All The Most Important Pharmaceutical News Stories Of The Week – February 2018 – Week #1
Amgen Receives CHMP Positive Opinion to Add Updated Overall Survival Data to KYPROLIS® (carfilzomib) Label
January 30, 2018
Amgen has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending a label variation for KYPROLIS® (carfilzomib) to include updated overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial in patients with relapsed or refractory multiple myeloma (KYPROLIS and dexamethasone [Kd] versus Velcade® [bortezomib] and dexamethasone [Vd]). The ENDEAVOR trial demonstrated that Kd reduced the risk of death by 21 percent and increased OS by 7.6 months versus Vd in patients with relapsed or refractory multiple myeloma (median OS 47.6 months for Kd versus 40.0 months for Vd, HR=0.79; p=0.01).
AB Biosciences and Shire Enter into Agreement for Development and Commercialization of AB Biosciences’ PRIM Program for Potential Treatment of Autoimmune Diseases and Other Immune-Mediated Disorders
January 30, 2018
AB Biosciences, Inc. and Shire plc, the global biotechnology leader in rare diseases, have announced that they have entered into an agreement granting Shire an exclusive worldwide license to develop and commercialize AB Biosciences’ pan receptor interacting molecule (PRIM) program, which uses AB Biosciences’ proprietary oligomeric Fc technology platform. PRIM, a recombinant immunoglobulin product candidate, has shown encouraging preclinical data, including enhanced biological activity relative to currently approved intravenous immunoglobulin (IVIg) therapies, in preclinical models of autoimmune and inflammatory diseases.
Seattle Genetics to Acquire Cascadian Therapeutics, Adding Late-Stage Breast Cancer Program to Its Oncology Pipeline
January 31, 2018
Seattle Genetics, Inc. and Cascadian Therapeutics, Inc. have announced the signing of a definitive merger agreement under which Seattle Genetics has agreed to acquire Cascadian Therapeutics. Under the terms of the agreement, Seattle Genetics will pay $10.00 per share in cash, or approximately $614 million. The transaction was unanimously approved by the Boards of Directors of both companies.
Sage Therapeutics Announces Positive Results from Placebo-Controlled Trial in a Model of Insomnia Demonstrating Activity on Sleep Parameters and Supporting Development of SAGE-217 as Potential Treatment for Sleep Disorders
January 31, 2018
Sage Therapeutics, a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, has announced positive results from a Phase 1/2, double-blind, placebo-controlled study of SAGE-217 in the treatment of healthy adult volunteers using a 5-hour phase advance model of insomnia using polysomnography. SAGE-217, administered as a single dose at either 30 or 45 mg, significantly improved sleep efficiency (SE), the primary endpoint of the trial, to a median of 85 percent (30 mg; p<0.0001) and 88 percent (45 mg; p<0.0001), respectively, compared with a median SE of 73 percent for placebo. SAGE-217 also demonstrated statistically significant improvements in total sleep time as well as sleep maintenance.
Dermira Initiates Phase 2b Dose-Ranging Study Evaluating Lebrikizumab in Patients with Moderate-to-Severe Atopic Dermatitis
January 31, 2018
Dermira, Inc. has announced the initiation of a Phase 2b dose-ranging study evaluating the safety and efficacy of lebrikizumab in adult patients with moderate-to-severe atopic dermatitis, the most common form of eczema. Lebrikizumab is a novel, humanized monoclonal antibody designed to bind to IL-13 with high affinity, specifically preventing heterodimerization of the IL-13/IL-4 receptor and subsequent signaling. IL-13 plays a central role in type 2 inflammation and is an important pathogenic mediator in atopic dermatitis.
Novartis announces NEJM publication of updated analysis from ELIANA trial showing longer-term durable remissions with Kymriah(TM) in children, young adults with r/r ALL
Jan 31, 2018
Novartis has announced updated results from the pivotal ELIANA clinical trial of KymriahTM (tisagenlecleucel), formerly CTL019, in relapsed or refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL) have been published in The New England Journal of Medicine(NEJM). New data include longer-term follow-up and efficacy in 75 infused patients, analysis of expansion and persistence of Kymriah, and longer-term safety. In the analysis of 75 infused patients with three or more months of follow-up, Kymriah demonstrated an overall remission rate of 81% (95% CI: 71% – 89%).
Vertex Selects Two Next-Generation Correctors, VX-659 and VX-445, to Advance into Phase 3 Development as Part of Two Different Triple Combination Regimens for People with Cystic Fibrosis
February 1, 2018
Vertex Pharmaceuticals Incorporated has announced the selection of two next-generation correctors, VX-659 and VX-445, to advance into Phase 3 development as part of two different triple combination regimens for people with cystic fibrosis (CF). The decision to advance VX-659 and VX-445 into Phase 3 development was based on initial Phase 2 data, including new data from ongoing Phase 2 studies that showed mean absolute improvements in percent predicted forced expiratory volume in one second (ppFEV1) of up to 13.3 and 13.8 percentage points from baseline through four weeks of treatment for the triple combination regimens with VX-659 (400mg QD) or VX-445 (200mg QD), respectively, in people who have one F508del mutation and one minimal function mutation (F508del/Min). Regulatory discussions are ongoing to finalize the design of Phase 3 programs for VX-659 and VX-445.
FDA Approves AVYCAZ® (ceftazidime and avibactam) for the Treatment of Patients with Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia
February 1, 2018
Allergan plc, a leading global pharmaceutical company, has announced that the U.S. FDA has approved Allergan’s supplemental New Drug Application (sNDA) to expand the approved use of AVYCAZ® (ceftazidime and avibactam) to include the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by the following susceptible Gram-negative microorganisms: Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenzae in patients 18 years of age or older. This expanded use is based on positive results from a pivotal Phase 3 study evaluating the efficacy and safety of AVYCAZ for the treatment of adult patients with HABP/VABP. The sNDA received priority review from FDA based on the Qualified Infectious Disease Product (QIDP) designation for the HABP/VABP indication.
Pivotal Phase 3 CheckMate -227 Study Demonstrates Superior Progression-Free Survival (PFS) with the Opdivo Plus Yervoy Combination Versus Chemotherapy in First-Line Non-Small Cell Lung Cancer (NSCLC) Patients with High Tumor Mutation Burden (TMB)
February 5, 2018
Bristol-Myers Squibb Company has announced that the ongoing Phase 3 CheckMate -227 study met its co-primary endpoint of progression-free survival (PFS) with the Opdivo (nivolumab) plus Yervoy (ipilimumab) combination versus chemotherapy in first-line advanced non-small cell lung cancer (NSCLC) patients whose tumors have high (?10 mutations/megabase, mut/mb) tumor mutation burden (TMB), regardless of PD-L1 expression. In the study, TMB was evaluated using Foundation Medicine’s (Nasdaq: FMI) analytically validated assay FoundationOne CDx. Additionally, based on an interim analysis for overall survival (OS), the Data Monitoring Committee recommended that the study continue. The safety profile was consistent with previously reported findings in first-line NSCLC for the combination schedule of Opdivo 3 mg/kg every two weeks and low-dose Yervoy (1 mg/kg) every six weeks.Top Pharma News of the Weeklast edit: 2018-02-05T19:02:54+00:00da