FDA finds inconsistent amounts of belladonna in certain homeopathic teething tablets

Medical News | August 23, 2019

The U.S. Food and Drug Administration announced today that its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label. The agency is warning consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers not to use these products. In light of these findings, the FDA contacted Standard Homeopathic Company in Los Angeles, the manufacturer of Hylands homeopathic teething products, regarding a recall of its homeopathic teething tablet products labeled as containing belladonna, in order to protect consumers from inconsistent levels of belladonna. At this time, the company has not agreed to conduct a recall. The FDA recommends that consumers stop using these products marketed by Hyland's immediately and dispose of any in their possession. In November 2016, Raritan Pharmaceuticals (East Brunswick, New Jersey) recalled three belladonna-containing homeopathic products, two of which were marketed by CVS. Homeopathic teething products have not been evaluated or approved by the FDA for safety or effectiveness. The agency is unaware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children. In September 2016, the FDA warned against the use of these products after receiving adverse event reports.

Spotlight

If you have ever worked with Orphan Drugs, you know finding appropriate patients is a major commercial challenge. Pharmaceutical sponsors of Orphan Drugs often lack the infrastructure and capabilities necessary to identify physicians who diagnose, treat, and manage these rare patients. TrialCard developed a proven model for making this critical match and has helped many patients gain access to the therapy they so desperately need.

Spotlight

If you have ever worked with Orphan Drugs, you know finding appropriate patients is a major commercial challenge. Pharmaceutical sponsors of Orphan Drugs often lack the infrastructure and capabilities necessary to identify physicians who diagnose, treat, and manage these rare patients. TrialCard developed a proven model for making this critical match and has helped many patients gain access to the therapy they so desperately need.

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RESEARCH

MindMed Signs Partnership with Swiss Psychedelic Drug Discovery Startup MindShift Compounds AG

MindMed | February 15, 2021

MindMed, a leading psychedelic medicine biotech company announced another partnership with Swiss startup MindShift Compounds AG to develop and patent next-gen psychedelic compounds with psychedelic or empathogenic properties. As a component of this partnership, MindMed and MindShift Compounds AG have agreed to develop next-gen psychedelic and empathogenic substances together. The first initial compounds have just been combined by MindShift Compounds AG and related patent applications were documented by MindMed. MindMed plans to begin first-in-human Phase 1 clinical trials as ahead of schedule as Q1 2022 through its existing clinical preliminary stage for psychedelic and empathogenic compounds in Switzerland. The partnership on these initial targets will expand MindMed's current, grounded clinical pipeline with extra reinforcement and expansion compounds with comparative and possibly improved restorative properties. The connected combination intellectual property and drug technology will be possessed through and through by MindMed, and MindShift Compounds AG will give all intellectual property identified with the new psychedelic compounds only to MindMed. This partnership adds to MindMed's existing IP portfolio development endeavors in progress in collaboration with the University Hospital Basel's Liechti Lab for exemplary psychedelic compounds including LSD, MDMA, Psilocybin, MDMA-LSD combinations, personalized dosing technologies and a LSD Neutralizer technology, which depend on multiple clinical trials and long stretches of exploration led by the Liechti Lab. MindMed plans to work with the accomplished drug discovery group at MindShift Compounds AG to encourage extensively cover preclinical psychedelics investigation into novel compounds and hopes to continue to record a substantial number of licenses on countless novel substance matters, production innovations, and later clinical applications, allowing MindMed to additionally unite its leading situation in the in general psychedelic-medicine market as it moves these next-gen compounds into the clinic through advanced patient clinical trials. MindShift CEO, Dr. Felix Lustenberger, said "Our innovative psychedelic drug-discovery platform based in Switzerland is pioneering next-gen psychedelic compounds that complement in a synergistic pipeline approach the later-stage development work underway at MindMed. The compounds we are working on are typically derivatives or analogues of known substances with psychedelic properties, such as phenethylamines, tryptamines, and ergolines, and are therefore enhanced versions of both the established and classic psychedelic compounds such as mescaline, psilocybin, DMT, and LSD, as well as compounds with expected combined psychedelic-empathogenic effect profiles. These novel chemical structures, for example MDMA and LSD-like compounds, are designed and synthesized with expected ameliorated psychoactive properties and duration-of-effect profiles with potential added therapeutic benefits." About MindMed MindMed is a psychedelic medicine biotech company that discovers, develops and deploys psychedelic-inspired medicines and therapies to address addiction and mental illness. The company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including psilocybin, LSD, MDMA, DMT and an Ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to the company's groundbreaking approach to developing the next generation of psychedelic-inspired medicines and therapies.

