FDA Approves Yale Medical Cannabis Human Trials

Ganjapreneur | November 12, 2019

FDA Approves Yale Medical Cannabis Human Trials
The Food and Drug Administration has granted approval to the Yale School of Medicine and CT Pharma for human drug trials to study the efficacy of cannabis-based medicines, according to a Connecticut Public Radio report. The study will be the first with FDA approval to test cannabis on human subjects. Yale University School of Medicine’s Dr. Rajita Sinha, the lead researcher for the clinical trial, said the studies will attempt to figure out how medical cannabis works, who it works for, what symptoms can be alleviated, dosages, and whether there is “a need for refinement.” Michael Fedele, board chair of the Portland, Connecticut-based CT Pharma, told CPR that he hopes the study will result in the first FDA-approved cannabis-based medicine to be manufactured in the U.S. According to the FDA, the agency “is aware that there is considerable interest in the use of marijuana to attempt to treat a number of medical conditions” and does support “research into the medical use of marijuana and its constituents through cooperation with other federal agencies involved in marijuana research.”

Spotlight

The developmental versatility of pluripotent stem cells (PSCs) offers a powerful approach for directing cell fate, and these cells are a promising source of progenitors and terminally differentiated somatic cells for cell replacement therapy and drug screening applications. In culture, PSCs have a unique trait of unlimited propagation while retaining their inherent potential to differentiate into cells from the three embryonic germ layers. When plated onto a non-adherent culture dish, these cells aggregate to form embryoid bodies (EBs) which undergo a process of spontaneous differentiation that closely imitates early human embryogenesis.

Related News

BUSINESS INSIGHTS

Ligand and GSK Expand Global Collaboration and License Agreement

Ligand Pharmaceuticals | December 22, 2021

Ligand Pharmaceuticals Incorporated announced today the expansion of an existing collaboration and license agreement between its subsidiary, Icagen, and GlaxoSmithKline. The expansion will leverage Icagen’s ion-channel-based discovery technology and unique expertise in small molecule therapeutics targeting transmembrane proteins. This new agreement builds upon the initial December 2020 agreement to identify and develop inhibitors of a specific genetically-validated molecular target relevant to neurological diseases. “We are very pleased to expand our collaboration with GSK to include a second neurological target. Over the past year this has been a productive relationship combining our technologies and expertise with GSK’s history of successfully working with others to access innovation and deliver next-generation transformational medicines.” Matt Foehr, President and COO of Ligand “We look forward to strengthening our collaboration to identify genetically-validated targets for neurological diseases utilizing Icagen’s technology,” said John Lepore, Senior Vice President, Head of Research, GSK. “Our expanded collaboration provides a framework to advance drug discovery by maximizing the strengths of our two scientific organizations to develop novel drug candidates efficiently and effectively.” In addition to all payments available under the original 2020 collaboration and license agreement, under the terms of the expanded collaboration and license agreement, Ligand will receive an upfront payment of $10 million and is eligible for development and regulatory milestones up to $67.5 million. Furthermore, should the potential new medicine receive regulatory approval in major markets, the deal provides for commercial milestone payments to Ligand of up to $60 million at first commercial sale, and up to $120 million in sales-related milestone payments. Ligand will receive tiered royalties on net sales of any drug that is commercialized by GSK. Ligand will be responsible for most preclinical activities up to lead optimization, with Ligand and GSK collaborating to identify candidates for entry into IND-enabling studies. GSK has the exclusive option to license any identified molecules and will be responsible for the further development and commercialization of any drug candidates identified through the collaboration. About Icagen Ion Channel Technology The Icagen technology is focused primarily on ion channel and transporter novel drug discovery. Ion channels and transporters are key components in a wide variety of biological processes that involve rapid changes in cells and have broad therapeutic applicability including oncology, metabolic disease, pain, neurological diseases, infectious diseases and others. The Icagen technology leverages proprietary expertise in the combination of biological assays, medicinal chemistry, and in silico and computational chemistry applications to enable the discovery of ion channel targeting therapeutics. Partners in the pharmaceutical industry leverage Icagen’s platform to develop first-in-class therapies for patients in need, typically under collaborative arrangements through the time of clinical candidate selection, with partners responsible for subsequent clinical development and commercialization. About Ligand Pharmaceuticals Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. Our business model creates value for stockholders by providing a diversified portfolio of biotech and pharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Our goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable, diversified and lower-risk business than a typical biotech company. Our business model is based on doing what we do best: drug discovery, early-stage drug development, product reformulation and partnering. We partner with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory management and commercialization) ultimately to generate our revenue. Ligand’s OmniAb® technology platform is a patent-protected transgenic animal platform used in the discovery of fully human monoclonal and bispecific therapeutic antibodies. The Captisol platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Ligand’s Pelican Expression Technology is a robust, validated, cost-effective and scalable platform for recombinant protein production that is especially well-suited for complex, large-scale protein production where traditional systems are not. Ab Initio™ technology and services for the design and preparation of customized antigens enable the successful discovery of therapeutic antibodies against difficult-to-access cellular targets. Ligand has established multiple alliances, licenses and other business relationships with the world’s leading pharmaceutical companies including Amgen, Merck, Pfizer, Sanofi, Janssen, Takeda, Servier, Gilead Sciences and Baxter International.

