2017

FDA approves Genentech’s Lucentis for myopic choroidal neovascularization

Wednesday, January 11, 2017

Genentech, a member of the Roche Group, announced that the FDA has approved Lucentis (ranibizumab injection) 0.5mg for the treatment of patients with myopic choroidal neovascularization (mCNV), a complication of severe near-sightedness that can lead to blindness. Lucentis is the first FDA-approved anti-vascular endothelial growth factor (VEGF) therapy to treat mCNV in the U.S. This is the fifth FDA-approved indication for Lucentis since the medicine was launched in 2006.

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TLC Biopharmaceuticals reports results of phase I/II tlc599 osteoarthritis trial

Wednesday, January 11, 2017

TLC has reported top-line results from the phase I/II trial of TLC599 for sustained pain management in patients with osteoarthritis of the knee. The trial demonstrated a positive safety profile for a single intra-articular injection of either a 6mg or 12mg dose of TLC599. In addition, the trial demonstrated a trend of sustained, clinically meaningful decrease from baseline through week 12 in several widely-used assessments of pain. These results support the potential for TLC599 to address the problem of a limited duration of action for steroid therapy in patients with osteoarthritis. 

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NICO enrolls first patient in phase III hemorrhagic stroke trial

Wednesday, January 11, 2017

Indianapolis Medical device maker NICO has announced the enrollment of the first patient in the ENRICH (Early MiNimally-invasive Removal of ICH) randomized clinical trial. This trial is designed to determine the procedural safety, as well as the economic and functional benefit, of early surgical removal of intracerebral hemorrhage using the BrainPath Approachä compared to the medical management standard of care. The BrainPath Approach uses a combination of technologies, including the FDA-cleared NICO BrainPath for non-disruptive access and NICO Myriad to achieve the goal of maximum clot evacuation.

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NCI’s new drug formulary will expedite agent use in clinical trials

Wednesday, January 11, 2017

The National Cancer Institute (NCI) has launched a new drug formulary that will enable investigators at NCI-designated Cancer Centers to have quicker access to approved and investigational agents for use in preclinical studies and cancer clinical trials. The NCI Formulary could ultimately translate into speeding the availability of more-effective treatment options to patients with cancer.

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LabCorp to acquire assets of Mount Sinai Clinical Outreach Laboratories

Wednesday, January 11, 2017

Laboratory Corporation of America Holdings (LabCorp), a life sciences company, and the Mount Sinai Health System, one of the largest health systems in metropolitan New York City, have entered into a definitive agreement for LabCorp to acquire assets of Mount Sinai’s Clinical Outreach Laboratories. When the transaction is complete, LabCorp will be available to provide comprehensive laboratory services to physicians and patients that currently use Mount Sinai’s outreach laboratory.

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Johnson & Johnson Innovation, New York Genome Center to launch JLABS

Wednesday, January 11, 2017

Johnson & Johnson Innovation, New York State and the New York Genome Center have announced a collaboration to launch a new JLABS in New York City. Called JLABS @ NYC, the 30,000-square foot facility will be located at the New York Genome Center (NYGC) in SoHo and will open in 2018. The project is receiving $17 million in New York State funding. The site will be open to biotech, pharmaceutical, medical device and consumer health companies. A QuickFire Challenge seeking companies working in these areas, particularly startups working on cross-sector solutions to prevent, intercept or cure diseases, will be launched by Johnson & Johnson Innovation, with the winner(s) eligible for one year of residency at JLABS @ NYC.

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University of Pittsburgh, Bayer form research alliance

Wednesday, January 11, 2017

The University of Pittsburgh and Bayer have established a master collaboration agreement to advance research for heart, lung and blood disease indications. This broad collaboration spans from early research studies, to drug development and big data analysis including real-world evidence studies. In addition to the research partnership, Bayer will be supporting an independent investigator-initiated clinical trial in sickle cell disease.

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