United States

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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CHOP, Seven Bridges form Cavatica for pediatric cancer genomics data

Friday, February 26, 2016

The Children’s Hospital of Philadelphia (CHOP), the lead operations center for the Childhood Brain Tumor Tissue Consortium (CBTTC), and Seven Bridges, a biomedical data analysis company, have announced the joint development of Cavatica, a new cloud-based environment for securely storing, sharing and analyzing large volumes of pediatric cancer patient genomics data. Cavatica will support CHOP’s commitment to the White House Precision Medicine Initiative (PMI) through the newly launched Center for Data Driven Discovery in Biomedicine (D3b), located at CHOP. 

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FDA seeks $5.1B for FY 2017

Wednesday, February 10, 2016

The FDA is requesting a total budget of $5.1 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2017 budget—an 8% increase over the enacted budget for FY 2016. The overall request includes a net increase of $14.6 million in budget authority and $268.7 million in user fees for initiatives tied to several key areas, including the implementation of the FDA Food Safety Modernization Act (FMSA) and efforts to improve medical product safety and quality. The agency is also seeking $75 million in new mandatory funding to support the National Cancer Moonshot initiative being led by the vice president.

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Epizyme’s Tazemetostat granted FDA Orphan designation for malignant rhabdoid tumors

Tuesday, February 9, 2016

The FDA has granted Orphan Drug status to Epizyme’s first-in-class EZH2 inhibitor, tazemetostat, for the treatment of malignant rhabdoid tumors (MRTs). In December 2015, the company initiated a phase II study in adults and a phase I study in children with genetically defined tumors, including MRTs. Tazemetostat is also being investigated in an ongoing five-arm phase II study in patients with non-Hodgkin lymphoma.

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Bipartisan legislation introduced to combat Zika virus

Friday, February 5, 2016

U.S. Representatives G. K. Butterfield (NC-01) and Susan Brooks (IN-05) have introduced H.R. 4400, a bipartisan bill that seeks to add the Zika virus to the list of diseases included in the Tropical Disease Priority Review Voucher Program at the FDA. The Zika virus, which is transmitted to humans by mosquitoes, can infect pregnant women and result in birth defects, including microcephaly and neurological disorders in newborns. The virus also causes skin rashes, conjunctivitis, muscle and joint pain, and headaches in adults. The World Health Organization has labeled Zika a global public health emergency.

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