All The Most Important Pharmaceutical News Stories Of The Week – August 2018 – Week # 3
August 14, 2018
Bayer and Haplogen GmbH, a Vienna-based biotechnology company, have entered into a multi-year research collaboration agreement to identify new drug candidates for the treatment of pulmonary diseases such as chronic obstructive pulmonary disease (COPD).
FDA Approves KALYDECO® (ivacaftor) as First and Only Medicine to Treat the Underlying Cause of CF in Children Ages 12 to <24 Months with Certain Mutations in the CFTR Gene
Aug. 15, 2018
Vertex Pharmaceuticals Incorporated has announced the U.S. Food and Drug Administration (FDA) approved KALYDECO® (ivacaftor) to include use in children with cystic fibrosis (CF) ages 12 to <24 months who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to KALYDECO based on clinical and/or in vitro assay data.
Regeneron and Teva Announce Positive Topline Phase 3 Fasinumab Results in Patients with Chronic Pain from Osteoarthritis of the Knee or Hip
August 16, 2018
Pharmaceuticals, Inc. and Teva Pharmaceutical Industries Ltd. have announced positive topline results from a Phase 3, randomized, double-blind, placebo-controlled study of fasinumab in patients with chronic pain from osteoarthritis (OA) of the knee or hip. At the week 16 primary efficacy analysis, the study met both co-primary endpoints and all key secondary endpoints. Fasinumab-treated patients experienced significantly less pain and significantly improved functional ability from baseline compared to placebo.
August 17, 2018
Ziylo and Novo Nordisk A/S have announced that Novo Nordisk has acquired all of the shares of Ziylo, a University of Bristol spin-out company based at Unit DX science incubator in Bristol, UK. Ziylo has been pioneering the use of its platform technology – synthetic glucose binding molecules – for therapeutic and diagnostic applications.
August 17, 2018
Regeneron Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). The sBLA was based on second-year data from the Phase 3 VIEW 1 and 2 trials in which patients with wet AMD were treated with a modified 12-week dosing schedule (doses given at least every 12 weeks, and additional doses as needed). These data are now included in the updated EYLEA label.
Eisai And Merck & Co., Inc., Kenilworth, N.J., U.S.A. Announce FDA Approval of Lenvima® (Lenvatinib) Capsules for First-Line Treatment of Unresectable Hepatocellular Carcinoma (HCC)
August 17, 2018
Eisai Co., Ltd. and Merck & Co., Inc., known as MSD outside of the United States and Canada, have announced that the U.S. Food and Drug Administration (FDA) approved the kinase inhibitor LENVIMA® (lenvatinib mesylate) for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). This approval was based on results from REFLECT (Study 304), where LENVIMA demonstrated a proven treatment effect on overall survival (OS) by statistical confirmation of non-inferiority, as well as statistically significant superiority and clinically meaningful improvements in progression-free survival (PFS) and objective response rate (ORR) when compared with sorafenib in patients with previously untreated unresectable HCC. This is the second approval of LENVIMA for use in the treatment of HCC following approval in Japan earlier this year, and the first new systemic therapy to be approved in the U.S. for the first-line treatment of unresectable HCC in approximately 10 years.
U.S. Food and Drug Administration Approves Opdivo® (nivolumab) as the First New Medication in Nearly 20 Years for Certain Patients with Previously Treated Small Cell Lung Cancer
August 17, 2018
Bristol-Myers Squibb has announced that Opdivo (nivolumab) received approval from the U.S. Food and Drug Administration (FDA) as the first and only Immuno-Oncology treatment option for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy. Approval for this indication has been granted under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
China National Drug Administration grants rapid approval of Roche’s Alecensa (alectinib) as a treatment for ALK-positive lung cancer
August 20, 2018
Roche has announced that the China National Drug Administration (CNDA) has granted marketing authorisation for Alecensa® (alectinib) as a monotherapy treatment for patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC). The approval follows priority review of Alecensa in China and has been granted just eight and nine months after European Medicines Agency (EMA) and US Food and Drug Administration (FDA) approvals, respectively.Top Pharma News of the Week – August 20th last edit: 2018-08-21T17:22:31+00:00 da