Trump seeks favored-nation order on drug prices-but what would that even look like?

fiercepharma | July 08, 2019

Despite tough talk, President Donald Trump has watched U.S. drug prices climb since he took office. Now, Trump says he favours an executive order to address the problem—but his approach has some experts bewildered. In a wide-ranging face-to-face with reporters Friday, Trump said the White House was considering an order creating a “favored-nation” clause for drugs sold to the U.S. government, which would essentially secure the lowest possible prices on the market—or so he says. While it’s not yet clear what the scope of the proposal would be—or how it differs from the administration’s international price index pilot program—Trump said the measure would level the playing field for government payers. “For years and years, other nations paid less for drugs than we do—sometimes by 60% or 70%,” Trump said. “Why should other nations—like Canada—but why should other nations pay much less than us? They’ve taken advantage of this system for a long time: pharma.” On the heels of Trump’s comments, Nasdaq’s Biotechnology Index tumbled from a high of $3,480.81 on Friday morning to $3,435.35 at market close—a 1.13% decrease. The index is down roughly 6.6% from the same time last year. So far, experts don't think such an order would have much effect. And typically, "favored nation" status is something the U.S. bestows on trading partners—other countries—rather than companies. According to the World Trade Organization, a most-favored-nation clause "denotes the equal treatment of all countries" when it comes to trade.

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EU Approves Zynlonta for Relapsed or Refractory Diffuse Large B-cell Lymphoma

ADC Therapeutics | January 03, 2023

Sobi® and ADC Therapeutics SA informed that Zynlonta® (loncastuximab tesirine) has recently received conditional marketing authorization from the European Commission (EC) for the treatment of diffuse large B-cell lymphoma ((DLBCL) that has relapsed or become resistant. The approval comes after the European Medicines Agency's Committee for Medicinal Products for Human Use issued a favorable opinion in September. Sobi has said that it wants to give Zynlonta, a new treatment for diffuse large B-cell lymphoma, to people in the European Union who have this debilitating blood cancer. The approval was granted based on the findings from LOTIS-2, which was a large (n=145), phase 2 multinational, single-arm clinical study of Zynlonta for treating adult patients who had relapsed or refractory DLBCL following two or more prior lines of systemic therapy. Zynlonta was granted accelerated approval by the United States Food and Drug Administration in April 2021. This approval made it the first CD19-targeted antibody-drug conjugate to be used as a single-agent treatment for adult patients who had relapsed or been resistant to two or more lines of systemic therapy for their DLBCL. Sobi announced an exclusive license agreement with ADC Therapeutics to develop and commercialize Zynlonta in Europe and other international markets. The license aims to boost Sobi's presence in hematology, one of its two main disease areas. Besides, Zynlonta will be sold with other Sobi hematology drugs. ADC Therapeutics added that this approval expands Zynlonta's global reach. Zynlonta will fill a critical unmet need for DLBCL patients in Europe. The EU decision applies to Iceland, Norway, and Liechtenstein. According to the terms of the license agreement and as previously communicated, Sobi will pay ADC Therapeutics USD 50 million as a result of the EU's approval of DLBCL. Sobi's clinical development and product supply are handled by ADC Therapeutics. About ADC Therapeutics ADC Therapeutics next-generation, targeted antibody-drug conjugates help cancer patients. With a deep understanding of oncology and an ADC platform that the FDA's approval of Zynlonta has proven, the company is working to meet unmet medical needs and improve outcomes for people with hard-to-treat hematological cancers and solid tumors. ADC Therapeutics' highly skilled global team is committed to fighting cancer with science, bringing targeted therapies and hope to patients and their families.

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BUSINESS INSIGHTS

Silo Pharma Issues Letter to Shareholders Detailing Progress on Pipeline Assets Combining Traditional Therapeutics with Psychedelic Medicine

