All The Most Important Pharmaceutical News Stories Of The Week – April 2018 – Week #4
Boehringer Ingelheim and Lilly announce an academic collaboration with University of Oxford to investigate the effects of Jardiance® in adults with chronic kidney disease
April 16, 2018
Boehringer Ingelheim and Eli Lilly and Company have announced an academic collaboration with the University of Oxford to investigate the effects of Jardiance® on the progression of kidney disease and the occurrence of cardiovascular death, in adults with established chronic kidney disease with and without diabetes. EMPA-KIDNEY will be independently conducted, analyzed and reported by the Medical Research Council Population Health Research Unit at the University of Oxford (MRC PHRU), which is based in the Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU), in partnership with the Duke Clinical Research Institute. Boehringer Ingelheim and Lilly will provide the funding for the study.
Amgen Presents First-Of-Its-Kind Data at AAN Annual Meeting Reinforcing Robust and Consistent Efficacy Of Aimovig™ (erenumab) For Migraine Patients With Multiple Treatment Failures
April 17, 2018
Amgen has announced full results from the Phase 3b LIBERTY trial of Aimovig™ (erenumab) in episodic migraine patients who had previously failed two to four preventive treatments, due to lack of efficacy or to intolerable side effects.1 The data, which will be presented at the 70thAnnual Meeting of the American Academy of Neurology (AAN) in Los Angeles, show the potential of Aimovig as an effective preventive treatment option for these patients, who have tried several treatment options without gaining relief. Aimovig is the only investigational fully human monoclonal antibody under regulatory review that was designed to selectively block the calcitonin gene-related peptide (CGRP) receptor, which plays a critical role in migraine activation. LIBERTY is the first study to investigate a treatment targeting the CGRP pathway specifically in this challenging patient population.
Sandoz signs agreement with Pear Therapeutics to develop and commercialize prescription digital therapeutics for patients with substance use disorder and opioid use disorders
April 18, 2018
Sandoz, a Novartis division, has announced that it has entered into a collaboration with Pear Therapeutics to commercialize and continued development of novel prescription digital therapeutics designed to effectively treat disease and improve clinical outcomes for patients. The collaboration brings together Sandoz expertise in launching and commercializing treatments with Pear’s leading experience in digital therapeutics design and implementation.
New Novartis analyses at AAN show siponimod’s efficacy on disability and cognition in secondary progressive MS patients
April 20, 2018
Novartis has announced new analyses from the Phase III EXPAND study of oral, once-daily siponimod (BAF312) in patients with secondary progressive multiple sclerosis (SPMS). In pre-specified statistical analyses, treatment with siponimod consistently reduced the risk of confirmed disability progression in SPMS patients, with and without relapses. In addition, new post-hoc analyses using more accurate methods to estimate the treatment effect on disability progression, now substantiate that the risk reduction with siponimod is largely disassociated from relapses. Siponimod also showed a significant benefit on cognitive processing speed, the key cognitive function impacted by MS, which frequently deteriorates in people with the disease.
Biogen and Ionis Expand Strategic Collaboration to Develop Drug Candidates for a Broad Range of Neurological Diseases
April 20, 2018
Biogen and Ionis Pharmaceuticals have announced that they have expanded their strategic collaboration through a new ten-year collaboration agreement to develop novel antisense drug candidates for a broad range of neurological diseases. This collaboration capitalizes on Biogen’s expertise in neuroscience research and drug development and Ionis’ leadership in RNA targeted therapies with the goal of developing a broad pipeline of investigational therapies. It builds upon a productive collaboration that produced SPINRAZA, the first and only approved treatment for patients with spinal muscular atrophy.
April 20, 2018
Following the last proposal made on April 12, 2018, and after careful consideration, Takeda Pharmaceutical Company Limited (“Takeda”) is making an improved proposal to the Board of Shire plc (“Shire”) to acquire the entire issued and to be issued share capital of Shire. The Improved Proposal is at a price equivalent to £47.00 per share, comprised of £21.00 in cash (to be paid in U.S.$) and £26.00 of new Takeda shares.
Lilly Reports Additional Top-Line Results from CYRAMZA® (ramucirumab) Phase 3 RANGE Study in Advanced or Metastatic Urothelial Cancer
April 20, 2018
Eli Lilly and Company has announced additional results from its global, randomized, double-blind, placebo-controlled Phase 3 RANGE trial evaluating CYRAMZA® (ramucirumab) in combination with docetaxel in patients with locally advanced or unresectable or metastatic urothelial carcinoma whose disease progressed on or after platinum-based chemotherapy. A positive trend was seen in the secondary endpoint of overall survival (OS) which did not reach statistical significance. An improvement in objective response rate (ORR) was observed.
Pivotal Phase 3 Study of Merck’s Investigational Beta-Lactamase Inhibitor Relebactam in Combination with Imipenem/Cilastatin Demonstrated Favorable Overall Response Against Certain Imipenem–Non-Susceptible Bacterial Infections
April 22, 2018
Merck, known as MSD outside the United States and Canada, has announced that a pivotal Phase 3 study of relebactam, the company’s investigational beta-lactamase inhibitor, in combination with imipenem/cilastatin, demonstrated a favorable overall response in the treatment of certain imipenem–non-susceptible bacterial infections, the primary endpoint, with lower treatment-emergent nephrotoxicity (kidney toxicity), a secondary endpoint, compared to a Colistin (colistimethate sodium) plus imipenem regimen.
New OCREVUS (ocrelizumab) data at AAN demonstrate significant reductions in disease activity and disability progression in relapsing multiple sclerosis
April 23, 2018
Roche has announced that new OCREVUS (ocrelizumab) data showcase the efficacy of OCREVUS in relapsing multiple sclerosis (RMS) through several measures of underlying disease activity and disability progression, including magnetic resonance imaging (MRI), cognitive function, and spinal fluid biomarkers of inflammation and neurodegeneration. New safety data remain consistent with OCREVUS’ favourable benefit-risk profile in both relapsing and primary progressive multiple sclerosis (PPMS).Top Pharma News of the Week – April 23rd last edit: 2018-04-24T16:12:04+00:00 da