Coronavirus Update: SK Bioscience, Biological E, DongWha And Celltrion Report Progress
SK Bioscience has received an IND approval from South Korea's Ministry of Food and Drug Safety (MFDS) to begin a Phase I clinical trial with its COVID-19 vaccine candidate NBP2001.The ..... see more
Source : 'Scrip Intelligence'
Catchup Capsule: Key APAC Insights You Need To Read
A selection of key stories from the Asia-based content team for the Pink Sheet and Scrip over the past few weeks reflects both the diversity of region and broader developments in the ..... see more
Source : 'The Pink Sheet'
COVID-19: Could Lateral Flow Test Using Glycan Recognition Be A Rapid Testing Breakthrough?
A low-cost, rapid test for SARS-CoV-2 that detects the virus’s interaction with sugars around cells, and may perform just as well if the virus mutates, is being tested in UK ..... see more
Source : Medtech Insight
COVID-19: New Emergency Guidance From AAMI Targets Remote-Controlled Devices
The Association for the Advancement of Medical Instrumentation (AAMI) has released an emergency-use guidance that targets medical devices that can be used remotely during the coronavirus pandemic. ..... see more
Source : Medtech Insight
COVID-19 Serology Templates: FDA Updates Sponsor Template, Adds Home Test Document
The US Food and Drug Administration has issued two new templates for developers to use in drafting emergency use authorization (EUA) requests for serology tests for COVID-19, reflecting the growing ..... see more
Source : Medtech Insight
Transparency On COVID Vaccine Clinical Holds Needed, Sharfstein Says; US FDA Advisory Cmtes Offer Venue
The US Food & Drug Administration needs to be more transparent about the details on the clinical holds that have been placed on COVID-19 vaccine candidates, including the reasons for ..... see more
Source : 'The Pink Sheet'
Quick Listen: Scrip’s Five Must-Know Things
Join us in our regular podcast covering major industry events over the past week, in this audio version of Scrip's Five Must-Know Things, this time for the business week ended ..... see more
Source : 'Scrip Intelligence'
Revlon Staves Off Bankruptcy, Reports Q3 With Notes Of Optimism
Revlon, Inc. has staved off bankruptcy with a hard-won exchange offer with investors, giving the company additional time to turn around its beleaguered business.According to its 13 November announcement, Revlon ..... see more
Source : 'HBW Insight'
COVID-19 Vaccines: Can US FDA Complete Assessment In Less Than Six Weeks?
A 2020 emergency use authorization for a coronavirus vaccine still remains possible with interim data now available, but with less than two months left in the year, the pressure on ..... see more
Source : 'The Pink Sheet'
Coronavirus Notebook: Moderna Claims 94.5% Vaccine Efficacy, Janssen Starts Second ENSEMBLE Trial
The big news of the week – and it’s only Monday – is that the US firm Moderna, Inc. is claiming an efficacy rate of 94.5% for its mRNA ..... see more
Source : 'The Pink Sheet'
EU Mandates Monthly Safety Summaries For Approved COVID-19 Vaccines
EU regulators have finalized additional safety reporting requirements for companies developing COVID-19 vaccines to support their ongoing monitoring in the post-authorization phase. The new requirements include submission of monthly summary ..... see more
Source : 'The Pink Sheet'
Trump’s Big Bet On COVID-19 Vaccines May Have Shortchanged Therapeutics. Should Biden Rectify The Difference?
The US government has invested about four and a half times as much money in the development and manufacturing of potential COVID-19 vaccines to prevent the disease as it has ..... see more
Source : 'The Pink Sheet'
Next Year’s Congress Likely To Reinforce ACA Preexisting Conditions, Attorneys Say
Industry attorneys are predicting that the new US Congress will work quickly to reestablish key provisions of the Affordable Care Act to assure the continuity of the ACA’s preexisting conditions, ..... see more
Source : Medtech Insight
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Experts Skeptical As Russia’s COVID-19 Vaccine Outshines Pfizer Results
Russian scientists have claimed their COVID-19 vaccine candidate achieved a 92% efficacy rate in its first interim analysis of its Phase III trial, a remarkable result which suggests Sputnik V ..... see more
Source : 'Scrip Intelligence'