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Improving Drug Safety Through Cardiotoxicity Assessment

PerkinElmer

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. With around 90% of candidates failing during clinical development, 1 the process is not only long and risky, but also expensive for those involved. Sci Rep 9, 18911 (2019). References Hingorani, A.D.,

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FDA Action Alert: MacroGenics and Amgen

The Pharma Data

We will continue to work closely with the Agency to potentially bring margetuximab as a treatment option to patients with HER2-positive metastatic breast cancer.”. Zai Labs obtained regional development and commercialization rights for the programs in mainland China, Hong Kong, Macau and Taiwan.

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FDA Action Alert: Supernus, Adamis, Alkermes, Amgen, BMS and Eiger

The Pharma Data

Supernus Pharmaceuticals has a target action date of November 8, 2020 for SPN-812 for the treatment of attention deficit hyperactivity disorder (ADHD). The resubmission came after a meeting with the FDA in February 2020 and addresses issues raised by the agency’s Complete Response Letter (CRL) in November 2019. “We Source link.

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NorthSea Therapeutics doses first patient in Phase 1 trial of SEFA-1024 in dyslipidemia and further expands its clinical pipeline

The Pharma Data

This Phase 1 trial will evaluate the safety, tolerability, and pharmacokinetics of SEFA-1024 in 96 otherwise healthy volunteers with elevated plasma triglyceride levels. NST’s lead program, icosabutate, is currently in a phase 2b ‘ICONA’ study for the treatment of NASH. SEFA-1024 is one of NST’s three SEFA programs. Notes to Editors.

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Concert Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Company Update

The Pharma Data

“Both of our clinical candidates represent important opportunities for new medicines that we hope will have a meaningful impact on the lives of patients.”. CTP-543: An Investigational Treatment for Moderate to Severe Alopecia Areata. CTP-692: An Investigational Adjunctive Treatment for Schizophrenia.

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Roche presents new data from multiple Phase III studies of Tecentriq in triple-negative breast cancer at ESMO Virtual Congress 2020

The Pharma Data

Results from the Phase III IMpassion131 study, evaluating Tecentriq in combination with paclitaxel for the treatment of people with metastatic TNBC and whose tumours expressed PD-L1, did not meet its primary endpoint of progression-free survival . Roche’s Chief Medical Officer and Head of Global Product Development. “We

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Retevmo® (selpercatinib) in Advanced RET Fusion-Positive Gastrointestinal and Other Cancers at 2021 American Association for Cancer Research (AACR) Annual Meeting

The Pharma Data

In this cohort, the most common treatment-emergent adverse events of any grade (?20%) No patients in this cohort discontinued treatment due to treatment-related adverse events. Treatment-emergent hypertension was most commonly managed with anti-hypertension medications. chief medical officer, oncology at Lilly.