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CHMP meeting highlights: April 2024
In its April meeting, the EMA’s human medicines committee recommended eight new medicines, including treatments for cancer and autoimmune diseases.
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Rheumatoid arthritis (RA)
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Developing a first-in-class small molecule drug for inflammatory disease
In this exclusive Q&A, Dr Jenna Brager, Executive Vice President of Drug Development for MyMD Pharmaceuticals® explains to EPR why its oral small molecule drug could transform how TNF-α based diseases are treated.
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Alfasigma to acquire Jyseleca from Galapagos
31 October 2023 | By
Italy-based Alfasigma has agreed to acquire the Jyseleca (filgotinib) business from Belgian biotech Galapagos for €170 million.
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CHMP meeting highlights – March 2023
In the European Medicines Agency's March human medicines committee meeting, nine new medicines were recommended, including one for multiple sclerosis.
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First biosimilar to HUMIRA® available in US
AMJEVITA™, the first biosimilar to Humira® is now available in the US, based on four years of real-world experience in over 300,000 patients.
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Citrate-free HCF of adalimumab biosimilar gets positive opinion
A positive opinion has been adopted by the CHMP for a citrate-free high concentration formulation of its biosimilar Hyrimoz® (adalimumab).
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Gilead’s $658.5m immunotherapy collaboration
Gilead will develop immunotherapy products through a $658.5m agreement with EVOQ Therapeutics using EVOQ’s NanoDisc technology.
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JAK inhibitors increase risk of cardiovascular problems and cancer, warns PRAC
Janus kinase inhibitors used for chronic inflammatory conditions are only safe for certain patients, advises the EMA’s safety committee.
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Tackling immune-mediated disease with CAR Tregs
Here, Jason Fontenot, Chief Scientific Officer of Sangamo Therapeutics, discusses with EPR’s Hannah Balfour how the industry is developing chimeric antigen receptor (CAR) T regulatory cells (Tregs) as a potentially paradigm-shifting therapeutic option for conditions driven by the immune system, such as autoimmunity and transplant rejection.
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Sanofi to sell Japanese manufacturing plant
Sanofi’s Japan-based manufacturing site near Tokyo will be sold to a European contract development and manufacturing organisation.
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Technologies and tactics for accelerating end-to-end biologic drug development
Creating new biologic drugs from early research is a complex process, but certain development methodologies and practices are proving to reach clinical and commercial goals faster. In this article, Seahee Kim from Samsung Biologics provides insight into how contract development and manufacturing organisations (CDMOs) are applying new and effective methodologies…
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Rinvoq® shows positive results in rheumatoid arthritis post-hoc analysis
In the analysis, 34 percent of rheumatoid arthritis patients receiving Rinvoq® achieved Clinical Disease Activity Index (CDAI) remission.
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Developing and delivering live biotherapeutic products
The microbial content of the gut has a well established role in health and disease. In this article, European Pharmaceutical Review’s Hannah Balfour explores the development and formulation of live biotherapeutic products (LBPs), an emerging treatment modality that seeks to capitalise on the interaction between the microbiota and host in…
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Pill may replace injections for monoclonal antibody treatments
An innovative new pill can deliver large quantities of monoclonal antibodies and other drugs into the stomach lining after swallowing.
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Cell line development services market to value $2.4 billion by 2030
New report suggests the cell line development services market will witness a 14.3 percent CAGR between 2021 and 2030.
