US Food & Drug Administration

SILVER SPRING, Md., May 31, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration issued warning letters to 30 retailers, including one distributor, for illegally selling unauthorized tobacco products. The unauthorized products were various types of Puff and Hyde brand disposable e-cigarettes, which were two of the most commonly reported brands used by youth e-cigarette users in 2022. The Puff products include Puff Bar. Today's action underscores the agency's unwavering commitment to addressing the role retailers and distributors of unauthorized tobacco products play in this concerning public health issue facing America's youth. "Protecting our nation's youth from tobacco products – including disposable e-cigarettes – is a top priority for the FDA," said FDA Commissioner Robert M. Califf, M.D. "We're committed to holding all players in the supply chain – not just manufacturers but also retailers and distributors – accountable to the law." Today's warning letters are a result of a nationwide blitz to crack down on the sale of unauthorized e-cigarettes that are popular with youth – specifically Puff and Hyde products. The blitz included investigations of hundreds of retailers and distributors across the country. All products cited in the warning letters are disposable e-cigarettes, which are the most commonly used e-cigarette product type among youth. Puff Bar and Hyde were the first and third most popular brands used by youth who reported using e-cigarettes, according to the 2022 National Youth Tobacco Survey. Among youth e-cigarette users, about 20 percent reported usually using Puff Bar or Hyde brand products in 2022. "Since becoming director of CTP, I've been crystal clear that FDA will not stand by while retailers and distributors seek to profit off illegally selling products that are well-known to appeal to youth," said Brian King, Ph.D., M.P.H., director of the FDA's Center for Tobacco Products. "Retailers and distributors play a key role in keeping unauthorized tobacco products off the shelves, and if they fail to do so, we're committed to taking appropriate action." When e-cigarettes lack a marketing authorization order from the FDA, selling or distributing them to consumers in the U.S. is prohibited under the Federal Food, Drug, and Cosmetic Act. The FDA generally sends warning letters the first time an inspection or investigation reveals a violation of the law, and recipients are given 15 working days to respond with the steps they'll take to correct the violation and to prevent future violations. A majority of recipients of warning letters voluntarily correct the stated violation. However, failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure and/or civil money penalties. In addition to today's actions among retailers, the FDA issued a warning letter to an importer of Puff Bar in October 2022; that investigation remains ongoing. To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. These are the only e-cigarette products that currently may be lawfully sold in the U.S. The distribution or sale of unlawfully marketed products is subject to enforcement action. The FDA remains steadfast in its commitment to protecting youth from the harms of tobacco products by ensuring illegal products are not marketed, sold, or distributed. These efforts include ongoing surveillance of the marketplace to identify violative products, including existing and emerging disposable e-cigarette products. In February, FDA filed the agency's first civil money penalty complaints against four e-cigarette manufacturers; to date, FDA has filed civil money penalty complaints against ten e-cigarette manufacturers. And in October 2022, the first complaints for permanent injunctions were filed against six e-cigarette manufacturers. From January 2021 through May 2023, FDA issued more than 560 warning letters. All of these actions are part of FDA's standing compliance and enforcement portfolio, and the latest counts of these actions will continue to be reported on a routine basis. FDA will continue to take action against anyone making, distributing, importing, or selling unauthorized e-cigarette products, especially those most used by youth. Additional Resources: Warning Letters Advisory and Enforcement Actions Against Industry for Unauthorized Tobacco Products Results from the Annual National Youth Tobacco Survey Media Contact: Abby Capobianco, 240-461-9059 Consumer Inquiries: Email or 888-INFO-FDA (888-463-0332) The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. SOURCE U.S. Food and Drug Administration

