United States

FDA accepts Mylan, BioCon’s biosimilar trastuzumab BLA

Thursday, January 12, 2017

Mylan and Biocon has announced that the FDA accepted Mylan’s biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, for filing through the 351(k) pathway. This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast cancers. The anticipated FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Sept. 3, 2017.

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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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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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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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ACRES, Task Force Dagger Foundation partner

Monday, January 9, 2017

Task Force Dagger Foundation (TFD) Managing Director Keith David and the Alliance for Clinical Research Excellence and Safety (ACRES) President and CEO Greg Koski announced that their nonprofit charitable organizations have established a strategic alliance to address the grave health challenges impacting America’s elite special operations forces and their families through application of ACRES systems-based approaches to accelerate research and advance integrated care.   

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Viriom, NIH partner on Zika and other major viral diseases

Monday, January 9, 2017

Viriom has entered into a collaboration with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to identify new drug candidates for treatment of the Zika and other important virus infections. Under the collaboration agreement, Viriom and Dr. Leo Margolis of NICHD will study and improve the antiviral properties of Viriom’s lead compounds against the Zika virus, HBV, HCV, HIV, RSV and other clinically relevant viruses.

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Three Questions: Mary Schmoll, American Health Network of Indiana

Monday, January 9, 2017

CWWeekly presents this feature as a spotlight on issues faced by executives in clinical research. This week, writer Karyn Korieth spoke with Mary Schmoll, director of clinical research at the American Health Network of Indiana (AHNI), which offers clinical research at seven investigative sites in Indiana. AHNI’s Research Department won the Society for Clinical Research Sites’ 2016 Site Patient Recruitment Innovation Award (SPRIA), which recognizes research sites that have developed and implemented innovative patient recruitment programs.

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Early-phase trial demonstrates shrinkage in pediatric neural tumors

Tuesday, January 3, 2017

In an early-phase clinical trial of a new oral drug, selumetinib, children with the common genetic disorder neurofibromatosis type 1 (NF1) and plexiform neurofibromas, tumors of the peripheral nerves, tolerated selumetinib and, in most cases, responded to it with tumor shrinkage. NF1 affects 1 in 3,000 people. The study results appeared Dec. 29, 2016, in the New England Journal of Medicine.

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