2017

TESARO announces EC approval of ZEJULA for recurrent ovarian cancer

Monday, November 20, 2017

TESARO, an oncology focused biopharmaceutical company, announced that the European Commission (EC) has granted marketing authorization for ZEJULA (niraparib) as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response (CR) or partial response (PR) to platinum-based chemotherapy. ZEJULA is the first once-daily, oral poly (ADP-ribose) polymerase (PARP)1/2 inhibitor to be approved in Europe that does not require BRCAmutation or other biomarker testing.

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CrownBio launches grant program to Fund Preclinical Oncology Research

Monday, November 20, 2017

Crown Bioscience, a wholly-owned subsidiary of Crown Bioscience International and a global drug discovery and development services company providing translational platforms to advance oncology, inflammation, cardiovascular and metabolic disease research, announced the launch of a grant program supporting oncology research scientists which provides funding for projects that show promise for scientific advancement of Patient Derived Xenograft (PDX) technology.

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New Oracle Cloud Infrastructure innovations

Monday, November 20, 2017

Oracle announced the general availability of a range of new Oracle Cloud Infrastructure compute options, providing customers with unparalleled compute performance based on Oracle’s recently announced X7 hardware. Newly enhanced virtual machine (VM) and bare metal compute, and new bare metal graphical processing unit (GPU) instances enable customers to run even the most infrastructure-heavy workloads such as high-performance computing (HPC), big data, and artificial intelligence (AI) faster and more cost-effectively.

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To support women entrepreneurs in biotech, MassNextGen initiative launches

Monday, November 20, 2017

Takeda Pharmaceutical Company and the Massachusetts Life Sciences Center (MLSC) have formed a $1 million initiative aimed at supporting women entrepre­neurs in early-stage biotech with an eye toward addressing gender gaps in the life sciences sector. The five-year program, called the Massachu­setts Next Generation (MassNextGen) Initiative, provides funding and customized support, including mentoring from investors and industry executives, to empower women entrepreneurs and allow them to develop the network and skills necessary to become industry leaders.

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Relationship sustainability—It’s the bigger picture

Monday, November 20, 2017

The Pulse on Study Conduct by Elizabeth Weeks-Rowe

In clinical research, we are taught to always move forward—through change to a better process, through error toward the true lesson. Our industry is constantly evolving: risk-based monitoring, ClinicalTrials.gov, social media for patient recruitment. Progress has made us so efficient with accomplishing the short-term goals (interim analysis deadlines and query resolutions) that it can take our sight off of the bigger picture tasks that, though more time-intensive, have a longer-lasting impact. Relationship development is one of these. 

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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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