Sat.Nov 21, 2020

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FIP expert group issues advice for pharmacists on COVID-19 tests

Pharma Mirror

The Hague — To help pharmacists advise people on COVID-19 tests, the International Pharmaceutical Federation (FIP), has today issued a guidance document. The guidance has been produced by FIP’s SARS-CoV-2 Testing Working Group, which has evaluated the diagnostic testing methods and devices currently available. The document covers how different types of diagnostic test work and the interpretation of results.

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Politics, Science and the Remarkable Race for a Coronavirus Vaccine

NY Times

The furious race to develop a coronavirus vaccine played out against a presidential election, between a pharmaceutical giant and a biotech upstart, with the stakes as high as they could get.

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UCB taps Medisafe in development of digital companion to support patient engagement

Pharma Mirror

Medisafe, a leading digital therapeutics company specializing in digital companions, has been selected by UCB to develop branded digital drug companions for its antiepileptic medications, with greater capabilities to expand across additional brands. The digital companions streamline support for patients to access financial assistance, patient diaries, and doctor discussion guides throughout their treatment journey.

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Middle Stone Age populations repeatedly occupied West African coast

Scienmag

Excavations at Tiémassas, Senegal, indicate roughly 40,000 years of behavioural continuity, in contrast to other African regions over this period Credit: K. Niang Although coastlines have widely been proposed as potential corridors of past migration, the occupation of Africa’s tropical coasts during the Stone Age is poorly known, particularly in contrast to the temperate coasts […].

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Tips For Selecting References

ECRG Media's Clinical Research Podcast

Tips For Selecting References Don't forget to Subscribe for new content! Subscribe: [link] Call or Text: 910-502-3732 Email: eliteclinicalgroup@gmail.com Podcast: [link] Steemit: [link] Advertise: eliteclinicalgroup@gmail.com Watch: » Industry News: [link] » All Videos: [link] » Interview Recaps: [link] » Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education Send in a voice messag

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States unfairly burdening incarcerated people with ‘pay-to-stay’ fees

Scienmag

Rutgers researcher examines how states sue incarcerated people in civil court to recoup incarceration costs Pay-to-stay, the practice of charging people to pay for their own jail or prison confinement, is being enforced unfairly by using criminal, civil and administrative law, according to a new Rutgers University-New Brunswick led study. The study, published in the […].

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U.S. should look at how other high-income countries regulate health care costs

Scienmag

Standardizing fee-for-service payments and structuring negotiations between insurers and providers could make U.S. health care more affordable, Rutgers study says Structuring negotiations between insurers and providers, standardizing fee-for-service payments and negotiating prices can lower the United States’ health care spending by slowing the rate at which healthcare prices increase, according to a Rutgers study.

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New patent expiration for AGILE drug TWIRLA

Drug Patent Watch

Annual Drug Patent Expirations for TWIRLA Twirla is a drug marketed by Agile and is included in one NDA. There are eight patents protecting this drug. This drug has fifty-six…. The post New patent expiration for AGILE drug TWIRLA appeared first on DrugPatentWatch - Make Better Decisions.

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B 11/21 — Which Kids With COVID Will Get Very Sick?

The Pharma Data

SATURDAY, Nov. 21, 2020 — Scientists have identified symptoms that may predict the severity of COVID-19 in children. According to the researchers, children with respiratory disease and those with multisystem inflammatory syndrome (a rare but serious condition linked with COVID-19) have the most severe illness. “Much of the discussion to date around COVID-19 suggests that children don’t typically suffer serious illness,” said researcher Dr.

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Which pharmaceutical companies have the most SPCs in Sweden?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Sweden. SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating…. The post Which pharmaceutical companies have the most SPCs in Sweden? appeared first on DrugPatentWatch - Make Better Decisions.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Statement from the Chief Public Health Officer of Canada on November 22, 2020

The Pharma Data

OTTAWA, ON , Nov. 22, 2020 /CNW/ – In lieu of an in-person update to the media, Dr. Theresa Tam , Canada’s Chief Public Health Officer, issued the following statement today: “As the resurgence of COVID-19 activity continues in Canada , we are tracking a range of epidemiological indicators to monitor where the disease is most active, where it is spreading and how it is impacting the health of Canadians and public health, laboratory and healthcare capacity.

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F.D.A. Grants Emergency Authorization of Antibody Treatment Given to Trump

NY Times

The treatment, made by the biotech company Regeneron, is a cocktail of two powerful antibodies that have shown promise for people who get it early in the course of the disease.

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Regeneron’s REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization

The Pharma Data

TARRYTOWN, N.Y. , Nov. 21, 2020 /PRNewswire/ — First treatment of any kind to have prospectively confirmed and statistically significant anti-viral activity against SARS-CoV-2. Authorized for recently diagnosed, mild to moderate COVID-19 in high-risk patients. Initial doses of REGEN-COV2 will be made available to approximately 300,000 patients, with no medication out-of-pocket costs, under U.S. government allocation program.

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Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19

The Pharma Data

SILVER SPRING, Md. , Nov. 21, 2020 /PRNewswire/ — Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.