The NIH has amended its definition of clinical trials to include brain studies, introducing new regulations considered unnecessary by many researchers.
Pfizer Inc. today announced full results from the Phase 2 clinical trial of the investigational, next-generation tyrosine kinase inhibitor lorlatinib that exhibited clinically meaningful activity against lung tumors and brain metastases in a range of patients with ALK-positive and ROS1-positive advanced non-small cell lung cancer (NSCLC), including those who were heavily pretreated.
After initially setting out to test two vaccines on 28,000 volunteers during West Africa's deadly Ebola epidemic, a U.S.-Liberia research team had to dramatically reduce its aspirations when the outbreak started coming to an end. But the investigators have now published results showing the shots from GlaxoSmithKline and Merck elicited antibody responses that lasted one year after vaccination.
Ardelyx, Inc. (ARDX) reported positive results from T3MPO-2, its second Phase 3 study of tenapanor for irritable bowel syndrome with constipation (IBS-C). The study hit statistical significance for the primary endpoint and all secondary endpoints evaluated for the topline results and demonstrated the ability to normalize bowel movements.
Merck took a dominant position in frontline lung cancer with the approval of a combination of Keytruda and chemo. And it isn’t just waiting around to see if any combination of a PD-(L)1 with a CTLA4 can come along and knock it off its market-leading perch.
In a first for the Big Pharma and as part of a new model, Pfizer is taking drugs from its shelves and licensing them to, while investing in, its SpringWorks Therapeutics startup.
AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced that the Phase 3 MURANO study of VENCLEXTA/VENCLYXTO (Venetoclax) Tablets in combination with Rituxan® (rituximab) met its primary endpoint.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the pivotal Phase 3 LIBERTY ASTHMA QUEST study of dupilumab in a broad population of patients with uncontrolled, persistent asthma met its two primary endpoints.
Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to improve the survival and quality of life of cancer patients, today reported positive top-line results from the Phase 3 DUO study evaluating the efficacy and safety of duvelisib, a first in class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
US regulators have placed on hold studies of French drugmaker Cellectis’ CAR-T therapy following a patient fatality.
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