H1 2019 Report Featuring Daewoong Pharmaceutical, RaQualia Pharma

businesswire | May 23, 2019

Functional (Non Ulcer) Dyspepsia - Pipeline Review, H1 2019, provides comprehensive information on the therapeutics under development for Functional (Non Ulcer) Dyspepsia (Gastrointestinal), complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The guide covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases.
The Functional (Non Ulcer) Dyspepsia (Gastrointestinal) pipeline guide also reviews of key players involved in therapeutic development for Functional (Non Ulcer) Dyspepsia and features dormant and discontinued projects. The guide covers therapeutics under Development by Companies /Universities /Institutes, the molecules developed by Companies in Phase III, Phase II, Phase I and Preclinical stages are 2, 1, 2 and 1 respectively. Similarly, the Universities portfolio in Discovery stages comprises 1 molecules, respectively.Functional (Non Ulcer) Dyspepsia (Gastrointestinal) pipeline guide helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage.

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BUSINESS INSIGHTS

Virpax Pharmaceuticals Enters Into CRADA With The U.S. Army Institute of Surgical Research

Virpax® Pharmaceuticals, Inc. | May 06, 2022

Virpax® Pharmaceuticals, Inc. a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder, central nervous system (CNS) disorders and anti-viral indications, today announced that it has entered into a cooperative research and development agreement with the U.S. Army Institute of Surgical Research to evaluate Virpax’s Probudur™, an injectable long-acting liposomal bupivacaine in a hydrogel formulation that is injected at the wound site. Probudur is being developed to significantly reduce or eliminate the need for opioids after surgery in approved indications. Probudur is a local anesthetic that binds to the sodium channel, preventing pain signals from reaching the brain. In pre-clinical trials, Probudur has shown long duration pain control for at least 96 hours. The USAISR is the U.S. Department of Defense’s (DOD) primary laboratory for developing solutions for trauma and critical care challenges in combat casualties. “We are excited to announce this CRADA with the DOD as these military and government research collaborations are an integral part of our non-dilutive funding strategy,” Anthony P. Mack, chairman and CEO of Virpax In August of 2020, Virpax entered into a CRADA with the National Center for Advancing Translational Sciences, an institute of the National Institutes of Health (NIH), for the development of Envelta™, it’s intranasal spray product candidate for severe post-cancer pain and non-cancer pain. Under that agreement, multiple contracts to support the research, development, and manufacturing of Envelta have been awarded by the NIH to continue the product’s progress. About Virpax Pharmaceuticals Virpax is developing branded product candidates for non-addictive pain management and neurological disorders using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking FDA approval of its three patented drug delivery platforms. Epoladerm™ is a topical diclofenac spray film formulation being developed to manage osteoarthritis pain. Probudur™ is a single injection long-acting liposomal bupivacaine formulation being developed to manage post-operative pain. Envelta™ is an intranasal Molecular-Envelope Technology (MET) enkephalin formulation being developed for the management of post-cancer pain and non-cancer pain, as well as post-traumatic stress disorder (PTSD) under the name PES200. MET technology is also used in AnQlar™, Virpax’s product candidate to inhibit viral replication caused by influenza or SARS-CoV-2. Virpax recently acquired global rights to VRP324, a product candidate for the nasal delivery of a pharmaceutical-grade cannabidiol (CBD) for the management of rare pediatric epilepsy.

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BUSINESS INSIGHTS

EyePoint Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

EyePoint Pharmaceuticals, Inc. | April 19, 2022

EyePoint Pharmaceuticals, Inc. a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders, announced that the Company granted non-statutory stock options to new employees as inducement awards outside the Company’s 2016 Long-Term Incentive Plan in accordance with NASDAQ Listing Rule 5635(c)(4). The Company granted stock options to purchase up to an aggregate of 56,500 shares of EyePoint Pharmaceuticals common stock to four new employees. The stock options were granted on April 14, 2022. The grants were approved by the Compensation Committee and made as an inducement material to each employee entering into employment with EyePoint Pharmaceuticals in accordance with NASDAQ Listing Rule 5635(c)(4). The option awards have an exercise price of $12.69 per share, the closing price of EyePoint Pharmaceuticals’ common stock on April 14, 2022. The options have a ten-year term and vest over four years, with 25% of the original number of shares vesting on the first anniversary of the applicable employee’s date of grant and the remainder vesting in equal monthly installments over the following three years. Vesting of the options is subject to the employee’s continued service with EyePoint Pharmaceuticals through the applicable vesting dates. About EyePoint Pharmaceuticals EyePoint Pharmaceuticals is a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. The Company's pipeline leverages its proprietary Durasert® technology for sustained intraocular drug delivery including EYP-1901, a potential six-month intravitreal anti-VEGF treatment initially targeting wet age-related macular degeneration. Durasert’s proven intravitreal drug delivery platform has been safely administered to thousands of patients' eyes across four U.S. FDA approved products, including YUTIQ® for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye, which is currently marketed by the Company. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts.

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BUSINESS INSIGHTS

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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PHARMA TECH

Zynex Submits FDA Application for its Next Generation Fluid and Blood Volume Monitor

Zynex | January 04, 2022

Zynex, Inc. an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, rehabilitation, and patient monitoring, announced that it has submitted a 510(k) application to the U.S. Food and Drug Administration for the CM-1600, its next generation fluid monitoring system. "I am thrilled to announce that we have submitted a 510(k) premarket notification to the FDA for our CM-1600. We have worked diligently at adding key enhancements to our FDA-cleared CM-1500 Fluid Monitoring System, including wireless connectivity to the non-invasive wrist wearable. This 510(k) submission is an important step in the evolution of our fluid monitoring system, which we believe will become a vital tool to ensure optimal fluid management and quality care for patients at risk for hemorrhagic events." said Thomas Sandgaard, CEO "We are pleased to bring a meaningful treatment improvement to market through the submission of the CM-1600 to the FDA for 510(k) clearance," said Donald Gregg, Vice President, Zynex Monitoring Solutions. "The improved fluid and blood volume monitor will provide more accurate patient observance before, during, and after surgical procedures. We look forward to working closely with the FDA throughout the submission and clearance process to bring this next generation, first of its kind technology to the market." The Zynex Fluid Monitoring System is a 100% non-invasive solution for monitoring fluid changes throughout patient care environments. Patient fluid status is determined using an algorithm that combines the trends of several physiological parameters to generate a single Relative IndexTM (RI) value, allowing for fast interpretation of changes in fluid volume. About Zynex, Inc. Zynex, founded in 1996, markets and sells its own design of electrotherapy medical devices used for pain management and rehabilitation as well as developing noninvasive patient fluid, pulse oximetry and sepsis monitoring systems.

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