GLP

Silo Pharma Announces Pipeline Prioritization for 2024 Targeting Mental Health, Chronic Pain, and Neurology

Retrieved on: 
Thursday, February 1, 2024
Traffic barrier, PTSD, Multiple sclerosis, Inflammation, Fibromyalgia, Chronic pain, Research, Plasma protein binding, Therapy, SILO, Neurology, IND, New Drug Application, UMB, Central nervous system, FDA, Columbia University, Ketamine, GLP, Food, Mental health, CNS, Social media, Post-traumatic stress disorder, Administration, University, Pharmaceutical industry

SARASOTA, FL, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced updates for its strategic 2024 focus for its clinical pipeline. The Company is advancing a diversified portfolio of four drugs targeting three health areas: mental health, chronic pain, and neurology.

Key Points: 
  • The Company is advancing a diversified portfolio of four drugs targeting three health areas: mental health, chronic pain, and neurology.
  • A dose-ranging non GLP study of SPC-15 is in progress, with a final validation report expected in the first half of 2024.
  • As a self-administered treatment, SP-26 holds the potential to be the first at-home ketamine treatment approved for chronic pain management.
  • Silo Pharma Inc. (Nasdaq: SILO) is a developmental stage biopharmaceutical company developing novel therapeutics that address underserved conditions including stress-induced psychiatric disorders, chronic pain conditions, and central nervous system (CNS) diseases.

Microbot Medical Expands US Clinical Infrastructure in Support of the Upcoming IDE Submission to Commence its First in Human Clinical Study

Retrieved on: 
Thursday, January 18, 2024
IDE, Clinical research associate, CRA, Clinical trial, GLP, Pharmaceutical industry

BRAINTREE, Mass., Jan. 18, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announced that following the recent positive results of its pivotal GLP Pre-Clinical Study, and to support its anticipated IDE submission to commence its first in human clinical trial, the Company added a US- based Clinical Research Associate (CRA).

Key Points: 
  • BRAINTREE, Mass., Jan. 18, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announced that following the recent positive results of its pivotal GLP Pre-Clinical Study, and to support its anticipated IDE submission to commence its first in human clinical trial, the Company added a US- based Clinical Research Associate (CRA).
  • The CRA will join the already established clinical team in the USA, led by Dr. Juan Diaz-Cartelle, the Company’s Chief Medical Officer.
  • "Following the successful completion of our pivotal GLP pre-clinical trial, and as we are in the final stage of submitting our IDE, having an in house CRA is a key piece for establishing the right infrastructure for clinical trial execution" said Dr. Diaz-Cartelle, Chief Medical Officer.

Verastem Oncology Outlines Key 2024 Strategic Priorities and Upcoming Catalysts for Advancing Avutometinib and Defactinib and Broader Pipeline in RAS Pathway-Driven Cancers

Retrieved on: 
Monday, January 29, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Verastem Oncology, Patient, Accelerated approval (FDA), Toxicology, GLP, BIW, Part, Diagnosis, Safety, RAMP, Cancer, NSCLC, IND, Food, NDA, RAS, Lung cancer, FDA, Avutometinib, QD, Pancreatic cancer, Pharmaceutical industry

Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today outlined key 2024 strategic priorities and upcoming catalysts to support advancement of its clinical programs in RAS pathway-driven cancers.

Key Points: 
  • Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today outlined key 2024 strategic priorities and upcoming catalysts to support advancement of its clinical programs in RAS pathway-driven cancers.
  • “We have made significant progress in our commitment to advancing new solutions for RAS pathway-driven cancers and look forward to an exciting and catalyst-filled year ahead.
  • Safety and tolerability continued to be favorable and consistent with previously reported data.
  • Entered into a discovery and development collaboration with GenFleet Therapeutics (“GenFleet”) to advance three oncology discovery programs targeting RAS pathway-driven cancers.

Advanced Medicine Partners Launches to Set New Standard for Manufacturing and Testing Advanced Medicines

Retrieved on: 
Wednesday, January 17, 2024
Health, Genetics, Other Health, General Health, Research, Science, Pharmaceutical, CMC, Patient, Amgen, GLP, Biotechnology, AAV, Novartis, GMP, Medicine, IND, Therapy, ARCH Venture Partners, Novartis Gene Therapies, Pharmaceutical industry

“Advanced Medicine Partners is a science- and mission-driven organization made up of one of the most experienced genetic medicines teams in the industry, and we are driven to deliver products and services that aim to set a new standard in the manufacturing and testing of innovative therapies,” said Andrew Knudten, CEO of Advanced Medicine Partners.