Silo Pharma, Inc. | December 02, 2022

Silo Pharma, Inc. a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, today issued a letter to shareholders highlighting the Company’s progress and potential for its portfolio of novel, IP-protected technologies and assets developed in collaboration with world-class medical research partners. The letter, in its entirety, is reprinted below. Dear fellow Silo Pharma shareholders, The healthcare market continues to build momentum as science and technology lead to new developments for therapeutics. Nowhere is this more evident than in the growing body of scientific research supporting the therapeutic potential of psychedelics. More than ever, alternative new therapies for numerous diseases and mental health disorders are needed to address the health challenges of today. Our Company, Silo Pharma, Inc. is working diligently to make further advances in the medical and psychedelic space. To date, the research conducted has shown encouraging promise in the delivery, efficacy, and safety of our pipeline therapeutics and technologies. This has been an exciting year where we have achieved numerous milestones and anticipate upcoming updates as our pipeline progresses. The purpose of this letter is to provide shareholders with an update on our current business. With over $12 million in cash, we are prepared to advance our pipeline, and believe, with our strong balance sheet, no debt, and recent listing on Nasdaq, that we are in a position to further advance the Company and create shareholder value. Valuable Intellectual Property and Collaboration We are focused on advancing traditional therapeutics with psychedelic research to treat underserved large markets. We believe that our novel IP-protected technologies and assets, developed in collaboration with world-class medical research partners, offer disruptive market potential. The unique assets in our portfolio are well protected with issued and numerous provisional patents pending. We obtained these assets through exclusive drug development collaborations, including a joint venture with Zylö Therapeutics, Inc.; a license and option agreement and an investigator-sponsored study agreement with the University of Maryland, Baltimore; a sponsored study agreement and a licensing option agreement with Columbia University; and a sponsored research agreement with the University of California, San Francisco. About Ketamine Ketamine is an FDA-approved fast-acting general anesthetic administered through intravenous injection or nasal spray. Scientific research has shown that ketamine’s interactions with certain brain chemicals may be connected to its pain management, anti-inflammatory, and antidepressant effects. Since 2000, increasing research on ketamine has demonstrated significant results as a treatment for pain conditions including chronic neuro-inflammatory disorders and for mood disorders including depression, PTSD, and anxiety. About Psilocybin Considered a serotonergic hallucinogen, this substance is an active ingredient in some species of mushrooms. While classified as a Schedule I controlled substance under the Controlled Substances Act there is an accumulating body of evidence that psilocybin may have beneficial effects on depression and other mental health conditions. The U.S. Food and Drug Administration and the U.S. Drug Enforcement Agency have permitted the use of psilocybin in clinical studies for a range of psychiatric conditions. About Silo Pharma Silo Pharma. Inc. is a development-stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research for people suffering from indications such as PTSD, Alzheimer’s disease, and other rare neurological disorders. Silo’s mission is to identify assets to license and fund the research which we believe will be transformative to the well-being of patients and the healthcare industry.

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Nephron and Sharps Announce Manufacturing and Research Partnership

Nephron Pharmaceuticals Corporation | November 15, 2022

Nephron Pharmaceuticals Corporation and Sharps Technology, Inc. announced a brand new partnership focused on developing and sharing best practices in innovative manufacturing, product development, customer support, and quality as Nephron prepares to launch the InjectEZ component of expansion. Sharps Technology is a medical device and pharmaceutical packaging company specializing in developing and manufacturing innovative drug delivery systems. Nephron Pharmaceuticals is known across the country to health systems and hospitals as a leader in the production of affordable generic inhalation solutions and suspension products, as well as pre-filled sterile syringes, luer-lock vials, IV bottles, and IV bags. InjectEZ is part of the Nephron investment of hundreds of millions of dollars of expansion in Lexington County, S.C., over the last two years. Lou Kennedy, Nephron CEO, knows that when launching an endeavor as ambitious as InjectEZ, partnerships are key. "We are excited to kick off a partnership with Sharps Technology, as our InjectEZ expansion project opens, for a variety of innovative initiatives, including research and development," said Kennedy. "Just as the InjectEZ syringe manufacturing facility is poised to play a critical role in assisting those with whom we work on tackling emerging public health crises, Sharps Technology also offers key solutions to healthcare challenges. We look forward to working with them." Sharps product lines have historically focused on low waste and ultra-low waste syringe technologies, which allow up to 40% more injections per vial of therapy while incorporating multiple passive safety features. These features protect front-line healthcare workers from life-threatening needle stick injuries and protect the public from needle re-use. The partnership with Nephron opens up opportunities for Sharps to expand its portfolio and make an impact on the specialized pre-fillable syringe and drug delivery systems market. "Sharps Technology has identified a unique opportunity to collaborate with a leader in the industry like Nephron. Through my previous industry experience supporting and working with most of the leading healthcare and pharmaceutical companies in the world, it was easy for me to evaluate Nephron Pharmaceuticals as a potential partner. They truly are a leader in all areas of business and an example of best in class for the industry. I appreciate and look forward to the opportunity to work with Bill and Lou Kennedy and their leadership team to make this collaboration a success for both companies." Robert Hayes, CEO of Sharps Technology Sharps Technology brings extensive expertise in syringes to Nephron, including experience with specialized pre-filled syringe systems and ready-to-use processing. The pre-filled syringe lines will utilize the highly automated equipment and controlled environments established by Nephron. These premium pre-filled polymer offerings will be made from the highest quality raw materials, on the most innovative technology, and will be compliant with the USP standards required in the United States as well as the EP and JP international standards. The products that will be developed and commercialized provide solutions to support the current Nephron fill/finish strategies as well as their pipeline of new drug applications and sets forward a strategy to support branded pharma and advanced therapies, including ophthalmic and biologic applications. Sharps Technology will also be partnering with Nephron Pharmaceuticals in the development of a Pharmaceuticals Services Program designed to support healthcare customers that need innovative solutions and products to support their business. The development of this program will help create new fill/finish project opportunities for Nephron that will utilize innovative packaging solutions developed by Sharps Technology. These new customer projects will fuel the growth of both companies, and the opportunity to create new technologies to support the healthcare industry will be transformative for Nephron and Sharps as they navigate a bright future working together.

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