Phase II

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The FDA, as part of efforts to update clinical trial eligibility criteria, published four draft guidance documents on cancer clinical trial criteria and one final draft on adolescents in adult oncology trials.
TLC590 demonstrated durable, statistically significant and clinically meaningful improvement over the standard of care through 96 hours
FDA accepts study protocol, providing green light for GENFIT to initiate Phase 2 clinical trial in pediatric NASH
Axovant has been busy, releasing interim results from two different clinical trials, one for Tay-Sachs, the other for Parkinson’s disease.
SOTIO, a biotechnology company owned by the PPF Group, announces that final data from the SOV02 Clinical Trial with DCVAC/OvCa will be presented in the plenary session as an oral presentation at the 2019 SGO’s 50th Annual Meeting on Women’s Cancer.
This year could be the big year for the company. Its chief executive officer and president, Isaac Ciechanover, is leaving the company by June 30, but says 2019 could be transformative.
The company said rapastinel will not likely hit primary and secondary endpoints in three acute studies based on data from an interim analysis.
Biotech and pharma companies from across the globe share data and news in a weekly roundup.
Coming off its record-breaking initial public offering (IPO) in December, where it raised $604.3 million, Moderna released its fourth-quarter financials, outlining an ambitious company buzzing with activity.
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