FARMINGDALE, New York, May 31, 2023 (GLOBE NEWSWIRE) -- DepYmed, Inc. (“DepYmed” or the “Company”) is a preclinical stage pharmaceutical company focused on developing transformative treatments for rare diseases and oncology that target the protein tyrosine phosphatase (PTP) family of enzymes. Today DepYmed announces it will be presenting two abstracts on its small molecule PTP1B inhibitor program at the 2023 International Rett Syndrome Foundation (IRSF) Rett Syndrome Scientific Meeting. The conference will be held June 5-7, 2023 at the Nashville Marriott at Vanderbilt University in Nashville, Tenn. “This is a unique opportunity for us to present our mechanism-based approach to treating Rett Syndrome and to report progress on our lead clinical candidate at this important scientific forum. We believe our data continue to validate the potential of our compound for this devastating disease,” said Andreas Grill, DepYmed’s President and CEO. “We look forward to sharing these early data at the conference and with the wider scientific community.” About IRSFIn 1983, a small, dedicated group of parents whose children had Rett syndrome formed the first non-profit to focus exclusively on Rett syndrome – the International Rett Syndrome Association (IRSA). In 2007, IRSA and Rett Syndrome Research Foundation (RSRF) consolidated resources to better serve families and maximize research investments toward a cure. The International Rett Syndrome Foundation (IRSF) emerged with a mission to accelerate research and empower families that builds upon these foundations’ pioneering work toward care and cure. empower families with information, knowledge, and connectivity. Today, the International Rett Syndrome Foundation continues its almost 40-year commitment to creating a world without Rett. It remains focused on accelerating research to treat and cure Rett syndrome as it seeks to empower families with information, knowledge, and connectivity. About DPM-1003Protein tyrosine phosphatases are major players in the control of cell signaling pathways that are disrupted in many diseases, yet no drug modulators of these enzymes have been successfully developed to date. DepYmed is the first company to develop a new class of orally bioavailable drug candidates that act by inhibiting PTP1B, one of the most important PTP drug targets. One of its lead compounds has shown promising efficacy in preclinical models of Rett syndrome, and the Company hopes to initiate a Phase 1 clinical trial in 2024. DPM-1003 has been granted Orphan Drug designation by the U.S. Food and Drug Administration and conditionally designated under the FDA’s Rare Pediatric Disease program. About Rett SyndromeRett syndrome is a progressive neurodevelopmental disorder that almost exclusively affects females. Infants with Rett syndrome generally develop normally for 6 to 18 months after birth. At this point, they lose previously acquired skills (developmental regression) such as purposeful hand movements and the ability to communicate. Affected children often develop autistic-like behaviors, breathing irregularities, feeding and swallowing difficulties, growth retardation, and seizures. Most Rett syndrome cases are caused by mutations of the MECP2 gene on the X chromosome and can present with a wide range of disability ranging from mild to severe. The expression of PTP1B, DepYmed’s target in Rett syndrome, is regulated by MECP2; in turn, PTP1B controls important cell functions that are disrupted in the disease. About DepYmed, Inc.DepYmed Inc., is a New York based rare disease and cancer therapeutic development company that was founded to capitalize on the scientific discoveries of the Tonks lab at Cold Spring Harbor Laboratory in the physiological function of PTP1B and ways to modulate its role in various human diseases. DepYmed is currently developing a new class of potent, orally bioavailable small molecule inhibitors of the enzyme PTP1B as novel therapeutics for Rett Syndrome and different types of cancer. In addition, DepYmed has also discovered a novel class of small molecules with copper chelating properties that it is developing as potential therapeutic agents for such diseases as Wilson disease and various cancers. The company is actively developing a deep pipeline of new compounds with broad therapeutic potential in these emerging drug classes in collaboration with Cold Spring Harbor Laboratory. For more information, please visit the Company’s website at: www.depymed.com. For Media Inquiries please contact: Jules AbrahamJQA Partners, Inc.jabraham@jqapartners.com 917-885-7378 DepYmed:info@depymedinc.com

The proportion of acute cerebral ischemic stroke patients with the mRS of 0-2 on day 90 post-randomization was statistically significant (p=0.002) Sovateltide is a first-in-class drug that increases blood flow, inhibits apoptosis, and induces neurovascular remodeling WILLOWBROOK, Ill., May 31, 2023 (GLOBE NEWSWIRE) -- Pharmazz, Inc. (“Pharmazz” or the “Company”), a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, announced that The Directorate General of Health Services, India on May 31st, 2023, granted the manufacture and marketing of Sovateltide Injection for cerebral ischemic stroke patients. The company is preparing to launch Sovateltide, an endothelin-B receptor agonist, for the treatment of patients with acute cerebral ischemic stroke. The company plans to make Sovateltide available to patients in India in the third quarter of 2023. “Marketing authorization is a significant milestone for Pharmazz and acute ischemic stroke patients in India,” said Anil Gulati, M.D., Ph.D. Inventor, Chief Executive Officer, and Chairman of the Board of Pharmazz. “Previously, we reported the results of our successful Phase III trial in acute cerebral ischemic stroke patients that we conducted in India. That trial demonstrated a significantly (p=0.0045) greater number of patients showing an improvement of 2 or more points on the modified Rankin Score (mRS). Additionally, the proportion of acute cerebral ischemic stroke patients with the mRS of 0-2 on day 90 post-randomization was statistically significant (p=0.002). Moreover, the drug was well tolerated, with no drug-related adverse events reported.” In addition, the US Food and Drug Administration (FDA) has issued a proceed forward letter regarding the Company’s Investigational New Drug (“IND”) application that includes the protocol entitled, “A Multicentric, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase III Study To Assess The Safety And Efficacy Of Sovateltide In Patients With Acute Cerebral Ischemic Stroke.” Pharmazz is working with the FDA on suggestions for the study design and updating the protocol for a Special Protocol Assessment. More details on the clinical trial design, including the complete list of secondary endpoints, can be found on clinicaltrials.gov (NCT05691244). About Pharmazz, Inc. Pharmazz, Inc. is a privately held company developing novel products in critical care medicine. Additional information may be found on the Company’s website, www.pharmazz.com. Media Contact:Shruti GulatiPharmazz Inc.Email: shruti.gulati@pharmazz.comPhone: (630) 780-6087