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11 December 2019
Blockbuster-to-be for depression flunks pivotal Phase III
Sage Therapeutics was aiming to enter a bigger market, through the potential launch of SAGE-217.
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11 December 2019
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) in various organs.
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11 December 2019
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 of Amphora and provide a new market opportunity for the product with the added benefit...
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11 December 2019
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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11 December 2019
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 there has been some regulatory delay in opening sites.
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10 December 2019
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: genetic regulation.
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5 December 2019
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 for pain is concerned.
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4 December 2019
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 in mid-2020.
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4 December 2019
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 additional baseline information.
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3 December 2019
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 lateral sclerosis (ALS). ALS is a rare and fatal neurodegenerative...