All The Most Important Pharmaceutical News Stories Of The Week – May 2018 – Week #3
Lynparza tablets receive EU approval for the treatment of platinum-sensitive relapsed ovarian cancer
May 8, 2018
AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US have announced that the European Medicines Agency (EMA) has approved Lynparza (olaparib) tablets (300mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed high-grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy, regardless of BRCA status.
May 8, 2018
Takeda Pharmaceutical Company Limited and Shire plc have announced that they have reached agreement on the terms of a recommended offer pursuant to which Takeda will acquire the entire issued and to be issued ordinary share capital of Shire. Under the terms of the acquisition, each Shire shareholder will be entitled to receive $30.33 in cash for each Shire share and either 0.839 new Takeda shares or 1.678 Takeda ADSs. The transaction has been approved by both companies’ boards of directors, and is expected to close in the first half of calendar year 2019. Upon the closing of the transaction, Takeda shareholders will own approximately 50 percent of the combined group.
Daiichi Sankyo Announces Single Agent Quizartinib Significantly Prolongs Overall Survival Compared with Chemotherapy in Patients with Relapsed/Refractory AML with FLT3-ITD Mutations (QuANTUM-R Study)
May 8, 2018
Daiichi Sankyo Company, Limited announces that the pivotal QuANTUM-R phase 3 study of single agent quizartinib met its primary endpoint of significantly prolonging overall survival compared to salvage chemotherapy in patients with relapsed/refractory acute myeloid leukemia (AML) with FLT3-ITD mutations after first-line treatment with or without hematopoietic stem cell transplantation (HSCT). Safety appears consistent with that observed at similar doses in the quizartinib program.
May 10, 2018
Eli Lilly and Company and ARMO BioSciences, Inc. have announced a definitive agreement for Lilly to acquire ARMO for $50 per share, or approximately $1.6 billion, in an all-cash transaction. ARMO BioSciences is a late-stage immuno-oncology company that is developing a pipeline of novel, proprietary product candidates designed to activate the immune system of cancer patients to recognize and eradicate tumors.
FDA Advisory Committee Votes in Favor of WAYLIVRA for Treatment of Familial Chylomicronemia Syndrome
May 10, 2018
Akcea Therapeutics, Inc., an affiliate of Ionis Pharmaceuticals, Inc., and Ionis Pharmaceuticals, Inc have announced that the U.S. Food and Drug Administration’s (FDA) Division of Metabolism and Endocrinology Products Advisory Committee voted 12-8 to support approval of WAYLIVRATM (volanesorsen) for the treatment of people with familial chylomicronemia syndrome (FCS). The committee’s non-binding recommendation will be considered by the FDA in its review of Akcea’s New Drug Application for WAYLIVRA.
Roche provides update on Phase III study of Tecentriq (atezolizumab) and Cotellic (cobimetinib) in people with heavily pre-treated locally advanced or metastatic colorectal cancer
May 10, 2018
Roche has announced that the Phase III IMblaze370 study evaluating the combination of Tecentriq® (atezolizumab) and Cotellic® (cobimetinib) did not meet its primary endpoint of overall survival (OS) compared to regorafenib. The study evaluated the combination in people with difficult-to-treat, locally advanced or metastatic colorectal cancer (CRC) whose disease progressed or who were intolerant to at least two systemic chemotherapy regimens.
AstraZeneca provides update on GALATHEA Phase III trial for Fasenra in chronic obstructive pulmonary disease
May 11, 2018
AstraZeneca and MedImmune, its global biologics research and development arm, have announced top-line results from the GALATHEA Phase III trial for Fasenra (benralizumab) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). The trial did not meet the primary endpoint of a statistically-significant reduction of exacerbations in patients with COPD.
Novartis announces FDA approval of Gilenya® as the first disease-modifying therapy for pediatric relapsing multiple sclerosis
May 12, 2018
Novartis has announced that the US Food and Drug Administration (FDA) has approved Gilenya® (fingolimod) for the treatment of children and adolescents 10 to less than 18 years of age with relapsing forms of multiple sclerosis (RMS), making it the first disease-modifying therapy indicated for these patients. This approval expands the age range for Gilenya, which was previously approved for patients aged 18 years and older with RMS. Gilenya was granted Breakthrough Therapy designation by the FDA in December of 2017 for this pediatric indication.
May 14, 2018
Eli Lilly and Company has announced an agreement to acquire AurKa Pharma, Inc., a company established by TVM Capital Life Science to develop oncology compound AK-01, an Aurora kinase A inhibitor that was originally discovered at Lilly. The compound is a potential first-in-class asset that AurKa Pharma is studying in Phase 1 clinical trials in multiple types of solid tumors.Top Pharma News of the Week – May 14th last edit: 2018-05-16T19:54:09+00:00 da