FDA recommends LC-HRMS to test for NDMA in ranitidine products

European Pharmaceutical Review | October 03, 2019

The US Food and Drug Administration (FDA) has announced an update on its method recommendation of testing for NDMA in ranitidine medication products. The ingredient is a probable human carcinogen. A previous method published by the FDA for testing angiotensin II receptor blockers (ARBs) for nitrosamine impurities has been utilised by a third-party laboratory to test ranitidine products. However, this uses high temperatures which results in ranitidine generating NDMA. Therefore, the FDA has recommended using a Liquid Chromatography-High Resolution Mass Spectrometry (LC-HRMS) technique to test samples as this does not use high temperatures. These tests have shown the presence of much lower levels of NDMA in ranitidine products than the third-party laboratory. Other international regulators using a similar LC-MS method have also demonstrated low levels of NDMA in ranitidine samples.

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Jazz Pharmaceuticals Announces Agreement to Divest Sunosi® (solriamfetol) to Axsome Therapeutics

Jazz Pharmaceuticals plc | March 28, 2022

Jazz Pharmaceuticals plc announced that it has entered into a definitive agreement to divest Sunosi® a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea to Axsome Therapeutics. Under the terms of the agreement, Axsome will receive the rights to Sunosi in all of the existing territories available to Jazz. Jazz will receive attractive financial terms including an upfront payment of $53 million, a high single-digit royalty on Axsome's U.S. net sales of Sunosi in current indications and a mid-single-digit royalty on Axsome's U.S. net sales of Sunosi in future indications. The divestiture of Sunosi to Axsome will enable Jazz to sharpen its focus on its highest strategic priorities designed to deliver sustainable growth and enhanced shareholder value. In assessing the positioning of Sunosi in the overall treatment landscape, Jazz determined Axsome would be well positioned to deliver access to this important medication and to maximize the value of Sunosi to Jazz through future growth. Sunosi's consistent positive feedback from patients, HCPs and providers is underscored by its well-established and clinically meaningful efficacy. Importantly, Jazz and Axsome are committed to ensuring that patients receive uninterrupted access to Sunosi throughout the transition. Wake-promoting agents are most often prescribed by psychiatrists, neurologists and general practitioners. Therefore, Jazz believes Axsome is well placed to leverage its commercial business, which will have highly complementary call points, to drive Sunosi as one of the lead products in their portfolio and ensure Sunosi can continue to reach those patients who may benefit from this important medicine. "This transaction advances our efforts to deliver sustainable growth, enhanced shareholder value and drive the transformation of Jazz to an innovative, global biopharmaceutical leader. Jazz will continue to be laser-focused on investing in our highest strategic priorities including our ongoing launches, advancing our pipeline, pursuing opportunistic corporate development and achieving margin expansion. Through our development and launch of Sunosi, the Jazz team has laid the foundation for Axsome to continue supporting people who may benefit from this much-needed treatment. As a leader in sleep medicine and rare epilepsies, with a growing oncology franchise, Jazz remains committed to developing new, innovative therapies in neuroscience and oncology for patients and delivering on our recently announced Vision 2025." Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals "We are impressed by the clinically meaningful efficacy, unique mechanism of action, positive patient and physician feedback and growth potential of Sunosi, and are excited by the excellent strategic fit with the Axsome portfolio. The addition of Sunosi will augment and accelerate our commercial preparedness ahead of the potential near-term launches of our two existing lead assets and allows us to fully leverage our first-in-class Digital Centric Commercialization™ platform with three complimentary assets," said Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics. Sunosi is a dopamine and norepinephrine reuptake inhibitor indicated for the treatment of excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) in adult patients. Sunosi is the first DNRI approved to treat EDS in adults living with narcolepsy or OSA. About Sunosi® Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea (OSA). Sunosi received U.S. Food and Drug Administration approval on March 20, 2019, to improve wakefulness in adult patients with EDS associated with narcolepsy or OSA and was designated a Schedule IV medicine by the U.S. Drug Enforcement Agency on June 17, 2019. In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize solriamfetol from Aerial Biopharma LLC. Jazz Pharmaceuticals has worldwide development, manufacturing, and commercialization rights to solriamfetol, excluding certain jurisdictions in Asia. SK Biopharmaceuticals Co., Ltd., the discoverer of the compound, maintains rights in 12 Asian markets, including Korea, China and Japan. Sunosi has orphan drug designation for narcolepsy in the United States. About Jazz Pharmaceuticals Jazz Pharmaceuticals plc is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases – often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. Within these therapeutic areas, we are identifying new options for patients by actively exploring small molecules and biologics, and through innovative delivery technologies and cannabinoid science. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries.

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BUSINESS INSIGHTS

AIkido Pharma Announces Strategic Investment in Social Communications Platform Provider Discord, Inc

AIkido Pharma Inc. | May 05, 2022

AIkido Pharma Inc. announced that the Company has secured an early equity interest in privately-held Discord, Inc. a social communications platform provider that is particularly popular with gamers. Bloomberg Technology reported on March 14, 2022, that Discord "is interviewing bankers about going public as soon as this year." According to the Bloomberg report, "Discord, last valued by private investors at about $15 billion, is especially popular with gamers and young people. Its success caught the attention of potential suitors, including Microsoft Corp., which was rebuffed after offering $12 billion for it last year." According to The Straits Times, Discord has also held discussions with Epic Games and Amazon.com in the past. "This investment fits well into our strategy to maximize opportunity for liquidity and monetization events for our shareholders. We believe the offer by Microsoft to buy the company bodes well for this investment, as does a potential near-term IPO." Anthony Hayes, CEO of AIkido About AIkido Pharma Inc. AIkido Pharma Inc. was initially formed in 1967 and is a biotechnology Company with a diverse portfolio of small-molecule anticancer and antiviral therapeutics. The Company's platform consists of patented technology from leading universities and researchers, and we are currently in the process of developing an innovative therapeutic drug platform through strong partnerships with world renowned educational institutions, including The University of Texas at Austin and University of Maryland at Baltimore. Our diverse pipeline of therapeutics includes therapies for pancreatic cancer, prostate cancer. We are constantly seeking to grow our pipeline to treat unmet medical needs in oncology. The Company is also developing a broad-spectrum antiviral platform that may potentially inhibit replication of multiple viruses including Influenza virus, SARS-CoV MERS-CoV, Ebolavirus and Marburg virus.

