United States

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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Executives of Juno Therapeutics under investigation

Monday, August 14, 2017

Shareholder and consumer rights law firm Schubert Jonckheer & Kolbe LLP has launched an investigation into whether certain officers and directors of Juno Therapeutics breached their fiduciary duties to Juno and its shareholders by exposing Juno to civil liability for failing to disclose patient deaths in the phase II/ROCKET trial of its leading product candidate, JCAR015, during the period June 24, 2016, to November 22, 2016. 

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