Top Pharma News – November 2016

  1. New Research Details Published by Merck Scientists About the Early Development of Verubecestat

Merck Igea Luca Dezzani

November 2, 2016

Merck has announced the publication of research conducted by Merck scientists on the discovery and development of verubecestat. It is an investigational small molecule inhibitor of the enzyme beta-site amyloid precursor protein cleaving enzyme 1 (BACE1), which is used for treating Alzheimer’s disease (AD). The latest edition of the online peer-reviewed journal Science Translational Medicine published the research first. It included results from the Phase 1 clinical trials in healthy volunteers and people with AD. The safety and efficacy of verubecestat is currently being evaluated in two pivotal Phase 3 clinical trials, EPOCH and APECS, for treating mild-to-moderate AD and prodromal AD, respectively.

  1. Expanded Use Of ENBREL® (etanercept) is Approved by FDA for Treating Children with Chronic Moderate-To-Severe Plaque Psoriasis

Amgen Igea Luca Dezzani

Nov. 4, 2016

Amgen has announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the expanded use of ENBREL® (etanercept). This makes it the first and only systemic therapy for treating pediatric patients of ages 4 to 17 with chronic moderate-to-severe plaque psoriasis.

  1. Quintiles and IMS Health Complete Merger


October 4, 2016

Quintiles and IMS Health have completed their merger in order to transform the two companies into a single, information and technology-led healthcare service provider. The new offering is renamed as QuintilesIMS. It has become the world’s largest pharma services provider, with around 50,000 employees and a market value of almost $18bn.

  1. Pfizer to Present Additional Research For XELJANZ® (Tofacitinib Citrate) In Rheumatoid Arthritis and Psoriatic Arthritis

Pfizer Igea Luca Dezzani

November 7, 2016

Pfizer Inc. has announced that it will present 20 abstracts for XELJANZ® (tofacitinib citrate) at the upcoming 2016 ACR/ARHP Annual Meeting (November 11-16, Washington, DC). More importantly, for the first time, results from the two pivotal Phase 3 OPAL (Oral Psoriatic Arthritis TriaL) studies of tofacitinib – the only Janus kinase (JAK) inhibitor under investigation for psoriatic arthritis (PsA) – will be presented. OPAL Beyond will be presented during a late-breaking abstract poster session, and OPAL Broaden will be highlighted during a plenary session. Furthermore, new and updated research for XELJANZ in rheumatoid arthritis (RA) will be presented.

  1. European Union Gives Approval to IBRANCE® (palbociclib) for the Treatment of Women with HR+/HER2- Metastatic Breast Cancer

Pfizer Igea Luca Dezzani

November 10, 2016

Pfizer Inc. has announced that the European Commission (EC) has approved IBRANCE® (palbociclib) for treating women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer. The approval is for IBRANCE for using in combination with an aromatase inhibitor. It also covers the use of IBRANCE combining with fulvestrant in women who have received endocrine therapy previously.

  1. Opdivo (nivolumab) and Yervoy (ipilimumab) Regimen Shows Promising Safety and Efficacy in Previously Treated Patients with Advanced Form of Bladder Cancer

BMS Igea Luca Dezzani

November 12, 2016

Bristol-Myers Squibb Company has announced positive results from the Phase 1/2 open-label CheckMate-032 trial that investigates two combination schedules of Opdivo (nivolumab) plus Yervoy (ipilimumab) in patients with locally advanced or metastatic urothelial carcinoma (mUC) previously treated with platinum-based therapy. These data were presented during the Oral Late-breaking Abstract Session II, at the 31st Annual Meeting and Associated Programs of the Society for Immunotherapy of Cancer (SITC) in National Harbor, Md.

  1. Pfizer Collaborates with National Cancer Institute to Study Three Immunotherapy Agents that Target Multiple Cancers

Pfizer Igea Luca Dezzani

November 14, 2016

Pfizer Inc. has announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), which is a part of the National Institutes of Health (NIH). According to this agreement, Pfizer will collaborate with NCI’s Center for Cancer Research (CCR) for arranging and conducting preclinical and clinical trials to evaluate three investigational immunotherapy agents. These include Pfizer’s proprietary immunotherapy agonistic monoclonal antibodies targeting OX40 (CD134), (also known as PF-04518600); utomilumab that targets 4-1BB (CD137), (also known as PF-05082566); as well as avelumab, a fully human anti-PD-L1 IgG1 monoclonal antibody (also known as PF-06834635 and MSB0010718C), which is currently being developed through an alliance between Pfizer and Merck KGaA, Darmstadt, Germany.

