Sun.Aug 21, 2022

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The BIOMEDevice Shows and Why They Matter with Adrienne Zepeda, Group Event Director

Medical Device Success

Reading time: 2 – 3 minutes. Have you ever heard of BIOMEDevice Boston or BIOMEDevice Silicone Valley? These are two of several MedTech Industry shows that are known as hubs of new technologies, startup guidance and networking opportunities. Do you know what goes on at these meetings? I can tell you that they are organized to give MedTech leaders and startups a view into the technologies and best practices that will shape our devices and services for years to come.

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Healthcare costs for employers to rise 6.5% in 2023, Aon report predicts

MedCity News

The 6.5% increase in average costs for U.S. employers is more than double the 3% increase employers experienced in 2022, the report said. However, the increase is below the 9.1% increase in the Consumer Price Index.

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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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An audiologist’s take on the news that OTC hearing aids are on their way to consumers

MedCity News

If FDA’s decision on making hearing aids available over the counter leads to greater adoption, it could encourage consumers to learn more about their condition, and therefore improve the health literacy of the public. The downstream effect of this is to increase the perceived value of the audiologist beyond mere salespeople of a medical device, which audiologists everywhere should applaud.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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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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FDA warning letter puts maker of nicotine gummies in a sticky situation

MedCity News

The FDA issued a warning letter about nicotine gummies—the first ever notification sent for such a product. The agency’s concern is that the flavored gummies resemble candy and pose a toxicity risk to children.

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The price is not right

MedCity News

Last year’s price transparency laws were an important step for the industry, but there is still much work to do. The only way we can ensure a better functioning healthcare system is to create clear pricing. We need to base that pricing on consistently-defined and well-communicated healthcare service units.

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Incredible Health rakes in $80M to combat the nursing shortage

MedCity News

Nurse staffing platform Incredible Health recently closed a $80 million Series B funding round, bringing the company’s valuation to $1.65 billion. CEO Iman Abuzeid claims Incredible Health is the only healthcare hiring platform that uses automation to help screen nurses’ credentials and employment preferences before matching them with an employer.