FDA grants Priority Review for Lynparza in metastatic breast cancer

Wednesday, October 18, 2017

AstraZeneca and Merck, known as MSD outside the U.S. and Canada, announced that the 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 (gBRCA), HER2-negative metastatic breast cancer (MBC) who have been previously treated with chemotherapy either in the neoadjuvant, adjuvant or metastatic settings. A Prescription Drug User Fee Act (PDUFA) date is set for the first quarter of 2018.

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Ethris, AstraZeneca to develop mRNA therapies for respiratory diseases

Tuesday, August 22, 2017

Ethris, a leader in mRNA-based therapeutics with specific expertise in pulmonary disease, announced a five-year strategic research collaboration with AstraZeneca and its global biologics research and development arm, MedImmune. The collaboration is focused on developing new stabilized non-immunogenic modified RNA therapies for respiratory diseases using Ethris’ proprietary SNIM RNA technology.

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Champions Oncology, AstraZeneca collaborate

Tuesday, August 22, 2017

Champions Oncology, a company engaged in the development and sale of advanced technology solutions and products to personalize the development and use of oncology drugs, announced a strategic collaboration with AstraZeneca to develop novel cohorts of PDX models. These models will be used in AstraZeneca’s oncology R&D programs in breast and lung cancer, in addition to being added to Champions’ existing TumorGraft bank for translational oncology research for academic and industry customers. Champions’ global network of collaborating sites will be leveraged to support this multi-year initiative.

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Acalabrutinib granted FDA Breakthrough Designation for MCL

Wednesday, August 2, 2017

AstraZeneca and its hematology research and development center of excellence, Acerta Pharma, announced that the FDA has granted Breakthrough Therapy Designation for acalabrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Acalabrutinib is a highly-selective, potent Bruton tyrosine kinase (BTK) inhibitor in development for the treatment of multiple B-cell cancers.

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AstraZeneca, Merck to partner

Friday, July 28, 2017

AstraZeneca and Merck & Co., Inc. have announced that they have entered a global strategic oncology collaboration to co-develop and co-commercialize AstraZeneca’s Lynparza (olaparib) for multiple cancer types. Lynparza is an innovative, first-in-class oral poly ADP ribose polymerase (PARP) inhibitor currently approved for BRCA-mutated ovarian cancer in multiple lines of treatment.

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Vaxil BioTherapeutics appoints Dr. Terry Plasse chief medical officer

Tuesday, July 25, 2017

Vaxil Bio, an Israeli-Canadian biotech developing innovative immunotherapy treatments for cancer, announced the appointment of Dr. Terry Plasse as its chief medical officer, responsible for the company’s clinical program surrounding its drug candidate, ImMucin. Dr. Plasse brings 30 years of clinical development experience, including advancing products from IND through to commercially marketed treatments for several big-pharma companies.

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MAGI Award for Excellence in Site Payments winners announced

Monday, June 5, 2017

Nimblify, a clinical trials technology company, helped announce the winners of the MAGI Award for Excellence in Site Payments at MAGI‘s Clinical Research Conference on May 22, 2017 in Philadelphia, Pennsylvania. Nimblify partnered with MAGI to perform an analysis on the state of the industry as it relates to site payments and to honor and recognize sponsors and CROs that pay sites promptly. Site customers of Nimblify’s parent company, Forte Research Systems, contributed data for hundreds of studies across 142 sponsors and CROs with nearly 32,000 payment records. Dr. Wendy Tate, director of Data Analytics at Nimblify, curated and analyzed the data to identify trends and averages in timeliness of payments made to sites.

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AstraZeneca, Pieris collaborate for respiratory disease treatments

Wednesday, May 3, 2017

AstraZeneca announced a strategic collaboration in respiratory diseases with Pieris Pharmaceuticals to develop novel inhaled drugs that leverage Pieris’ Anticalin platform. Anticalin molecules are engineered proteins which can mimic antibodies by binding to sites either on other proteins or on small molecules. They are smaller than monoclonal antibodies, offering the potential of direct delivery to the lung.

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H3 Biomedicine appoints Lihua Yu chief data sciences officer

Tuesday, May 2, 2017

H3 Biomedicine, a clinical stage biopharmaceutical company specializing in the discovery and development of precision medicines for oncology and a member of Eisai’s global Oncology Business Group, announced that Lihua Yu, Ph.D., has been promoted to chief data sciences officer (CDSO). Dr. Yu previously served as H3 Biomedicine’s vice president, Data Science and Information Technology.

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