PCI Pharma Services | July 28, 2020
PCI Pharma Services, a leading pharmaceutical and biopharmaceutical global outsourcing solutions provider, today announced a significant milestone in its global clinical footprint with the creation of a new Clinical Center of Excellence (COE) in Western Europe at its Berlin location, a major investment that will represent a new flagship site for customers. This is part of PCI’s global strategy to expand its clinical supply-chain network into continental Europe to complement offerings available at its UK and Ireland sites. The COE is expected to be completed in January 2021.
“With this expansion, our Berlin Clinical Center of Excellence will address the needs of European and global clients,” said Brian Keesee, vice president and general manager, Global Clinical Operations and Supply, PCI Pharma Services. “Berlin is an excellent logistical hub that will serve as a proactive solution to Brexit, ensuring there are no gaps in the supply chain and our clients conducting clinical trials in all parts of Europe continue to be served.”
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RESEARCH
Eli Lilly | November 11, 2020
The U.S. just had another COVID-19 drug authorized for emergency use. But the approval is limited—and, with at least one vaccine launch on the horizon, industry watchers wonder whether drugs to treat the illness have any staying power. The FDA authorized Eli Lilly’s bamlanivimab for emergency use on Monday, making it the first antibody therapy to win that distinction. Dubbed LY-CoV555, it's an anti-SARS-CoV-2 antibody therapy the Indianapolis pharma is co-developing with AbCellera. The OK comes with some caveats: It's limited to patients 12 years and older who aren't hospitalized but who are at high risk of developing severe illness, including elderly people and those with certain underlying conditions. And Lilly is advising infusion within 10 days of symptom onset.
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PHARMA TECH
MyMD | November 24, 2021
MyMD Pharmaceuticals, Inc. a clinical stage pharmaceutical company committed to extending healthy lifespan by delaying aging, announced that the U.S. Patent and Trademark Office (USPTO) today issued U.S. Patent 11,179,382 B2, titled “Methods of Reversing Normal Aging Process and Extending Lifespan.” The allowed claims protect the use of MYMD-1 in a method designed to extend the lifespan of an individual.
“This patent is a timely addition to our IP portfolio as we advance toward the launch of our fully funded Phase 2 trial of MYMD-1 for aging. After a comprehensive review by USPTO, we are pleased with the broad scope of the granted claims which offer further protection for our lead drug candidate, which we believe has the potential to become the first and only FDA-approved therapeutic solution for delaying aging and prolonging healthy lifespan,”
Chris Chapman, M.D., President, Director and Chief Medical Officer of MyMD
“Our primary focus for MYMD-1 is to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan,” Dr. Chapman added. “It’s also important to note that MYMD-1 shows promise in pre-clinical studies as a treatment for immune diseases including rheumatoid arthritis, multiple sclerosis, and Hashimoto’s thyroiditis, and as an anti-fibrotic and anti-proliferation therapeutic.”
The latest patent adds to MyMD’s intellectual property portfolio of 14 granted patents (12 U.S. and two foreign) covering MYMD-1 in methods of treating chronic inflammation, autoimmune disorders, diabetes, multiple sclerosis, viral infections, addictions, fibrosis, asthma, and other disorders. MyMD also holds two patents for its synthetic cannabidiol (CBD) derivative Supera-CBD. An additional 30 patent applications are pending worldwide.
About MYMD-1
Originally developed for autoimmune diseases, MYMD-1’s primary purpose is to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan. Because it can cross the blood-brain barrier and gain access to the central nervous system (CNS), MYMD-1 is also positioned to be a possible treatment for brain-related disorders. Its mechanism of action and efficacy in diseases including multiple sclerosis (MS) and thyroiditis have been studied through collaborations with several academic institutions. MYMD-1 is also showing promise in pre-clinical studies as a potential treatment for post- COVID-19 complications and as an anti-fibrotic and anti-proliferation therapeutic.
MYMD-1 has shown effectiveness in pre-clinical studies in regulating the immune system by performing as a selective inhibitor of tumor necrosis factor-alpha (TNF-α), a driver of chronic inflammation. Unlike other therapies, MYMD-1 has been shown to selectively block TNF-α when it becomes overactivated in autoimmune diseases and cytokine storms, but not block it from doing its normal job of being a first responder to any routine type of moderate infection. MYMD-1’s ease of oral dosing is another differentiator compared to currently available TNF-α blockers, all of which require delivery by injection or infusion. No approved TNF inhibitor has ever been dosed orally. In addition, the drug is not immunosuppressive and has not been shown to cause the serious side effects common with traditional therapies that treat inflammation.
About MyMD Pharmaceuticals, Inc.
MyMD Pharmaceuticals, Inc. a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. MYMD-1 is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. MYMD-1 is being developed to delay aging, increase longevity, and treat autoimmune diseases and COVID-19- associated depression. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs.
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