Top Pharma News of the Week

European Medicines Agency Validates Bristol-Myers Squibb’s Type II Variation Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) in Intermediate- and Poor-Risk Patients with Advanced Renal Cell Carcinoma

November 28, 2017

Bristol-Myers Squibb Company has announced that the European Medicines Agency (EMA) validated its type II variation application, which seeks to expand the current indications for Opdivo (nivolumab) plus Yervoy (ipilimumab) to include the treatment of intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC). Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.

Merck and Pfizer Provide Update on Phase III JAVELIN Gastric 300 Study in Patients with Pre-Treated Advanced Gastric Cancer

November 28, 2017

Merck KGaA and Pfizer Inc. have announced that the Phase III JAVELIN Gastric 300 trial did not meet its primary endpoint of superior overall survival (OS) with single-agent avelumab compared with physician’s choice of chemotherapy. The trial investigated avelumab as a third-line treatment for unresectable, recurrent or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma patients whose disease progressed following two prior therapeutic regimens, regardless of programmed death ligand-1 (PD-L1) expression. The safety profile of avelumab was consistent with that observed in the overall JAVELIN clinical development program.

Novartis announces Phase III STRIVE data published in NEJM demonstrating significant and sustained efficacy of erenumab (AMG334) in migraine prevention

November 29, 2017

Novartis has announced that the New England Journal of Medicine (NEJM) published positive results from the six-month Phase III STRIVE study evaluating erenumab in the prevention of episodic migraine (defined in STRIVE as 4 to 14 migraine days per month). Erenumab delivered clinically meaningful and statistically significant differences from placebo for all primary and secondary endpoints including those measured by the novel, validated Migraine Physical Function Impact Diary (MPFID). Treatment with erenumab was well tolerated, with a safety profile comparable to placebo. Erenumab is the first and only fully human monoclonal antibody of its kind, designed to specifically block the CGRP receptor, which plays a critical role in migraine activation.

Astellas Acquires Mitobridge Under Existing Collaboration

November 30, 2017

Astellas Pharma Inc. and Mitobridge, Inc. have announced that Astellas has exercised its exclusive option right to acquire Mitobridge under the amended terms of the October 2013 partnership agreement governing their R&D collaboration focused on discovering and developing novel drugs that target mitochondrial function. Mitobridge will become a wholly-owned subsidiary of Astellas following the close of the acquisition.

Johnson & Johnson and Partners Announce First Efficacy Study for Investigational Mosaic HIV-1 Preventive Vaccine

November 30, 2017

On the eve of World AIDS Day (December 1), Johnson & Johnson announced that its Janssen Pharmaceutical Companies together with a consortium of global partners have initiated the first efficacy study for an investigational mosaic HIV-1 preventive vaccine. The Bill & Melinda Gates Foundation and National Institutes of Health are joining forces with Johnson & Johnson to advance the potential prevention option, which is designed to be a “global vaccine” that could prevent a wide range of viral strains responsible for the HIV pandemic.

CheckMate -078, a Pivotal, Multinational Phase 3 Opdivo (nivolumab) Lung Cancer Trial with Predominantly Chinese Patients, Stopped Early for Demonstrating Superior Overall Survival

November 30, 2017

Bristol-Myers Squibb Company has announced that the Phase 3 study CheckMate -078, evaluating Opdivo (nivolumab) versus docetaxel in previously treated advanced or metastatic non-small cell lung cancer (NSCLC), was stopped early because the independent Data Monitoring Committee (DMC) concluded that the study met its primary endpoint, demonstrating superior overall survival (OS) in patients receiving Opdivo compared with the control arm. The safety profile of Opdivo was consistent with previously reported studies in solid tumors. CheckMate -078 is a multinational Phase 3 study with predominantly Chinese patients. The Company submitted a Biologics License Application (BLA) for Opdivo to the China Food and Drug Administration (CFDA) for the proposed indication of previously treated NSCLC, which has been accepted by the CFDA.

Novartis’ Cosentyx® is first biologic to show long-term efficacy in nail and palmoplantar psoriasis, which can impact up to 90% of psoriasis patients


November 30, 2017

Novartis, a global leader in Immunology & Dermatology, has announced first-of-its-kind long-term data showing that Cosentyx®(secukinumab) provided sustained improvements in nail and palmoplantar psoriasis out to 2.5 years. These data are unique as it is the first time any biologic has demonstrated long-term efficacy and safety in nail and palmoplantar psoriasis. These new data from a clinical study were presented at the 8th International Congress of Psoriasis from Gene to Clinic in London, UK.

FDA Approves Amgen’s Repatha® (evolocumab) To Prevent Heart Attack And Stroke

December 1, 2017

Amgen has announced that following priority review of its supplemental Biologics License Application, the U.S. Food and Drug Administration (FDA) approved Repatha® (evolocumab) as the first PCSK9 inhibitor to prevent heart attacks, strokes and coronary revascularizations in adults with the established cardiovascular disease.

Pfizer Enters into Agreement to Develop and Commercialize Cresemba® (Isavuconazole) in China and Asia Pacific Region

December 1, 2017

Pfizer Inc. and Basilea Pharmaceutica Ltd., an international biopharmaceutical company specializing in the research and development of anti-infective and oncological medicines, have announced that they have entered into an agreement whereby Pfizer will be granted the exclusive development and commercialization rights in China and several countries in the Asia Pacific region to CRESEMBA (isavuconazole). CRESEMBA is a novel antifungal medicine for the treatment of adult patients with diagnosed invasive aspergillosis and mucormycosis, two serious infections associated with significant morbidity and mortality among immunocompromised patients, such as those with advanced HIV and those with cancer.

FDA approves Foundation Medicine’s FoundationOne CDx, the first pan-tumor comprehensive genomic profiling assay incorporating a broad range of companion diagnostics

December 4, 2017

Roche has announced that the US Food and Drug Administration (FDA) has approved FoundationOne CDx™, Foundation Medicine’s comprehensive companion diagnostic assay for personalized oncology care. FoundationOne CDx supports physicians in clinical decision-making by providing a report that describes the unique genomic profile of the patient’s tumor as well as associated approved therapies and relevant clinical trial information. FDA approval of this assay, based on its clinical and analytical validation, now means the service can be used as a companion diagnostic for therapy selection when people have been diagnosed with solid tumors.

Top Pharma News of the Week last edit: 2017-12-09T03:16:25+00:00 da Luca

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