United States

Personalized medicine development tied to showing value of companion diagnostics

Monday, August 24, 2015

With interest in personalized medicines growing, drug and diagnostics companies are investing in the development of companion diagnostics that can show that their use in conjunction with personalized therapeutics will lead to positive health outcomes, according to R&D leaders participating in a roundtable recently hosted by the Tufts Center for the Study of Drug Development (CSDD).

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DrugDev hiring in Massachusetts

Monday, August 24, 2015

DrugDev, a health technology company, is putting out a call to SaaS developers in the Boston area to join the team behind a cloud-based software platform that enables clinical trial sponsors, CROs and sites to do more clinical trials together.

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Sprout receives FDA approval of Addyi for women’s sexual dysfunction

Thursday, August 20, 2015

The FDA has granted approval of Sprout Pharmaceuticals’ Addyi (flibanserin 100mg), a once-daily, non-hormonal pill for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Addyi is the first and only FDA-approved treatment for this condition, the most common form of female sexual dysfunction, affecting up to one in 10 women in the U.S.

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Remedy initiates phase IIa study of CIRARA

Wednesday, August 19, 2015

Remedy Pharmaceuticals, a company focused on the development and commercialization of CIRARA, a breakthrough drug for treating acute central nervous system conditions, has initiated a prospective, multicenter, open-label pilot study of CIRARA in patients with acute traumatic cervical spinal cord injuries.

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Pfenex wins $143.5M anthrax vaccine contract

Wednesday, August 19, 2015

Pfenex, a San Diego-based clinical-stage biologics company, has signed a five-year, cost plus fixed-fee contract valued at up to $143.5 million with the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS), for the advanced development of Px563L, a mutant recombinant protective antigen anthrax vaccine.

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BMC selects PFS Clinical for trial coverage analysis

Wednesday, August 19, 2015

PFS Clinical, a Middleton, Wis.-based provider of turnkey administration solutions that address the key pain points of establishing and running a clinical trial office, has been engaged by the Boston Medical Center (BMC) Clinical Trial Office to provide Medicare Coverage Analysis (CA) of its research trials. PFS Clinical also is helping streamline the transfer of trial information into BMC’s recently deployed clinical trial management system (CTMS) and will provide employee training through its CA workshops.

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