Phase II
InflaRx N.V. today announced the approval of an Investigational Medicinal Product Dossier (IMPD) from the European regulatory authorities, allowing InflaRx to initiate a phase II study with IFX-1, a first-in-class anti-human complement factor C5a antibody, in patients with ANCA-associated vasculitis (AAV).
EvaluatePharma and Vantage recently released their Vantage 2019 Preview which looks at the current year’s biopharma market and makes projections about the upcoming year.
Although Sophiris Bio plans to continue development, investors weren’t enthused, letting stock plunge more than 38 percent after the company released mixed results from its Phase IIb clinical trial of topsalysin in prostate cancer.
VAXIMM AG, announced that the first patient has been dosed in a Phase I/II trial evaluating VXM01 oral immunotherapy in combination with avelumab*, a human anti-PD-L1 antibody, for the treatment of glioblastoma.
In writing literally hundreds of stories this year, two BioSpace writers, Alex Keown and Mark Terry, found certain stories particularly intriguing or impactful. Some of those were such big topics that they were covered over a series of stories. Looking back at 2018, here are their Top 10.
Shares of New Jersey-based Advaxis have plunged more than 28 percent in premarket trading after the company quietly disclosed that Amgen terminated its collaboration on an immuno-oncology program. The deal between the two companies was first inked in 2016 and had a value of up to $540 million.
Although every year, big biopharma companies give up on some programs, 2018 seems like it has been marked by unusually extensive program abandonment.
KaNDy Therapeutics, a clinical-stage company developing a potential breakthrough non-hormonal treatment for multiple debilitating symptoms of the menopause, today announces initiation of the Phase 2b clinical trial evaluating NT-814 in women with troublesome symptoms of the menopause.
White Americans make up the vast majority of clinical trial participants, despite evidence that some cancers affect minority populations in greater numbers.
There is very little doubt that developing drugs for neuroscience disorders in general and dementias in particular is a high-risk business. Axovant Sciences, unfortunately, seems to be finding that out the hard way.
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