Key Points: 
  • “Advanced Medicine Partners is a science- and mission-driven organization made up of one of the most experienced genetic medicines teams in the industry, and we are driven to deliver products and services that aim to set a new standard in the manufacturing and testing of innovative therapies,” said Andrew Knudten, CEO of Advanced Medicine Partners.
  • Advanced Medicine Partners’ process has been used with multiple genes of interest as well as multiple wild-type AAV serotypes and engineered capsids.
  • Advanced Medicine Partners brings extensive operational experience from Jaguar Gene Therapy and other biotechnology companies, including AveXis, Novartis and Amgen.
  • In addition to Advanced Medicine Partners’ manufacturing and analytical testing capabilities, the company offers GMP tech transfer capabilities and virtual CMC support.

Biora Therapeutics Provides Outlook for 2024

Retrieved on: 
Tuesday, January 16, 2024
Patient, Therapy, Research, Animal, UC, GLP, SAN, Partnership, SAD, Human, Ulcerative colitis, Aviation, AstraZeneca, Trial of the century, Pharmaceutical industry

SAN DIEGO, Jan. 16, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today provided guidance on anticipated milestones during 2024.

Key Points: 
  • SAN DIEGO, Jan. 16, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today provided guidance on anticipated milestones during 2024.
  • “In 2023, we completed the transformation of the company, focusing on strong execution which laid the foundation for significant value inflection in the coming months,” said Adi Mohanty, Chief Executive Officer of Biora Therapeutics.
  • “We begin 2024 in the clinic with our phase 1 study for BT-600, which will be a major de-risking step in the development of our NaviCap™ platform.
  • We already have data on the device alone in humans, and tofacitinib is already used to treat UC.

ZyVersa Therapeutics’ CEO, Stephen C. Glover, Featured on Benzinga All Access

Retrieved on: 
Wednesday, January 10, 2024
Entrepreneurship, Patient, Therapy, Proteinuria, Diabetic nephropathy, Toxicology, GLP, Interview, Structural Damage, Initial public offering, Kidney disease, Environment, Optimism, IND, Inflammasome, Inflammation, VAR, Investigational New Drug, DKD, Pharmaceutical industry

During the interview, Mr. Glover described the significant unmet need and market opportunity in kidney disease, and how ZyVersa’s Cholesterol Efflux MediatorTM VAR 200 has the potential to improve kidney function and reduce kidney disease progression.

Key Points: 
  • During the interview, Mr. Glover described the significant unmet need and market opportunity in kidney disease, and how ZyVersa’s Cholesterol Efflux MediatorTM VAR 200 has the potential to improve kidney function and reduce kidney disease progression.
  • Current treatments target glomerular hypertension and inflammation, but there are no treatments that target lipid accumulation, which is known to contribute to structural damage, proteinuria, and progression of kidney disease.
  • ZyVersa plans to initiate a Phase 2a trial with VAR 200 in patients with diabetic kidney disease (DKD) in the first quarter of 2024, with preliminary data anticipated by mid-year 2024.
  • ZyVersa plans to complete GLP toxicology studies with IC 100 and submit an Investigational New Drug (IND) application in the fourth quarter of 2024, followed by initiation of a Phase 1 trial.

Sapio Sciences Announces Full GxP Validation of its Unified Lab Informatics Platform and Suite of Solutions

Retrieved on: 
Thursday, January 11, 2024
Software, Research, Networks, Pharmaceutical, Data Management, Apps, Applications, Technology, Health Technology, Security, Science, Biotechnology, Health, Other Science, ISO/IEC 27001:2013, HIPAA, GLP, ELN, GCP, Documentation, GxP, GMP, Good manufacturing practice, Accreditation, SOC, Good laboratory practice, Safety, LIMS, Medical device

Sapio Sciences , the science-aware™ lab informatics platform , today announced that its unified platform for research and clinical informatics has been validated to comply with “good practice” quality guidelines and regulations.

