PRACTICE MANAGEMENT

AvKARE bottles mix Viagra generics with antidepressant, triggering recall

AvKARE | December 15, 2020

A conventional drugmaker with a Rolodex loaded with government customers is pulling an energizer and an erectile brokenness medications after the two were bundled together in similar containers.

Pulaski, Tennessee-based AvKARE reviewed one parcel of sildenafil 100-mg tablets and one parcel of trazodone 100-mg tablets after the items were stirred up by an outsider bundling provider, the organization said before the end of last week. The jugs had just been delivered to drug stores.

AvKARE markets its own private-name conventional medications to a record of government customers, including the branches of Defense, Veterans Affairs and the Health and Human Services. The organization additionally supplies the Indian Health Services, in addition to nongovernment clients around the world.

The customer level review influences parts sent to merchants and wholesalers and afterward delivered out from one side of the country to the other, the organization said. The sildenafil part has a March 2022 termination date, while the trazodone parcel lapses in June 2022.

AvKARE said it so far hasn't got any result reports from the reviewed parcels. Sildenafil—a nonexclusive rendition of Viagra—can blend inadequately with nitrate-containing drugs for diabetes, hypertension or coronary illness, conceivably bringing pulse down to perilous levels.

The upper trazodone hydrochloride, in the interim, can cause sluggishness, dazedness, stoppage and obscured vision, AvKARE cautioned. Those results represent a more serious danger of falls and impeded driving in more seasoned clients who may have bought the organization's erectile brokenness copycat.

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BUSINESS INSIGHTS, PHARMA TECH

Neochromosome Announces Successful Collaboration with Sumitovant Biopharma

Sumitovant Biopharma, Inc. | January 20, 2023

On January 19, 2023, Neochromosome, Inc., announced a partnership with Sumitovant Biopharma, Inc., a technology-driven biopharmaceutical firm expediting the discovery and commercialization of novel therapeutics. This collaboration blends Neochromosome's neoYeast™ platform with Sumitovant's DrugOME™ computational ecosystem to identify new proteins that would benefit from non-canonical amino acid chemistries that are unavailable in nature. As part of the collaboration, Sumitovant used a combination of natural language processing (NLP), artificial intelligence (AI), machine learning (ML), and computational algorithms to identify opportunities for Neochromosome to enhance the discovery and production of proteins limited by evolution and traditional fabrication processes. For example, non-canonical amino acid inclusion allows new-to-nature proteins with improved structures and functions but often requires chemical synthesis, which is expensive, size- and complexity-restricted, and environmentally damaging. neoYeast™, based on Neochromosome's world-leading genome-scale cell engineering technology stack, enables the highly efficient and environmentally friendly integration of non-canonical amino acids into proteins, with both discovery and manufacturing possible in a single genome-engineered yeast strain. Sumitovant used DrugOME to explore libraries of traditional and non-traditional sources of data to recommend targeted protein development candidates for neoYeast. Co-Founder and CEO of Neochromosome, Leslie Mitchell, commented, "The combination of Sumitovant's technology platform and life-sciences expertise with Neochromosome's ability to both discover and biomanufacture novel proteins in a single system enables Neochromosome to accelerate and streamline the delivery of better therapies for patients." She added, "We are excited to partner with the world-class team at Sumitovant to identify opportunities to create better versions of existing drugs, along with new-to-nature compounds, and to manufacture them efficiently at scale." (Source – Business Wire) Sumitovant Biopharma, Inc. The firm has supported the development of multiple FDA-approved products and a strong pipeline of early-through late-stage investigational assets addressing unmet needs in pediatrics, oncology, urology, women's health, specialty respiratory, and infectious diseases through its proprietary computing and data platforms, scientific expertise, and diverse company portfolio. It is a wholly-owned subsidiary of Sumitomo Pharma.

