BERGEN, Norway — BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, announced that a poster presentation detailing additional data from a Phase II trial of bemcentinib in combination with MSD’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in second line Non-Small Cell...
treatment News
BerGenBio has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for bemcentinib in combination with an anti-PD-(L)1 agent for the treatment of patients with AXL-positive advanced/metastatic non-small cell lung cancer (NSCLC). The FDA’s decision represents the first recognition by a regulator of AXL-positive patients...
INDIANAPOLIS — A beta blocker typically used to treat heart problems, hemangioma, migraines and anxiety could be a new therapeutic for patients with sickle cell disease. Researchers led by Ankit A. Desai, MD, associate professor of medicine at the Krannert Cardiovascular Research Center (KCVRC) at Indiana University School of Medicine, have been...
SAN FRANCISCO, Calif. — Better Therapeutics, Inc. (NASDAQ: BTTX), a pioneer in developing prescription digital therapeutics (PDTs) for treating cardiometabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its novel Cognitive Behavioral Therapy (CBT) platform intended to treat adults with metabolic...
TOSSE, France – While Bruton’s tyrosine kinase inhibitors are often hailed as the next big breakthrough in multiple sclerosis, Immunic Therapeutics and others are leveraging neuroprotective targets and remyelination to keep the disease at bay. One of the largest gatherings of multiple sclerosis researchers took place in Barcelona last month,...
HAMILTON, Bermuda — Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc. and a clinical stage biotechnology company developing ultra-high concentration nitric oxide (UNO) as an immunotherapeutic for solid tumors, today announced that the Phase 1 Study evaluating UNO in advanced, relapsed or refractory unresectable, primary or metastatic cutaneous and...
– The UK approval is based on positive results from the Phase 3 ATTRibute-CM study, in which acoramidis demonstrated the most rapid benefit seen in any Phase 3 study of ATTR-CM to date – In as few as 3 months, the time to first event (all-cause mortality (ACM) or cardiovascular-related...
In the Japanese Phase 3 study, 0% mortality was reported over the 30-month treatment period and acoramidis was well-tolerated The approval was based on a Japanese Phase 3 study and the global ATTRibute-CM Phase 3 trial, which demonstrated the most rapid benefit seen in any Phase 3 study of...
MENLO PARK, Calif. — BillionToOne (BTO), a molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, is pleased to announce a global collaboration with Janssen Research & Development, LLC, a Johnson & Johnson company (Johnson & Johnson), in the AZALEA Phase 3...
ATLANTA, Georgia — UCB, a global biopharmaceutical company, today announced three-year data from the BE HEARD trials for BIMZELX® (bimekizumab-bkzx) in adults with moderate-to-severe hidradenitis suppurativa (HS). BIMZELX, the first and only approved medicine to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F),2 continued to be generally well tolerated, and demonstrated sustained symptom...