United States

Almac opens companion diagnostic laboratory in North Carolina

Thursday, March 10, 2016

Almac Group’s Diagnostics Business Unit has opened a new companion diagnostic development facility located in the Research Triangle Park region of North Carolina. The North Carolina facility will provide a U.S. base to support Almac’s increased demand for its CDx development partnerships as well as a CLIA-accredited laboratory to support the downstream delivery of assays for patient testing.

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Bristol-Myers Squibb, LabCentral partner for startups in Massachusetts

Tuesday, March 8, 2016

Bristol-Myers Squibb and LabCentral, an innovative, shared laboratory space designed as a launch pad for life-sciences and biotech startups, have announced an agreement in which Bristol-Myers Squibb has become a LabCentral platinum sponsor. Bristol-Myers Squibb can nominate up to two innovative life sciences and biotech startup companies per year to take up residence in LabCentral’s Kendall Square facilities. The 2016 nomination process for Bristol-Myers Squibb-sponsored Golden Tickets will launch by the end of the first quarter.

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J&J Innovation launches JLABS @ TMC to catalyze early-stage research

Thursday, March 3, 2016

Johnson & Johnson Innovation has opened JLABS @ TMC, a new 34,000-square-foot life sciences incubator providing entrepreneurs shared lab space, private offices and modular laboratory suites, as well as state-of-the-art equipment and value-added operational, education and business services. The new JLABS facility can accommodate up to 50 startups, and will open with 21 companies that represent a range of disciplines and geographies. This first “class” of resident startups includes the four winners of the JLABS Quick Fire Challenge, which awards promising early-stage innovation companies with residency at the facility.

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FDA files Genentech’s sBLA of Xolair for pediatric allergic asthma

Wednesday, March 2, 2016

Genentech, a member of the Roche Group, has announced the FDA accepted for review the company’s supplemental Biologics License Application (sBLA) to extend the indication of Xolair (omalizumab) in allergic asthma to pediatric patients. The FDA will review Xolair in children from six through 11 years for the treatment of moderate to severe persistent asthma in those patients with a positive skin test or in vitro reactivity to a perennial aeroallergen (airborne allergen) and symptoms that are inadequately controlled with inhaled corticosteroids. Genentech anticipates hearing from the FDA later this year.

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PhRMA sues to block Ohio drug pricing initiative from Nov. 2016 ballot

Tuesday, March 1, 2016

Backers of an Ohio ballot initiative addressing inflated drug prices have criticized the Pharmaceutical Researchers and Manufacturers of America (PhRMA), a drug industry trade group, for filing a lawsuit to block the ballot initiative from even appearing on the November 2016 ballot. The lawsuit was filed in the Supreme Court of Ohio (Case # 2016-313) challenging The Ohio Drug Price Relief Act, a citizen-driven ballot initiative that will revise Ohio law to require state programs pay no more than the U.S. Department of Veterans Affairs for prescription medications. V.A. pricing is generally believed to be 20% to 24% lower than for almost any other government program.

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