Top Pharma News of the Week

FDA Accepts Bristol-Myers Squibb’s Application for Opdivo (nivolumab) in Patients with Resected High-Risk Advanced Melanoma and Grants Priority Review

October 16, 2017

Bristol-Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection. The FDA also previously granted Breakthrough Therapy Designation for this application, which is the seventh indication for which Opdivo has received this designation.

Amgen And Boston Children’s Hospital Enter A Collaboration To Find New Genes And Drug Targets For Severe Pain Syndromes

October 16, 2017

Amgen and Boston Children’s Hospital have announced that they have entered into a neuroscience research collaboration aimed at identifying novel pain targets based on human genetic analyses. The one-year collaboration will focus on patients with genetic anomalies of pain sensitivity. Amgen will leverage its industry-leading expertise in genetic target identification and validation and will have access to Boston Children’s Hospital’s Division of Pain Medicine to identify patients with abnormal pain conditions. Amgen and Boston Children’s Hospital will collaborate to validate the genetic findings as potential pain targets.

Semaglutide receives positive 16-0 vote in favor of approval from FDA Advisory Committee

October 18, 2017

Novo Nordisk today announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) voted 16-0 in favor of the approval of once-weekly semaglutide to improve glycaemic control in adults with type 2 diabetes. The recommendation for approval was based on a global development programme involving more than 8,000 adults with type 2 diabetes in the eight SUSTAIN phase 3a clinical trials, including a cardiovascular outcomes trial.

Novartis drug Revolade® shows long-term disease control for chronic/persistent immune thrombocytopenia (ITP)

October 18, 2017

Novartis has announced long-term study results supporting the positive safety and efficacy of Revolade (eltrombopag) in adults with chronic/persistent (enrolling patients that were 6 or more months from diagnosis) immune (idiopathic) thrombocytopenia (ITP) were published online in Blood. The EXTEND study found that a majority of patients maintained a substantial clinical response and many no longer needed concomitant ITP medications. The research evaluated patients for up to 8 years of continuous treatment (median exposure of 2.4 years).

Kite’s Yescarta™ (Axicabtagene Ciloleucel) Becomes First CAR T Therapy Approved by the FDA for the Treatment of Adult Patients with Relapsed or Refractory Large B-Cell Lymphoma After Two or More Lines of Systemic Therapy

October 18, 2017

Kite, a Gilead Company, has announced that the U.S. Food and Drug Administration (FDA) has granted regular approval to Yescarta™ (axicabtagene ciloleucel), the first chimeric antigen receptor T cell (CAR T) therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma (transformed follicular lymphoma, or TFL). Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.

US FDA accepts regulatory submission for Lynparza in metastatic breast cancer and grants Priority Review

October 18, 2017

AstraZeneca and Merck & Co., Inc. have announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review for a supplemental New Drug Application (sNDA) for the use of Lynparza (olaparib) tablets in patients with germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic settings. A Prescription Drug User Fee Act date is set for the first quarter of 2018.

Lilly and CureVac Announce Global Collaboration to Develop mRNA Cancer Vaccines

October 18, 2017

Eli Lilly and CureVac AG have announced a global immuno-oncology collaboration focused on the development and commercialization of up to five potential cancer vaccine products based on CureVac’s proprietary RNActive® technology. The companies will use messenger RNA (mRNA) technology that targets tumor neoantigens for a more robust anti-cancer immune response.

Janssen Receives Two FDA Approvals for SIMPONI ARIA ® (golimumab) for the Treatment of Adults with Active Psoriatic Arthritis or Active Ankylosing Spondylitisrthritis or Active Ankylosing Spondylitis

October 20, 2017

Janssen Biotech, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved SIMPONI ARIA® (golimumab), the only fully-human anti-tumor necrosis factor (TNF)-alpha therapy administered via a 30-minute infusion, for the treatment of adults with active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS). The PsA and AS approvals are supported by comprehensive clinical development programs that demonstrated the significant efficacy of SIMPONI ARIA® over placebo, while offering a consistent safety profile across all indications. In the study for the treatment of active PsA, patients experienced improvement in joint symptoms and inhibition of structural damage. In the study for treatment of active AS, results showed improvement in measures of disease activity.

Top Pharma News of the Week last edit: 2017-10-23T18:51:57+00:00 da Luca

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