Jaano & Seekho – Know More. Think Deeper. Stay Ahead.
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GSK Advances mRNA Flu Vaccine to Late-Stage Trials Following Positive Mid-Stage Results British pharmaceutical giant GSK has announced promising results from a mid-stage trial of its mRNA-based seasonal flu vaccine, marking a key milestone towards late-stage clinical development. The trial demonstrated that the new vaccine candidate elicited strong immune responses against both influenza A and…
AI and Biosimilars: Bridging Global Health Disparities and Enhancing Treatment Efficiency The intersection of artificial intelligence (AI) and biosimilars is creating new opportunities to address global health disparities and improve treatment outcomes. As the patents for many original biological drugs expire, biosimilars—medications that are highly similar to these original biologics—are emerging as cost-effective alternatives. The…
The Importance of Chemistry, Manufacturing, and Controls (CMC) Regulatory Documentation in Pharmaceuticals Chemistry, Manufacturing, and Controls (CMC) regulatory documentation is a critical component in the pharmaceutical and biological product development process. It ensures that these products meet the necessary standards for quality, safety, and efficacy. Below are some key components that make up CMC documentation:…
Drug scheduling – a classification system used by regulatory authorities to control the availability of medicines to the public based on their safety risk and potential for abuse. Medicines and chemicals are categorized into different schedules, each with specific rules regarding their sale, purchase, storage, and disposal. The scheduling system helps ensure public health and…
The Crucial Role of Preformulation Studies in Drug Development The journey from a novel compound to a market-ready medication is fraught with complexities, risks, and uncertainties. At the heart of this journey lies the process of preformulation studies—a critical phase aimed at understanding the physicochemical characteristics of drug candidates and their interactions with excipients. This…
In the world of medicine, there are several methods by which clinical professionals administer drugs to their patients for the purposes of treatment, recovery, illness prevention, and/or relief. The most widely known methods of administering drugs are orally, topically, and via injections. Choosing the most effective method is based on many different factors but include…
Extractables and leachables are critical considerations in the development and quality control of injectable drug products. Extractables are chemical compounds that can be extracted from packaging materials, container closures, or delivery systems when exposed to solvents under exaggerated conditions (e.g., high temperatures, aggressive solvents). Leachables are chemical compounds that migrate into the drug product under…
The two companies intend to leverage their complementary expertise and technology to bring a novel long acting injectable and drug product manufacturing platform to market. Persist AI and Nivagen have announced a collaboration to co-develop a next-generation manufacturing process for long-acting injectable (LAI) drugs, using Persist’s AI-based formulation technology and Nivagen’s manufacturing capabilities. The collaboration aims…
