Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Regeneron Pushes Legal, Ethical Boundaries With Offer Of COVID-19 Antibody To Biden Campaign

Company may have violated FDA’s preapproval promotion restrictions by discussing compassionate use option with Joe Biden’s team and by publicizing it on TV, highlighting the fine line between making the general public aware of expanded access and touting an investigational product as useful for a particular illness.

Topic Coronavirus Advertising Marketing Sales us-election-2020

HBW Insight : コンシューマーヘルスケア産業のニュース

UK Trial Seeks 'Definitive Answer' In Vitamin D's Role For COVID-19 Protection

UK trial involving 5,000 participants "has the potential to give a definitive answer to the question of whether vitamin D offers protection against COVID-19," according to researchers.

Topic Coronavirus clinical-trials Dietary Supplements

Medtech Insight: 世界の医療機器・医療技術の最新情報

EU Faces MDR Failure Unless It Adjusts To COVID-19 Crisis And Grows Notified Bodies

Is the current pandemic too big a hurdle for the EU’s medtech regulators and industry alike? What else might hold EU medtech back from the successful implementation of the MDR?

Topic EU policy-and-regulation

Medtech Insight: 世界の医療機器・医療技術の最新情報

COVID-19 Has Prompted An 18-Fold Increase In German IVDs Production Capacity

How coronavirus affects IVDs businesses depends on the branch of the industry they are in, a German survey of manufacturers shows. German labs performed one million COVID-19 tests last week.

Topic Coronavirus EU policy-and-regulation

Scrip: 世界の医療用医薬品＆製薬産業に関するニュース

Coronavirus Update: US Adds To Antibody Push With $486m AstraZeneca Deal

After a week of monoclonal antibody therapies hitting the headlines - including a personal endorsement from President Trump - the US government bulks up its potential supplies. AZ's long-acting monoclonal antibody product enters large-scale trials for both a treatment and prophylaxis of COVID-19.

Topic Coronavirus

Scrip: 世界の医療用医薬品＆製薬産業に関するニュース

J&J Says It's Wait And See On COVID-19 Vaccine Delay Outlines Rosier Outlook for 2021

It will be several days at least before more information is available about the unexpected illness in J&J's Phase III COVID-19 vaccine trial, the firm said during its third quarter financial call.

Topic Coronavirus vaccines clinical-trials

HBW Insight : コンシューマーヘルスケア産業のニュース, Generics B...

Pharma Intelligence Launches Alexa Skill

Keep up with topics you care about in Pharma and Medtech with the new Alexa Skill from Informa Pharma Intelligence. Access daily news briefings to stay up to date with the latest news, right from your Alexa smartphone app!

Topic Artificial Intelligence Consumer Innovation

Medtech Insight: 世界の医療機器・医療技術の最新情報

Cancer Research UK: Early Diagnosis And Disease Detection Must Not Be Eclipsed By COVID-19

Coronavirus has diverted the focus of health systems away from early cancer detection, says a new report by Cancer Research UK, urging a rebalancing of priorities.

Topic cancer policy-and-regulation

Medtech Insight: 世界の医療機器・医療技術の最新情報

87636 And 87637: New CPT Codes From AMA For COVID-19/Flu Combo Antigen Tests

The American Medical Association has added two new Current Procedural Terminology (CPT) codes for reporting antigen tests that detect COVID-19 and influenza. And a third new code, 87811, should be used to report “infectious agent antigen detection by immunoassay with direct visual observation.”

Topic Coronavirus