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.

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Sartorius Cubis® II is designed to follow US FDA data integrity principles that require data to be accurate, legible, contemporaneous, original and attributable.

Spotlight

Sartorius Cubis® II is designed to follow US FDA data integrity principles that require data to be accurate, legible, contemporaneous, original and attributable.

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RESEARCH

DarwinHealth Announces Scientific Collaboration with Prelude Therapeutics in Oncology

Prelude Therapeutics | October 13, 2021

DarwinHealth, Inc. today announced a scientific research collaboration that uses its Biomarker Enrichment Strategies for Assays (BEST platform ) to elucidate novel biomarkers that guide translational trajectories of multiple cancer molecules being developed by Prelude Therapeutics. Under the collaboration, DarwinHealth will use its proprietary, quantitative, systems biology-based algorithms, CLIA-approved technologies, and validated approaches focused on Protein Master Regulator (MR) and tumor checkpoints to identify novel protein-based biomarkers that will add a significant precision a Selection of patient cohorts for clinical trials to be conducted at Prelude's discretion in hematological and solid tumors. The goal of this biomarker-focused collaboration, is to assess and characterize the general and tumor-specific mechanisms of action of molecules in the Prelude pipeline in an attempt to identify new biomarkers that can align these agents with responding patient cohorts. In addition, the The collaboration will mechanically characterize potential therapeutic opportunities for Prelude pipeline molecules that target various oncogenic pathways through multiple hematologic malignancies and solid tumor subtypes, as selected by Prelude Therapeutics.The study will leverage the VIPER algorithm to characterize the activity of these various compounds against key Master Regulator (MR) protein modules (tumor checkpoints) required for subtype-specific tumor viability. - Professor Andrea Califano , Professor and Director of Clyde and Helen Wu , Department of Systems Biology, Columbia Universityand co-founder of DarwinHealth "The BEST initiative will provide accurate and actionable tumor- and compound-specific information to assess the potential of Prelude's pipeline molecules to reverse the activity of subtype-specific tumor checkpoints," explained Dr. Mariano Alvarez , Chief Scientific Officer of DarwinHealth. "The purpose of such studies is to generate a range of validated compound / tumor subtype / biomarker alignments that represent evidence-based roadmaps and mechanisms for biomarker development and patient selection to potentially accelerate clinical studies." As part of the BEST initiative, DarwinHealth will provide a comprehensive reading of the potential clinical value of selected Prelude molecules in a spectrum of tumor types. Using quantitative modeling and biomarker-focused translation pathways, DarwinHealth will also assist in the design of in vivo validation studies to exploit key opportunities that may not be apparent with conventional technologies. "The BEST collaboration addresses one of the critical unmet needs of the biotech and biopharmaceutical spaces focused on cancer drug discovery, that is, the development of highly predictive biomarkers of clinical response to compounds whose ultimate efficacy may be the result of an incompletely decipherable range of both in - and multi-target off-target drug effects of regulatory programs underlying cancer dependencies, These uncertainties lend themselves to extending the concept of biomarkers beyond the primary target (ie, high affinity) of a drug, to multiple protein classifiers identified by our experimental and computational integrative methodologies." - Dr. Gideon Bosker, CEO and Co-Founder of DarwinHealth. These technologies are ideal for identifying mechanical alignments between drug candidates and cancer patients based on the ability of drugs to inactivate patient-specific MR proteins that are necessary for maintenance of tumor status. Importantly, these discoveries can rapidly mature into precision biomarker-driven human clinical trials and commercial development. About DarwinHealth, Inc. DarwinHealth: Precision Therapeutics for Cancer Medicine is a cancer frontier biotechnology-focused company, co-founded by CEO Gideon Bosker, MD, and Professor Andrea Califano, Clyde and Helen Wu Professor of Chemical Systems Biology and Chair of the Department of Systems Biology from Columbia University. The company's technology was developed by Califano's laboratory over the past 14 years and is exclusively licensed by Columbia University. DarwinHealth technology has been developed to identify mechanistic and biomarker-driven, processable and often unforeseen alignments at the proteomic level between small molecules and specific tumor subtypes / patient cohorts and is therefore positioned to accelerate the development of oncology pipelines. About Prelude Therapeutics Prelude Therapeutics is a precision clinical-stage oncology company developing innovative drug candidates that target critical pathways in cancer cells. The company's main candidate products are designed to be potent and selective oral inhibitors of PRMT5. Prelude's first clinical candidate, PRT543, is in phase 1 development for advanced solid tumors and selected myeloid cancers. Prelude also advances PRT811, a second PRMT5 inhibitor optimized for high brain exposure, in a phase 1 clinical trial that includes glioblastoma multiforme (GBM). The company's portfolio also includes its third clinical candidate, PRT1419,

