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AstraZeneca-Daiichi Sankyo’s Enhertu gets US FDA approval for breast cancer

Pharmaceutical Technology

The approval was based on findings from the international, randomised, open-label Phase III DESTINY-Breast04 clinical trial. Furthermore, Enhertu’s safety profile was in line with prior clinical trials without any new safety concerns detected. months compared with 5.1 months for the chemotherapy arm.

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Specialised Therapeutics’ breast cancer drug gets Philippines FDA approval

Pharmaceutical Technology

The company claimed that the utmost benefit is reported in hormone-receptor positive (HR+) women and those who commence treatment with Nerlynx within a year of receiving trastuzumab-based therapy. In a Phase III ExteNET clinical trial, neratinib offered a 34% decline in the risk of recurrence and a 2.3%

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AstraZeneca and MSD’s Lynparza combo bags FDA approval for prostate cancer

Pharmaceutical Technology

A prior orchiectomy or receipt of gonadotropin-releasing hormone (GnRH) analogs was also necessary. According to figures from GlobalData’s clinical trials database, research into mCRPC treatments has been on the rise over the past 10 years. Trials peaked at 115 in 2018 before declining to 91 last year.

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Neurocrine Biosciences’ Crenessity Approved as First New Treatment in Decades for Rare Genetic Disorder CAH

XTalks

The therapy is approved to be used in combination with glucocorticoid replacement therapies (steroids) to control androgen levels in adults and pediatric patients four years of age and older with classic CAH. Currently, the standard treatment for CAH involves glucocorticoids, which replace cortisol and help regulate hormone levels.

Genetics 116
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US FDA approves expanded indication for Lilly’s breast cancer therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for the expanded indication for Eli Lilly and Company ’s (Lilly) Verzenio (abemaciclib) to treat breast cancer patients. Last week, the company and Confo Therapeutics signed a global licence deal for CFTX-1554, the latter’s clinical-stage peripheral pain candidate.

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Lilly’s new drug Mounjaro (tirzepatide ) wins US FDA approval

pharmaphorum

GLP-1 and GIP are hormones involved in blood sugar control and Mounjaro, a first-in-class medicine that activates both GLP-1 and GIP receptors, demonstrated improved blood sugar control. The findings were made via Lilly’s SURPASS phase 3 global clinical development programme, which comprised studies ranging from 40 to 52 weeks.

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Sling Therapeutics’s Linsitinib Meets Primary Endpoint in Thyroid Eye Disease Trial, Eyes Competition with Amgen’s Tepezza

XTalks

Sling Therapeutics has positive topline results from its Phase IIb/III LIDS clinical trial evaluating its oral small-molecule therapy linsitinib for the treatment of thyroid eye disease (TED). It is a complication of Graves disease, an immune system condition that causes the thyroid gland to make excess amounts of thyroid hormone.

Trials 59