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Promising schizophrenia drug faces tough competition

European Pharmaceutical Review

According to the pre-IND meeting with the US Food and Drug Administration (FDA), Luye Pharma plans to submit the New Drug Application (NDA) for LY03010 to the FDA through the 505(b)(2) pathway. The post Promising schizophrenia drug faces tough competition appeared first on European Pharmaceutical Review.

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Biosimilar competition saves US healthcare $21 billion

European Pharmaceutical Review

Amgen’s 2022 market report has detailed how competition has driven savings across healthcare, estimating that a considerable number of biologics will be in competition with biosimilars in five to 10 years. A rise in savings per quarter was recognised in this year’s data. Seven more are expected to be launched in 2023.

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PolarisAR Receives Clearance from the U.S. Food and Drug Administration for Stellar Knee

Legacy MEDSearch

Food and Drug Administration (FDA). With minimal physical setup, an easy integration process, and competitive pricing compared to traditional surgical guidance systems, STELLAR Knee has the ability to shift the standard of care. POLARIS AR is pleased to announce today that their STELLAR Knee has received 510(k) clearance from the U.S.

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ESMO 2022: shrinking market for Trodelvy, with fierce ADC competition

Pharmaceutical Technology

While Trodelvy is expected to be the first ADC approved in the HR+/HER2-negative breast cancer setting, Daiichi / AstraZeneca’s Enhertu (trastuzumab deruxtecan) received US Food and Drug Administration (FDA) approval just last month for patients with HER2-low expressing breast cancers.

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FDA approves long-acting injectable for schizophrenia and bipolar disorder

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Rykindo ® (risperidone) for extended-release injectable suspension. So, Rykindo ® will have to contend with the competition of other antipsychotic LAIs as treatments for psychosis disorders. Promising schizophrenia drug faces tough competition.

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FDA accepts AstraZeneca’s NDA for breast cancer combination therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted AstraZeneca’s new drug application (NDA) for the combination of capivasertib and FASLODEX (fulvestrant), and granted it priority review. The regulator will announce its decision during the fourth quarter of 2023. AstraZeneca stated that its NDA is being reviewed under Project Orbis.

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FDA Clears Dexcom’s First Over-the-Counter Continuous Glucose Monitor

Legacy MEDSearch

Food and Drug Administration (FDA) announced the clearance of Dexcom’s device, marking it as the first continuous glucose monitor available over the counter. The company aims to offer the device at a competitive price point, but further pricing details will be shared closer to the product’s release date.