Bevespi Aerosphere demonstrates statistically significant improvement in lung function in patients with COPD
AstraZeneca has announced positive top-line results of the Phase III, PINNACLE 4 trial in which Bevespi Aerosphere (glycopyrronium and formoterol fumarate 14.4/9.6 µg) demonstrated a statistically significant improvement in lung function as measured by trough forced expiratory volume in one second (FEV1), compared to its monotherapy components (glycopyrronium 14.4 µg and formoterol fumarate 9.6 µg) and placebo, all administered twice daily via pressurised metered-dose inhaler (pMDI) to patients with moderate to very severe chronic obstructive pulmonary disease (COPD). AstraZeneca will make regulatory filing applications for Bevespi Aerosphere in Japan and China in 2018, based on data from PINNACLE 4, as well as previously reported trials.
Amgen And Simcere Announce Strategic Collaboration to Co-Develop And Commercialize Biosimilars In China
September 26, 2017
Amgen and Simcere Pharmaceutical Group have announced the execution of an exclusive agreement to co-develop and commercialize four biosimilars in China. The collaboration includes undisclosed biosimilars in the areas of inflammation and oncology. Under the terms of the agreement, Amgen will remain responsible for the co-development, marketing approval applications and manufacturing of the biosimilars. Simcere will be responsible for distribution and commercialization in China, while Amgen will have a limited right to co-promote the products. The biosimilars included in the agreement are a part of Amgen’s existing biosimilars portfolio.
September 28, 2017
Merck and Pfizer Inc. have announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved BAVENCIO® (avelumab, genetically recombinant Injection 200mg/mL for intravenous use) as the first and only treatment indicated for curatively unresectable Merkel cell carcinoma (MCC), a rare and aggressive skin cancer, in Japan.
Roche’s OCREVUS (ocrelizumab) approved in Switzerland for primary progressive and relapsing forms of multiple sclerosis
28 September 2017
Roche has announced that the Swiss agency for the authorization and supervision of therapeutic products (Swissmedic) has granted authorization of OCREVUS® (ocrelizumab) for the treatment of adult patients with active relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). MS, which affects almost 15,000 people in Switzerland, is the leading cause of non-traumatic disability in young adults and often results in serious and permanent disabilities.
Novartis has joined forces with researchers from the University of California, Berkeley, to develop new technologies for the discovery of next-generation therapeutics, pursuing the vast number of disease targets in cancer and other illnesses that have eluded traditional small-molecule compounds and are considered “undruggable.”
Sanofi and Regeneron Announce Approval of Dupixent® (dupilumab) to Treat Adult Patients with Moderate-to-Severe Atopic Dermatitis in the European Union
Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the European Commission has granted marketing authorization for Dupixent® (dupilumab), for use in adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.
FDA grants Priority Review for Roche’s Perjeta (pertuzumab) for adjuvant treatment of HER2-positive early breast cancer
29 September 2017
Roche has announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Perjeta® (pertuzumab), in combination with Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant (after surgery) treatment of HER2-positive early breast cancer (eBC). The FDA is expected to make a decision on approval by 28 January 2018. The sBLA is based on results of the phase III APHINITY study. A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.
Allergan plc, a leading global pharmaceutical company, has announced the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for AVYCAZ®(ceftazidime and avibactam) for priority review. The sNDA filing seeks to expand the current indications for AVYCAZ to include hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP) in adult patients based on positive results from a Phase 3 clinical trial evaluating AVYCAZ for the treatment of patients with HABP/VABP. The FDA granted priority review status to the application based on the previous Qualified Infectious Disease Product (QIDP) designation for AVYCAZ, and is expected to take action on the filing in the first quarter of 2018.
Janssen Submits Supplemental New Drug Application (sNDA) to U.S. FDA Seeking New Indication for INVOKANA® (canagliflozin) to Reduce the Risk of Major Adverse Cardiovascular Events (MACE) Based on Landmark CANVAS Program
Janssen Research & Development, LLC (Janssen) has announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food & Drug Administration (FDA) seeking a new indication for INVOKANA® (canagliflozin) to reduce the risk of major adverse cardiovascular events (MACE), composed of cardiovascular (CV) death, myocardial infarction and stroke, in adults with type 2 diabetes who have established CV disease or are at risk for CV disease. The application also applies to INVOKANA® ’s fixed-dose combinations, INVOKAMET® and INVOKAMET® XR, and is based on findings from the landmark CANVAS clinical trial program.Top Pharma News of the Week last edit: 2017-10-03T21:18:49+00:00 da