Key Points: 
  • Sapio Sciences , the science-aware™ lab informatics platform , today announced that its unified platform for research and clinical informatics has been validated to comply with “good practice” quality guidelines and regulations.
  • GxP refers to good practice quality guidelines and regulations that span various industries, including pharmaceutical and biotech companies and contract development and manufacturing organizations (CDMOs), which Sapio’s platform serves.
  • In addition to validating its software, Sapio has also developed a premium validation package for its customers.
  • Visit the Sapio website for a guide reviewing the impact of GxP on life science organizations.

ClearPoint Neuro Reports Fourth Quarter and Full Year 2023 Preliminary Revenue Results and Guidance for Full Year 2024 Revenue

Retrieved on: 
Monday, January 8, 2024
Paper, Conference, Demonstration, FDA, Brain, Continue, Bank statement, GLP, AI, PRISM, Growth, SmartFrame

These preliminary unaudited financial results are management’s estimates and are subject to revision in the course of completing annual audit processes.

Key Points: 
  • These preliminary unaudited financial results are management’s estimates and are subject to revision in the course of completing annual audit processes.
  • Audited results for 2023 will be publicly reported by the Company later in the first quarter of 2024, prior to a Form 10-K filing for the year with full financial statements.
  • Preliminary unaudited revenue of approximately $6.8 million, a 32% year-over-year increase;
    Increased biologics and drug delivery revenue to approximately $4.1 million, a 76% year-over-year increase; and
    Cash burn of approximately $1.2 million in the fourth quarter.
  • The Company had approximately $23.1 million in cash and cash equivalents at December 31, 2023.

Silo Pharma Successfully Completes First Phase of Dose-Ranging Study of SPC-15 an Intranasal Treatment for PTSD

Retrieved on: 
Thursday, January 4, 2024
IND, FDA, SILO, Columbia University, Investigational New Drug, GLP, PTSD, Animal, Post-traumatic stress disorder, Toxicity, Safety, Therapy, Pharmaceutical industry

ENGLEWOOD CLIFFS, NJ, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or “the Company”), a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, today provided an update on its previously announced dose-ranging study of SPC-15, a targeted prophylactic treatment for post-traumatic stress disorder (PTSD). The purpose of the study is to identify the maximum tolerated intranasal dose of the drug and pharmacokinetic in small animals to determine the therapeutically relevant dose range with the goal of bringing us closer to human trials.

Key Points: 
  • The purpose of the study is to identify the maximum tolerated intranasal dose of the drug and pharmacokinetic in small animals to determine the therapeutically relevant dose range with the goal of bringing us closer to human trials.
  • The six- to eight-week non-GLP study includes single ascending dose evaluation (phase 1) and a 7-day repeat intranasal dose toxicity and pharmacokinetic study.
  • In the first phase of the study, all of the animals appeared to tolerate the intranasal dosing procedure well, with minimal struggling and no sneezing observed.
  • Eric Weisblum, Chief Executive Officer of Silo Pharma, commented “There have been no adverse clinical observations reported to date for this study, which began in late November 2023 and will conclude in first quarter 2024.

Microbot Medical Announced Positive Results of Its GLP Pivotal Pre-Clinical Study Where All Study Objectives Were Met

Retrieved on: 
Thursday, December 28, 2023
FDA, Catheter, GLP, IDE

BRAINTREE, Mass., Dec. 28, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announces the successful completion of its GLP pivotal pre-clinical study, done under the guidelines of FDA-required levels of planning, controlling, monitoring, and reporting, using a porcine model.

Key Points: 
  • BRAINTREE, Mass., Dec. 28, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announces the successful completion of its GLP pivotal pre-clinical study, done under the guidelines of FDA-required levels of planning, controlling, monitoring, and reporting, using a porcine model.
  • As previously announced on December 7, 2023, the study was conducted by three leading interventional radiologists that utilized the LIBERTY Endovascular Robotic Surgical System to perform a total of 96 robotic navigations.
  • “I am very pleased with the positive outcomes of the histopathology report and the completion of the GLP study,” said Juan Diaz Cartelle, Chief Medical Officer.
  • “We expect to submit our IDE application to the FDA soon and commence our pivotal human clinical trial, completing our transition to a clinically stage company.”