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BUSINESS INSIGHTS

Louis Drapeau Has Resigned from the Board of Directors of Avita Medical, Inc

AVITA Medical | April 22, 2022

Louis Drapeau has resigned from the Board of Directors of AVITA Medical, Inc. a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, effective April 29, 2022. Mr. Drapeau's resignation is not the result of a disagreement with the Company over any of its operations, policies, or procedures. Rather, he is stepping down for personal reasons. Since January 2016, Mr. Drapeau has served as Chair of the Audit Committee and as a non-executive Director of AVITA Medical. Louis Drapeau had already stepped down as Chair of the Audit Committee as of February 23, 2022, as disclosed in the Company Form 10-KT dated March 1, 2022. James Corbett was appointed Chair of the Audit Committee in his place as of February 23, 2022, as disclosed in the Company Form 10-KT dated March 1, 2022. “We want to thank Louis for his time, dedication and contributions to AVITA Medical over the past six years. We appreciate his insights and dedication to the Company and wish him the best.” Lou Panaccio, Chairman of the Board

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BUSINESS INSIGHTS

NovaBay Pharmaceuticals Collaborates with Harrow Health’s ImprimisRx to Promote Prescription Avenova

NovaBay Pharmaceuticals | July 20, 2021

NovaBay Pharmaceuticals, Inc., a pharmaceutical firm focused on commercializing Avenova for the eye care market, has announced a collaboration with ImprimisRx, one of the nation's top ophthalmology-focused pharmaceutical companies, to promote prescription Avenova. ImprimisRx, a wholly-owned subsidiary of Harrow Health, Inc., will offer national sales, marketing, and distribution support for NovaBay's FDA-cleared 0.01% hypochlorous acid Avenova in 40 ml bottles. Avenova is a clinically approved antimicrobial lid and lash solution used to treat various chronic eye conditions. Avenova serves a large and rapidly growing dry eye market, with 30 million Americans suffering from chronic eye diseases such as blepharitis and meibomian gland dysfunction. It is the only lid and lash spray made with NovaBay's patented pure hypochlorous acid and is suitable for daily usage. In addition, Avenova is usually prescribed by ophthalmologists and optometrists before and after cataract and Lasik procedures, making it a complementary therapy for many ImprimisRx's existing products. About ImprimisRx ImprimisRx is one of the nation's top ophthalmology-focused pharmaceutical companies, with 40 proprietary ophthalmic formulations serving thousands of ophthalmologists and optometrists throughout all 50 states. About Harrow Health Harrow Health, Inc. is a healthcare company specializing in ophthalmology. ImprimisRx, the leading ophthalmology-focused pharmaceutical company, and Visionology, a direct-to-consumer eye care subsidiary focusing on chronic eye disease, are owned and operated by the company. Harrow Health also owns stakes in Eton Pharmaceuticals, Surface Ophthalmics, and Melt Pharmaceuticals, all of which began as Harrow Health subsidiaries. Harrow Health also has royalty rights to four clinical-stage drug candidates developed by Surface Ophthalmics and Melt Pharmaceuticals. About NovaBay Pharmaceuticals, Inc. NovaBay Pharmaceuticals, Inc. is a biopharmaceutical company focused on high-quality, differentiated anti-infective consumer products such as Avenova, the top antimicrobial lid and lash spray, CelleRx Clinical Reset, a game-changing product in the beauty category, and NeutroPhase Skin and Wound Cleanser for wound healing. NovaBay products include its patented, pure, stable, pharmaceutical-grade hypochlorous acid, replicating the antimicrobial chemicals used by white blood cells to combat infection. NovaBay's hypochlorous acid products cause no stinging or irritation, are nontoxic, and are non-sensitizing, making them entirely safe for daily usage. In addition, Avenova is the first commercial hypochlorous acid lid and lash spray product that has clinically proven to reduce bacterial load on ocular skin surfaces, effectively addressing the underlying cause of bacterial dry eye.

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