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The Big Health Care Conundrum: How To Sustainably Unlock The Value Of Diagnostics

It is never a bad time to spotlight the value of early and effective diagnosis, the benefits of which extend far beyond the innovator, beyond individual patients and to national ..... see more

Source : IN VIVO

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FDA Updates Guidance On ANDAs During COVID

A US Food and Drug Administration question-and-answer document on the development of abbreviated new drug applications during the COVID-19 pandemic has today been updated by the agency to offer additional ..... see more

Source : 'Generics Bulletin'

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Fresh Australian Industry Pact Will Insure Against Shortages

A new five-year strategic agreement running from mid-2022 to 2027 has been finalized between Australia’s government and the country’s Generic and Biosimilar Medicines Association, offering “improved stability, predictability and viability” ..... see more

Source : 'Generics Bulletin'

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Pandemic ‘Dividend’ Must Not Be Squandered

The shock of COVID-19 led many device and diagnostics companies to pivot, rapidly and successfully, to a response mode and then to medium-term coping mechanisms. They learnt much about the ..... see more

Source : IN VIVO

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A drug costing less than $2 a day helps in the treatment of severely ill COVID-19 patients

Metoprolol, a drug widely used to treat cardiovascular disease, is beneficial when administered to COVID-19 patients. This is the finding of a study by investigators at the Centro Nacional de ..... see more

Source : https://medicalxpress.com/news/2021-08-drug-day-treatment-severely-ill.html

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US FDA Touts Big Improvements In Product Review Process: Report

In a new report the US Food and Drug Administration says it has met or exceeded all components of its 2018-2020 strategic priorities, including simplifying processes critical to product review.The ..... see more

Source : Medtech Insight

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New FDA Webform Makes It Easier For Device Makers To Report Shortages

The US Food and Drug Administration on 3 August announced a new online webform to make it easier for makers of medical devices deemed critical to fighting the ..... see more

Source : Medtech Insight

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The Missing Link: COVID-19 Antibody Tests Need Buy-In From FDA

Along the patient’s journey of care for COVID-19, the use of antibody testing can play a critical role in the decision-making and management of the virus. These tests not only ..... see more

Source : IN VIVO

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The Indemnity Calculus For Covid-19 Vaccines, India’s Path Ahead

Developing nations like India should consider consenting to pharma’s indemnity demand, albeit with sharp drafting of the nuances and secure supplies of COVID-19 vaccines, given that a large part of ..... see more

Source : IN VIVO

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from Commented on 's Post

Risk of acute myocardial infarction and ischaemic stroke
following COVID-19 in Sweden: a self-controlled case series
and matched cohort study.

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  • from Cardiologist Connect 1 month 2 weeks
    https://www.thelancet.com/action/showPdf?pii=S0140-6736%2821%2900896-5
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Come On In, The Water’s Fine: FDA Should Fully Embrace Remote Inspections

The COVID-19 pandemic produced a near endless list of challenges for the US Food and Drug Administration, including how to handle medical device facility inspections. As the pandemic showed, the ..... see more

Source : Medtech Insight

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COVID-19: FDA Schedules 4 More Virtual Town Halls Through August

The US Food and Drug Administration is continuing its run of virtual town halls aimed at labs and manufacturers that are developing – or have developed – diagnostic tests for ..... see more

Source : Medtech Insight

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Moderna’s Stronger Vaccine AdComm Vote Indicative Of Second Mover Advantage, Not Data Profile

Moderna’s COVID-19 vaccine got a more solid ‘yes’ vote than Pfizer/BioNTech’s, but committee chair cautions against drawing any comparisons between the products from the different tallies. Last-minute bickering over FDA’s ..... see more

Source : 'The Pink Sheet'

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Monoclonal Antibodies For COVID Suffer Access Problems Due To Limited Infusion Reimbursement

Unused supply for the Lilly and Regeneron therapies has policymakers considering Medicare payment changes for providers managing outpatient infusion, but those may require legislation. National Academies of Sciences, Engineering and ..... see more

Source : 'The Pink Sheet'

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Rare Liver Disease Drug Contenders Among Latest EU Filings

Among the 13 new drug marketing applications that the European Medicines Agency has most recently accepted for review are two products that could become the first approved treatments for children ..... see more

Source : 'The Pink Sheet'

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Fast-Track Loss In EU For Celgene’s CAR-T Cell Therapy

The review of liso-cel, Celgene/Bristol Myers Squibb's potential new CAR T-cell therapy for R/R DLBCL, is facing regulatory setbacks in the EU as well as in the US.Celgene’s investigational CAR ..... see more

Source : 'The Pink Sheet'