All The Most Important Pharmaceutical News Stories Of The Week – August 2018 – Week # 4
August 21, 2018
AstraZeneca has announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Tagrisso (osimertinib) for the 1st-line treatment of patients with inoperable or recurrent epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC), following the priority review. The approval is based on results from the global Phase III FLAURA trial which included Japanese patients and which were published in the New England Journal of Medicine.
Allergan Receives Complete Response Letter from the U.S. Food and Drug Administration for Ulipristal Acetate New Drug Application
August 21, 2018
Allergan plc has announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) in response to the New Drug Application (NDA) for ulipristal acetate (UPA) for the treatment of abnormal uterine bleeding in women with uterine fibroids. The letter from the FDA indicates it is not able to approve the ulipristal acetate NDA in its current form and is requesting additional information. The agency cited safety concerns regarding ESMYA post-marketing reports outside the United States. Allergan plans to meet with the FDA to discuss their comments and next steps.
AbbVie Announces Positive Topline Results from Phase 3 Extension Study Evaluating Investigational Elagolix in Women with Uterine Fibroids
Aug. 22, 2018
AbbVie, a research-based global biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced that results from the Phase 3 ELARIS UF-EXTEND extension study (MI2-816) showed at month 12 that elagolix (300 mg twice daily), in combination with low-dose hormone (add-back) therapy (estradiol 1.0 mg / norethindrone acetate 0.5 mg), reduced heavy menstrual bleeding with 87.9 percent of women with uterine fibroids achieving clinical response.
SOLAR-1 trial of Novartis investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) meets primary endpoint in HR+/HER2- advanced breast cancer with PIK3CA mutation
August 23, 2018
Novartis has announced the global Phase III SOLAR-1 trial evaluating the investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) has met the primary endpoint showing an improvement in progression-free survival (PFS). SOLAR-1 is evaluating BYL719 in combination with fulvestrant compared to fulvestrant alone in postmenopausal women and men with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) PIK3CA-mutant advanced or metastatic breast cancer that progressed on or following aromatase inhibitor treatment with or without a CDK4/6 inhibitor.
Shire Announces FDA Approval of TAKHZYRO™ (lanadelumab-flyo), a First-of-its-Kind mAb Preventive Treatment for Hereditary Angioedema
August 23, 2018
Shire has announced that following priority review, the U.S. Food and Drug Administration (FDA) has approved TAKHZYRO™ (lanadelumab-flyo) injection, for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older. HAE is a rare, genetic and potentially life-threatening disorder that can result in recurrent attacks of edema (swelling) in various parts of the body.
AstraZeneca provides update on AERISTO Phase IIIb trial for Bevespi Aerosphere in chronic obstructive pulmonary disease
August 23, 2018
AstraZeneca has announced top-line results from the AERISTO Phase IIIb trial for Bevespi Aerosphere (glycopyrronium/formoterol fumarate) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). In the trial, Bevespi Aerosphere demonstrated non-inferiority to umeclidinium/vilanterol on peak forced expiratory volume in one second (FEV1) but did not demonstrate superiority on peak FEV1 or non-inferiority on trough FEV1.
Bluebird bio and Gritstone Oncology Announce Strategic Collaboration to Develop Novel Cancer Cell Therapies
August 23, 2018
Bluebird bio, Inc. and Gritstone Oncology, Inc. today announced a collaboration to research, develop and commercialize products for the treatment of cancer using cell therapy. Gritstone Oncology will leverage its proprietary EDGE™ artificial intelligence platform to analyze specific tumor types to identify tumor-specific targets and natural T-cell receptors (TCRs) directed to those targets for use in bluebird bio’s established cell therapy platforms. Bluebird bio will conduct all development, manufacturing and commercial activities. Gritstone Oncology will utilize its proprietary technology platform to enable patient selection for clinical development of such therapies.
Novartis announces new data that show Entresto® (sacubitril/valsartan) can be initiated early & safely in hospitalized patients after an acute heart failure episode
August 25, 2018
Data from the TRANSITION study presented at the European Society of Cardiology (ESC) Congress in Munich, Germany has shown that Entresto® (sacubitril/valsartan) can be initiated early and safely in a wide range of heart failure patients with reduced ejection fraction (HFrEF) who have been stabilized after hospitalization due to an acute heart failure episode. Patients involved in the study included those with no prior experience of Entresto or conventional HF therapies, as well as those with prior experience of conventional HF therapies.
Novartis receives European Commission approval of its CAR-T cell therapy, Kymriah® (tisagenlecleucel)
August 27, 2018
Novartis has announced that the European Commission (EC) has approved Kymriah® (tisagenlecleucel, formerly CTL019). The approved indications are for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse; and for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Kymriah developed in collaboration with the University of Pennsylvania (Penn) is a ground-breaking one-time treatment that uses a patient’s own T cells to fight cancer, and the only chimeric antigen receptor T cell (CAR-T) therapy to receive regulatory approval in the EU for these two distinct B-cell malignancies. Kymriah was also the first CAR-T cell therapy ever approved by the US Food and Drug Administration (FDA).Top Pharma News of the Week – August 27th last edit: 2018-08-27T18:13:08+00:00 da