United States

FDA approves Ironwood’s duzallo for gout

Thursday, August 24, 2017

Ironwood Pharmaceuticals announced DUZALLO was approved by the FDA as a once-daily oral treatment for hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with a medically appropriate daily dose of allopurinol alone. DUZALLO is not recommended for the treatment of asymptomatic hyperuricemia. Ironwood expects DUZALLO to be commercially available early in the fourth quarter of 2017.

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CRISPR, Massachusetts General Hospital partner on CRISPR/Cas9 in T cell cancer therapies

Thursday, August 24, 2017

CRISPR Therapeutics, a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, and Massachusetts General Hospital Cancer Center (MGHCC), a scientific and clinical institution, have entered into a two-year research collaboration and license option agreement to develop novel T cell therapies for cancer. As part of the collaboration, CRISPR/Cas9 gene editing will be utilized to improve upon current T cell therapies in development, ultimately addressing unmet needs in both hematologic and solid tumors. Marcela V. Maus, M.D., Ph.D., director of the Cellular Immunotherapy Program at MGHCC and Assistant Professor of Medicine at Harvard Medical, will lead the scientific work at MGH.

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Alkermes initiates ALKS 5461 NDA for major depressive disorder

Tuesday, August 22, 2017

Alkermes announced the initiation of its rolling submission of a New Drug Application (NDA) to the FDA, seeking marketing approval of ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action, for the adjunctive treatment of major depressive disorder (MDD). The company expects to complete the submission of the NDA for this Fast Track designated medicine by year-end 2017.

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LifeNet Health to create 321 new jobs in Virginia

Friday, August 18, 2017

LifeNet Health, a global regenerative medicine company, has announced that it will invest $12.25 million to expand its global headquarters operation in the City of Virginia Beach. The non-profit will add a 100,000-square-foot warehouse, 20,000 square feet of office space, and an 18,000-square-foot R&D and production facility across three campuses. Virginia successfully competed against Florida, North Carolina, and Washington for the project, which will create 321 new jobs.

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Affinity Bio Partners launches Pennsylvania cannabis biotech company

Tuesday, August 15, 2017

Affinity Bio Partners CEO Christina DiArcangelo Puller announced that she is adding another organization to the Affinity family of organizations by launching Affinity BioCeuticals, a “first of its kind” Cannabis Biotech Pennsylvania corporation. Affinity BioCeuticals is a Neutraceutical company focused on research and development of cannabinoid based therapies. The emergence of more and more indications where cannabinoid based treatment may be impactful to patient’s lives will be the primary focus for Affinity BioCeuticals. 

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Pfizer expands in North Carolina

Tuesday, August 15, 2017

Pfizer, a biopharmaceutical company, has selected Lee County for a new expansion of its manufacturing facilities as the company prepares to produce new gene therapy medicines. Governor Roy Cooper announced the company plans to invest $100 million in its Sanford facilities, creating 40 jobs and building upon a technology first developed at the University of North Carolina at Chapel Hill.

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