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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'

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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'

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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'

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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

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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'

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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'

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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

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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'

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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'

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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

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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

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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

Source : https://pubmed.ncbi.nlm.nih.gov/32424745/

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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'

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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

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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