Top Pharma News of the Week

European Medicines Agency Accepts Filing For EVENITY™ (Romosozumab)

Jan. 7, 2018

Amgen and UCB (Euronext Brussels) have announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for EVENITY™ (romosozumab) for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. If approved in Europe, EVENITY will be a novel osteoporosis treatment that increases bone formation and reduces bone resorption simultaneously to increase bone mineral density (BMD) and reduce the risk of fracture.

Merck’s KEYTRUDA® (pembrolizumab) Significantly Improved Recurrence-Free Survival Compared to Placebo as Adjuvant Therapy in Patients with Stage 3 Resected High-Risk Melanoma

January 8, 2018

Merck and The European Organisation for Research and Treatment of Cancer (EORTC) have announced that the phase 3 EORTC1325/KEYNOTE-054 trial investigating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, as monotherapy for surgically resected high-risk melanoma, met the primary endpoint of recurrence-free survival (RFS). Based on an interim analysis and following review by the Independent Data Monitoring Committee, post-resection adjuvant therapy with KEYTRUDA resulted in significantly longer recurrence-free survival than placebo (HR=0.57; 98.4% CI, 0.43-0.74; p<0.0001). The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies involving patients with advanced melanoma.

Teva Announces Global License Agreement with Alder BioPharmaceuticals® in the Field of Anti-CGRP-Based Therapy

January 8, 2018

Teva Pharmaceutical Industries Ltd. has announced that its subsidiary, Teva Pharmaceuticals International GmbH., has signed a global license agreement with Alder BioPharmaceuticals. The agreement validates Teva’s IP and resolves Alder’s opposition to Teva’s European Patent No. 1957106 B1, with respect to anti-calcitonin gene-related peptide (CGRP) antibodies and methods for their use. It also provides Alder with clarity for its ongoing plans in the field.


FDA Accepts New Drug Applications for Merck’s Doravirine, the Company’s Investigational Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), for Treatment of HIV-1 Infection

January 8, 2018

Merck has announced that the U.S. Food and Drug Administration (FDA) has accepted for review two New Drug Applications (NDAs) for doravirine, the company’s investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV-1 infection in adults. The NDAs include data for doravirine (DOR) as a once-daily tablet for use in combination with other antiretroviral agents, and for use of doravirine with lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) in a once-daily fixed-dose combination single tablet as a complete regimen (DOR/3TC/TDF). The FDA has set a target action date of Oct. 23, 2018, for both applications under the Prescription Drug User Fee Act (PDUFA).

Eisai and Merck Receive Breakthrough Therapy Designation from FDA for LENVIMA® (lenvatinib mesylate) and KEYTRUDA® (pembrolizumab) as Combination Therapy for Advanced and/or Metastatic Renal Cell Carcinoma

January 9, 2018

Eisai Co., Ltd. and Merck has announced that they received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for Eisai’s multiple receptor tyrosine kinase inhibitor LENVIMA® (lenvatinib) in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for the potential treatment of patients with advanced and/or metastatic renal cell carcinoma (RCC). The LENVIMA and KEYTRUDA combination therapy is being jointly developed by Eisai and Merck. This is the second Breakthrough Therapy Designation for LENVIMA and the twelfth Breakthrough Therapy Designation granted to KEYTRUDA.

AstraZeneca receives EU approval of Fasenra for severe eosinophilic asthma

January 10, 2018

AstraZeneca and its global biologics research and development arm, MedImmune, have announced that the European Commission (EC) has approved Fasenra (benralizumab) as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting beta-agonists. The approval is based on the results from the WINDWARD programme, including the pivotal Phase III exacerbation trials, SIROCCO and CALIMA, and the Phase III OCS-sparing trial, ZONDA.

Roche’s OCREVUS (ocrelizumab) approved in the European Union for relapsing forms of multiple sclerosis and primary progressive multiple sclerosis

January 12, 2018

Roche has announced that the European Commission (EC) has granted marketing authorisation for OCREVUS® (ocrelizumab) for patients with active relapsing forms of multiple sclerosis defined by clinical or imaging features and for patients with early primary progressive multiple sclerosis in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity. Multiple sclerosis (MS) affects approximately 700,000 people in Europe, of which around 96,000 have the highly disabling primary progressive form. Most people with MS have a relapsing form (RMS) or primary progressive MS (PPMS) at diagnosis.

Lynparza approved by US FDA in germline BRCA-mutated metastatic breast cancer

January 12, 2018

AstraZeneca and Merck & Co., Inc. have announced that the US Food and Drug Administration (FDA) has approved Lynparza (olaparib), for use in patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor positive (HR+) breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Patients are selected for therapy based on an FDA-approved companion diagnostic from Myriad Genetics.

Top Pharma News of the Week last edit: 2018-01-16T18:47:51+00:00 da Luca

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