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BUSINESS INSIGHTS

BC Platforms Partners with EU Funded, AI-Driven, Cancer Data Initiative

BC Platforms | November 25, 2022

BC Platforms a global leader in healthcare data management and analytics announced that it has been chosen as key partner in a European Commission project. Under the EC's Horizon Europe program*, Helsinki University Hospital has been awarded a contract to lead a EURO 7 million consortium project termed ONCOVALUE. BCP will work closely with HUS as a key delivery partner in this major EC project. ONCOVALUE is an Artificial Intelligence-based framework which assesses, in real-time, real-life effectiveness of novel cancer therapies. It does this by standardising data processing in hospitals enabling them to efficiently measure the cost effectiveness of new cancer therapies for Health Technology Assessment (HTA) and regulatory purposes. BCP will aid in core aspects of the project, including creating the technical architecture and providing the data analysis, to ensure this technology can transform unstructured patient data from medical notes and images into structured data and real-world evidence (RWE) that clinicians can use in treatment management and with health regulatory and HTA bodies "This latest partnership with ONCOVALUE is part of our rapidly expanding Trusted Collaborative Environment solution. I'm proud our sophisticated healthcare data management and analytics products have been recognised by this significant, four-year, Horizon Europe project. By opening the door to widespread regulatory and HTA integration of real-world data, ONCOVALUE should lead to better, more environmentally sustainable therapies, technologies, and digital solutions for cancer care." Tero Silvola, CEO of BC Platforms Johanna Mattson, HUS's Senior Medical Director in Oncology, said, "ONCOVALUE aims to develop novel AI-based tools to automate the collection and analytics of clinical data. This will contribute to the increased cost-effectiveness and sustainability of European cancer care. Systematic collection and evaluation of patient reported outcomes should lead to improved health and well-being and should reduce the growing global burden of cancer treatment." The ONCOVALUE consortium is made up of eleven institutions and companies in Finland, The Netherlands, Denmark, Portugal, and Italy. Over the four-year project span, annually around 40,000 European patients will participate from hospitals in the consortium. About BC Platforms BC Platforms is a global leader in building data networks for the life sciences industry and provides versatile technology platforms for personalised medicine, accelerating the translation of innovations into clinical practice. We convert complex biological information collected in the healthcare setting into actionable insights. With our innovative technology we are creating a patient centric infinity loop between the life sciences and healthcare sectors. Data we generate, harmonise, and manage, from diverse biobanks and healthcare institutions, is made accessible for pharmaceutical and biotech companies to enhance their core strengths in research and development. In parallel, we enable stratification of patients towards targeted therapies, delivering on the promise of more personalized healthcare.

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BUSINESS INSIGHTS, PHARMACY MARKET

Visiox Pharma Announces FDA Acceptance of New Drug Application for Glaucoma

Visiox Pharma LLC | December 09, 2022

Visiox Pharma, LLC., a privately funded biopharmaceutical company focused on the development and commercialization of ophthalmic drugs to address highly prevalent diseases in need of new treatment options, today announced that it has received notification from the U.S. Food and Drug Administration that the agency has completed its filing review and accepted for filing the New Drug Application for PDP-716 for the treatment of glaucoma. The FDA has assigned a Prescription Drug User Fee Act target action date of August 4, 2023. "The NDA acceptance for filing is an exciting milestone and an important next step towards the planned approval and commercial launch of PDP-716. If approved, Visiox has the potential to bring the first once-daily brimonidine to market for the treatment of glaucoma to patients and eye care professionals." Ryan Bleeks, Chief Executive Officer About Visiox Visiox is a privately funded biopharmaceutical company focused on the development and commercialization of ophthalmic therapeutic candidates to address highly prevalent diseases in need of new treatment options. Each day is an opportunity for us to disrupt and revolutionize the current market to maximize patient and physician satisfaction. As an agile business partner, we will achieve this through a high level of collaboration with all eye care professionals. Visiox plans to soon submit a second New Drug Application for SDN-037 to the U.S. FDA to address an unmet need for cataract surgery. SDN-037 is a twice daily topical difluprednate corticosteroid utilizing patented TJMTM proprietary formulation. The novel technology provides powerful post-surgical control of inflammation in a clear solution enabling convenient dosing with a proven active ingredient. Cataract extraction is the most frequently performed eye surgery in the U.S. It accounts for 70% of all ocular surgeries. 50 million people are projected to have cataracts in the U.S. by 20501. PDP-716, SDN-037, and TearActTM delivery technology were licensed by Visiox from Sun Pharma Advanced Research Company Ltd.

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