Certara
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- -
- Employees
- 1.3K
- Market Cap
- -
- Introduction
Cerrado Gold Inc is a precious metals mining and exploration company building a portfolio of assets in South America. The company owns the Minera Don Nicolas Project, located in Santa Cruz, Argentina. It is also focused on exploration at its Monte do Carmo gold Project in Tocantins State, Brazil.
Certara Launches Non-Animal Navigator Solution to Reduce Animal Testing in Drug Development
• Certara has introduced the Non-Animal Navigator solution to help pharmaceutical companies reduce reliance on animal testing in preclinical safety studies, aligning with FDA's recent roadmap initiative.
• The solution combines AI-enabled biosimulation with regulatory guidance, leveraging physiologically based pharmacokinetic modeling and quantitative systems pharmacology to provide more predictive human outcomes.
• Particularly relevant for monoclonal antibodies and antibody-drug conjugates in early development, the approach aims to accelerate timelines, lower costs, and maintain regulatory compliance while advancing ethical drug development.
FDA to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Drugs
• The FDA announced it will phase out requirements for animal testing of monoclonal antibodies and other drugs, citing the availability of "more effective, human-relevant methods" for safety evaluation.
• The initiative aims to improve drug safety, accelerate evaluation processes, reduce R&D costs, and ultimately lower drug prices by implementing AI-based computational models, humanoid models, and real-world human data.
• This regulatory shift, enabled by the bipartisan FDA Modernization Act 2.0 of 2022, represents what FDA Commissioner Marty Makary calls "a paradigm shift in drug evaluation" that could expedite development of new treatments.
Cabaletta Bio Announces Positive Clinical Updates for CABA-201 in Autoimmune Diseases
• Cabaletta Bio reported clinical data from RESET-Myositis™, RESET-SLE™, and initial data from RESET-SSc™ trials at ACR Convergence 2024, showcasing CABA-201's potential in autoimmune disease treatment.
• Sixteen patients have been enrolled, with ten dosed across the RESET™ clinical development program, and 40 U.S. clinical sites are actively recruiting patients for CABA-201 trials.
• Cabaletta anticipates a meeting with the FDA in 2025 to discuss potential registrational program designs for CABA-201, pending data outcomes.
• EMA has authorized clinical trials for CABA-201 in Europe for lupus, expanding the clinical development program internationally.
Cabaletta Bio Advances CABA-201 Trials, Expands to Europe, and Reports $183M Cash Position
• Cabaletta Bio reports 40 active U.S. clinical sites recruiting for its RESET trials, with 16 patients enrolled and 10 dosed as of November 12.
• The company received EMA CTA authorization for CABA-201 in lupus, facilitating expansion into Europe and broadening the clinical development program.
• Clinical data from RESET-Myositis, RESET-SLE, and initial RESET-SSc trials will be presented at ACR Convergence 2024, highlighting potential efficacy.
• Cabaletta Bio's cash position stands at $183.0 million as of September 30, 2024, expected to fund operations into the first half of 2026.
MDMA Therapy Faces Scrutiny Despite Potential for Mental Health Treatment
• The FDA issued a Complete Response Letter to Lykos Therapeutics for its MDMA capsules (midomafetamine) intended to treat PTSD, citing concerns about safety and efficacy data.
• Experts emphasize the need for well-blinded, placebo-controlled studies due to MDMA's psychoactive nature and its potential impact on patient behavior during clinical trials.
• The FDA has drafted guidelines for psychedelic drug research, focusing on chemistry, manufacturing, control information, and abuse potential assessments to ensure drug quality.
• Combination therapy with psychotherapy is deemed critical for the long-term success of MDMA therapy, though challenges remain regarding costs, insurance reimbursements, and optimal protocols.
AI Simulations Enhance Clinical Trial Efficiency and Accuracy in Drug Development
• AI-driven simulations are improving clinical trial success rates by preemptively modeling trials and optimizing dosing strategies.
• QuantHealth reports 85% accuracy across 100 simulated clinical trials, leveraging AI to refine trial parameters and predict outcomes.
• Certara employs AI to enhance drug development by integrating simulations that model dosing based on non-human studies and predict clinical endpoints.
• AI applications in drug development range from data analysis to building biological models, potentially saving billions and accelerating timelines.
DAV132 Adsorbent Does Not Interfere with Plasma Concentrations of Key Antibiotics
• A randomized, controlled study (CL-006) found that DAV132, a colon-targeted adsorbent, did not significantly alter plasma concentrations of ceftriaxone, piperacillin, tazobactam, ceftazidime, and avibactam.
• The study involved 148 healthy volunteers who received DAV132 at two different doses (7.5g or 12g) in combination with antibiotics or without antibiotics over 7 days.
• Exploratory analyses suggest DAV132 may protect the intestinal microbiome diversity during antibiotic treatment, warranting further investigation into its potential role in mitigating antibiotic-associated dysbiosis.
• Research in mice suggests DAV132 may enhance the efficacy of anti-PD-1 immunotherapy by modulating the gut microbiota and immune response, offering a potential strategy to overcome resistance.
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