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UK Variant Of Coronavirus May Be Harder To Diagnose With Many Current Tests: FDA

The US Food and Drug Administration alerted clinical laboratories and health care providers that mutations in the SARS-CoV-2 virus, including the B.1.1.7 variant, may result in false negative ..... see more

Source : Medtech Insight

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India Grants Controversial Conditional Approvals To Serum, Bharat COVID-19 Vaccines

In a move indicative of the unusual times the world finds itself in due to COVID-19, India has granted conditional accelerated approvals to two vaccines, one for which Phase III ..... see more

Source : 'The Pink Sheet'

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Asia Medtech Reg Discussions: COVID-19 Is A Golden Moment For Medtech And Governments To Learn How To Deal With Future Crises

The experiences of COVID-19 within the medtech industry have varied from company to company and from country to country. Asia was hardest hit by rising infections in the early months ..... see more

Source : Medtech Insight

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Moderna Increases Minimum Supply Of Coronavirus Vaccine Doses For 2021

Amid concerns about the rollout of vaccines against SARS-CoV-2 in the US, one of the companies that has received an emergency use authorization, Moderna, Inc., has raised the ..... see more

Source : 'Scrip Intelligence'

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Conditional Approval for Serum, Bharat Bio COVID-19 Vaccines In India Amid Uproar

In a move indicative of the unusual times that the world finds itself in due to COVID-19, India granted conditional accelerated approvals to two vaccines, one of them still in ..... see more

Source : 'Scrip Intelligence'

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2021 Deal Action In India: Watch Private Equity And E-Pharmacy

The overall deal-making environment may have been scarred by the pandemic in 2020, but Indian firms appeared to emerge as partners of choice for scaling up COVID-19 therapies and expanding ..... see more

Source : 'Scrip Intelligence'

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Pandemic Will Continue Limiting US FDA Inspections In Driving FY 2021 Drug GMP Warnings

Many if not most of the drug adulteration regulatory actions by the US Food and Drug Administration in fiscal year 2021 will be based on alternatives to agency inspections that ..... see more

Source : 'HBW Insight'

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Operation Warp Speed’s Difficult Holiday Season

Operation Warp Speed has run into some engine trouble. After helping drive development of a COVID vaccine in record time, OWS ended up falling short of its stated goal of ..... see more

Source : 'The Pink Sheet'

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China Taps Conditional Approval Mechanism For COVID Vaccine

China's National Medical Products Administration announced 31 December that it has granted conditional approval to a COVID-19 vaccine developed by the state-owned China National Biotec Group.Since entering the ..... see more

Source : 'The Pink Sheet'

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FDA Warns Of False Negatives With Curative’s COVID-19 Test

One of the first COVID-19 tests to gain emergency use authorization (EUA) from the US Food and Drug Administration could be giving false-negative results if not used properly, the agency ..... see more

Source : Medtech Insight

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COVID Advocacy Exchange Platform Unites Patients, Industry And Experts

The spread of COVID-19 across the globe in early spring – and the resulting cancellation of in-person meetings and conferences – stifled the connection between bioharma companies and the global ..... see more

Source : IN VIVO

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OTC Sanitizers Lather Up US Drug Recalls In 2020

The number of containers of pharmaceuticals recalled in the US during the third quarter nearly doubled from the second quarter to nearly 33.8m as recalls increased nearly 50%, says Stericyle ..... see more

Source : 'HBW Insight'

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US Recalls: Taro Anti-Fungal Topicals, Wellness Clinic’s Drugs And Supplements, More Sanitizers

OTC drug recalls in the US ended 2020 much the same way they were for much of the year as additional hand sanitizers made in Mexico were found to contain ..... see more

Source : 'HBW Insight'

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After UK OK, Argentina Backs AstraZeneca/Oxford Vaccine

While debate about the data behind AstraZeneca PLC and Oxford University’s COVID-19 vaccine rages on in Europe and the US, countries in South and Central America seem happy to ..... see more

Source : 'Scrip Intelligence'

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UK Authorizes ‘Gamechanger’ AstraZeneca Vaccine Despite Data Doubts

The UK has granted a temporary authorization to AstraZeneca PLC and Oxford University’s COVID-19 vaccine, a move which has been hailed as a game-changer for the country and the ..... see more

Source : 'Scrip Intelligence'

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How COVID-19 Defined 2020 For Biopharma

The annus horribilis that was 2020 ends on a far more hopeful note than it began, with two vaccines against COVID-19 receiving emergency use authorizations from the US Food and ..... see more

Source : 'Scrip Intelligence'

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Argentina Follows UK In Backing Oxford/AstraZeneca COVID-19 Vaccine

While debate about the data behind AstraZeneca PLC and Oxford University’s COVID-19 vaccine continues in Europe and the US, countries in South and Central America seem happy to follow ..... see more

Source : 'The Pink Sheet'

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One-Two Punch Of HHS Rules On Guidance Docs, Regs Will ‘Tie Hands’ Of Biden Admin: Expert

Two new rules put forward by the US Department of Health and Human Services in the final days of the Trump administration could have a chilling effect on future guidance ..... see more

Source : Medtech Insight