United States

FDA selects Box for cloud content management

Wednesday, October 18, 2017

Box announced that the FDA has selected Box’s cloud content management platform to modernize its technical infrastructure and drive new ways to work in the cloud. With Box, the FDA is furthering its IT innovation strategy to digitize business processes and envision new ways to engage with the pharmaceutical and life sciences industry.

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U.S. District Court issues Restasis patents trial decision

Wednesday, October 18, 2017

Allergan, a global biopharmaceutical company, acknowledged that the U.S. District Court for the Eastern District of Texas has issued an adverse trial decision finding that the four asserted patents covering Restasis (Cyclosporine Ophthalmic Emulsion) 0.05% are invalid. The company will appeal the Court’s ruling.

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NIH partners with 11 biopharmaceutical companies on cancer immunotherapy strategies

Friday, October 13, 2017

The NIH and 11 biopharmaceutical companies launched the Partnership for Accelerating Cancer Therapies (PACT), a five-year public-private research collaboration totaling $215 million as part of the Cancer Moonshot. PACT will initially focus on efforts to identify, develop and validate robust biomarkers—standardized biological markers of disease and treatment response—to advance new immunotherapy treatments that harness the immune system to attack cancer. The partnership will be managed by the Foundation for the National Institutes of Health (FNIH), with the Food and Drug Administration serving in an advisory role. 

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Eli Lilly’s Verzenio grabs Priority Review for advanced breast cancer

Friday, October 13, 2017

Eli Lilly announced that the FDA has granted Priority Review designation for its New Drug Application (NDA) for Verzenio (abemaciclib), a cyclin-dependent kinase (CDK)4 & 6 inhibitor. The NDA was based upon the positive interim results from MONARCH 3, a study of abemaciclib in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

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Bioasis establishes U.S. presence with office in Connecticut

Wednesday, October 11, 2017

Bioasis Technologies, a biopharmaceutical company focused on the delivery of therapeutics across the blood-brain barrier (BBB) and into the central nervous system for the treatment of neurological diseases and disorders, announced the establishment of its U.S. office in Guilford, Conn. Additionally, the company has launched its new corporate website, bioasis.us.

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Children’s Hospital Los Angeles to study “Bubble Boy” syndrome

Tuesday, October 10, 2017

Michael Pulsipher, M.D., of the Children’s Center for Cancer and Blood Diseases at Children’s Hospital Los Angeles, along with co-principal investigator, Sung-Yun Pai, M.D., of Boston Children’s Hospital, has been awarded nearly $9 million from the National Institute of Allergy and Infectious Diseases of the NIH to study a new treatment approach for babies born with severe combined immunodeficiency (SCID), which prevents the immune system from functioning normally. In a multi-site study, investigators plan to determine the lowest dose of chemotherapy needed for babies with SCID undergoing bone marrow transplant—the standard treatment for SCID. The goal is to restore the immune system safely and effectively with less toxicity than the higher dose regimens currently in use.

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