Top Pharma News of the Week

All The Most Important Pharmaceutical News Stories Of The Week – March 2018 – Week #1

Lilly Receives Additional FDA Approval for Verzenio™ (abemaciclib), as Initial Treatment for Advanced Breast Cancer

February 26, 2018

Eli Lilly and Company has announced that the U.S. Food and Drug Administration (FDA) has approved Verzenio™ (abemaciclib) in combination with an aromatase inhibitor (AI) as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. This additional FDA approval marks the third indication for Verzenio within five months. In September 2017, Verzenio became the first and only cyclin-dependent kinase (CDK)4 & 6 inhibitor approved in combination and as a single agent in metastatic breast cancer.

Bristol-Myers Squibb Announces Expansion of the International Immuno-Oncology Network (II-ON) with Addition of Yale Cancer Center

February 26, 2018

Bristol-Myers Squibb Company has announced that Yale Cancer Center has joined the International Immuno-Oncology Network (II-ON), a global peer-to-peer collaboration between Bristol-Myers Squibb and academia that aims to advance translational Immuno-Oncology (I-O) science. Formed in 2012 by Bristol-Myers Squibb, the II-ON was one of the first networks to bring academia and industry together to further the scientific understanding of I-O, and has since expanded from 10 to 16 sites across North America, Europe, Japan and Australia. The partners collaborate to generate innovative I-O science, launch biology-driven trials and apply cutting-edge technologies with the goal of translating research findings into clinical trials and, ultimately, supporting efforts to improve survival outcomes across tumor types.

New Data Show Lilly’s Trulicity® (dulaglutide) in Combination with an SGLT-2 Inhibitor Improves Blood Sugar Control in People with Type 2 Diabetes

February 26, 2018

Trulicity® (dulaglutide) significantly improves A1C  when added to ongoing treatment with a sodium-glucose co-transporter-2 (SGLT-2) inhibitor, according to results from AWARD-10, a new Phase 3b clinical study. These data were published online first in The Lancet Diabetes & Endocrinology. Trulicity is Eli Lilly’s once-weekly, injectable glucagon-like peptide-1 (GLP-1) receptor agonist approved to improve glucose in adults with type 2 diabetes. Trulicity should be used along with diet and exercise.

European Commission approves Roche’s Hemlibra for people with haemophilia A with inhibitors


February 27, 2018

Roche has announced that the European Commission has approved Hemlibra® (emicizumab) for routine prophylaxis of bleeding episodes in people with haemophilia A with factor VIII inhibitors. Hemlibra can be used in all age groups. Nearly one in three people with severe haemophilia A can develop inhibitors to factor VIII replacement therapies, putting them at greater risk of life-threatening bleeds or repeated bleeding episodes that can cause long-term joint damage. People with haemophilia A with inhibitors have a 70% increased risk of death compared to those without inhibitors.

Celgene Provides Regulatory Update on Ozanimod for the Treatment of Relapsing Multiple Sclerosis

February 27, 2018

Celgene Corporation has announced that it has received a Refusal to File letter from the US FDA regarding its New Drug Application (NDA) for ozanimod in development for the treatment of patients with relapsing forms of multiple sclerosis. Ozanimod is a novel, oral, selective sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator. Upon its preliminary review, the FDA determined that the nonclinical and clinical pharmacology sections in the NDA were insufficient to permit a complete review. Celgene intends to seek immediate guidance, including requesting a Type A meeting with the FDA, to ascertain what additional information will be required to resubmit the NDA.

MedImmune to create stand-alone company for early-stage inflammation and autoimmunity biologics

February 28, 2018

AstraZeneca has announced that its global biologics research and development arm, MedImmune, is spinning out six molecules from its early-stage inflammation and autoimmunity programs into an independent biotech company, Viela Bio. The new company will focus on developing medicines for severe autoimmune diseases by targeting the underlying causes of each disease.

IONIS-HTT Rx (RG6042) Top-Line Data Demonstrate Significant Reductions of Disease-Causing Mutant Huntingtin Protein in People with Huntington’s Disease

March 1, 2018

Ionis Pharmaceuticals, Inc., a leader in antisense therapeutics, has announced the presentation of positive top-line data from a completed Phase 1/2 study of IONIS-HTTRx (RG6042) in people with early stage Huntington’s disease (HD) at the 13th Annual CHDI HD conference. The data demonstrate that IONIS-HTTRx(RG6042) is the first drug in development to lower the disease-causing protein in people with HD.

Novartis and Pear Therapeutics to develop digital therapeutics for patients with schizophrenia and multiple sclerosis

March 1, 2018

Novartis has entered into a collaboration with Pear Therapeutics to develop novel prescription digital therapeutics, software applications designed to effectively treat disease and improve clinical outcomes for patients. The collaboration brings together Novartis expertise in biomedical research and clinical development with Pear’s leading experience in digital therapeutics design and implementation.

Biogen and AbbVie Announce the Voluntary Worldwide Withdrawal of Marketing Authorizations for ZINBRYTA® (daclizumab) for Relapsing Multiple Sclerosis

March 2, 2018

Biogen and AbbVie have announced the voluntary worldwide withdrawal of ZINBRYTA for relapsing multiple sclerosis. The companies believe that characterizing the complex and evolving benefit/risk profile of ZINBRYTA will not be possible going forward given the limited number of patients being treated.

Top Pharma News of the Week last edit: 2018-03-05T17:32:23+00:00 da Luca

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