Good laboratory practice

A Practical Roadmap for IND-Enabling Safety and Toxicology Studies, Upcoming Webinar Hosted by Xtalks

Thursday, October 14, 2021 - 1:30pm

Preclinical toxicology studies should reliably assess the safety of new drug entities, thus building a multi-faceted understanding of compounds to lay the groundwork for clinical trials and regulatory approval.

Key Points: 
  • Preclinical toxicology studies should reliably assess the safety of new drug entities, thus building a multi-faceted understanding of compounds to lay the groundwork for clinical trials and regulatory approval.
  • In this webinar, our featured speaker will present a roadmap that seamlessly integrates the various preclinical studies, thus accelerating the initiation of clinical trials.
  • Register for this webinar to learn about the best way to plan for investigational new drug (IND)-enabling preclinical toxicology studies.
  • For more information, or to register for this event, visit A Practical Roadmap for IND-Enabling Safety and Toxicology Studies.

PharmaCyte Biotech Announces Encapsulation Material Does Not Alter Cellular DNA

Monday, September 27, 2021 - 2:00pm

The tests results showed that the empty capsule material is not mutagenic.

Key Points: 
  • The tests results showed that the empty capsule material is not mutagenic.
  • A mutagen is a physical or chemical agent that permanently changes genetic material, usually DNA, in an organism and thus increases the frequency of mutations above the natural background level.
  • In line with data generated previously, we are confident that the encapsulation material used for CypCaps is biocompatible, safe and not toxic.
  • PharmaCyte Biotech, Inc. is a biotechnology company developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as Cell-in-a-Box.

Small Pharma Successfully Completes Phase I Clinical Trial of DMT in Combination with Supportive Psychotherapy

Tuesday, September 21, 2021 - 12:50pm

LONDON, Sept. 21, 2021 (GLOBE NEWSWIRE) -- Small Pharma Inc. (TSXV: DMT) (the “Company” or “Small Pharma”), a neuropharmaceutical company focused on psychedelic-assisted therapies, today announced both the successful completion of the Phase I part of the combined Phase I/IIa clinical trial and the initiation of the Phase IIa part in combination with psychotherapy of its lead candidate, SPL026, for the treatment of Major Depressive Disorder (“MDD”).

Key Points: 
  • Peter Rands, CEO of Small Pharma, said: We are delighted to have made such swift and excellent progress in the seven months since starting Phase I.
  • Dr. Carol Routledge, Chief Medical and Scientific Officer of Small Pharma added: We have achieved a significant milestone in the development of SPL026.
  • With a strong safety and tolerability profile, now demonstrated, we can move ahead with the first regulated clinical trial of DMT-assisted therapy in patients.
  • Small Pharma is advancing a pipeline of DMT-based therapies and is leading the worlds first DMT clinical trial for depression, in collaboration with Imperial College London.

Metrion Biosciences Expands Into New Headquarters to Support Continued Growth

Wednesday, September 22, 2021 - 11:06am

Metrion Biosciences Limited (Metrion), the specialist ion channel contract research and drug discovery company, today announced that the Company has moved to larger, custom designed laboratory and office premises at Granta Park, Cambridge, UK.

Key Points: 
  • Metrion Biosciences Limited (Metrion), the specialist ion channel contract research and drug discovery company, today announced that the Company has moved to larger, custom designed laboratory and office premises at Granta Park, Cambridge, UK.
  • The new headquarters will allow the Company to significantly expand its range of services and cell lines.
  • Metrion has increased its headcount by 50% over the past three years and is actively recruiting.
  • Our new headquarters has been specifically designed to support Metrions ambitious business plan for global growth, with a particular focus on the USA in 2022.

PharmaCyte Biotech Releases More Positive Results From FDA-Required Biocompatibility Tests

Tuesday, September 21, 2021 - 2:00pm

The Chief Executive Officer of PharmaCyte Biotech, Kenneth L. Waggoner, said of the positive results, Were pleased to report that we have received positive results from the second of the biocompatibility tests performed under Good Laboratory Practices and required by the FDA in connection with PharmaCytes clinical hold.

Key Points: 
  • The Chief Executive Officer of PharmaCyte Biotech, Kenneth L. Waggoner, said of the positive results, Were pleased to report that we have received positive results from the second of the biocompatibility tests performed under Good Laboratory Practices and required by the FDA in connection with PharmaCytes clinical hold.
  • The data shows that, as expected, the capsule material does not cause blood cells to lyse either after direct or indirect contact with blood.
  • Moreover, it confirms prior data that was observed previously in animal models and previous clinical trials.
  • More information about PharmaCyte Biotech can be found at www.PharmaCyte.com .

Predictive Health Diagnostics Company Announces Rollout of Proprietary LIS Cloud-Based Laboratory Information System Software

Wednesday, September 15, 2021 - 6:00pm

Planned future enhancements to the PHDC laboratory information system include an integrated patient and physician portal, a reporting template builder, and inventory tracking for reagents.

