Two Roche drugs were placed on partial clinical hold as the U.S. FDA continues to examine potential dangers of checkpoint inhibitors following deaths associated with Merck’s Keytruda.
FDA placed a clinical hold on three trials studying Merck’s PD-1 inhibitor Keytruda in combination with products developed by Celgene following Merck’s initial reporting of several patient deaths.
Merck & Co. halted two Phase III multiple myeloma trials testing the company’s blockbuster anti-PD-1 drug Keytruda after an external monitoring committee expressed concern over trial patient deaths in the groups taking the drug.
Allegations were made that Celgene donated millions of dollars to charities that help patients afford high-priced cancer drugs as part of a profit-making scheme.
The pharma industry’s R&D concentration has been shifting towards specialty therapy areas as research and development returns decline for some leaders.
The U.S. Food and Drug Administration said on Monday it had approved a drug to be sold by Bristol-Myers Squibb Co as a treatment for a form of blood cancer. The FDA said it approved the treatment, Empliciti, to be used in multiple myeloma patients in combination with Celgene Corp’s Revlimid and common anti-inflammatory drug […]
DARZALEX (daratumumab) Approved by U.S. FDA: First Human Anti-CD38 Monoclonal Antibody Available for the Treatment of Multiple Myeloma
First-in-class immunotherapy approved for multiple myeloma patients who have received three or more prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agent PR Newswire, HORSHAM, PA, November 16, 2015 Janssen Biotech, Inc., a Janssen Pharmaceutical Company of […]
U.S. regulators have approved an experimental treatment from Johnson & Johnson that may offer hope to multiple myeloma patients who have run out of other options against the blood cancer. The U.S. Food and Drug Administration on Monday said it had approved Darzalex (daratumumab) for patients who had already undergone at least three prior standard […]
Biotechnology company Spectrum Pharmaceuticals Inc said the U.S. Food and Drug Administration declined to approve its Evomela injection to treat patients with multiple myeloma, a form of blood cancer that arises from plasma cells found in bone marrow. Spectrum Pharmaceuticals said it received a complete response letter, which the FDA sends to let a drug […]