Tag: FDA
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Univ. of Arizona Spin-Off Licenses Cancer Therapy
10 July 2015. A new company spun-off from University of Arizona licensed a cancer therapy based on research by a pharmacy faculty member at the school, also the company’s founder. Synactix Pharmaceuticals Inc. in Tucson is founded by pharmacology professor Hong-yu Li and postdoctoral fellow Brendan Fett. Li’s lab at Arizona studies cancer therapeutics, particularly…
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FDA Grants Orphan Status to Brain Cancer Surgery Aid
7 July 2015. The U.S. Food and Drug Administration is granting orphan drug status to an engineered peptide that illuminates brain cancer cells making them easier to surgically remove. The treatment, code-named BLZ-100, is made by Blaze Bioscience, a biotechnology company in Seattle. Blaze Bioscience is a spin-off enterprise from Fred Hutchinson Cancer Research Center,…
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Trial Shows Safety, Benefits of Diabetic Eye Disease Drug
25 June 2015. An early-stage clinical trial of a drug to treat eye disorders caused by diabetes shows the drug is well-tolerated and reduces swelling in the eye associated with the disease. Stealth BioTherapeutics, developer of the drug brand-named Ocuvia, reported the results today at a company symposium in New York City. The study is…
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Smartphone Eye Exam Company Raises $6M in Venture Funds
24 June 2015. Smart Vision Labs Inc., a two-year-old company developing vision exam technology that works on smartphones, raised $6.1 million in its first venture funding round. Financing for the New York City enterprise was led by Techstars Ventures, with contributions from Heritage Group, Connectivity Capital, and Red Sea Ventures. The company’s technology aims to…
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Trial Begins Testing Sickle Cell Blood Therapy
23 June 2015. A clinical trial began enrolling participants testing a synthesized therapy for sickle cell disease to improve the flow of blood cells blocked by the condition and relieve the intense pain that results. The late-stage trial is being conducted by drug maker Pfizer Inc., with biotechnology company GlycoMimetics Inc. in Gaithersburg, Maryland. Sickle…
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Study Urges Better Heart Implant Device Tracking
22 June 2015. Current methods of monitoring implanted heart devices, conclude researchers at University of California in San Francisco, may not be adequate for spotting the number of problems with the devices leading to patients’ deaths. The findings of the team led by UCSF cardiologist Zian Tseng were reported today in the journal JAMA Internal Medicine…
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Report Evaluates Industry-Academic Biotech Partner Roles
16 June 2015. A report released today by Biotechnology Industry Organization, or Bio, indicates academic research labs are playing an increasingly key role in research and development of new therapies, but it also highlights areas where partnerships between academia and industry are still evolving. Bio released the report, Advancing Translational Research for Biomedical Innovation: Measuring…
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FDA Approves Pediatric HIV Drug Formulation
5 June 2015. The U.S. Food and Drug Administration approved an application for a current HIV drug formulated to better treat infections in infants and young children, especially in limited resource regions. The formulation is a combination of lopinavir and ritonavir in pellet form designed to mix with food, and manufactured by the generic drug…
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Antibody Improves Lung Cancer Survival Time in Trial
1 June 2015. A late-stage clinical trial shows an engineered antibody that harnesses the immune system increases the survival time of people with a common form of lung cancer compared to standard chemotherapy. The study of the drug nivolumab, marketed as Opdivo by Bristol-Myers Squibb, was reported yesterday at the annual meeting of American Society…
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Orphan Status Granted Eye Cancer Treatment
21 May 2015. Food and Drug Administration designated an experimental treatment for uveal melanoma, a rare and aggressive form of cancer in the eye, as an orphan drug that qualifies for incentives to expedite its development. Aura Biosciences also revealed results of preclinical tests showing the ability of its lead biologic therapy code-named AU-011 to…