GLP

424 Capital Announces Investment in VaLogic

Retrieved on: 
Wednesday, November 29, 2023

WAKEFIELD, Mass., Nov. 29, 2023 /PRNewswire/ -- 424 Capital announced today that it has completed a significant investment in VaLogic, a leading provider of GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) compliance software and services based in Frederick, MD.

Key Points: 
  • WAKEFIELD, Mass., Nov. 29, 2023 /PRNewswire/ -- 424 Capital announced today that it has completed a significant investment in VaLogic, a leading provider of GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) compliance software and services based in Frederick, MD.
  • The partnership with 424 Capital is an important milestone in VaLogic's business growth and expansion plans.
  • "424 Capital seeks to invest in important mission-driven companies, and VaLogic provides vital technology and services to clients in the life science and biotechnology sectors.
  • The partnership between VaLogic and 424 Capital is expected to have a significant impact on early-stage life science and biotechnology companies, expediting research, product development, and production.

Rani Therapeutics Reports Third Quarter 2023 Financial Results; Provides Corporate Update

Retrieved on: 
Wednesday, November 8, 2023

In October 2023, Rani announced preclinical data from a 60-day, repeat oral-administration GLP safety study of the RaniPill capsule in healthy animals.

Key Points: 
  • In October 2023, Rani announced preclinical data from a 60-day, repeat oral-administration GLP safety study of the RaniPill capsule in healthy animals.
  • Presented an Abstract on RT-102 at the 2023 Annual Meeting of the American Society for Bone and Mineral Research.
  • Rani has completed two preclinical studies of the RaniPill HC with antibodies, adalimumab and an undisclosed interleukin (“Interleukin”).
  • Initiation of Phase 2 clinical trial of RT-102, a RaniPill GO containing teriparatide for osteoporosis, expected by year-end 2023.

Silo Pharma to Initiate Dose-Ranging Study of Novel Intranasal Therapeutic SPC-15 for the Treatment of PTSD

Retrieved on: 
Wednesday, November 8, 2023

ENGLEWOOD CLIFFS, NJ, Nov. 08, 2023 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“the Company”), a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, today announced plans to initiate a dose-ranging study of its targeted prophylactic treatment SPC-15 for the treatment of post-traumatic stress disorder (PTSD).

Key Points: 
  • ENGLEWOOD CLIFFS, NJ, Nov. 08, 2023 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“the Company”), a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, today announced plans to initiate a dose-ranging study of its targeted prophylactic treatment SPC-15 for the treatment of post-traumatic stress disorder (PTSD).
  • The study will identify the maximum tolerated intranasal dose of the drug and pharmacokinetic in small animals to determine the therapeutically relevant dose range.
  • In collaboration with AmplifyBio, Silo Pharma’s contract research organization (CRO) partner, the six- to eight-week non-good laboratory practice (GLP) study will include single ascending dose evaluation (phase 1) and a 7-day repeat intranasal dose toxicity and pharmacokinetic study.
  • “Determining the dose range that should be studied is an important step before taking a new drug candidate into a first-in-human trial,” said Eric Weisblum, Chief Executive Officer of Silo Pharma.

Voyager Therapeutics Reports Third Quarter 2023 Financial and Operating Results

Retrieved on: 
Monday, November 6, 2023

LEXINGTON, Mass., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to breaking through barriers in gene therapy and neurology, today reported third quarter 2023 financial and operating results.

Key Points: 
  • ET today -
    LEXINGTON, Mass., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to breaking through barriers in gene therapy and neurology, today reported third quarter 2023 financial and operating results.
  • SOD1 gene therapy program for amyotrophic lateral sclerosis (ALS): Voyager expects to identify a lead development candidate in 2023 to support an IND in mid-2025.
  • Collaboration Revenues: Voyager had collaboration revenue of $4.6 million for the third quarter of 2023, compared to $41.1 million for the same period in 2022.
  • ET to discuss the third quarter 2023 financial and operating results.

The RaniPill® Capsule, Rani Therapeutics’ Oral Delivery Platform, was Well-Tolerated in 60-Day, Repeat-Administration, GLP Safety Study

Retrieved on: 
Wednesday, October 25, 2023

SAN JOSE, Calif., Oct. 25, 2023 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today announced preclinical data supporting the safety and tolerability of the RaniPill® drug delivery platform following 60-day repeat administration. In the 60-day good laboratory practices (“GLP”) study in healthy animals, the RaniPill® capsule was well-tolerated with no treatment-related adverse events.

Key Points: 
  • SAN JOSE, Calif., Oct. 25, 2023 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today announced preclinical data supporting the safety and tolerability of the RaniPill® drug delivery platform following 60-day repeat administration.
  • In the 60-day good laboratory practices (“GLP”) study in healthy animals, the RaniPill® capsule was well-tolerated with no treatment-related adverse events.
  • “The preclinical data announced today are highly encouraging and we believe these data further validate the safety and tolerability of our RaniPill® drug delivery platform,” said Mir Hashim, PhD, Chief Scientific Officer of Rani.
  • RT-100 was well-tolerated with no treatment-related adverse events and all animals remained clinically healthy throughout the study.

