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Renaissance Pharma licenses Hu14.18 for neuroblastoma

Drug Discovery World

Renaissance Pharma has announced its first development programme focused on Hu14.18, a humanised anti-GD2 monoclonal antibody (mAb), licensed from St Jude Children’s Research Hospital for the treatment of newly diagnosed high-risk neuroblastoma. ” The post Renaissance Pharma licenses Hu14.18 s submission.

Licensing 246
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FDA Orphan Drug Designation awarded to rare disease therapies

Drug Discovery World

This second ODD allows research and development of a therapy for another form of the disease, Isolated Hypomyelination. Dan Williams, CEO at SynaptixBio, said; “This ODD is a huge boost to our efforts in tackling these devastating, life-limiting rare diseases.

FDA 130
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UK regulator rules benefits of lecanemab do not justify the cost

Drug Discovery World

The benefits of Alzheimer’s drug lecanemab (Leqembi) are too small to justify the cost of providing the treatment to NHS patients, the UK regulator has ruled. Lecanemab is for slowing progression in mild cognitive impairment or mild dementia due to Alzheimer’s disease (AD) in adults.

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Covid researchers launch Monkeypox study  

Drug Discovery World

A new study investigating a potential treatment for people who have been diagnosed with monkeypox has been launched by the same team who helped develop Covid-19 treatments. . The trial will see participants receive either a 14-day course of 600 mg tecovirimat twice daily or a matched placebo treatment.

Research 246
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ADCs: the next generation of targeted therapies 

Drug Discovery World

Mylotarg was ahead of its time in many ways: its novel structure of an antibody to target diseased cells, plus a cancer-killing payload attached via a special linker, is the blueprint for the antibody-drug conjugates (ADCs) that followed. Challenges for ADCs There are, of course, challenges for ADCs. “The

Therapies 162
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Novartis receives European Commission approval for Jakavi® to be the first post-steroid treatment for acute and chronic graft-versus-host disease

The Pharma Data

Novartis today announced the European Commission (EC) has approved Jakavi (ruxolitinib) for the treatment of patients aged 12 years and older with acute or chronic GvHD who have inadequate response to corticosteroids or other systemic therapies. GvHD occurs when donor cells see the recipient’s healthy cells as foreign and attack them.

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FDA broadens existing emergency use of Lilly and Incyte’s baricitinib in patients hospitalized with COVID-19 requiring oxygen

The Pharma Data

Food and Drug Administration (FDA) has broadened the Emergency Use Authorization (EUA) for baricitinib to allow for treatment with or without remdesivir, whereas the EUA was previously restricted to use only in combination with remdesivir. percent (24/515) for baricitinib plus remdesivir versus 7.1 Wesley Ely, M.D.,