April 30th 2025
Bempikibart (ADX-914) is a human anti-IL-7Rα antibody that blocks the IL-7 and TSLP pathways, which have been implicated in driving T cell-mediated pathological processes in autoimmune diseases.
Determining Low PPB Levels of Nitrite in Polymeric Excipients
September 9th 2024In this paper, the authors introduce a method that combines ion exchange chromatography with an easier-to-perform, simpler one-step post-column derivatization that is selective to nitrite and visible spectrophotometric detection to allow high sample loading volumes without affecting resolution.
AstraZeneca’s Imfinzi Gets Expanded Indication in Lung Cancer on FDA Approval
August 29th 2024Phase III trial results showed that Imfinzi (durvalumab in combination with chemotherapy reduced the risk of recurrence, progression, or death by 32% in patients with resectable non-small cell lung cancer before and after surgery.
Behind the Headlines: Mpox Resurges; Eli Lilly Adds CGT Facilities; FDA Updates
August 21st 2024This Behind the Headlines news roundup panel discussion covers news items such as the resurgence of mpox in Africa, “medical tourism” in India, Eli Lilly’s new Boston CGT facilities, and contract development and manufacturing organization (CDMO) projected growth rates for the 2023–2029 period, and the reasons behind them.
The Role of Dry (Water-free) Process Equipment Cleaning in Continuous Pharmaceutical Manufacturing
August 11th 2024The growing use of continuous manufacturing in the pharmaceutical industry merits a review of the application of dry cleaning and sanitization methods, especially for non-sterile oral solid drug product manufacturing of dry powders.
The Quest for Quality: Challenges and Strategies in Raw Material Selection for Biopharmaceuticals
August 8th 2024Biopharmaceutical production faces the challenge of ensuring the quality of raw materials due to a lack of specific guidelines. By implementing effective risk assessment strategies and working with reliable, selected solution providers, biopharmaceutical manufacturers can minimize these challenges and improve product quality.
GSK’s Application Seeking Blenrep Combinations for Treating Multiple Myeloma Accepted by EMA
July 25th 2024GSK's MAA is supported by an interim analyis of Phase III trials, which demonstrated significant progression-free survival benefit and positive overall survival trends from Blenrep combination therapies.
Beyond GenAI: The Training-Free Discovery Potential of LLMs in a Drug Safety and Regulatory Context
July 1st 2024Life sciences data sets can be vast and complex to process, but up to now bringing intelligent automation systems up to speed and validating them has felt debilitatingly onerous. Large language models tackle these barriers head on. Ramesh Ramani and RaviKanth Valigari, technology innovators at ArisGlobal, explain.