Blueprint’s Phase II avapritinib sparks concerns on risk-benefit profile
AdvSM is a rare condition indicated by the uncontrolled accumulation of neoplastic mast cells (MCs)...
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Evofem’s non-hormonal contraceptive Amphora scores attractive added benefit for bacterial infection prevention
GlobalData believes that the favourable data demonstrated in the AMPREVENCE trial will drive broader use...
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Intercept’s Phase II-ready Ocaliva/bezafibrate has mixed experts views in primary biliary cholangitis
Primary biliary cholangitis is a long-term, autoimmune condition which affects the liver.
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GlycoMimetics’ Phase III trial in relapsed/refractory AML protocol under review
Enrolment is proceeding as expected across the majority of trial sites except for Europe, where...
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Astellas expands into gene therapy with $3bn acquisition of Audentes
The acquisition of Audentes will allow Astellas to expand into a fifth primary focus area:...
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Evaluating NICE guidelines in regards to cannabis-based medicinal products targeting pain
Campaigners argue the new regulations are not extensive enough where the recommendation of cannabis-based medicine...
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Immunic in talks with Roche for Ocrevus use in planned Phase II/III multiple sclerosis combination
Immunic (in discussions with Roche) plans to conduct FDA regulatory meetings for two trials sometime...
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Biogen’s aducanumab evokes debate on FDA approvability in Alzheimer’s disease
Investigators said they’ve only been shown publicly available percentage results, and so are calling for...
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Exservan is approved by FDA to address major unmet ALS need
The US Food and Drug Administration (FDA) has approved Aquestive Therapeutics’ Exservan (riluzole oral film) for the treatment of amyotrophic…
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Janssen’s Invokana: New analysis of the CREDENCE study
Janssen has announced results from a new analysis of its Phase 3 CREDENCE, which demonstrated that Invokana (canagliflozin), its flagship…
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