Posts Tagged: Food and Drug Administration (FDA)
BioTuesdays features Xagenic and company’s molecular diagnostic beta trials
"Closely-held Xagenic plans to conduct beta studies this year, in advance of a major chlamydia and gonorrhea clinical trial, with its rapid X1 molecular diagnostic testing system in preparation for market launches in Europe and the U.S.," Leonard Zahr wrote in a feature article on Xagenic's product development progress for BioTuesdays on April 19, 2016.
Xagenic was founded by University of Toronto Professor Shana Kelley in partnership with MaRS Innovation and U of T's Innovations & Partnerships Office in 2010. The company ...
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Triphase secures FDA orphan drug designation for Marizomib in Malignant Glioma
TORONTO and SAN DIEGO (November 19, 2015) -- Triphase Accelerator Corporation, a private drug development company dedicated to advancing novel compounds through Phase 2 proof-of-concept, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for marizomib to treat patients with malignant glioma.
Malignant glioma is an aggressive form of brain cancer for which there is a significant unmet need in current treatments due to the disease's poor prognosis. Triphase is evaluating marizomib, a novel and highly ...
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Triphase announces proteasome inhibitor marizomib demonstrates potent synergistic anti-multiple myeloma activity in combination with pomalidomide
Findings from Preclinical Study Presented at American Society of Hematology 2014 Annual Meeting
TORONTO AND SAN DIEGO (Dec. 6, 2014) -- Triphase Accelerator Corporation, a private drug development company dedicated to advancing novel compounds through Phase II proof-of-concept clinical studies, today announced preclinical study results demonstrating that the combination of its highly differentiated proteasome inhibitor, marizomib, and pomalidomide (Pomalyst®) was synergistic in killing multiple myeloma cells.
MaRS Innovation is an early-stage investor in Triphase. See our web archive for more details.
Combined doses of ...
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Triphase announces Celgene collaborations and license deal with PharmAbcine
Triphase Accelerator Corporation, a private, drug development company dedicated to advancing novel compounds through Phase II proof-of-concept, announced October 27, 2014 new and expanded strategic collaborations with Celgene Corporation.
This announcement was covered in Genetic Engineering and Biotechnology News (GEN), BioCentury Extra (no link available), Pharmaceutical Business Review (no link available), Scrip and BioWorld Today (no link available). It builds on Triphase's original collaborative agreement with Celgene in January 2014.
The company has also announced a new global license for a fully human, bi-specific ...
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MaRS Innovation’s 2013 Top 10 List
2013 was an exceptional year for MaRS Innovation. Here are the top 10 news stories from our commercialization portfolio.
1. MaRS Innovation secures a $15 million CECR funding extension
In January, MaRS Innovation was one of four Centres of Excellence for Commercialization and Research to be successfully extended by the Networks of Centres of Excellence of Canada.
This achievement reflects and recognizes the quality of the startups and licensable technologies within the MaRS Innovation portfolio, as well as the rigour of its business model and the achievements of its ...
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Bedside Paediatric Early Warning System (BedsidePEWS™) Earns FDA 510(k) Approval
Bedside Clinical Systems to bring paediatric care solution to U.S. hospitals
TORONTO, Canada (October 24, 2013) — Bedside Clinical Systems (BCS)’s flagship solution, Bedside Paediatric Early Warning System (BedsidePEWSTM), has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). For the complete BedsidePEWS™ FDA Medical Device listing (K124038), click here.
This story was covered in Biotechnology Focus.
BedsidePEWSTM tracks a patient’s vital signs, such as heart rate and blood pressure, as part of routine clinical assessments and outputs a single score to ...
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Stem Cell Therapeutics licenses UHN’s Clinical Cancer Stem Cell Program
Stem Cell Therapeutics Corp. (TSX-V: SSS), a biopharmaceutical company developing cancer stem cell-related technologies, has signed a definitive license agreement with University Health Network (UHN), Toronto, Canada.
The agreement, developed in collaboration with MaRS Innovation, provides Stem Cell Therapeutics (SCT) with exclusive worldwide rights to an innovative clinical cancer stem cell program.
This announcement builds upon the existing stem cell program agreement between MI, Stem Cell Therapeutics and UHN, which was announced in November 2012.
The initial consideration of $1.6 million for the UHN ...
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Bedside Clinical Systems featured in Philadelphia’s MedCity News
Bedside Clinical Systems (BCS) participated in Philadelphia's 2012 Canada-U.S. eHealth Summit on November 28.
Twelve of the 65 participating companies were selected to pitch a group of over 100 chief medical information officers, chief information officers and chief medical officers from U.S. hospitals, along with venture capitalists and industry representatives.
BCS's CEO Rajesh Sharma delivered a strong pitch and was interviewed for a story in MedCity News. (more…)
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