All The Most Important Pharmaceutical News Stories Of The Week – April 2018 – Week #3
AbbVie and Neurocrine Biosciences Announce PDUFA Target Date of Q3 2018 for Elagolix in Endometriosis-Associated Pain
April 10, 2018
AbbVie, a global research and development-based biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced notification by the U.S. Food and Drug Administration (FDA) that it requires extended time to review additional information regarding the results of liver function tests provided by AbbVie in connection with its New Drug Application (NDA) for elagolix in endometriosis-associated pain. The Prescription Drug User Fee Act (PDUFA) date has been extended three months to Q3
Pfizer Provides Update on Phase 3 Trial of Axitinib As Adjuvant Treatment for Patients at High Risk of Renal Cell Carcinoma Recurrence After Surgery
April 10, 2018
Pfizer Inc. has announced that the independent Data Monitoring Committee for the Phase 3 ATLAS trial evaluating INLYTA® (axitinib) as adjuvant therapy for patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy recommended stopping the trial at a planned interim analysis due to futility. The recommendation was based on the study failing to demonstrate a clear improvement in the primary endpoint of extending disease-free survival (DFS) for patients treated with INLYTA compared with patients treated with placebo. No new safety signals were observed, and the safety profile was consistent with the known profile of INLYTA in advanced RCC.
GSK signs strategic agreement to transfer rare disease gene therapy portfolio to Orchard Therapeutics
April 12, 2018
GSK and Orchard Therapeutics have announced a strategic agreement, under which GSK will transfer its portfolio of approved and investigational rare disease gene therapies to Orchard, securing the continued development of the programmes and access for patients. This acquisition strengthens Orchard’s position as a global leader in gene therapy for rare diseases. GSK will continue to invest in the development of its platform capabilities in cell and gene therapies, with a focus on oncology.
Pfizer Doses First Patient Using Investigational Mini-Dystrophin Gene Therapy for The Treatment of Duchenne Muscular Dystrophy
April 12, 2018
Pfizer Inc. has initiated a Phase 1b clinical trial for its mini-dystrophin gene therapy candidate, PF-06939926, in boys with Duchenne muscular dystrophy (DMD). The first boy received an infusion of the mini-dystrophin gene on March 22nd, administered under the supervision of principal investigator, Edward Smith, MD, Associate Professor of Pediatrics and Neurology at Duke University Medical Center. Screening and enrollment of patients is expected to continue at up to four clinical research sites in the United States. Early data from this trial are expected in the first half of 2019, once all patients have been evaluated for one full year post-treatment.
Allergan Announces Launch of the TrueTear® Intranasal Neurostimulation Device During 2018 ASCRS-ASOA Annual Meeting
April 13, 2018
Allergan plc, a leading global pharmaceutical company, has announced the official launch of TrueTear®, the first and only FDA-cleared device developed to temporarily increase tear production during neurostimulation in adult patients. TrueTear®, a handheld neurostimulation device with disposable tips that is inserted into the nasal cavity to induce the production of natural tears, is a novel and innovative approach for those patients with inadequate tear production. In two clinical trials, TrueTear® was shown to be safe and effective for temporarily increasing tear production in adult patients.
1st-line Tagrisso demonstrates sustained benefit post progression in patients with EGFR-mutated non-small cell lung cancer
April 13, 2018
AstraZeneca has presented new post-progression outcomes data from an exploratory analysis of the global Phase III FLAURA trial, which assessed the efficacy and safety of Tagrisso (osimertinib) as 1st-line therapy in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). The presentation at the European Lung Cancer Conference (ELCC) in Geneva during the “Best of ELCC” session showed that the progression-free survival (PFS) benefit of 1st-line Tagrisso over the EGFR tyrosine kinase inhibitors (TKIs), erlotinib or gefitinib, was sustained throughout post-progression outcomes.
Alnylam Presents New Positive Clinical Results for Givosiran, an Investigational RNAi Therapeutic for the Treatment of Acute Hepatic Porphyrias
April 14, 2018
Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, has announced new results from the Phase 1 and Phase 1/2 open-label extension (OLE) studies of givosiran, an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) for the treatment of acute hepatic porphyrias (AHPs). In randomized, double-blind, placebo-controlled phase 1 study, monthly Givosiran demonstrated an over 80 percent lowering of urinary aminolevulinic acid (ala), a disease biomarker, and an over 75 percent decrease in mean annualized porphyria attack rate, relative to placebo.
Bristol-Myers Squibb Announces Worldwide Collaboration with Janssen to Develop and Commercialize Next-Generation Cardiovascular Therapy
April 16, 2018
Bristol-Myers Squibb Company has announced a worldwide collaboration with Janssen Pharmaceuticals, Inc. (Janssen) on a Factor XIa (FXIa) inhibitor program that includes the development and commercialization of Bristol-Myers Squibb’s Factor XIa (FXIa) inhibitor, BMS-986177, an investigational anticoagulant compound being studied for prevention and treatment of major thrombotic conditions. The companies are expected to advance BMS-986177 into Phase 2 clinical trials in the second half of 2018 for the study of secondary stroke prevention.Top Pharma News of the Week – April 16th last edit: 2018-04-18T18:48:51+00:00 da