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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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Thyroid Awareness Month 2024: Increasing Awareness and Exploring New Treatments for Thyroid Diseases

XTalks

The thyroid plays a critical role in the body by producing hormones that regulate metabolism, heart rate and body temperature among others. Types of Thyroid Conditions There are several different thyroid conditions, with each affecting thyroid hormone production or the gland’s structure, leading to a range of health issues.

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AstraZeneca-Daiichi Sankyo’s breast cancer ADC gets FDA priority review

Pharmaceutical Technology

AstraZeneca and Daiichi Sankyo have received Priority Review for their supplemental Biologics License Application (sBLA) from the US Food and Drug Administration (FDA) of antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), to treat unresectable or metastatic HER2-low breast cancer in adults.

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Buparlisib hydrochloride by Adlai Nortye Biopharma for Mantle Cell Lymphoma: Likelihood of Approval

Pharmaceutical Technology

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. Adlai Nortye utilizes PAINT-2D and ANEAT-Id platform technologies to identify and develop immunotherapies and antibodies. Adlai Nortye is headquartered in Hangzhou, Zhejiang, China.

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Trodelvy has been Approved for ER+/HER2- Patients with Advanced or Metastatic Breast Cancers

XTalks

Current treatments for HR+ breast cancer patients include hormonal therapies, chemotherapies for those that do not respond to hormonal therapy alone and targeted therapies, either stand-alone or in combination with hormonal therapies. Trodelvy is a Targeted Therapy Trodelvy is a Trop -2 directed antibody-drug conjugate therapy.

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Developmental and Reproductive Toxicology (DART) Studies: What Are They, and How Do They Fit into Your Program?

Camargo

In general, they run in parallel to clinical trials depending on the target populations, typically starting around Phase I and finishing prior to the end of Phase III. Biologics : Several factors should be considered for biologic products such as monoclonal antibodies, for which NHPs are often the only relevant species.

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Risk adjusted net present value: What is the current valuation of Chinook Therapeutics’s Atrasentan Hydrochloride?

Pharmaceutical Technology

According to Globaldata, it is involved in 24 clinical trials, of which 19 were completed, 2 are ongoing, 1 is planned, and 2 were terminated. formerly Aduro BioTech Inc is a clinical-stage immunotherapy company that discovers, develops and commercializes therapies for the treatment of cancer.

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