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Novel immunotherapy combination approved for endometrial cancer
The new approval of KEYTRUDA (pembrolizumab) combined with chemotherapy is indicated for certain patients with the most common gynaecologic cancer, according to Merck/MSD.
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Drug Development
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Haemophilia drug could reduce treated bleeding episodes
Once-weekly or once-monthly dosing of Mim8 provides optionality and flexibility for people living with haemophilia A with or without inhibitors, stated Novo Nordisk’s EVP for Development.
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Modifier gene therapy – clinical development and manufacturing considerations
Expanding on his earlier podcast discussion with EPR, Dr Arun Upadhyay, Chief Scientific Officer and Head of Research & Development at Ocugen, discusses the company’s promising modifier gene therapy candidates for ophthalmic disorders.
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ABPI embraces proposals for pharma’s growth ahead of UK elections
The UK pharmaceutical industry body has invited proposals on economic investment, support for manufacturing, clinical trials and R&D.
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Developing the EU’s first intestinal microbiota-based biologic
In this final installment of EPR's Microbiome therapeutics: microscope to medicine, Dr Olaia Aurtenetxe, Head of Clinical Research at Mikrobiomik, reveals study data demonstrating why MBK-01, an investigational drug based on faecal microbiota transplantation, presents a promising alternative to the current standard of care for Clostridioides difficile infections (CDI), potentially…
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EFPIA sets out targets for pharma environmental sustainability
To drive environmental sustainability in pharma, EFPIA strives “to go beyond compliance on the targets set within the various EU legislative requirements as part of the EU Green Deal initiatives under the Zero Pollution, Circular Economy and Climate Action plans”.
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Webinar: Overcoming contamination risks during biologicals production: Mycoplasma & virus testing
Listen to the discussion on contamination risks in biomanufacturing, featuring mycoplasma and virus testing per European Pharmacopoeia and USP standard
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New polymer-based drug delivery system developed for tuberculosis
The formulation was developed through a single emulsion solvent evaporation technique and offers new delivery approach which could improve patient compliance, the paper stated.
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Delivering long-acting oral treatments
In this interview, Kyle Haraldsen, Chief Technology Officer of Lyndra Therapeutics, explores how the drug delivery landscape is evolving to increase focus on patient centricity and sustainability through development of long-acting, oral-delivery technologies.
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GLP-1 treatment displays best-in-class potential for MASH
These results from the Phase II trial could lead to clinically meaningful benefits for cardiovascular, renal, and metabolic diseases, Boehringer Ingelheim suggests.
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Regulation and legislation in the era of automation and digitalisation
Experts at IP firm Finnegan discuss if the pharmaceutical industry is ready for the innovation and technologies that digitalisation and automation will bring, and whether these advances are a threat or ally to intellectual property rights in the sector.
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Combination therapy may hold potential for severe viral hepatitis
New findings from a Phase II study suggest the curative potential of a combination treatment for chronic hepatitis delta virus, according to Gilead Sciences.
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WuXi facility boosts bioprocessing capacity with new bioreactors
The new installation increases capacity at WuXi Biologics’ Hangzhou manufacturing facility from 8,000L to 23,000L.
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Fresh or frozen? Navigating the cryopreservation dilemma for CGT
Cell and gene therapy development grapples with a paradox: fresh starting material is often equated with higher-quality drug products, but cryopreservation is crucial for scale-up. In fact, every approved autologous cell-based therapy relies on freezing cells. Reconciling these truths can be key for the success of any commercial therapy based on…
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Biologic demonstrates durable tumour regression in rectal cancer
The updated, longer-term Phase II trial results suggest that the antibody therapy could offer a novel approach for treating advanced rectal cancer.
