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Coronavirus Update: Moderna Hold Up, Sanofi and Regeneron's Kevzara Fails In Phase III

COVID-19 vaccine frontrunner has been hit by reports that the start of its Phase III trial could be delayed.The 30,000-patient trial of Moderna’s mRNA-based candidate MRNA-1273 WAS expected to start ..... see more

Source : 'Scrip Intelligence'

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UK Gov Orders 65 Million Injection Devices For COVID-19 Vaccines

The UK government has signed a deal with Becton Dickinson & Co. to obtain 65 million injection devices to prepare for a COVID-19 vaccination program. The first shipments of ..... see more

Source : Medtech Insight

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Device Week, 3 July 2020 – Asia Regulatory Update & International Medical Device School

In this Device Week, we speak to Singapore-based regulatory specialist Jack Wong, founder of the Asia Regulatory Professional Association, and go deeper into the regional Asian themes explored in our ..... see more

Source : Medtech Insight

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WHO’s Cooke Takes Lead At EMA

Emer Cooke has been nominated as the new executive director of the European Medicines Agency. Cooke, who worked with the EMA until 2016 at the position of head of international ..... see more

Source : 'Generics Bulletin'

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Sonica Health Develops Wearable For Early Warning Of COVID-19

The US government’s Biomedical Advanced Research and Development Authority (BARDA) has awarded Sonica Health more than $650,000 to help develop a wearable device that can detect SARS-CoV-2 infection, especially in ..... see more

Source : Medtech Insight

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Methanol-Contaminated Sanitizers Stain Production Flexibility Spurred By Pandemic In US

Looser manufacturing standards the US Food and Drug Administration allowed to spur production of hand sanitizers during the coronavirus pandemic combined with its lack of authority to order drug recalls ..... see more

Source : 'HBW Insight'

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Not Renewing COVID-19 Public Health Emergency Could Have Serious Consequences: Lobby Group

AdvaMed is asking the US Department of Health and Human Services (HHS) to renew the COVID-19-related Public Health Emergency (PHE) that has been in effect since January. The group also ..... see more

Source : Medtech Insight

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Coronavirus Update: Oxford Racing Ahead With 8,000 Vaccinated In Phase III Trial

The University of Oxford team developing a coronavirus vaccine with AstraZeneca is well ahead in the race to conduct late-stage trials, with 8,000 volunteers already dosed in its Phase III ..... see more

Source : 'Scrip Intelligence'

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Coronavirus Notebook: New Nordic Studies, Vaccine Solidarity Pledges, And The Re-Start Of COPCOV

Concern is growing that some countries or regions will have first call on limited supplies of potential COVID-19 products at the expense of less well resourced areas of the world. ..... see more

Source : 'The Pink Sheet'

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Remdesivir Compulsory Licensing Is A Dead End For Europe

Compulsory licensing will be “practically speaking inapplicable in Europe,” regional off-patent industry association Medicines for Europe has warned, in the wake of the procedure being widely mooted as a possible ..... see more

Source : 'Generics Bulletin'

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US COVID-19 Fraud: TCM, Nasal Gel And Vitamin Pack Offered As Remedies

US regulatory agencies’ latest warnings on fraudulent COVID-19 claims went to a Hong Kong firm offering a traditional Chinese medicine, a Florida cosmetics shop with a nasal gel and a ..... see more

Source : 'HBW Insight'

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COVID-19 Puts Spotlight On Clinical Trial Networks: 'We Really Need Them Right Now'

In gathering data on potential COVID-19 therapeutics, clinical trial networks can accomplish what individual study sites are unable to do, Mark McClellan, director of the Duke-Margolis Center for Health Policy ..... see more

Source : 'The Pink Sheet'

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US FDA Invites Warning Letter Follow-Up Inspection Alternative Proposals As Pandemic Persists

Drug manufacturers that have remediated serious quality problems identified during US Food and Drug Administration inspections will have to keep waiting until after the coronavirus pandemic subsides for the follow-up ..... see more

Source : 'The Pink Sheet'

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Senators: Lack Of Full Coverage For Coronavirus Testing In US A Barrier To COVID-19 Surveillance

The lack of full insurance coverage for all coronavirus testing performed in the US is creating barriers to federal surveillance and random testing efforts designed to control COVID-19, senators said ..... see more

Source : Medtech Insight

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ResMed Ready To Supply Digital Answers To Health Care’s Demand Challenges

Now that peak COVID-19 infection rates have been reached and passed in many countries, governments and health care systems are turning their attention towards managing a sustainable recovery. Returning secondary ..... see more

Source : IN VIVO

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COVID-19 Vaccine Expectations Are Ambitious Not Impossible

In late May, Janssen Pharmaceutical Cos., a Johnson & Johnson company, received a positive recommendation in Europe for approval of its investigational Ebola vaccine regimen for prevention ..... see more

Source : IN VIVO

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BGMA Backs UK COVID-19 Recovery Roadmap

In a ‘Life Sciences Recovery Roadmap’ submitted by the British Generic Manufacturers Association – along with multiple other trade bodies representing the life sciences sector – to the UK government, ..... see more

Source : 'Generics Bulletin'

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COVID-19 Unveils Social Media Might: Is Pharma Listening Hard Enough?

COVID-19 has amplified health-related conversations on social media like never before and pharma may want to "listen in" harder to leverage insights from such unfettered big data across product life ..... see more

Source : 'Scrip Intelligence'