  1. Pfizer Announces Results from Phase 3 OPAL Clinical Development Program Investigating XELJANZ® (Tofacitinib Citrate) for Psoriatic Arthritis

Pfizer Igea Luca Dezzani

November 15, 2016

Pfizer Inc. has announced that new results from the Phase 3 Oral Psoriatic Arthritis TriaL(OPAL) studies, Broaden and Beyond, will be presented at the ACR/ARHP Annual Meeting 2016, which will be held in November 11-16, in Washington, DC. OPAL Broaden and OPAL Beyond evaluated the safety and efficacy of XELJANZ® (tofacitinib citrate) in adult patients with active psoriatic arthritis (PsA). These patients had an inadequate response (IR) to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or to tumor necrosis factor inhibitors (TNFis), respectively.

  1. Investigational, Pan-Genotypic Regimen of Glecaprevir/Pibrentasvir (G/P) from AbbVie Shows High SVR Rates in Chronic Hepatitis C Patients with Severe Chronic Kidney Disease


Nov 15, 2016

AbbVie, a global biopharmaceutical company has announced that 98 percent (n=102/104) of chronic hepatitis C virus (HCV) infected patients with severe chronic kidney disease (CKD) achieved sustained virologic response following 12 weeks of treatment (SVR12) with its investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) in the primary intent-to-treat (ITT) analysis. These new data from the Phase 3 EXPEDITION-4 study that evaluates patients with chronic HCV infection were presented as a late-breaker at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston.

  1. Roche launches a global network of cancer immunotherapy centers of research excellence (imCORE™)

Roche Igea Luca Dezzani

15 November 2016

Roche has launched the global network of cancer immunotherapy Centers of Research Excellence (imCORE™), which will bring together many of the world’s leading scientific and clinical experts in cancer immunotherapy for collaborating in the investigation of the most promising new treatment approaches. The target is to start pre-clinical and clinical research rapidly based on the latest scientific discoveries and to aggregate and share data for accelerating the search for cures for people with cancer. The imCORE™ Network will focus on finding ways to expand the number of people who benefit from cancer immunotherapy by exploring new approaches for activating a person’s immune system to fight their cancer.

  1. Bristol-Myers Squibb and Enterome Announce Immuno-Oncology Collaboration Focused on Microbiome-Derived Biomarkers, Bioactive Molecules, and Drug Targets

BMS Igea Luca Dezzani

November 16, 2016

Bristol-Myers Squibb Company and Enterome, a pioneer in developing pharmaceuticals and diagnostics based on the gut microbiome, announced that they have entered into an Immuno-Oncology focused collaboration agreement for discovering and developing microbiome-derived biomarkers, bioactive molecules, and drug targets. These will be developed as potential companion diagnostics and therapeutics for cancer. Furthermore, through this collaboration, efforts will be made for identifying novel microbiome-derived biomarkers in order to improve clinical outcomes for patients treated with Bristol-Myers Squibb’s Immuno-Oncology portfolio.

  1. Top-Line Results of Solanezumab Phase 3 Clinical Trial Announced by Lilly


Nov. 23, 2016

Eli Lilly and Company has announced that solanezumab did not meet the primary endpoint in the EXPEDITION3 clinical trial. This is a phase 3 study of solanezumab in people with mild dementia due to Alzheimer’s disease (AD). Patients treated with solanezumab did not experience a statistically significant slowing in cognitive decline compared to patients treated with placebo (p=.095), as measured by the ADAS-Cog14 (Alzheimer’s Disease Assessment Scale-Cognitive subscale). No new safety signals were identified in the study. Lilly has decided not to pursue regulatory submissions for solanezumab for the treatment of mild dementia due to Alzheimer’s disease.

  1. Janssen Submits Application Seeking Approval of Anti-Interleukin-23 Monoclonal Antibody Guselkumab to EMA for Treating Moderate-to-Severe Plaque Psoriasis


November 25 2016

Janssen-Cilag International NV has announced about the submission of a Marketing Authorization Application to the European Medicines Agency (EMA) that seeks approval of guselkumab for treating adults with moderate to severe plaque psoriasis. Guselkumab is a human monoclonal antibody targeting the protein interleukin (IL)-23, which plays an important role in developing immune-mediated inflammatory diseases. Psoriasis is a chronic, autoimmune inflammatory disorder that results in the overproduction of skin cells. This is often characterized by raised, scaly, inflamed, red lesions, or plaques, that can cause itching, discomfort and pain. According to a recent estimate, 14 million people in Europe have psoriasis, which can range from mild to severe and disabling, and can often impair quality of life significantly.

  1. U.S. Food and Drug Administration Gives AbbVie the Orphan Drug Designation for Investigational IL-23 Inhibitor Risankizumab for Treating Pediatric Patients with Crohn’s Disease


Nov 30, 2016

AbbVie, a global biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to risankizumab (ABBV-066; formerly BI 655066) for the investigational treatment of pediatric patients with Crohn’s disease. It is a special type of inflammatory bowel disease which commonly involves the end of the small intestine and the large intestine.

Top Pharma News – November 2016 last edit: 2016-12-07T16:20:04+00:00 da Luca

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