Sun.Aug 21, 2022

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Hearing loss is a direct link to dementia. Easier access to hearing aids could help

NPR Health - Shots

Ayesha Rascoe speaks with Dr. Frank Lin of the Johns Hopkins Bloomberg School of Public Health about the link between hearing loss and dementia, and how over-the-counter hearing aids may help.

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Axsome bounces back as FDA clears depression drug

pharmaphorum

Shares in Axsome Therapeutics have rocketed on FDA approval of its depression therapy Auvelity (formerly AXS-05) – a year after its approval was held up by the regulator. The FDA has cleared Auvelity (dextromethorphan/bupropion) for the treatment of major depressive disorder (MDD) in adults, setting up a launch in the fourth quarter of this year. It is the first and only oral NMDA receptor antagonist to be approved for this use, and the first oral therapy with a new mechanism of action in around

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Through community-based care, doula SeQuoia Kemp advocates for radical change

NPR Health - Shots

SeQuoia Kemp has been providing support to birthing mothers, their partners and families before, during and after pregnancy and childbirth in Syracuse, New York, for more than a decade.

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EMA evaluating Skycovion COVID-19 vaccine

BioPharma Reporter

EMA has begun its review of the conditional marketing authorization application from South Korean developer, SK biosciences, for its COVID-19 vaccine, Skycovion, a recombinant protein-based vaccine with adjuvant from GSK.

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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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COVID-19 Disease Severity With Omicron Sublineages and Vaccination Status

JAMA Internal Medicine

This retrospective study compares the severity of SARS-CoV-2 infection among persons infected with BA.1 and BA.2 sublineages by vaccination status.

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Bavarian Nordic engages US contract manufacturer to increase smallpox/monkeypox vaccine capacity

BioPharma Reporter

Bavarian Nordic has entered into an agreement with Grand River Aseptic Manufacturing (GRAM), a US based contract manufacturer, for fill and finish of the Jynneos smallpox/monkeypox vaccine in the country.

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CureVac starts Phase 1 trials for Omicron-specific vaccine

BioPharma Reporter

CureVac has started the Phase 1 clinical study for its modified COVID-19 mRNA vaccine candidate CV0501: intended to be administered as a booster dose.

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Which pharmaceutical companies have the most liquid dosed drugs?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most liquid dosed drugs. For a different perspective, see the most popular dosage types. The companies with the most liquid dosed drugs…. The post Which pharmaceutical companies have the most liquid dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.

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DNA plasmid manufacturer’s new Texas site has ‘greatly expanded’ capabilities

BioPharma Reporter

VGXI, a contract developer and manufacturer (CDMO), says its new headquarters and manufacturing facility in Texas is slated to open in the fall.

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China NMPA grants IND clearance for Ascletis’ Covid-19 therapy

Pharmaceutical Technology

The China National Medical Products Administration (NMPA) has granted clearance for Ascletis Pharma’s Investigational New Drug (IND) application of its drug candidate, ASC10, for Covid-19. An RNA-dependent RNA polymerase (RdRp) inhibitor, ASC10 is an oral double prodrug. Compared to molnupiravir, a single prodrug, ASC10 has a varied chemical structure.

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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.