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1/25/2022

An emergency use authorization application has been submitted by Applied DNA to the FDA for its Linea 2.0 COVID-19 Assay and Linea Unsupervised At-Home Sample Collection Kit. "We believe this EUA request positions us to service existing demand for enterprise-scale Covid-19 testing with a compelling selling proposition where remote work is not a scalable option and a dependence on less sensitive, antigen-based tests can potentially lead to outbreaks and interruptions in business continuity," said President and CEO James Hayward.

1/25/2022

Seegene's Allplex SARS CoV-2 FluA/FluB/RSV assay has received emergency authorization from Health Canada.

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SARS
1/25/2022

Rather than use a celebrity spokesperson or TV ads, BioDelivery Sciences will target digital, print leave-behinds, and advocacy groups to market its new oral solution for migraines, Elyxyb. BDSI's Sai Rangarao says the marketing strategy is to use the current wave of awareness created by other new migraine medications and focus on branded messaging that is appropriate and targeted.

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FiercePharma
1/25/2022

The COVID-19 pandemic has made household names out of arcane drugs and pharma firms, says Ogilvy Health chief creative officer Adam Hessel, giving pharmaceutical companies an opportunity to communicate their larger vision for how their work can help society. An example is Pfizer's "Will and Grit" TV ad during the NFL playoffs, he says, which touches on the future of technological development. "They're not selling a product," Hessel says. "They're just selling what their vision is to develop technology for humanity."

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FiercePharma
1/25/2022

Marketing technology firms use artificial intelligence to analyze data so they can help pharmaceutical companies focusing on rare diseases reach physicians and patients. "We look at a provider's schedule of appointments coming up with patients through different sets of data that we have access to, and then we marry that back to clinical data about those patients in a privacy-safe way," says Chris Paquette, CEO of marketing technology firm DeepIntent.

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FiercePharma
1/25/2022

-- Ogilvy Health's new chief creative officer Adam Hessel commenting in a FiercePharma article about pharma marketing opportunities brought by the COVID-19 pandemic

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FiercePharma
1/25/2022

New draft guidance released by the FDA outlines the regulatory requirements for providing and collecting portions of official samples of treatments, cosmetics and foods as required under section 702(b) of the Federal Food, Drug, and Cosmetic Act. The guidance, which consists of 10 questions and answers, includes explanations on what constitutes an official sample and a 702(b) portion and when FDA should collect a 702(b) portion.

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Regulatory Focus
1/25/2022

Medtronic is recalling 95,110 units of its HawkOne Directional Atherectomy System that were distributed to customers between January 2018 and October 2021 due to problems with the catheter's guidewire. The FDA classified the recall as Class 1 as it "may cause serious injuries or death," and there have been 163 complaints and 55 injuries reported so far that were linked to the recalled devices.

1/25/2022

Only about 25% of eligible, HIV-negative people take a pre-exposure prophylactic drug, but new CDC clinical practice recommendations to tell any sexually active adolescent or adult information about PrEP and offer it without requiring the disclosure of risk factors may increase uptake, writes clinical psychologist Kathryn Macapagal, associate director of the THRIVE Center at the Institute for Sexual and Gender Minority Health and Wellbeing at Northwestern University.

1/25/2022

The NIH is holding a virtual information session on Feb. 7 to discuss details of a $9.8 million competition to develop novel neuromodulation therapies. The competition, offered through the Institutes' Stimulating Peripheral Activity to Relieve Conditions program, seeks "tangible plans for harnessing the power of the body's electrical system to help transform treatments for millions of people living with chronic or acute illnesses," said James Anderson, director of the NIH's Division of Program Coordination, Planning, and Strategic Initiatives, in a statement.

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