The Pharma Flash - Week of June 30, 2023

FDA Approvals and Draft Guidance in this Week’s PharmaFlash
5.Andelyn Biosciences, a biopharmaceutical CDMO has inaugurated its new manufacturing headquarters spanning 180,000 square feet. The Columbus Ohio facility is designed to support the production of gene therapies, viral vectors, and other advanced biologics. It features state-of-the-art manufacturing capabilities, including multiple cleanrooms, specialized equipment, and quality control laboratories. The expansion will enable Andelyn Biosciences to meet the growing demand for biologics manufacturing services and contribute to the advancement of innovative therapies in the biopharmaceutical industry.
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4.The FDA released draft guidance outlining the process for filing formal disputes regarding final orders for over-the-counter (OTC) monograph drugs. The guidance aims to provide clarity and instructions for manufacturers and other interested parties on how to challenge FDA decisions related to OTC monograph drug regulations. It explains the types of issues that can be disputed, the procedures for submitting a dispute, and the timelines involved in the resolution process. This draft guidance is part of the FDA's ongoing efforts to ensure transparency and promote accountability in the regulation of OTC drugs.
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3.Veeva Business Consulting expanded its services with the introduction of new research and development (R&D) offerings. The company aims to support pharmaceutical companies in optimizing their R&D processes and accelerating drug development timelines. The new services will focus on areas such as clinical operations, data management, regulatory affairs, and medical affairs. By leveraging their expertise and technology solutions, the company aims to enhance efficiency and productivity within the R&D landscape for its clients in the pharmaceutical sector.
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2. The FDA approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as additions to diet and exercise to improve blood sugar control in children 10 years and older with type 2 diabetes. These approvals provide a new class of medicines taken by mouth to treat pediatric type 2 diabetes. Metformin, the only other oral therapy available for the treatment of children with type 2 diabetes, was first approved for pediatric use in 2000.
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1. AGEPHA Pharma USA announced that, following a Priority Review, the FDA approved LODOCO® as the first anti-inflammatory atheroprotective cardiovascular treatment demonstrated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.
The company anticipates that LODOCO, which can reduce the risk of cardiac events in patients with established cardiovascular diseases by 31% on top of standard of care, will be available for prescription in the second half of 2023.
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[@MyMuzzamil]

Agepha pharma rocking for good cause.thanks agepha for new treatment option