Key Points: 
  • Planned future enhancements to the PHDC laboratory information system include an integrated patient and physician portal, a reporting template builder, and inventory tracking for reagents.
  • Predictive Health Diagnostics Company (PHDC) is a leading specialty diagnostics development platform company that develops, manufactures,and distributesunique medical tests combining science, technology, and proprietary analytics that detect diseases with significant unmet medical needs and support better therapeutic outcomes.
  • PHDC's laboratory information systems use data from multiple sources including proteomics, genetics, metabolics, biochemistry, phenotype, and imaging to address among the most challenging clinical problems.
  • Morningstar Laboratories, a PHDC company, is a Clinical Laboratory Improvement Amendments (CLIA)-certified and College of American Pathologists (CAP)-accredited laboratory offering comprehensive and customized services based on Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) regulations and ISO 15189 standards.

Taysha Gene Therapies Announces Publication of Positive Preclinical Data for TSHA-104 Demonstrating Therapeutic Potential in SURF1-associated Leigh Syndrome in Journal Molecular Therapy: Methods & Clinical Development

Wednesday, September 15, 2021 - 12:00pm

There are currently no approved therapies to treat SURF1-associated Leigh syndrome.

Key Points: 
  • There are currently no approved therapies to treat SURF1-associated Leigh syndrome.
  • SURF1 is part of cytochrome c oxidase, a mitochondrial enzyme known as COX involved in the metabolic production of ATP.
  • Children with SURF1 deficiency have severely impaired COX activity and cannot generate ATP by aerobic respiration appropriately.
  • TSHA-104 is an AAV9-based gene replacement therapy encoding the human SURF1 protein that is administered intrathecally for the treatment of SURF1-associated Leigh syndrome.

ProMIS Neurosciences Inc. Announces US$15 Million Offering of Units

Tuesday, August 17, 2021 - 9:40pm

TORONTO, Aug. 17, 2021 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (“ProMIS” or the “Company”) (TSX: PMN), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, has filed today a preliminary prospectus supplement (the “Supplement”) to its final short form base shelf prospectus dated June 30, 2021 (the “Base Prospectus”) in connection with a proposed commercially reasonable efforts public offering of units (the “Units”) for gross proceeds to the Company of up to US$15,000,000, exclusive of the Agent’s Option (as defined herein) (the “Offering”). 

Key Points: 
  • The Units offered under the Offering will be priced in the context of the market and pricing will be reflected in a final prospectus supplement.
  • The Supplement was filed with the securities regulatory authorities in each of the province and territories of Canada (other than Qubec).
  • Additionally, the Offering is expected to be conducted by way of private placement other jurisdictions where the Offering can lawfully be made.
  • ProMIS common shares are listed and posted for trading on the Toronto Stock Exchange under the symbol PMN.

Titan Medical Reports Second Quarter 2021 Financial Results

Wednesday, August 11, 2021 - 12:30pm

Titan Medical Inc. (Nasdaq: TMDI; TSX: TMD), a medical device company focused on the development and commercialization of its innovative surgical technologies for robotic single access surgery, today announced financial results for the three and six months ended June 30, 2021.

Key Points: 
  • Titan Medical Inc. (Nasdaq: TMDI; TSX: TMD), a medical device company focused on the development and commercialization of its innovative surgical technologies for robotic single access surgery, today announced financial results for the three and six months ended June 30, 2021.
  • Stephen Lemieux joined Titan as Chief Financial Officer with experience leading successful company financings, licensing and M&A transactions valued at over $400 million.
  • Research and development (R&D) expenses increased to $7.1 million in the quarter compared to $0.1 million in the second quarter of 2020.
  • ET today (August 11, 2021) to discuss the companys financial results for the second quarter ended June 30, 2021, and recent business highlights.

Skye Bioscience Completes THCVHS IND-enabling In Vitro Genotoxicity Studies

Tuesday, August 10, 2021 - 1:30pm

SAN DIEGO, CA, Aug. 10, 2021 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (OTCQB: SKYE) (“Skye”), a biopharmaceutical company developing proprietary, synthetic cannabinoid-derived molecules to treat diseases with significant unmet need, has successfully completed genotoxicity studies of THCVHS required prior to beginning its planned Phase 1 clinical study in Australia. Skye is initially developing THCVHS as a treatment of glaucoma.

Key Points: 
  • SAN DIEGO, CA, Aug. 10, 2021 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (OTCQB: SKYE) (Skye), a biopharmaceutical company developing proprietary, synthetic cannabinoid-derived molecules to treat diseases with significant unmet need, has successfully completed genotoxicity studies of THCVHS required prior to beginning its planned Phase 1 clinical study in Australia.
  • Although the safety profile for the active pharmaceutical ingredient, THC, is well-recognized, this was the first time these studies were performed with our proprietary molecule THCVHS, a prodrug of THC, said Punit Dhillon, CEO of Skye Bioscience.
  • Two studies were carried out to assess the genotoxicity potential of THCVHS.
  • Except as expressly required by law, Skye disclaims any intent or obligation to update these forward-looking statements.