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FDA begins review of Samsung Bioepis/Biogen’s Lucentis biosimilar

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But it has been a source of controversy – it works by attacking the rogue blood vessels that build up in the retina that are the root cause of wet AMD, something that Roche’s Avastin (bevacizumab) cancer drug can do in an off-label use at a fraction of the price.

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Lyfgenia and Casgevy Become First FDA-Approved Gene Therapies for Sickle Cell Disease

XTalks

How do Casgevy and Lyfgenia Work? Both Casgevy and Lyfgenia work to produce normal versions of hemoglobin. The US Food and Drug Administration (FDA) has approved the first gene therapies for the treatment of sickle cell disease, approving two on the same day. Casgevy is also the first ever CRISPR/Cas9-based therapy approved in the US.

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Oslo Medicines Initiative asks how to balance innovation incentivisation with security of access

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Access to medicines is “one of the most challenging policy areas in every country in the European region” – it’s time to develop a solution that works for everyone. In recent years, revolutionary medicines have come with price tags to match, but this is simply a symptom of our current model. About the author.

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Perfusion MRI and Other Perfusion Imaging Techniques for Clinical Trials

XTalks

An example of an anti-angiogenic compound working to decrease tumor perfusion is shown by representative images collected by DCE-MRI for a Phase I study ( Figure 1 ); here, the red and yellow areas of the baseline image are areas with very high blood flow, and Liu et al., An Example of an Anti-Angiogenic Therapy in Oncology.

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A history of Pfizer

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This caused Pfizer to change its tactics, and instead the company ended up signing a deal with GSK to combine the two companies’ consumer health businesses and form a joint venture with combined annual sales of $12.7 For all the latest Pfizer news follow pharmaphorum’s Pfizer tag.

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New Rare Disease Drugs and Research Advancements

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Despite high price tags of a couple of million dollars, gene therapy makers say they are working to ensure patients are able to access the treatments through patient assistance programs developed in conjunction with the support of governments. Both therapies were awarded their approvals on the same day in December 2023.

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Bluebird’s $2.8M Gene Therapy Zynteglo Wins Landmark FDA Approval for Beta Thalassemia

XTalks

Zynteglo is administered as a one-time treatment, with each dose consisting of a patient’s own bone marrow stem cells engineered to make functional beta-globin through insertion of working copies of the beta-globin gene. Zynteglo’s hefty price tag of $2.8 Bluebird has a total of three gene therapies in its pipeline.