Sun.Jul 31, 2022

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Millions of Americans have long COVID. Many of them are no longer working

NPR Health - Shots

An estimated 4 million workers in the U.S. are struggling to work due to debilitating symptoms from long COVID. The government is urging employers to provide accommodations to keep them on the job.

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Medical Imaging in Clinical Trials with Elizabeth Dalton

Clinical Trial Podcast

In this episode, I’m excited to talk about medical imaging in clinical trials. . We’ll discuss the role of a medical imaging CRO, imaging endpoints in clinical trials, expensive mistakes to avoid as a trial Sponsor/ CRO, saving money on medical imaging services, imaging data collection process, and more. The guest for today’s show is a long time friend of mine, Elizabeth Hartunian Dalton, Vice President at Calyx.

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Banana Boat recalled a sunscreen spray after detecting trace amounts of a carcinogen

NPR Health - Shots

The maker of Banana Boat Hair & Scalp Sunscreen Spray SPF 30 said trace amounts of the cancer-causing chemical benzene were found in the propellant that sprays the product from the can.

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Opinion: WTO: Don’t make a bad situation worse by granting intellectual property waivers for Covid-19 therapeutics and diagnostics

STAT News

The World Trade Organization recently agreed to suspend patent protections for Covid-19 vaccines. The trade body is now considering going one step further: extending the intellectual property waiver to Covid-19 therapeutics and diagnostics. That misguided idea would have disastrous consequences: further eroding intellectual property protections will discourage research and development and make it even harder to fight deadly diseases and future pandemics.

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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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How we talk about monkeypox matters. Experts offer ways to reduce stigma

NPR Health - Shots

Experts caution against fear-based messaging, especially when it targets communities that have historically been discriminated against.

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Clinical Research Data Transparency with Darshan Kulkarni

Clinical Trial Podcast

Who owns the clinical trial data generated in industry sponsored or investigator initiated clinical trials? What responsibilities do Sponsors, CROs, or Sites have when it comes to sharing clinical trial results with patients? Should a Sponsor get access to patient data collected outside a clinical trial setting? To answer these questions and more, I invited Darshan Kulkarni to the show.

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New patent expiration for Sprout Pharms drug ADDYI

Drug Patent Watch

Annual Drug Patent Expirations for ADDYI Addyi is a drug marketed by Sprout Pharms and is included in one NDA. It is available from one supplier. There are four patents…. The post New patent expiration for Sprout Pharms drug ADDYI appeared first on DrugPatentWatch - Make Better Decisions.

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CDRH is NOW Accepting Electronic Submissions

FDA Law Blog

By Allyson B. Mullen — On July 19, 2022, CDRH announced to users of its Customer Collaborations Portal (CCP) that it is now accepting premarket submissions electronically. This came quickly after an announcement was made earlier in the summer that this functionality would soon be enabled for existing users of the CCP (see our prior post here ). As previously noted, this is very exciting news for the device industry, which up to this point has had to continue to ship electronic media to CDRH ea

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New patent expiration for NOVO drug MACRILEN

Drug Patent Watch

Annual Drug Patent Expirations for MACRILEN Macrilen is a drug marketed by Novo and is included in one NDA. It is available from two suppliers. There are two patents protecting…. The post New patent expiration for NOVO drug MACRILEN appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Expirations for the Week of July 31, 2022

Drug Patent Watch

MACRILEN (macimorelin acetate) Novo Patent: 6,861,409 Expiration: Aug 1, 2022 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or…. The post Drug Patent Expirations for the Week of July 31, 2022 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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Drugs facing the most patent expirations this year

Drug Patent Watch

Expiring drug patents are continuously driving innovation, as branded firms seek out new high-margin opportunities. Examining the patent expirations by year can indicate which pharmaceutical companies face the most peril…. The post Drugs facing the most patent expirations this year appeared first on DrugPatentWatch - Make Better Decisions.

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