FDA declares 40 generics free of carcinogens as 'sartan' recalls continue

FDA | April 05, 2019

As recalls on blood pressure drugs continue to plague drugmakers, the FDA declared a slate of 40 generic pills safe to use. On Thursday, the agency released a list of 40 generic angiotensin II receptor blockers (ARBs) that are free of three potentially carcinogenic compounds linked to various “sartan” drugs, including valsartan and losartan. The FDA launched a global recall in 2018 after a U.S. drug manufacturer found high levels of N-nitrosodimethylamine (NDMA) in the valsartan active ingredient it had bought from a Chinese supplier. Since then, the FDA discovered that NDMA, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) and NDEA—all considered unsafe at certain levels—can be created during sartan drug manufacturing under certain conditions. The first global recall included all non-expired generic valsartan sold by Major Pharmaceuticals, Teva and Huahai’s U.S. subsidiary, Solco Healthcare, as well as valsartan/hydrochlorothiazide (HCTZ) made by Teva and Solco.

Spotlight

Oligonucleotides are short strands of synthetic DNA or RNA that can selectively alter gene expression and protein production.

Spotlight

Oligonucleotides are short strands of synthetic DNA or RNA that can selectively alter gene expression and protein production.

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BUSINESS INSIGHTS, PHARMACY MARKET

COEUS Holdings Announces Rebranding to Reflect the Unification of Each Business Unit Into One Entity

Businesswire | May 02, 2023

COEUS, a leading healthcare communications, technology, talent, and consulting firm delivering a variety of services and platforms to all stakeholders in the healthcare ecosystem, announced today that it has completed a major rebranding. Following nearly 14 years of both organic growth and acquisitions, all business units have been combined to form one entity: COEUS. Since the company’s inception in 2009, the company sought to build a suite of services capable of providing end-to-end solutions for drug and therapy manufacturers ranging from preapproval, through launch, and eventual loss of exclusivity. “A little over 13 years ago, we started this company with just one employee. After a series of acquisitions, the hiring of more than 140 people, and the creation of numerous distinct business units all coming online at different times, we felt it was a necessary part of our evolution to consolidate the business units to one entity capable of servicing all clients,” stated Marc Hixson, CEO, COEUS. “Our clients have routinely told us that our experts, our strategic vision of what healthcare should be, and our commitment to leveraging — and building — technologies that improve the biotech, pharmaceutical, and payer audiences truly sets COEUS apart. It’s time to let the rest of the industry in on it.” Through the rebranding, the company has redesigned its logo, launched an entirely new website and reinvented all its marketing collateral to reflect the company’s new identity. As part of the consolidation, COEUS has appointed Jodie McVan to the position of Chief Commercial Officer. In her new role, Jodie will oversee the day-to-day operations, staffing, and the management of existing offerings, as well as drive the creation of new services and products for the consulting and agency business. “With the combination of end-to-end service offerings for manufacturers, our technology platforms and services for manufacturers and payers alike, and industry leading talent and deep subject matter expertise, COEUS is well-positioned to efficiently deliver world-class service to our clients,” stated Jodie McVan, Chief Commercial Officer, COEUS. Visit 1COEUS.com to explore the new website and brand. About COEUS Established in 2009, COEUS is a leading healthcare consulting, communications, technology, and talent firm. The company offers clients a variety of services, as well as SaaS technology platforms, for various stakeholders throughout the healthcare ecosystem including all payers and emerging or more established drug manufacturers. Leveraging the deep knowledge and experience of the company’s many subject matter experts, COEUS works on all drug types with a particular focus on cell and gene therapies, rare diseases, and oncology. The company also has unique expertise in the creation and management of value-based agreements by leveraging COEBRA™, the company’s evidence and outcomes adjudication platform. In its 13-year history, the company has supported the launch of more than 120 pharmaceutical brands and has worked with more than 300 pharma clients including many top global pharmaceutical manufacturers.

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BUSINESS INSIGHTS, PHARMA TECH

Simulations Plus Enters New Strategic Collaboration to Discover Anticancer Therapies Through Its AI-Driven Drug Design Technology

Businesswire | March 29, 2023

Simulations Plus, Inc. a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced that it established a strategic research collaboration with the Sino-American Cancer Foundation (SACF). This collaboration will leverage Simulations Plus’ staff and Artificial Intelligence-driven Drug Design technology in the ADMET Predictor® software platform to support the discovery and design of novel inhibitors of methylenetetrahydrofolate dehydrogenase 2 (MTHFD2), an emerging cancer target. Per the terms of the collaboration, Simulations Plus will develop quantitative structure-activity relationship (QSAR) models for efficacy against MTHFD2, using information from SACF as well as academic and patent literature. The biologists, computational and medicinal chemists in the Early Drug Discovery Services team at Simulations Plus will work with the researchers at SACF to define the multi-objective parameters against which the lead molecule(s) will be optimized. The new AIDD Module in ADMET Predictor® will then be employed to generate libraries of virtual compounds that are optimized for potency and other chosen parameters. The teams will select promising candidates for synthesis and testing, and ensuing rounds of QSAR model building and AIDD optimization will be performed until the milestone criteria in the collaboration agreement are achieved. “We value the trust and confidence SACF has in our team and AI technology to complement and accelerate conventional drug design and lead optimization processes,” said Dr. Jeremy Jones, Principal Scientist at Simulations Plus and project lead. “By combining their drug discovery expertise with our algorithmic and data science know-how, we are confident we will successfully support their hit-to-lead target development activities.” As part of this agreement, SACF will provide upfront funding to Simulations Plus to design a set number of compounds for efficacy against MTHFD2 which will be exclusive to SACF. Subsequent milestone payments will be made as key research and development goals are met. “SACF has had an active interest in AI for de novo design for some time, and we have found a trusted partner in Simulations Plus to help us integrate this into our research,” added Dr. Frank Luh, CEO of SACF. “Scientists from the two organizations will work side-by-side to combine SACF’s data with all that Simulations Plus offers to identify the next generation of compounds that could help in the treatment of cancer.” John DiBella, SLP Division President, said, “The Early Drug Discovery Services offering at Simulations Plus is tailor made for this type of partnership, where our team of experts, including computational, medicinal, and cheminformatics specialists, provide end-to-end AI-driven drug discovery and optimization support to complement the SACF team. Simulations Plus continues to invite future collaborations which benefit organizations and, most importantly, the global communities we serve.” About Simulations Plus, Inc. Serving clients worldwide for more than 25 years, Simulations Plus is a leading provider in the biosimulation market providing software and consulting services supporting drug discovery, development, research, and regulatory submissions. We offer solutions that bridge machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, and regulatory agencies worldwide.

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PHARMACY MARKET, PHARMA TECH

PANTHERx® Rare Launches Drug for APDS

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.

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