Johnson and Johnson aims to torpedo thousands of talc cases with one high-stakes hearing

Fiercepharma | July 22, 2019

Johnson and Johnson faces about 14,200 lawsuits alleging harm from talc, and Monday marks its next big test. In a New Jersey courtroom, the drugmaker plans to challenge expert evidence set to be presented at trial and the judges decision will determine the fate of most of the outstanding lawsuits. That evidence is key to 85% of the cases grouped for consideration in J&J's home state. If the court decides the plaintiffs' expert evidence can't be used in court, then "there's nowhere for these cases to go," a lawyer for J&J told the Wall Street Journal. Apparently, the company has high hopes for the outcome. "[W]hen folks have a chance to really look at the facts in these cases, they see that the product is safe and that the company acted responsibly," CFO Joe Wolk told analysts on the company's Q1 earnings call last week. The talc plaintiffs argue J&J's products caused them to develop cancer and that the company hid the risks from the public. Meanwhile, at a federal court in Delaware, J&J on Friday fell short in its attempt to combine 2,400 state lawsuits from around the country in the court where several units for its supplier Imerys filed for bankruptcy.

Spotlight

Merck & Co, known as MSD outside of the United States and Canada, is a global pharmaceutical company whose mission is to discover, develop and provide innovative products and services that save and improve lives around the world.

Spotlight

Merck & Co, known as MSD outside of the United States and Canada, is a global pharmaceutical company whose mission is to discover, develop and provide innovative products and services that save and improve lives around the world.

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Businesswire | March 29, 2023

Simulations Plus, Inc. a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced that it established a strategic research collaboration with the Sino-American Cancer Foundation (SACF). This collaboration will leverage Simulations Plus’ staff and Artificial Intelligence-driven Drug Design technology in the ADMET Predictor® software platform to support the discovery and design of novel inhibitors of methylenetetrahydrofolate dehydrogenase 2 (MTHFD2), an emerging cancer target. Per the terms of the collaboration, Simulations Plus will develop quantitative structure-activity relationship (QSAR) models for efficacy against MTHFD2, using information from SACF as well as academic and patent literature. The biologists, computational and medicinal chemists in the Early Drug Discovery Services team at Simulations Plus will work with the researchers at SACF to define the multi-objective parameters against which the lead molecule(s) will be optimized. The new AIDD Module in ADMET Predictor® will then be employed to generate libraries of virtual compounds that are optimized for potency and other chosen parameters. The teams will select promising candidates for synthesis and testing, and ensuing rounds of QSAR model building and AIDD optimization will be performed until the milestone criteria in the collaboration agreement are achieved. “We value the trust and confidence SACF has in our team and AI technology to complement and accelerate conventional drug design and lead optimization processes,” said Dr. Jeremy Jones, Principal Scientist at Simulations Plus and project lead. “By combining their drug discovery expertise with our algorithmic and data science know-how, we are confident we will successfully support their hit-to-lead target development activities.” As part of this agreement, SACF will provide upfront funding to Simulations Plus to design a set number of compounds for efficacy against MTHFD2 which will be exclusive to SACF. Subsequent milestone payments will be made as key research and development goals are met. “SACF has had an active interest in AI for de novo design for some time, and we have found a trusted partner in Simulations Plus to help us integrate this into our research,” added Dr. Frank Luh, CEO of SACF. “Scientists from the two organizations will work side-by-side to combine SACF’s data with all that Simulations Plus offers to identify the next generation of compounds that could help in the treatment of cancer.” John DiBella, SLP Division President, said, “The Early Drug Discovery Services offering at Simulations Plus is tailor made for this type of partnership, where our team of experts, including computational, medicinal, and cheminformatics specialists, provide end-to-end AI-driven drug discovery and optimization support to complement the SACF team. Simulations Plus continues to invite future collaborations which benefit organizations and, most importantly, the global communities we serve.” About Simulations Plus, Inc. Serving clients worldwide for more than 25 years, Simulations Plus is a leading provider in the biosimulation market providing software and consulting services supporting drug discovery, development, research, and regulatory submissions. We offer solutions that bridge machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, and regulatory agencies worldwide.

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COEUS Holdings Announces Rebranding to Reflect the Unification of Each Business Unit Into One Entity

Businesswire | May 02, 2023

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Endo Announces Agreement with Slayback Pharma to Distribute Prevduo™ the First and Only FDA-Approved Neostigmine-Glycopyrrolate Combination

prnewswire | April 28, 2023

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