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Regulatory Focus™ > News Articles > 2020 > 7 > Recon: Moderna coronavirus vaccine yields immune response in Phase 1 trial; FDA panel backs GSK’s mu

Recon: Moderna coronavirus vaccine yields immune response in Phase 1 trial; FDA panel backs GSK’s multiple myeloma drug

Posted 15 July 2020 | By Michael Mezher 

Recon: Moderna coronavirus vaccine yields immune response in Phase 1 trial; FDA panel backs GSK’s multiple myeloma drug

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Moderna coronavirus vaccine shows promising results in early clinical trial (Politico) (STAT) (Endpoints) (NYTimes) (In the Pipeline) (Financial Times)
  • FDA panel votes in favor of approving GSK's multiple myeloma drug (Reuters) (Endpoints)
  • J&J's Tremfya Receives FDA Approval for Psoriatic Arthritis (Press)
  • Fake pharmaceutical ad urges viewers to ‘take the shot’ (AFP)
  • Teva Picked as Bellwether Target in Generic Drug Price-Fix Case (Bloomberg) (Law360)
  • Ohio sues Express Scripts for ‘egregiously’ overcharging for medicines (STAT)
  • AbbVie uses dozens of patents to ward off competition for a pricey cancer medicine (STAT) (BioPharmaDive)
  • Sun Pharma employee says she was fired for complaining that samples were improperly shipped (STAT)
In Focus: International
  • Key UK Covid Trial to Add Drug to Tests Before Winter Threat (Bloomberg)
  • WHO and UNICEF warn of a decline in vaccinations during COVID-19 (WHO)
  • A day after Moderna vaccine results, rumors swirl of pending AstraZeneca data (Endpoints) (ITV)
  • Drug maker offers to slash prices on cancer medicines to end European price gouging probe (STAT)
  • Seeking EU approval on acquisition, Google pledges not to use Fitbit health data to target ads (STAT)
  • MilliporeSigma to build new $20 million, 12,000-square-foot lab in Switzerland (Endpoints)
  • Orchard licenses gene therapy tech from GSK (Fierce)
  • Zydus Cadila begins human clinical trials of COVID-19 vaccine candidate (Economic Times)
  • UK Eyeing Conditions On Stryker's $4B Wright Medical Deal (Law360)
Coronavirus Pandemic
  • What’s behind the explosive new fight over Covid-19 data (Politico)
  • Trump Administration Strips C.D.C. of Control of Coronavirus Data (NYTimes)
  • Despite Shortfalls And Delays, U.S. Testing Czar Says Efforts Are Mostly 'Sufficient’ (NPR)
  • Baby Was Infected With Coronavirus in Womb, Study Reports (NYTimes)
  • FDA Announces Resumption of Domestic Inspections – Will Foreign Inspections Soon Follow? (FDA Law Blog)
  • Covid-19 roundup: Vaccine by end of 2020? Ken Frazier warns hype doing 'grave disservice' (Endpoints)
  • Drug firms get DGCI nod for Covid drug favipiravir despite inconclusive study (Economic Times)
  • Nephron looks to break into COVID-19 vaccine territory with $216M investment (Fierce)
  • Ensuring the Safety of Patients in Clinical Trials Studying Investigational New Drugs to Prevent or Treat COVID-19 (FDA)
  • Coronavirus (COVID-19) Update: Daily Roundup July 14, 2020 (FDA)
Pharma & Biotech
  • The Record-Breaking Biotech Funding Tsunami Of 1H2020 (LifeSciVC)
  • Re-Wiring US FDA’s Regulatory Thinking (Pink Sheet)
  • EMA Presses On With Guidance On Secondary Use Of Health Data (Pink Sheet)
  • Clinical Trials: Industry Navigating Alternative Ways Of Delivering Investigational Drugs During Pandemic (Pink Sheet)
  • FDA raises questions about Mallinckrodt's HRS-1 drug before advisory hearing (Endpoints)
  • Gilead-partnered Glympse snares $46.7M for their NASH-snooping biosensors (Endpoints)
  • Preventive studies for Eisai, Biogen Alzheimer's drug could add years to amyloid debate (BioPharmaDive)
  • Samsung Biologics May Add Manufacturing Capacity at its Site in Korea (Big Molecule Watch)
  • Patients Call For EU-Level Differential Pricing (Pink Sheet)
  • Pfizer doubles down on Syneos Health with new services pact (Fierce)
  • Novartis' Entresto gains steam with cardiologists despite stinging heart failure trial flop (Fierce)
  • 'Longevity as a service': Insilico spins off AI biotech that trains deep learning on anti-aging treatments (Endpoints)
  • Journals endorse new checklist to clean up sloppy animal research (Science Mag)
  • The Flu May Linger in the Air, Just Like the Coronavirus (NYTimes)
Medtech
  • ElectroCore noninvasive nerve stimulator gets EUA for COVID-19 patients with asthma (MedtechDive)
  • European Commission On Track To Appoint Expert Panel Members By End Of July (MedtechInsight)
Government & Regulatory
  • C.D.C. Employees Accuse Agency of ‘Toxic Culture of Racial Aggressions’ (NYTimes)
  • Trump administration asks Supreme Court to reinstate Arkansas Medicaid work requirements (The Hill)
  • A Few More Words on the D.C. Cir.’s Dumping of the Drug Price Disclosure Rule (Drug & Device Law)
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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