Phase I
Auris Medical Announces Randomization of First Dose Cohort in AM-201 Phase 1b Proof-of-Concept Study
Auris Medical Holding Ltd. announced that the first cohort of subjects have been randomized in its Phase 1b proof-of-concept trial of AM-201, the Company’s investigational drug for the prevention of antipsychotic-induced weight gain and somnolence.
Theralase Technologies Inc. is pleased to announce that the results of the Phase Ib clinical study will be presented at the 17th International Photodynamic Association World Congress, to be held in Cambridge, Massachusetts from June 28th to July 4th, 2019.
Biotech and pharma companies from across Europe and Asia provide updates on pipeline and business activities.
Only a few months after GlaxoSmithKline acquired Waltham, Mass.-based Tesaro, Tesaro released promising data from its Phase I/II GARNET study of dostarlimab in endometrial cancer.
UK-based Allergy Therapeutics markets three allergy “jabs” for tree pollen, dust mites, and grass pollen. Later this year it is planning results from a Phase I trial of a dust mite vaccine. But the company’s results from its trial for a birch pollen vaccine are a bit puzzling—the vaccine flunked the trial, but appeared to show positive results.
PhaseBio Pharmaceuticals, Inc. announced that results from the Phase 1 clinical trial of PB2452, a novel reversal agent for the antiplatelet drug ticagrelor, demonstrated that PB2452 provided immediate and sustained reversal of ticagrelor antiplatelet effects without report of drug-related serious adverse events.
In addition to the planned BioNTech IPO, many other pharma and biotech companies in Europe, Asia and elsewhere shared news for the week.
The FDA, as part of efforts to update clinical trial eligibility criteria, published four draft guidance documents on cancer clinical trial criteria and one final draft on adolescents in adult oncology trials.
TLC Reports Positive Top-Line Results from Phase I/II Clinical Trial of TLC590 for Postsurgical Pain
TLC590 demonstrated durable, statistically significant and clinically meaningful improvement over the standard of care through 96 hours
Following last year’s stellar initial public offering in October, where it raised $80.5 million, about $10 million over initial expectations, LogicBio Therapeutics is planning a gene-editing clinical trial in children.
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