Tasigna® (nilotinib) approved for pediatric patients with newly diagnosed Ph+ CML-CP and children with Ph+ CML-CP resistant or intolerant to prior TKI therapy New indication approved under FDA Priority Review designation; provides clinicians with pediatric-specific safety and clinical data Novartis continues commitment to people living with CML, including pediatric patients with this cancer
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMpower131 study met its co-primary endpoint of progression-free survival (PFS) and demonstrated that the combination of TECENTRIQ® (atezolizumab) plus chemotherapy (carboplatin and ABRAXANE® [albumin-bound paclitaxel; nab-paclitaxel]) reduced the risk of disease worsening or death (progression-free survival; PFS) compared with chemotherapy alone in the initial (first-line) treatment of people with advanced squamous non-small cell lung cancer (NSCLC). Safety for the TECENTRIQ and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination. At this interim analysis a statistically significant overall survival (OS) benefit was not observed and the study will continue as planned. These data will be presented at an upcoming oncology congress.
Adaptimmune has seen partial responses in three of the first four myxoid/round cell liposarcoma (MRCLS) patients treated with its T cells. The early data raised hopes the GlaxoSmithKline-partnered drug will be effective in multiple types of solid tumor, sending Adaptimmune shares up nearly 20%.
Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, today reported interim clinical data of BPX-501 in pediatric patients with acute myeloid leukemia (AML) and primary immunodeficiencies (PIDs). BPX-501 is an adjunct T cell therapy incorporating CaspaCIDe® administered after haploidentical hematopoietic stem cell transplant (haplo-HSCT) for the treatment of hematologic cancers and inherited blood diseases.
Biogen (BIIB) today announced new interim Phase 2 results from NURTURE, the ongoing open-label, single-arm study evaluating the efficacy and safety of SPINRAZA® (nusinersen) among pre-symptomatic infants with spinal muscular atrophy (SMA). In NURTURE, all infants treated with SPINRAZA were alive, did not require permanent ventilation and showed improvement in motor function and motor milestone achievements as of July 5, 2017, compared to the disease’s natural history. This study, along with a case series demonstrating SPINRAZA’s effectiveness among teens and young adults, will be presented at the Muscular Dystrophy Association (MDA) Clinical Conference on March 11-14, 2018, in Arlington, Virginia.
GSK touted phase 3 data of its quadrivalent flu vaccine Fluarix Tetra. As a severe flu season continues to unfold in the U.S., GlaxoSmithKline is touting phase 3 study data showing its Fluarix Tetra can protect young children who are among the most vulnerable to the virus.
Eisai Co., Ltd. (CEO: Haruo Naito, "Eisai") and Purdue Pharma L.P. (President and CEO: Craig Landau, "Purdue Pharma") today announced positive topline results from multiple studies of lemborexant, an investigational agent for sleep and wake regulation currently being studied for the treatment of multiple sleep disorders.
Rani Therapeutics, the developer of a pill designed to replace injectable drug delivery for patients suffering from chronic diseases, today announced that it has raised $53 million to invest in manufacturing in preparation for human clinical trials. This investment brings the total raised to $142 million in funding.
Sanofi has found yet another partner to help digitize its clinical trial processes. In a statement, TriNetX announced that it will be assisting the pharmaceutical company by using patient EHRs to optimize recruitment, streamline trial investigators’ workflows, and otherwise impact the design of investigational drug trials. Sanofi has made similar arrangements to bolster its clinical trials with Science 37 and Evidation in March and July of last year, respectively.
AstraZeneca has GlaxoSmithKline and its chronic obstructive pulmonary disease (COPD) treatment Trelegy Ellipta squarely in its sights. This morning, AstraZeneca revealed Phase III data that shows its experimental three-in-one inhaler PT010 improved lung function in patients.
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