Jaano & Seekho – Know More. Think Deeper. Stay Ahead.
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Leading Hidradenitis Suppurativa Treatments in the Market Currently, some of the top medications for treating hidradenitis suppurativa (HS) include BIMZELX (bimekizumab) by UCB Biopharma, COSENTYX (secukinumab) by Novartis, and HUMIRA (adalimumab) by AbbVie/Eisai. Until 2023, HUMIRA dominated the market, even though its US patent expired in December 2016. AbbVie’s strong patent defense in the US…
Some basics of Pharmacokinetics (PK) analysis: Pharmacokinetics refers to the study of how a drug is absorbed, distributed, metabolized, and eliminated by the body. The pharmacokinetic analysis set is created to analyze PK data collected from study participants. This set typically includes patients who have received the drug of interest and have available PK data, such…
Bristol Myers Squibb Advances Opdualag to Phase 3 Trials for Non-Small Cell Lung Cancer Bristol Myers Squibb (BMS) is set to push its PD-1/LAG-3 combination therapy, Opdualag, into phase 3 trials for first-line non-small cell lung cancer (NSCLC), two years after its initial FDA approval in melanoma. The registrational trial, named RELATIVITY1093, will evaluate Opdualag,…
Keytruda’s Triumph in Early-Stage Triple-Negative Breast Cancer: A New Standard of Care Merck’s Keytruda (pembrolizumab) has achieved a significant milestone in the fight against early-stage triple-negative breast cancer (TNBC), with new data demonstrating a substantial improvement in overall survival rates. This development follows an earlier controversy over its approval based on preliminary endpoints. At the…
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…
