AstraZeneca

Fasenra receives FDA approval for severe eosinophilic asthma

Monday, November 20, 2017

AstraZeneca and its global biologics research and development arm, MedImmune, announced that the FDA has approved FASENRA (benralizumab) for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. FASENRA is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.

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Fasenra (Benralizumab) receives FDA approval for severe eosinophilic asthma

Friday, November 17, 2017

AstraZeneca and its global biologics research and development arm, MedImmune, announced that the FDA has approved FASENRA (benralizumab) for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. FASENRA is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.

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FDA approves Bydureon BCise for type 2 diabetes

Thursday, October 26, 2017

AstraZeneca announced that the FDA has approved Bydureon BCise (exenatide extended-release) injectable suspension, a new formulation of Bydureon (exenatide extended-release) injectable suspension in an improved once-weekly, single-dose autoinjector device for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines in addition to diet and exercise, to improve glycemic control.

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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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Fastest drug developers and their practices

Tuesday, August 1, 2017

Drug development is a long and costly process, and companies struggle with efforts to compress cycle times and reduce costs. A new CenterWatch analysis of new molecular entities (NMEs) approved by the FDA from 2014 through 2016 shows no signs of dramatic, industry-wide improvement. Sponsors interviewed by CenterWatch cited multiple factors that influence the speed of their development programs. In particular, the selection of investigative sites and vendors (including CROs), and the relationships forged with them, were an important focus of companies seeking to improve the speed and efficiency of clinical trials.

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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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