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FDA Approves Updated Indication for Merck’s KEYTRUDA® (pembrolizumab) for Treatment.

The Pharma Data

“While the treatment landscape has evolved, an unmet need remains for appropriate patients newly diagnosed with certain types of advanced urothelial carcinoma who are not eligible for platinum-containing chemotherapy,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “We

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Hypoxia-Inducible Factor-2 Alpha (HIF-2?) Inhibitor WELIREG™ (belzutifan) for the Treatment of Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors

The Pharma Data

WELIREG Approved for Adult Patients With VHL Disease Who Require Therapy for Associated Renal Cell Carcinoma, Central Nervous System Hemangioblastomas, or Pancreatic Neuroendocrine Tumors, Not Requiring Immediate Surgery. The recommended dose of WELIREG (40 mg tablets) is 120 mg once daily until disease progression or unacceptance toxicity.

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BioSpace Movers & Shakers, Nov. 20

The Pharma Data

Previously, Baffa was Therapeutic Area Head of Oncology, Global Clinical Development for Shire. Gelbman most recently served as the founding CEO of FDNA, a digital health startup that develops advanced AI tools to help diagnose patients with rare diseases. HotSpot Therapeutics – Eva Jack was named COO of Boston-based HotSpot.

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Positive EU CHMP Opinion for Updated Label of KEYTRUDA® (pembrolizumab)

The Pharma Data

“KEYTRUDA has become an important treatment option for certain patients with locally advanced or metastatic bladder cancer in the European Union and other countries around the world,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “We Head and Neck Squamous Cell Cancer.

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BioSpace Movers & Shakers, Dec. 18

The Pharma Data

Most recently, Cadavid served as senior vice president and Head of Clinical Development at Fulcrum Therapeutics where he led the development of multiple small molecules for the treatment of genetically defined rare diseases. He spent 27 years at Merck & Co. Immune Regulation – U.K.-based based Immune Regulation Ltd.

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Informed Design of Bioanalytical PCR Assay Testing Parameters

PPD

Since chimeric antigen receptor T cell (CAR-T) therapy was first approved in 2017, there has been a marked increase of cell and gene therapy studies resulting in significant changes in the way diseases are treated as well as patient outcomes.

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Getting to the Heart of Science: How Clinical Research Saved My Life and Continues to Inspire Me

Alta Sciences

Getting to the Heart of Science: How Clinical Research Saved My Life and Continues to Inspire Me pmjackson Fri, 04/04/2025 - 18:01 By Josiah Liang, Research Laboratory Technician, Clinical Diagnostic and Central Laboratory Services. How Clinical Research Saved My Life I was born in 2000.