Repatha® (Evolocumab) Phase 3 Cognitive Function Study Results Published In The New England Journal Of Medicine
August 16, 2017
Amgen has announced that the New England Journal of Medicine (NEJM) published results from the Repatha® (evolocumab) cognitive function trial (EBBINGHAUS), which was conducted in a subset of patients enrolled in the randomized, placebo-controlled Repatha cardiovascular outcomes study (FOURIER). The study demonstrated that Repatha was non-inferior to placebo, with no significant difference in cognitive function between the Repatha and placebo-treated groups.
Johnson & Johnson Announces Partnership with CSIR-IMTECH to Develop Innovative New Tuberculosis Treatments
Aug 16, 2017
Johnson & Johnson Private Limited has announced a new partnership with the Institute of Microbial Technology (IMTECH), part of the Council of Scientific and Industrial Research (CSIR), to unlock the potential of Indian science and help accelerate the discovery of innovative new treatments for tuberculosis (TB).
FDA Accepts Supplemental Biologics License Application and Grants Priority Review for ADCETRIS® (Brentuximab Vedotin) in Cutaneous T-Cell Lymphoma
Aug. 16, 2017
Seattle Genetics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplemental Biologics License Application (BLA) based on data from the phase 3 ALCANZA trial and two phase 2 investigator-sponsored trials of ADCETRIS (brentuximab vedotin) in patients with cutaneous T-cell lymphoma (CTCL). In November 2016, the FDA granted ADCETRIS Breakthrough Therapy Designation (BTD) for the treatment of patients with CD30-expressing mycosis fungoides and primary cutaneous anaplastic large cell lymphoma who require systemic therapy and have received one prior systemic therapy.
August 17, 2017
Pfizer Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved BESPONSA® (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). BESPONSA was reviewed and approved under the FDA’s Breakthrough Therapy designation and Priority Review programs.
17 August 2017
AstraZeneca and Merck & Co., Inc. have announced that the US Food and Drug Administration (FDA) has granted approval for the PARP inhibitor, Lynparza (olaparib), as follows:
- New use of Lynparza as a maintenance treatment for recurrent, epithelial ovarian, fallopian tube or primary peritoneal adult cancer who are in response to platinum-based chemotherapy, regardless of BRCA status;
- New use of Lynparza tablets (2 tablets twice daily) as opposed to capsules (8 capsules twice daily);
- Lynparza tablets also now indicated (conversion from the current accelerated approval) for the use in patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy.
August 17, 2017
Two of the nation’s leading health organizations, health and well-being company Humana Inc. and biotechnology company Amgen, have teamed up to identify opportunities to improve health outcomes and improve efficiency by unlocking new insights from the real world health care experiences of Humana’s 13 million members. The collaboration will initially target multiple serious conditions, including cardiovascular disease, osteoporosis, neurologic disorders, inflammatory diseases and cancer.