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PRACTICE MANAGEMENT

AstraZeneca's Farxiga scores a speedy FDA review in kidney disease—and gets another jump on rival Jardiance

Farxiga | January 07, 2021

Pushing for another endorsement for SGLT2 prescription Farxiga in persistent kidney illness (CKD), AstraZeneca a year ago posted amazing information in its critical preliminary. Presently, the FDA has acknowledged its CKD application and granted a need survey, setting up a choice for the subsequent quarter—and putting Farxiga significantly farther in front of its future adversaries. In that preliminary, named Dapa-CKD, AZ's Farxiga in addition to standard of care cut the joined danger of deteriorating kidney capacity or demise brought about via cardiovascular or kidney issues by 39% over fake treatment in certain CKD patients. Furthermore, the medication cut the danger of death from any reason by 31%. Initially endorsed to control glucose, Farxiga a year ago scored a class-first FDA gesture to lessen the danger of major cardiovascular occasions in patients with cardiovascular breakdown—regardless of whether they have diabetes. Presently, AstraZeneca is planning to change the therapy worldview in persistent kidney sickness. Johnson and Johnson's Invokana conveys a FDA endorsement in diabetic kidney infection, however Farxiga is gunning for a gesture in ongoing kidney sickness with or without type 2 diabetes. At the point when AZ introduced its definite stage 3 Dapa-CKD results back in August, an executive said the information "truly can possibly modify" clinical course readings. Before that, the organization halted its preliminary early last March after break information "demonstrated Farxiga's advantages sooner than initially envisioned." The FDA's Wednesday move "presents to us a bit nearer to conveying this new therapy choice for the large numbers of patients living with ongoing kidney illness in the U.S.," AZ's chief VP of biopharma R&D, Mene Pangalos, said in an assertion. "Farxiga can possibly be a really groundbreaking medication across an expansiveness of illnesses, including type 2 diabetes, cardiovascular breakdown with diminished discharge division and, whenever endorsed, constant kidney infection."

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RESEARCH

XtalPi Partners with Excelra for GOSTAR to Enhance its Intelligent Digital Drug Discovery and Development platform

Excelra Knowledge Solutions Pvt Ltd | January 19, 2022

Excelra, a leading global Data & Analytics organization, announced the partnership for its Global Online Structure Activity Relationship Database with XtalPi Inc., an AI-based pharmaceutical biotechnology company reinventing the industry's approach to drug research and development with its Intelligent Digital Drug Discovery and Development platform. Excelra will provide ADMET datasets in the GOSTAR database to XtalPi Inc. as part of the partnership. GOSTAR's ADMET data will power XtalPi's predictive models. The data helps XtalPi with high precision and predictability to confidently tackle clinical failures of new chemical entities. The well-annotated, high-quality ADMET datasets of GOSTAR are built with a proprietary QMS-ISO certified curation process powered by NLP and human intelligence. GOSTAR provides comprehensive information encompassing over 8 million compounds, manually curated from a variety of sources including patents and journal articles. The database contains over 29 million SAR associated data points. The well-structured relational database can be utilized for diverse applications across various stages of drug discovery and development lifecycle and aids in target validation, hit identification, early lead identification, and optimization. "In XtalPi Inc., we develop advanced AI-based algorithms to tackle the challenges in the drug design process. The size and quality of datasets are always a big concern for us to build high-accuracy predictive models. That is why we consider GOSTAR as a unique and precious resource. It has millions of data points covering different compounds' ADMET properties and is also trustful, structured, and updated. We highly recommend GOSTAR to whoever is involved in the innovation of drug design methodologies." Min Xu, Senior Scientist, Research Manager, XtalPi Inc Norman Azoulay, Product Leader, Excelra, said, "Artificial Intelligence and Machine Learning is bringing a paradigm shift to drug discovery and development. This partnership will help train XtalPi's models to accurately predict efficacy and safety parameters and to ultimately increase the success rate of drug design." About XtalPi XtalPi is a pharmaceutical technology company that is reinventing the industry's approach to drug research and development with its Intelligent Digital Drug Discovery and Development platform. With tightly interwoven quantum physics, artificial intelligence, and high-performance cloud computing algorithms, XtalPi's platform provides accurate predictions on the physiochemical and pharmaceutical properties of small-molecule candidates for drug design, solid-form selection, and other critical aspects of drug development. XtalPi is dedicated to improving the efficiency, accuracy, and success rate of drug research and development, and contributing to a healthier society worldwide. About Excelra Excelra's data and analytics solutions empower innovation in life sciences from molecule to market. The Excelra Edge comes from harmonizing heterogeneous data sets, applying innovative bioinformatics know-how and technologies to accelerate your drug discovery & development with reliable and result-oriented insights. Excelra's GOSTAR is available as an application for users to seek, find, and discover compounds. In addition, it is offered via APIs and as a downloadable dataset to power in-house libraries and machine learning models.

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