BUSINESS INSIGHTS, PHARMA TECH
prnewswire | April 28, 2023
Endo International plc announced that its subsidiaries Endo Ventures Limited and Par Pharmaceutical, Inc. have executed an agreement with Slayback Pharma LLC to distribute Slayback's Prevduo™ (neostigmine methylsulfate and glycopyrrolate injection) pre-filled syringe on an exclusive basis in the U.S. The U.S. Food and Drug Administration (FDA) approved Prevduo™ in February 2023 for the reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBA) after surgery, while decreasing the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) associated with cholinesterase inhibition following NMBA reversal administration.
Endo will commercialize Prevduo™ through its Par Sterile Products business and expects to launch the product in June 2023.
When launched, Prevduo™ will be the first and only FDA-approved neostigmine–glycopyrrolate combination product in the U.S. Both neostigmine methylsulfate and glycopyrrolate have been approved in the U.S. as single, active ingredient drug products. Neostigmine is always administered in conjunction with glycopyrrolate, and currently, its administration requires two syringes.
"Prevduo™ further strengthens our commitment to supporting healthcare providers and their patients through ready-to-use products that streamline operations," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. "We're proud to partner with Slayback to bring this critical care product to market and help hospitals deliver quality patient care."
"Following the development and FDA approval of Prevduo™, we're pleased to partner with Endo and tap into Endo's proven capabilities in commercializing injectable solutions, including ready-to-use products," said Ajay Singh, Founder and CEO of Slayback Pharma.
Ready-to-use, or RTU, products streamline operations for hospitals by eliminating the need to prepare or transfer the product before patient administration. This may reduce waste and costs, optimize convenience and workflow and reduce the chance for preparation error—all of which support quality patient care.
Endo is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them.
PHARMACY MARKET, PHARMA TECH
prnewswire | March 31, 2023
PANTHERx® Rare, one of the largest and fastest growing rare pharmacies in the United States, is pleased to announce the launch of Joenja® (leniolisib), an oral selective small-molecule PI3K delta inhibitor indicated for the treatment of APDS in adult and pediatric patients ages 12 or older.
"Our patients living with rare and devastating diseases deserve the best that medicine can offer. Through innovation and technology, we continue to make a positive impact on the quality of life of those living with rare diseases. We are pleased to add Joenja® to the list of medications in PANTHERx® portfolio," said Rob Snyder, president of PANTHERx® Rare.
Activated Phosphoinositide 3-Kinase-Delta Syndrome, or APDS, is a rare primary immunodeficiency affecting approximately one to two people per million with disease onset occurring as early as infancy. This condition results from a variant in the genes PIK3CD or PIK3R1 with both genes playing a role in the regulation of white blood cell maturation. The presence of a mutation in these genes lead to hyperactivity of the PI3Kδ pathway resulting in a failure for the immune cells (B and T cells) to mature and properly function. Imbalance in the PI3Kδ pathway results in immunodeficiency and dysregulation. Those with APDS may develop recurrent respiratory tract infections, bronchiectasis, lymphoproliferation as well as neurodevelopment delay and failure to thrive. Clinical presentation is highly variable ranging from asymptomatic adults to those suffering from lymphoproliferation or development of profound immunodeficiency.
Snyder explained Joenja® exerts its effects by blocking the active binding sites of PI3Kδ inhibiting the signaling pathway hyperactivity that leads to dysfunction and dysregulation of B and T cells. In clinical trials, Joenja® achieved both co-primary efficacy measures of reduction in lymph node size and correction of immunodeficiency in the target population. The most common adverse reactions (>10%) were headache, sinusitis, and atrophic dermatitis.
About PANTHERx Rare
PANTHERx Rare is one of the largest and fastest growing rare pharmacies in the United States. PANTHERx transforms lives by delivering medicine breakthroughs, clinical excellence, and access solutions to people living with rare and devastating conditions. Although the overall incidence of rare diseases is as common as diabetes, less than 7% of the 7,000 known rare and devastating disorders have an FDA-approved therapy. Changes in federal policy and advances in science have led to a surge in FDA orphan drug approvals, providing tremendous hope to the rare disease community.
PANTHERx was recently awarded Specialty Pharmacy of the Year by the National Association of Specialty Pharmacy and earned the inaugural Accredited Distinction in Rare Diseases and Orphan Drugs from the Accreditation Commission for Health Care. PANTHERx is now a five-time winner of the prestigious MMIT Patient Choice Award, including the 2022 honor. PANTHERx is headquartered in Pittsburgh, licensed in all 50 states, and holds accreditations from URAC, NABP, and ACHC.
RESEARCH, BUSINESS INSIGHTS
Medidata Solutions | March 13, 2023
Medidata, a leading provider of innovative software solutions for clinical trials that streamline the clinical trial process, reduce time and cost, and accelerate the development of new treatments, recently announced that Allucent, a contract research organization (CRO) that brings innovation to biopharma firms, is expanding the global use of Medidata's Clinical Cloud to enhance its clinical trial operations offering.
This agreement extends Allucent's current usage of Medidata's technology, which includes eCOA, Rave EDC, RTSM, and Rave Imaging, supporting crucial development areas such as rare and orphan indications, oncology and cell and gene therapies. As part of the deal, Allucent's team achieved 100% Rave EDC certification, reinforcing their dedication to quality and providing clients with industry-leading technology.
Allucent is a sponsor of Medidata NEXT London and will give a presentation on data analytics for early-phase oncology trials. The presentation will cover how working with Medidata has helped them apply visualization techniques and strategies to extract the total value of information for all stakeholders.
Medidata is a Dassault Systèmes company poised to drive the digital transformation of life sciences in the age of personalized medicine with its 3DEXPERIENCE platform. This platform is the first end-to-end scientific and business solution, from research to commercialization.
Medidata's head of Global Sales, Janet Butler, commented, "Allucent is leveraging the power of the Medidata Clinical Cloud to solidify their position at the forefront of clinical technology." She further emphasized, "Their work with novel therapies requires agile, patient-centric solutions. We are proud to build on our eight-year collaboration to advance the digital transformation of life sciences and deliver clinical innovations to help reach their goals."
(Source – Business Wire)
About Medidata Solutions
Medidata Solutions is a New York-based global provider of cloud-based software solutions for clinical trials. Its platform, the Medidata Clinical Cloud, enables pharmaceutical, biotechnology, medical device companies, and academic research organizations to manage all aspects of clinical trials, including study design, data capture, management, and analysis. Medidata's platform can capture real-time data from multiple sources, including electronic health records and wearable devices, to monitor patients closely, identify potential safety issues earlier, and make informed decisions about trial design and treatment protocols. The platform also features advanced analytics tools like machine learning and artificial intelligence algorithms to help researchers analyze and interpret their data. In 2019, Dassault Systèmes, a global leader in 3D design software and simulation solutions, acquired Medidata, further enhancing its platform.