Business Wire

Ipsen announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental indication for Somatuline® Depot (lanreotide) Injection 120 mg for the treatment of carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analogue rescue therapy.

Boehringer Ingelheim and Gubra announce a collaboration and license agreement for the development of novel peptide compounds to treat obesity. The collaboration will bring together Gubra’s expertise in the design, synthesis, characterization and in in vivo testing of therapeutic peptides with Boehringer Ingelheim’s expertise in the development of innovative medicines for patients with cardiometabolic disease. It further expands and complements Boehringer Ingelheim’s comprehensive research and development portfolio in cardiometabolic diseases, one of the company’s core focus areas.

ERYTECH Pharma a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announced the presentation of the full data from its Phase 2b study evaluating eryaspase (GRASPA®) in combination with chemotherapy for the treatment of metastatic pancreatic cancer. The open-label, multi-center, randomized Phase 2b clinical study met its co-primary endpoints and demonstrated significant improvement in both overall survival (OS) and progression-free survival (PFS). The results will be presented during the European Society for Medical Oncology (ESMO) Annual Meeting in Madrid.

Janssen Pharmaceutica NV entered into an exclusive distribution agreement for INVOKANA® (canagliflozin) and VOKANAMET® (a fixed-dose combination of canagliflozin and metformin) in countries in the European Economic Area (EEA) and Switzerland where the products have obtained Pricing and Reimbursement Approvals. The agreement with Mundipharma Medical Company (“Mundipharma”) became effective on 21st August 2017 in all concerned countries except in the UK and Italy where the agreement will become effective on 16 September.

ERYTECH Pharma a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, announced that two abstracts on its preclinical erymethionase and eryminase programs were accepted for poster presentation at the 13th International Congress of Inborn Errors of Metabolism (ICIEM), being held September 5 – 8, 2017 in Rio De Janeiro, Brazil.

GN Hearing announced the launch of ReSound ENZO 3D™, and the corresponding Beltone Boost Max™, which brings the renowned benefits of ReSound LiNX 3D™ and Beltone Trust™ to people with severe to profound hearing loss. Based on GN Hearing’s 5th generation 2.4 GHz wireless technology and GN Hearing’s 3rd generation binaural directionality, ReSound ENZO 3D has been proven to allow users to experience 60% more clarity of the sounds around them* and 60% better speech understanding in noise.

Pierre Fabre Laboratories the 2nd largest private French pharmaceutical group announced that the European Medicines Agency (EMA) has validated the review of the Marketing Authorization Applications (MAAs) for the use of the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once daily (COMBO450) for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The submissions are supported by data from the pivotal Phase 3 COLUMBUS study, which showed that patients who received the combination of binimetinib and encorafenib had a significantly longer progression free survival (PFS) compared to patients receiving vemurafenib.

Dr. Reddy’s Laboratories Ltd. announced that it has launched Cefixime for Oral Suspension, USP 100 mg/5mL and 200 mg/5mL, a therapeutic equivalent generic version of Suprax® (cefixime) for Oral Suspension, approved by the U.S. Food and Drug Administration (USFDA).

Bristol-Myers Squibb Company and Pfizer Inc. presented findings from EMANATE (Eliquis evaluated in acute cardioversion coMpared to usuAl treatmeNts for AnTicoagulation in subjEcts with NVAF), a Phase 4 clinical trial, during a late-breaking hot line presentation at the ESC Congress 2017, organized by the European Society of Cardiology, in Barcelona, Spain. This descriptive, randomized, open-label trial explored the safety and efficacy of apixaban 5 mg twice daily (2.5 mg lower dose when two of the following were present: age ≥80 years, weight ≤60 kg, or serum creatinine ≥1.5 mg/dL (133μmol/L)) vs. standard of care (parenteral heparin and/or vitamin K antagonist). The outcomes measured in this study were the occurrence of acute stroke, systemic embolism, major bleeding, clinically relevant non-major bleeding and all-cause death in non-valvular atrial fibrillation patients undergoing cardioversion. This is an investigational use for Eliquis. Eliquis is not FDA-approved for the reduction of stroke in NVAF patients undergoing cardioversion (please see indications and important safety information for Eliquis later in the press release).

Boehringer Ingelheim and pharmaceutical company Pharmaxis announce that Boehringer Ingelheim has initiated a European and North American Phase IIa trial in NASH with BI 1467335 (formerly known as PXS-4728A), acquired from Pharmaxis in May 2015. The compound is an oral inhibitor of amine oxidase, copper containing 3 (AOC3)1, and works by blocking leucocyte adhesion and tissue infiltration in inflammatory processes underlying NASH.