Valneva’s chikungunya virus vaccine granted breakthrough designation
Currently, no preventative vaccines or effective treatments are available for the chikungunya virus
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Tag: Breakthrough Therapy Designation
FDA Breakthrough granted for Roche’s Gazyva
The designation was based on the Phase II NOBILITY study.
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FDA breakthrough therapy designation granted for Bayer’s Aliqopa
The decision was primarily based on follow-up data from the pivotal Phase II study CHRONOS-1.
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AZ’s Selumetinib granted US Breakthrough Therapy Designation
The BTD is for the treatment of paediatric patients aged three years and older with neurofibromatosis type 1 (NF1).
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FDA Breakthrough Therapy Designation for Pompe disease drug
The FDA has granted Amicus’ AT-GAA a Breakthrough Therapy Designation (BTD) for the treatment of late onset Pompe disease.
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AZ’ RSV drug bags EMA PRIME, FDA Breakthrough statuses
AstraZeneca’s MEDI8897 has been granted access to both the European Medicines Agency (EMA) PRIME (PRIority MEdicines) scheme, and the US Food and Drug Administration’s (FDA) Breakthrough Therapy Designation (BTD).
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- MRM Health collaborates with Oncode Institute and Netherlands Cancer Institute
- Sobi to acquire Arthrosi Therapeutics, strengthening gout treatment pipeline
- Lindus Health and Quotient Sciences announce strategic partnership to accelerate drug development
- Title21 Health Solutions joins the Blood and Cells Advocacy Roster
- NADMED launches $30,000 metabolomics research award
