BioCentury | Jan 24, 2021
Regulation

Lupus nephritis patients gain oral option as FDA approves Aurinia’s Lupkynis

FDA’s approval Friday of Lupkynis voclosporin will allow Aurinia to introduce an oral therapy into a new marketplace for drugs to treat lupus nephritis, for which there had been no approved treatments before last month’s...
BioCentury | Dec 15, 2020
Product Development

Dec. 14 COVID roundup: Phase III miss for Incyte-Novartis JAK inhibitor; Queensland vaccine program axed; plus Sputnik V final efficacy and Phase II starts for CureVac and Inovio

No benefit in Phase III for Incyte, Novartis JAK inhibitorJakafi ruxolitinib from Incyte Corp. (NASDAQ:INCY) and Novartis AG (NYSE:NVS; SIX:NOVN) plus standard of care vs. SOC alone did not reduce the proportion of patients with severe complications...
BioCentury | Nov 24, 2020
Product Development

Nov. 23 Quick Takes: NIH panel says bamlanivimab should not be considered COVID-19 SOC; plus Eiger, Shionogi-Roche, Kiniksa, Schrödinger, Halozyme-Horizon and Immunicum-DCPrime

NIH panel says bamlanivimab should not be considered standard-of-care for COVID-19NIH’s COVID-19 Treatment Guidelines Panel said there is not enough data to recommend either for or against use of bamlanivimab from Eli Lilly and Co. (NYSE:LLY)...
BioCentury | Nov 6, 2020
Regulation

Nov. 5 Quick Takes: Setback for bluebird sinks shares; plus Cellectis, CRISPR, REMS, Novocure

bluebird delays sickle cell BLAbluebird bio Inc. (NASDAQ:BLUE) lost $9.72 (17%) to $48.83 Thursday after disclosing its BLA submission to FDA for LentiGlobin to treat sickle cell disease will be delayed to late 2022 from 2H21....
BioCentury | Oct 23, 2020
Regulation

Gilead’s Veklury becomes first FDA approved COVID-19 therapy, with NIH adaptive trial as focal point

Data from NIH’s master protocol trial was the cornerstone for the first FDA approval of a COVID-19 therapy, granted to Gilead’s Veklury Thursday. The approval highlights the critical role of master protocols for generating substantive evidence...
BioCentury | Sep 4, 2020
Emerging Company Profile

Lumen growing lean, green biologics with $16M series B and Gates funding

Having turned photosynthetic bacteria into protein production machines, Lumen believes it has cracked the code to making cheap, oral biologics for widespread diseases in the Western and developing worlds....
BioCentury | Aug 21, 2020
Product Development

EC looks to CureVac for first mRNA COVID-19 vaccine deal

The European Commission is nearing a procurement deal for CureVac’s COVID-19 mRNA-based vaccine, which would add mechanistic diversity of the portfolio of vaccines it is pursuing. The EU has secured doses of an adenovirus vector...
BioCentury | Aug 5, 2020
Product Development

I-SPY COVID brings new set of targets to master protocols for acute respiratory distress

While most master protocols for COVID-19 have converged on an overlapping set of experimental therapies, the COVID R&D Alliance’s adaptive trial is kicking off with five therapeutic targets largely untouched in the indication. Three members...
BioCentury | Jul 30, 2020
Product Development

Finding immunosuppression sweet spot could be next up for COVID-19 after second IL-6 failure

A Phase III miss for a second IL-6 inhibitor in COVID-19 patients could be the death knell for the drug class in the disease. But the mortality benefit demonstrated by dexamethasone suggests a broader immunosuppressive...
BioCentury | Jul 11, 2020
Product Development

Gilead’s RWD comparison for remdesivir is ‘not in the same league of evidence’ as controlled studies, says Bach

As real-world data continue to take on a more prominent role in clinical development, Gilead’s comparison of severe COVID-19 patients in a clinical trial of remdesivir versus a real-world cohort raises questions of how and...
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