All The Most Important Pharmaceutical News Stories Of The Week – March 2018 – Week #2
Celgene Completes Acquisition of Juno Therapeutics, Inc., Advancing Global Leadership in Cellular Immunotherapy
March 6, 2018
Celgene Corporation has announced that it has completed the acquisition of Juno Therapeutics, Inc. The Juno acquisition positions Celgene as a leading cellular immunotherapy company by adding novel technology and advanced cellular manufacturing capabilities to its broad commercial portfolio and pipeline of therapies in hematology and oncology. Celgene also gains full global rights to JCAR017 (lisocabtagene maraleucel; liso-cel), a CD-19 targeted CAR T therapy currently in pivotal trials for relapsed and/or refractory diffuse large B-cell lymphoma (DLBCL). Celgene expects the addition of JCAR017 and other cellular immunotherapy products in Juno’s pipeline to accelerate revenue diversification with meaningful growth drivers from 2020 and beyond.
Bristol-Myers Squibb’s Opdivo® (nivolumab) Now the First and Only FDA-Approved PD-1 Inhibitor to Offer Every Four-Week Dosing
March 6, 2018
Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) updating the Opdivo ® (nivolumab) dosing schedule to include 480 mg infused every four weeks (Q4W) for a majority of approved indications. This approval will provide health care professionals the flexibility to customize patient care with the option of using the newly approved Q4W (480 mg) flat dose in addition to the previously available option of every two weeks (Q2W) at 240 mg, now available in a new 240 mg vial. Opdivo also was approved for a shorter 30-minute infusion across all approved indications. Dosing schedule updates for an additional approved indication for Opdivo may be submitted to the FDA in the future.
Merck and Eisai Co., Ltd. Enter Global Strategic Oncology Collaboration for LENVIMA® (lenvatinib mesylate)
March 7, 2018
Merck, known as MSD outside the United States and Canada, and Eisai Co., Ltd. have announced that the companies have agreed upon a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA® (lenvatinib mesylate), an orally available tyrosine kinase inhibitor discovered by Eisai. Under the agreement, Eisai and Merck will develop and commercialize LENVIMA jointly, both as monotherapy and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab).
March 7, 2018
Esperion, the Lipid Management Company focused on developing and commercializing complementary, convenient, cost-effective, once-daily, oral therapies for the treatment of patients with elevated low density lipoprotein cholesterol (LDL-C), has announced positive top-line results from the first pivotal, Phase 3 study (Study 4 or 1002-048) of bempedoic acid 180 mg evaluating the LDL-C lowering efficacy and safety and tolerability of bempedoic acid versus placebo in patients with atherosclerotic cardiovascular disease (ASCVD) or at high risk for ASCVD with hypercholesterolemia inadequately treated with background ezetimibe 10 mg and up to the lowest daily starting dose of a statin.
March 7, 2018
Novartis has announced an additional strategic alliance with Science 37, a leader in decentralized clinical trial technology and design, to initiate up to 10 new clinical trials over the next three years. The studies will blend virtual and traditional models, with increasing degrees of decentralization towards a mostly “site-less” model. Novartis was an early investor in Science 37 and together we have already initiated virtual trials for cluster headache, acne and nonalcoholic steatohepatitis (NASH).
March 7, 2018
Merck KGaA, a leading science and technology company, has announced positive results from its Phase IIb study of evobrutinib (Bruton’s Tyrosine Kinase Inhibitor – BTK) in relapsing multiple sclerosis (MS). The study has met its primary endpoint, demonstrating that evobrutinib resulted in a clinically meaningful reduction of gadolinium enhancing T1 lesions measured at weeks 12, 16, 20 and 24 in comparison to patients receiving placebo.
Pfizer Announces Favorable Outcome of FDA Advisory Committee Meeting on Xeljanz® (Tofacitinib) For Moderately to Severely Active Ulcerative Colitis
March 8, 2018
Pfizer Inc. announced a positive outcome from the U.S. Food and Drug Administration (FDA) Gastrointestinal Drugs Advisory Committee (GIDAC) meeting. The GIDAC met to discuss Pfizer’s supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib), which is currently under review by the FDA, for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).
Voyager Therapeutics Announces Longer-Term Data from Ongoing Phase 1b Trial of VY-AADC for Advanced Parkinson’s Disease
March 9, 2018
Voyager Therapeutics, Inc., a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases, has announced longer-term data from its ongoing dose-ranging Phase 1b trial of VY-AADC in advanced Parkinson’s disease. The results continue to demonstrate durable, dose-dependent and time-dependent improvements across multiple measures of patients’ motor function after a one-time administration of the gene therapy. These measures include patient-reported diaries, Parkinson’s disease rating scales, and quality of life, with diary on-time without troublesome dyskinesia at twelve months as the proposed primary endpoint of the planned pivotal program. The update of results from the ongoing Phase 1b trial of VY-AADC include a durable 2.1-hour improvement in patient-reported diary on-time without troublesome dyskinesia from baseline to three years for patients in Cohort 1, a durable and clinically meaningful 3.5-hour improvement from baseline to 18 months in Cohort 2, and an improvement from baseline to six months of 1.5 hours that plateaued from six to 12 months in Cohort 3.
MyoKardia Announces Positive Results from Low-Dose Cohort of Phase 2 PIONEER-HCM Study of Mavacamten in Symptomatic, Obstructive Hypertrophic Cardiomyopathy Patients
March 11, 2018
MyoKardia, Inc., a clinical stage biopharmaceutical company pioneering a precision medicine approach for the treatment of heritable cardiovascular diseases, has announced positive results from the Phase 2 PIONEER-HCM clinical study of the investigational agent mavacamten in symptomatic, obstructive hypertrophic cardiomyopathy (oHCM) patients, including results from a low-dose patient cohort (“Cohort B”), which studied once-daily 2mg and 5mg oral doses of mavacamten.Top Pharma News of the Week – March 12th last edit: 2018-03-12T19:39:08+00:00 da