Coronavirus Notebook: BARDA Contracting Scrutiny; Part D Cost Sharing
The US Health and Human Services Office of Inspector General is considering whether to move ahead with a review of BARDA's procedures for rewarding research and development contracts, OIG Principal ..... see more
Source : 'The Pink Sheet'
Searle Licenses Beximco’s Remdesivir For Pakistan
The Searle Company has announced a licensing deal with Bangladesh’s Beximco Pharmaceuticals that will allow Searle to market Beximco’s generic remdesivir in Pakistan.The potential COVID-19 treatment was launched in Bangladesh ..... see more
Source : 'Generics Bulletin'
Seattle Biologics Firm Offers COVID-19 ‘Vaccine’ OTC Before Warnings By State, Federal Agencies
Some recent recipients of US Food and Drug Administration warnings probably wouldn’t have any reason to anticipate contact from the agency if they weren’t attempting to capitalize on consumer fear ..... see more
Source : 'HBW Insight'
South Korea Implements IVD Regulation Amid Renewed COVID-19 Scare
South Korea’s In Vitro Diagnostic Medical Device Act, a new standalone IVDs regulation, was implemented by the South Korean Ministry of Food and Drug Safety (MFDS) on 1 May. Diagnostics ..... see more
Source : Medtech Insight
Vitamin D No ‘Magic Bullet’ Against COVID-19, But Should Be Part Of Nutrition Arsenal
Vitamin D is no “magic bullet” for preventing or treating COVID-19 but most consumers who are self-isolating with limited sun exposure should take the nutrient at levels stated in government ..... see more
Source : 'HBW Insight'
REMS In The Time Of COVID-19: ACLU Sues FDA Over Abortion Pill Access
Medical organizations claim that the US Food and Drug Administration is restricting access to the abortion pill Mifeprex (mifepristone) by requiring patients to pick it up in-person at a clinic ..... see more
Source : 'The Pink Sheet'
FDA Guidances Cover Decontamination, Bioburden Reduction Systems For COVID-19 Masks, Respirators
In a policy aimed at aiding the safe reuse and conservation of surgical masks and respirators during the COVID-19 pandemic, the US Food and Drug Administration has recommended ways sponsors ..... see more
Source : Medtech Insight
Europe's COVID-19 Procedures ‘Must Not Be Delayed’
EU regulators have outlined the steps that will be taken to make sure that COVID-19-related centralized procedures are given the highest priority if the European Medicines Agency has problems fulfilling ..... see more
Source : 'The Pink Sheet'
Torrent Outlook Muted On COVID-19
After reporting a tepid performance in the fourth quarter of its fiscal year ended 31 March, India's Torrent Pharmaceuticals Ltd. is likely to see a slowdown in sales ..... see more
Source : 'Generics Bulletin'
COVID19: A Systematic Approach to Early Identification and Healthcare Worker Protection
The COVID-19 outbreak spread rapidly throughout the globe, with worldwide infections and deaths continuing to increase dramatically. To control disease spread and protect healthcare workers, accurate information is necessary. We ..... see more
Source : https://www.frontiersin.org/articles/10.3389/fpubh.2020.00205/full
Methylation Pathways and SARS-CoV-2 Lung Infiltration and Cell Membrane-Virus Fusion Are Both Subject to Epigenetics
The recent pandemic SARS-CoV-2 outbreak affects all kinds of individuals worldwide. The health, social, and economic impacts of the pandemic are dramatic, and vaccines or specific treatment options are not ..... see more
Source : https://www.frontiersin.org/articles/10.3389/fcimb.2020.00290/full
SARS-COV-2 Infection in Children and Newborns: A Systematic Review - PubMed
A recent outbreak of a novel Coronavirus responsible for a Severe Acute Respiratory Syndrome (SARS-CoV-2) is spreading globally. The aim of this study was to systematically review main clinical characteristics ..... see more
COVID-19 Staff Shakeup: Woodcock Moves to Commissioner's Office As Marks Drops Out Of 'Warp'
The latest staff shakeup at the US Food and Drug Administration to fight COVID-19 will likely make better use of senior career staffers in tackling the pandemic than a plan ..... see more
Source : 'The Pink Sheet'
Medtronic Sales Slump In Q4 2020 But CEO Reveals Appetite For Tuck-In Acquisitions
As medtech companies across the world grapple with the impact of the coronavirus pandemic, Medtronic PLC was no exception. On 21 May, the medtech giant reported revenues of $6bn ..... see more
Source : Medtech Insight
Interview: Lessons Learned From The Pandemic And Five Strategies For Medtech’s Recovery
While the COVID-19 pandemic is far from over, the global disruption it has caused will drive many health care organizations to rethink their business model. That’s the assessment of Ernst ..... see more
Source : Medtech Insight