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2021 Biopharma Outlook: Turning Uncertainty Into Opportunity

A singular focus on defeating COVID-19 will likely dominate the biopharma agenda at the beginning of 2021 and will determine how quickly the industry, and world, can bounce back to ..... see more

Source : IN VIVO

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FDA Cautions EUA-Holders They Have Same MDR Reporting Responsibilities As Other Manufacturers

Manufactures that have an emergency use authorized (EUA) product on the market due to the COVID-19 pandemic are still bound by the same regulations as other device-makers to notify regulators ..... see more

Source : Medtech Insight

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MHRA Must Seize UK Digital And Diagnostics Opportunity: ABHI Perspectives On Enabling Regulation – Part 2

The starting gun is yet to be fired for the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) consultation on the UKCA marking, which had initially been expected in early ..... see more

Source : Medtech Insight

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FDA Issues New EUA Product Codes To Track Adverse Events, Imports

The US Food and Drug Administration has published new product codes for emergency use authorized (EUA) products that have been allowed on the market during the COVID-19 pandemic.The agency says ..... see more

Source : Medtech Insight

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DiaSorin Completes $1.8bn acquisition of Luminex

Italian Diagnostics company DiaSorin SpA has completed its planned $1.8bn acquisition of Luminex Corporation, the company announced 14 July.Under the terms of the deal announced in April, DiaSorin will ..... see more

Source : Medtech Insight

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COVID Megalab To Boost Testing Infrastructure As UK Prepares For Future Diagnostic Needs

A new “megalab” that will be able to process and sequence “hundreds of thousands” of COVID-19 samples a day has been opened in Royal Leamington Spa, UK. Its genotype assay ..... see more

Source : Medtech Insight

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Generics Industry Fails To Match Last Year’s Growth In First Quarter

After experiencing an exceptionally strong performance due to COVID-induced stockpiling and panic buying in the first quarter of last year, the generics industry largely saw revenues drop due to pandemic-related ..... see more

Source : 'Generics Bulletin'

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COVID-19 Assay’s False-Negative Results Culminate In Class I Recall Designation From FDA

A recall of the Lyra SARS-CoV-2 Assay (M120) made by Quidel has been designated as high-risk class I by the US Food and Drug Administration.The FDA said on 7 July ..... see more

Source : Medtech Insight

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Proposed Changes to Medicare Seek To Extend Add-On Payments, Expand Program For Homebound Patients

In comments submitted to the US Centers for Medicare & Medicaid Services (CMS), industry and stakeholders expressed support for the agency’s planned extension of new technology add-on payments (NTAP) for ..... see more

Source : Medtech Insight

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Pacifying A Pandemic With Numbers

A key reveal from this past year of pandemic response is how timely, accurate and accessible data can inform and guide health system decision-making. Good data, effectively applied, can transform ..... see more

Source : IN VIVO

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BGMA ‘Astonished’ By UK Government Snub

Mark Samuels, CEO of the British Generic Manufacturers Association, has slammed the UK government after an extensive “Life Sciences Vision” strategy document published today contained no measures geared ..... see more

Source : 'Generics Bulletin'

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NEED OF COVID-19 BOOSTER DOSE RECOMMENDATION
Does everyone need a booster dose of Covid-19 vaccine every 12 months, similar to an annual influenza vaccine, to maintain ..... see more

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COVID-19 Vaccines: Declining Antibody Levels, Breakthrough Infections Could Spur Booster Recommendations

Significant declines in antibody levels or concerning numbers of breakthrough infections in vaccinated individuals should spur consideration for booster doses of currently authorized COVID-19 vaccines, members of the Centers for ..... see more

Source : 'The Pink Sheet'

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  • 2 months 2 weeks
    Booster dose recommendations could be triggered when antibodies decline to a certain level
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FDA Pulls EUAs For Non-NIOSH Masks And Decontamination Systems

The US Food and Drug Administration has revoked emergency use authorization (EUA) for certain imported respirators for health care workers, and decontamination systems that were allowed due to ..... see more

Source : Medtech Insight

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  • 2 months 2 weeks
    Thankfully ... access to domestic supply of disposable respirators continues to significantly improve
  • 2 months 2 weeks
    Thankfully ... access to domestic supply of disposable respirators continues to significantly improve
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Start Designing Vaccines For The Next Pandemic, Urges NIH Chief

US National Institutes of Health Director Francis Collins is putting out the call for the biopharma industry to start preparing to tackle the pathogens most likely to cause the next ..... see more

Source : 'The Pink Sheet'

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COVID-19: FDA Schedules 2 More Virtual Town Halls For July

The US Food and Drug Administration is continuing its run of virtual town halls aimed at labs and manufacturers that are (or have) developed diagnostic tests for COVID-19.The FDA announced ..... see more

Source : Medtech Insight

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Arizona Supplement Firm’s Problems Start With COVID-19 Claims, Reach SARMS, ED Drug

The US Food and Drug Administration would’ve saved time if it’d identified regulations an Arizona dietary supplement didn’t violate rather than list and describe in a warning all the problems ..... see more

Source : 'HBW Insight'

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Canadian Government Slammed Over 'Intransigence' On Compulsory Licensing

The Canadian government is afraid that adding COVID-19 vaccines to the list of products that can be subject to a compulsory license would “incur the wrath of the pharmaceutical industry,” ..... see more

Source : 'The Pink Sheet'

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Coronavirus Notebook: South Africa To Build mRNA Vaccine Tech Transfer Hub, EMA OKs More Comirnaty Production Capacity

The world’s first technology transfer hub for COVID-19 mRNA vaccines is to be set up in South Africa as part of global efforts to increase the availability of vaccines in ..... see more

Source : 'The Pink Sheet'

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COVID-Era Trial Flexibilities, Equity Focus, Could Be Used To Reshape Cancer Study Enrollment

Clinical trial operational and design changes made due to the COVID-19 pandemic are likely to be harnessed to improve the diversity and generalizability of studies long after the current infectious ..... see more

Source : 'The Pink Sheet'