Rocuronium Bromide

Partners working to expand program after successful six-month pilot study at North Mississippi Medical Center, which enabled production of 12,000 doses of multiple drugs in limited supply ORMOND BEACH, Fla., Dec. 3, 2024 /PRNewswire/ -- Germfree Laboratories, On Demand Pharmaceuticals (ODP), and North Mississippi Medical Center-Tupelo (NMMC) have teamed up to address the global drug shortage crisis with a groundbreaking point-of-care medicine production solution. The expanding partnership aims to bring agile production of essential medicines closer to the point of care across the country and globally, ensuring a reliable supply of life-saving drugs. Continue Reading Pharmacy staff monitoring pharmacy operations digitally With more than 75% of U.S. hospitals facing medication shortages and millions of people in low- and middle-income countries lacking access to critical medicines, the need for localized, flexible production is urgent. By combining Germfree's mobile cleanroom technology with ODP's Pharmacy on Demand platform, this collaboration empowers healthcare providers to produce high-quality medications on site, reducing reliance on fragile global supply chains. The partnership builds on a six-month pilot study that leveraged ODP's platform technology and Germfree's mobile cleanroom capability to produce syringes of common shortage medicines at NMMC, including lidocaine, rocuronium, and potassium chloride. This real-world pilot met all regulatory requirements, leveraged a state-of-the art quality management approach, and demonstrated a novel, agile compounding capability for drugs on shortage. It resulted in patients being treated with high-quality medicines that were made on-demand and on-site. "We're not just filling gaps in the supply chain, we're redefining it," said Kevin Kyle, CEO of Germfree. "With On Demand Pharma, we are enabling healthcare providers to meet patient needs faster and more reliably, whether in urban centers or rural areas. This partnership also demonstrates our commitment to using cutting-edge technologies to improve the way hospital pharmacies respond to the needs of their patients, with more to come." Matt Pietras, CEO of On Demand Pharmaceuticals, added, "This collaboration with Germfree provides us with the high-quality modular infrastructure needed to provide our Medication-as-a-Service (MaaS) where patients and healthcare providers need it most." The innovative model will allow hospitals like NMMC to produce critical medications locally, improving access for patients and ensuring continuity of care even during global supply disruptions. "Our pilot work completed through this collaboration has proven these new capabilities for on-site compounded medications are able to help us better serve our communities in a timelier manner," said Wes Pitts, System Director of Pharmacy at North Mississippi Health Services, which includes NMMC in Tupelo. "In our pilot program, we were able to successfully compound approximately 12,000 doses of shortage medications starting in December 2023 following regulations from the Board of Pharmacy." "We are on the cusp of expanding distributed medicine production through our network while creating a new paradigm," said John Lewin, Chief Medical Officer at ODP. "I envision a future where pharmacists take a leading role in medicine production – both today and as personalized medicine becomes the standard at the point of care." The collaboration between Germfree and On Demand Pharmaceuticals is set to transform the future of medicine accessibility by providing healthcare providers with the tools to produce medications on demand, whenever and wherever they are needed. About Germfree Laboratories: Germfree Laboratories is a global leader in cleanroom and critical environment technologies, specializing in providing innovative solutions for biopharmaceutical, healthcare, and research sectors. Learn more at . About On Demand Pharmaceuticals: On Demand Pharmaceuticals (ODP) is revolutionizing pharmaceutical access with its Pharmacy on Demand platform, offering agile, on-site production of medications. ODP is committed to overcoming industry barriers and ensuring high-quality medicines are accessible to all. Learn more at . About North Mississippi Medical Center: North Mississippi Medical Center (NMMC) is one of the largest non-metropolitan hospitals in the U.S., providing comprehensive medical services to a growing community. NMMC is committed to innovation in healthcare delivery to ensure high-quality, accessible care for its patients. For more information, visit . SOURCE Germfree Laboratories LLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Pictured: Merck research laboratories in California/iStock, hapabapa Merck in an SEC filing disclosed on Monday that Hikma Pharmaceuticals U.S. is seeking the FDA’s approval for its generic version of the muscle relaxant reversal injection Bridion (sugammadex) prior to the drug’s patent expiration. Hikma notified Merck of its intention on Feb. 5, 2024, according to the SEC filing. The British pharma is making its regulatory request under the Hatch-Waxman Act—also known as the Drug Price Competition and Patent Term Restoration Act of 1984—which established the approval pathway for generics. Specifically, Hikma is seeking approval for its Bridion copycat through a Paragraph IV Patent Certification letter, which according to the FDA’s website allows the approval of generics given that the patent for its reference product is “invalid, unenforceable, or will not be infringed by the generic product.” Under the Paragraph IV process, Merck has 45 days from being notified of the patent challenge to infringement suit against Hikma. While the court resolves the complaint, the FDA’s approval for the generic product is generally postponed for 30 months, unless the patent expires or a judge decides against the patent holder before then. Merck is “currently considering its options,” according to its SEC filing. Bridion is a modified gamma cyclodextrin that works by diffusing through the patient’s plasma and capturing the neuromuscular blocking agents rocuronium and vecuronium. The injectable drug first won the FDA’s approval in 2015 for use in adults undergoing surgery. It carries warnings against anaphylaxis and bradycardia, while its most common adverse events include vomiting, pain and nausea. The drug is one of Merck’s top-selling assets—and is still showing signs of growth. In 2023, Bridion brought in a little more than $1.84 billion, an increase from nearly $1.69 billion in revenue in 2022 and $1.53 billion in 2021, according to the SEC filing. In June 2023, the U.S. District Court for the District of New Jersey ruled in favor of Merck, finding that the company had correctly calculated its Patent Term Extension duration for Bridion. The court ruling protects Bridion from generic competition in the U.S. through at least January 2026. Bridion’s protections have already expired in the EU, in Japan and in China. At the time, Merck General Counsel Jennifer Zachary in a statement said that the decision will ultimately allow the company “to continue investing in research and development,” bringing new and innovative treatments to patients with unmet medical needs. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.