)
  • US FDA Advisory Cmte. To Evaluate Terlipressin's Clinical Outcomes, Risk Of Respiratory Failure (Pink Sheet)
  • Why pay $4B for a steady diet of disappointment? Porges turns thumbs down on Alexion’s M&A strategy, offers some pointers (Endpoints)
  • A neoantigen pioneer says its tech is working great. So what wrecked the share price? (Endpoints)
  • J&J nabs new OK for IL-23 drug Tremfya; Merck KGaA spinout ups Series A tally to €20.1M (Endpoints)
Medtech
  • Edwards to pay Abbott $468M to settle mitral, tricuspid repair device patent disputes (MedtechDive)
  • Quest Q2 better than feared, as demand surges for COVID-19 diagnostics (MedtechDive)
  • Shareholder challenges Thermo Fisher's $11.5B deal to buy Qiagen (MedtechDive) (Fierce)
  • Abbott lays out plan for US study of FreeStyle Libre 3 (MedtechDive)
  • An insider's look at how GM, Ventec ramped up ventilator production amid COVID-19 (MedtechDive)
  • QSR Author Kim Trautman: FDA Should Change Name Of New Quality System Reg (And Other Thoughts) (MedtechInsight)
  • Industry Fears Disruption For EU Medtech Market Surveillance System (MedtechInsight)
  • US House Panel Votes For 5.8% Cut In FDA Device Center’s 2021 Budget Authority, Seeks COVID-19 Review (MedtechInsight)
Government & Regulatory
  • Electronic Submissions; Data Standards; Support for Standard for the Exchange of Nonclinical Data (Federal Register)
  • New York Woman Sentenced for Selling Abortion-Inducing Pills Illegally Smuggled Into US (FDA)
  • 3rd Circ. Mulling FTC-AbbVie Pause Till High Court Acts (Law360)
  • 5 Compliance Lessons From Novartis' FCPA Settlement (Law360)
  • Lilly Bars Contract Pharmacies From 340B Discounts Despite HRSA Guidance (Pink Sheet)
  • Judge waives requirement for in-person visit to get abortion pill during pandemic (The Hill)
  • Mallinckrodt Aims To Nix Medicaid FCA Suit Over Acthar Gel (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.

Tags: US, worldwide

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe