FDA

Continuous manufacturing (CM) sends materials directly and continuously to the next step of a process, eliminating hold times and reducing processing times. The potential benefits of CM include improved product quality, reduced waste, lower costs, and increased manufacturing flexibility and agility.…
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With the on-going pandemic, vaccine developing methods have gained attention of the scientific community, specially towards the production, downstream and transport aspects, making it clear that new methods with less complex production and transport are needed, especially for developing…
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Purpose Mixing with liquids or soft foods is a common procedure to improve acceptability of oral medicines in children but may affect drug stability and the in vivo performance of the administered drug product. The aim of the present study was to obtain an overview of the variability of critical…
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Liposomes have been considered promising and versatile drug vesicles. Compared with traditional drug delivery systems, liposomes exhibit better properties, including site-targeting, sustained or controlled release, protection of drugs from degradation and clearance, superior therapeutic effects, and…
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The FDA approved 50 novel drugs in 2021, including the first KRAS inhibitor for cancer and the first anti-amyloid antibody for Alzheimer’s disease. Article by Asher Mullard - Nature Reviews Drug Discovery - 04 January 2022 The FDA’s approval count last year was in line with recent trends,…
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TORONTO/ANDERNACH, December 20, 2021 — PharmaTher Holdings Ltd. (“PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, and LTS LOHMANN Therapie-Systeme AG (“LTS”), a leading pharmaceutical technology company, today announced they have entered into a process…
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Core–shell particles are very well known for their unique features. Their distinctive inner core and outer shell structure allowed promising biomedical applications at both nanometer and micrometer scales. The primary role of core–shell particles is to deliver the loaded drugs as they are capable of…
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A total of 378 novel drugs and 27 biosimilars approved by the U.S. Food and Drug Administration (FDA) between 2010 and 2019 were evaluated according to approval numbers by year, therapeutic areas, modalities, route of administration, first-in-class designation, approval times, and expedited review…
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A drug dissolution profile is one of the most critical dosage form characteristics with immediate and controlled drug release. Comparing the dissolution profiles of different pharmaceutical products plays a key role before starting the bioequivalence or stability studies. General recommendations for…
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The Center for Drug Evaluation and Research (CDER) has launched the voluntary Novel Excipient Review Pilot Program (Pilot Program), which is intended to allow excipient manufacturers to obtain FDA review of certain novel excipients prior to their use in drug formulations. This Pilot Program will…
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