Focal Medical Complete Development of a Therapeutic System to Deliver Gemcitabine Directly to the Pancreas

Retrieved on: 
Wednesday, October 25, 2023

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20231025835095/en/
    Focal Medical's precision therapeutic system to deliver gemcitabine to the pancreas.
  • (Graphic: Business Wire)
    ACT-IOP-003 is a novel implanted precision therapeutic system intended to safely deliver multiple doses of gemcitabine (an FDA approved therapeutic agent) locally and actively into the pancreas using non-circulatory pathways.
  • Focal Medical expects to initiate a pancreatic cancer clinical development program in 2024.
  • “The completion of the development of our precision therapeutic system to deliver gemcitabine directly to the pancreas is an extraordinarily important milestone for Focal Medical,” commented Michael Aldridge, Focal Medical Chief Executive Officer.

Enveric Biosciences Initiates GLP Toxicology & Safety Pharmacology Studies for Lead Candidate EB-373, a Next Generation Psilocin Prodrug Targeting Psychiatric Disorders

Retrieved on: 
Wednesday, October 18, 2023

Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders, today announced initiation of Good Laboratory Practice (GLP)-toxicology and safety pharmacology studies for lead prodrug candidate EB-373, the company’s next generation psilocin prodrug being developed for the treatment of psychiatric disorders.

Key Points: 
  • Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders, today announced initiation of Good Laboratory Practice (GLP)-toxicology and safety pharmacology studies for lead prodrug candidate EB-373, the company’s next generation psilocin prodrug being developed for the treatment of psychiatric disorders.
  • Enveric has commenced preclinical studies to evaluate repeat-dose toxicity in animals, which are designed to strengthen the broad safety margin established in previous non-GLP studies and are intended to generate regulatory-compliant data that will help advance EB-373 to first-in-human clinical studies.
  • The GLP toxicology and safety studies are a final step as Enveric prepares to enter clinical-stage trials with its novel, next generation synthetic psilocin prodrug.
  • Notably, psilocin blood concentration peaked at one hour after administration of EB-373 indicating a quicker onset of effect.

TIER IV certified in Level 4 autonomous driving: Sharing its design and process with partners

Retrieved on: 
Friday, October 20, 2023

Roads within the GLP ALFALINK Sagamihara are regulated by the Road Traffic Act, and used by pedestrians and vehicles.

Key Points: 
  • Roads within the GLP ALFALINK Sagamihara are regulated by the Road Traffic Act, and used by pedestrians and vehicles.
  • Following the guidelines for customizing Level 4 commercial autonomous vehicles published in June 2023 , TIER IV commits to sharing the process and design for this certification as a solution for its partners that aim to develop AD systems, contributing significantly to the realization of autonomous driving.
  • Through continued research and development as well as evaluation and verification, TIER IV aims to further advance functions and performance of AD systems.
  • Building upon the Level 4 certification obtained under the Road Transport Vehicle Act, TIER IV is poised to utilize its knowledge for the mass production and development of electric vehicles (EVs).

Texcell- North America Announces Retirement of CEO and Founder, Jeff Schubert

Retrieved on: 
Thursday, October 19, 2023

FREDERICK, Md., Oct. 19, 2023 /PRNewswire/ -- Texcell- North America, a prominent name in the field of custom cell culture and virology biosafety testing, announced the retirement of its esteemed founder and CEO, Jeff Schubert, effective as of October 5, 2023.

Key Points: 
  • FREDERICK, Md., Oct. 19, 2023 /PRNewswire/ -- Texcell- North America, a prominent name in the field of custom cell culture and virology biosafety testing, announced the retirement of its esteemed founder and CEO, Jeff Schubert, effective as of October 5, 2023.
  • In December 2010, Cell Trends was acquired by the French company, Texcell Group, leading to the company re-branding as Texcell- North America.
  • Stepping into Jeff's formidable shoes is Alysia Birkholz, PhD, the newly appointed CEO for the North America branch of the Texcell Group.
  • Dr. Birkholz has been with Texcell- North America for over six years, having formerly worked as COO and Deputy CEO.

SOHM Collaborates with University of Arizona Center for Innovation to Advance ABBIE, a Groundbreaking Non-Viral Gene-Editing Technology

Retrieved on: 
Tuesday, October 10, 2023

UACI is a leading science and tech startup incubator that is directly connected to the University of Arizona.

Key Points: 
  • UACI is a leading science and tech startup incubator that is directly connected to the University of Arizona.
  • SOHM chose to advance the revolutionary ABBIE at UACI because of the robust resources and specialized infrastructure.
  • SOHM will establish offices and a wet lab bench, utilizing the best-practices environment with certified Good Laboratory Practices (GLP) to fast-track development.
  • “We are delighted to assist SOHM and the development of ABBIE technology.