Success or withdrawal hang in balance for Shire blood pressure drug

Shire (NASDAQ:SHPGY) has reached an agreement with U.S. regulators in the long-running saga over its low blood pressure drug, ProAmatine, that rests on the drug generating positive results in two clinical trials, or else face a withdrawal of its new drug application.The compromise was agreed to with the U.S. Food and Drug Administration’s Center for [...]

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Cancer vaccine developer appoints life sciences entrepreneur

A cancer vaccine developer has appointed a life sciences entrepreneur as chairman.Dr. Wolfgang Oster is a managing partner for the life sciences fund at PolyTechnos, which focuses on investment in early stage, technology-oriented companies. Although the venture capital firm’s focus has been primarily on German companies, it has invested in several U.S.-based life sciences businesses. [...]

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Philadelphia incubator gains international designation

A Philadelphia incubator and the country’s oldest urban research park has received the National Business Incubation Association’s Soft Landings International Incubator designation.The University City Science Center of Philadelphia earned the accreditation for its incubator’s focus on welcoming nondomestic firms into its domestic market with translation services, helping them to cut through governmental red tape, providing [...]

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Shire drug to manage ADHD symptoms in adults gets FDA approval

Shire (NASDAQ: SHPGY) has secured approval from U.S. regulators for a drug to manage symptoms of Attention Deficit and Hyperactivity Disorder in adults.Vyvanse has been approved as a maintenance treatment for ADHD. This new approval adds to the indication for Vyvanse as a treatment for ADHD in patients 6 years old and older, according to [...]

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Philadelphia translational medicine director plucked by rival hospital

Having several medical schools and hospitals in one region can lead to some keen competition, particularly when it comes to retaining staff. In the latest reflection of that competition and of the growing trend of translational medicine, Temple University Hospital in Philadelphia has poached the director of the Philadelphia-based Jefferson University Hospitals’ Center for Translational [...]

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Auxilium Pharmaceuticals shakes up management team

Auxilium Pharmaceuticals (NASDAQ: AUXL), a specialty pharmaceuticals company, has added two senior executives at the company and announced the departures of three in the latest management shakeup at the company.Andrew I. Koven has been named executive vice president, chief administrative officer and general counsel. Mark A. Glickman has been named senior vice president, sales, according [...]

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Human monoclonal antibody firm collaborating with Big Pharma

Immunome, which has developed a way to clone monoclonal human antibodies that can be used to help develop more effective cancer drugs and with potential applications for rare diseases, has signed its first research and development partnership with a Big Pharma company.The Wynnewood, Pennsylvania company’s approach differs from its competitors, says Timothy Pelura, the CEO. [...]

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Pennsylvania human antibody cloning company raising $1.5 million

 A Pennsylvania biotechnology company is raising $1.5 million to advance its human antibody cloning technology that it believes has broad applications for the treatment of unmet medical needs such as Alzheimer’s disease, cancer, infectious diseases and bioterror attacks.In its latest financing round, begun Jan. 4, Immunome has raised $145,000.AdvertisementDr. Scott K. Dessain, the founder and [...]

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FDA-approved device to detect macular degeneration raising $2 million

A company with a medical device to detect early onset of age-related macular degeneration, the leading cause of blindness in adults ages 50 or older, is raising $2 million in a series A preferred financing round to commercialize its diagnostic tool, which was approved by the U.S. Food and Drug Administration last year.Apeliotus Vision Science [...]

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Bladder cancer detection test firm to open U.S. office at Hershey incubator

A New Zealand bladder cancer detection firm is opening its U.S. office at the biotechnology incubator Hershey Center for Applied Research, in a move that will add 100 jobs over three years.Pacific Edge Diagnostics will market its bladder cancer detection test, Cx Bladder, to urologists at the end of the year, according to a statement [...]

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