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PHARMA TECH

ADDING MULTIMEDIA Entos Pharmaceuticals Expands R&D Operations into the US

Entos Pharmaceuticals | June 08, 2022

Entos Pharmaceuticals, a clinical-stage biotechnology company developing genetic medicines with its Fusogenix proteolipid vehicle (PLV) nucleic acid delivery platform, announced today the opening of its new 9,600 square foot research and development facility in the Torrey Pines community of San Diego, California. This collaborative space will be shared with Entos’ sister companies, Oisín Biotechnologies, OncoSenX, and Aegis Life, allowing the companies to expand their team and infrastructure and support continued growth. Entos’ new office and lab space is located at the MUSE in Torrey Pines, a redeveloped 186,000 square foot life sciences property completed in 2021. Featuring three buildings, the campus was designed with walking paths, a locally-sourced restaurant, and conference space with indoor and outdoor seating. The US location complements Entos’ existing Canadian headquarters and R&D facilities in Edmonton, Canada, and new offices in London, UK. “We’re excited to move into our new lab space in San Diego, which is becoming one of the largest biotechnology hubs in the world for pharmaceutical research and innovation. This is a significant milestone for Entos as we continue developing genetic medicines for some of our most challenging diseases.” John D. Lewis, Ph.D., founder, and CEO of Entos Pharmaceuticals Entos’ proprietary Fusogenix PLV drug delivery system is formulated with FAST proteins to enable the delivery of nucleic acid cargo, such as DNA and RNA, directly into target cells. This technology is applicable to a wide range of genetic medicines. Unlike conventional lipid-based and viral-based delivery systems, Fusogenix PLVs have demonstrated, in multiple studies, to be well tolerated at high systemic doses, redosable, and able to target multiple tissues in the body. This announcement comes on the heels of two significant collaborations that began in late 2021, granting exclusive rights to Entos’ Fusogenix PLV nucleic acid delivery technology to research, develop and commercialize therapeutic genetic medicines. The first agreement was with BioMarin to target certain rare diseases. The second was a license agreement with Eli Lilly for multiple programs for central and peripheral nervous system diseases and came with an initial payment of $50M and $400M in milestones per program. About Entos Pharmaceuticals A new reality in genetic medicine lies ahead, one that will be ushered in with the advent of safe, effective, and redosable nucleic acid delivery technologies. At Entos, we develop next generation genetic medicines using our proprietary Fusogenix proteolipid vehicle (PLV) drug delivery system. Fusogenix PLVs are formulated with FAST proteins to enable the delivery of nucleic acid into target cells through direct fusion.

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BUSINESS INSIGHTS

Ascletis Announces Submission of Marketing Authorization Applications for Ritonavir in Multiple European Countries

Ascletis Pharma Inc. | February 14, 2022

Ascletis Pharma Inc.announces that it has submitted marketing authorization applications for ritonavir in Germany, France, Ireland and United Kingdom through its agent in Europe. It is expected that more marketing authorization applications for ritonavir in certain other countries, including the ones in Europe, North America and Asian Pacific will soon be submitted. Ascletis has been in discussion with both domestic and international companies, including major multi-national pharmaceutical companies, for the commercial supplies of ritonavir in China and globally. Oral ritonavir tablet is a pharmacokinetic booster of multiple oral antiviral drugs targeting viral proteases and a component of oral antiviral drug Paxlovid. Ascletis aims to be one of the global commercial suppliers of oral ritonavir tablets. Ascletis owns the only authorized oral ritonavir tablet in China, which passed bioequivalence study. Ascletis' oral ritonavir tablet was approved in September 2021 by China National Medical Products Administration. Ascletis has been applying sophisticated formulation technology to significantly increase human bioavailability of ritonavir which has a very poor solubility and successfully achieved human bioequivalence with the oral ritonavir tablets produced by the originator, AbbVie. On January 3, 2022, Ascletis announced that oral ritonavir tablet annual production capacity has been expanded to 100 million tablets and can be further rapidly expanded based on market demand. About Ascletis Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange, a global platform covering the entire value chain from discovery and development to manufacturing and commercialization. Ascletis is committed to developing and commercializing innovative drugs in the areas of viral diseases, NASH/PBC, and cancer to address unmet medical needs both in China and globally. Led by a management team with deep expertise and a proven track record, Ascletis targets those therapeutic areas with unmet medical needs from a global perspective, and efficiently advances the developments of pipelines with an aim of leading in global competition. To date, Ascletis has three marketed products and 20 robust R&D pipelines of drug candidates with global competitiveness, and is actively exploring new therapeutic areas.

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Spotlight

Symmetry Rx Analytics, a pharmacy-based health risk assessment solution, reliably assesses member risk using pharmacy claims in only a few months, while traditional predictive modeling tools need 12 months of data. Although medical claims-based analytics are highly accurate, see how to approach that accuracy with pharmacy claims alone.

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