Read More

PHARMA TECH

Pfizer, BioNTech COVID-19 vaccine works in more contagious coronavirus variants

Pfizer | January 11, 2021

Newly emerged variants of the novel coronavirus have sparked a key question: Will existing COVID-19 vaccines be less effective against them? But scientists have preliminary data showing that may not be the case, at least for Pfizer and BioNTech’s shot. Researchers from the University of Texas and Pfizer found that, in lab dishes, the vaccine was able to neutralize an engineered version of a variant, which bears an N501Y mutation in its spike protein. The finding was published in bioRxiv and hasn’t been peer-reviewed. Variants of coronavirus with this mutation were first discovered in the U.K. and South Africa and immediately grabbed global attention because they are more contagious. Currently available COVID vaccines—including Pfizer and BioNTech’s Comirnaty, or BNT162b2—target the spike protein of SARS-CoV-2, the coronavirus behind COVID-19. The N501Y mutation improves the ability of the virus’ spike protein to bind to its receptor on human cells, making it easier to gain entry for infection. To test whether Comirnaty worked against the mutation, the scientists collected antibodies from 20 vaccinated trial participants and compared their ability to kill off the engineered virus with the N501Y mutation to their ability to neutralize the strain on which Pfizer and BioNTech based Comirnaty.

Read More

BUSINESS INSIGHTS

Azzur Group Announces Executive Leadership Changes

Azzur Group, LLC | January 13, 2022

To support rapid company growth and best meet the demands of the business, Azzur Group announces new executive leadership appointments. Originally founded in Philadelphia in 2010, Azzur is a market-leading provider of GxP services for the pharmaceutical, biotechnology, medical device, and healthcare industries with offices and on-demand cleanrooms locations throughout the United States. Today, the organization provides comprehensive GxP solutions through its on-demand cleanrooms, consulting and advisory services, microbiology labs, and aseptic and GxP training. Ryan Ott has been promoted to Chief Operating Officer of Azzur Group. A long-time partner at Azzur, Ryan most recently served as Chief Administrative Officer. During his tenure, he has been instrumental in the overall strategic development of Azzur Group, initially in the Greater Philadelphia Region, while taking on additional responsibility with ongoing national expansion. In his new role, he collaborates with corporate and service-line leaders throughout the organization to execute on Azzur Group's strategic business plan. This includes Shaleen Parekh, who has been appointed to Sr. Vice President of Professional Services, with continuing oversight for Azzur Consulting, Azzur Labs, and Azzur Training Center; and Molly McGlaughlin, who has been appointed Sr. Vice President of Facilities Services, with continuing oversight for Azzur Cleanrooms on Demand™ as its Chief Operating Officer. Appointed to the new role of Chief Innovation Officer is Ravi Samavedam. In this role, he will focus on bringing forward new business concepts and service areas for Azzur's continued expansion. Ravi's extensive life sciences industry experience and dynamic leadership of Azzur Cleanrooms on Demand™ from its creation in 2018 through its national expansion, ideally position him to proactively identify novel service offerings for the enterprise. Most recently, Ravi served as President and COO of Azzur Cleanrooms on Demand™. He has been a member of Azzur Group since 2014. Ilya Vasserman has been promoted to Chief Information Officer (CIO) of Azzur Group and is responsible for overseeing the management and scale-out of Azzur's corporate information technology infrastructure while forming and leading a new corporate-wide procurement group. Ilya will also continue to spearhead technology adoption and internal tool development, furthering our business insights capabilities. Ilya most recently served as Senior Director of Financial Services and has been a member of Azzur Group since 2016. After nearly two years with Azzur Group, David Frank has been promoted to Vice President of Client Development, furthering the growth and maturation of Azzur's business development and marketing capabilities. As part of his expanded responsibilities, David will work closely with the executive leadership team to develop client-centric strategies across the organization to meet customer needs. Since joining Azzur Group in 2020, David has served as the Senior Director, Sales and Marketing. "I'm incredibly thrilled to announce the changes to the Azzur Group executive leadership team. Not only have these individuals proven to be excellent strategic partners for our enterprise, but each embodies Azzur Group's core values in their daily leadership. I offer my sincerest congratulations to Ryan, Ravi, Shaleen, Molly, Ilya, and David, and wish them much success in their new roles." Michael Khavinson, Azzur's Chief Executive Officer About Azzur Group Azzur Group provides the life science community with full lifecycle solutions for all their GxP needs. From Azzur Cleanrooms on Demand™ facilities, to labs, training centers, and consulting and advisory offices across the nation, Azzur helps organizations start, scale, and sustain their enterprises. With four decades of service to the industry, we've become a trusted partner to leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain.

Read More

Spotlight

The developmental versatility of pluripotent stem cells (PSCs) offers a powerful approach for directing cell fate, and these cells are a promising source of progenitors and terminally differentiated somatic cells for cell replacement therapy and drug screening applications. In culture, PSCs have a unique trait of unlimited propagation while retaining their inherent potential to differentiate into cells from the three embryonic germ layers. When plated onto a non-adherent culture dish, these cells aggregate to form embryoid bodies (EBs) which undergo a process of spontaneous differentiation that closely imitates early human embryogenesis.