BioCentury | Apr 10, 2021
Product Development

Baricitinib improves on SOC survival benefit in hospitalized COVID patients

Lilly and Incyte believe the latest data for baricitinib underscore how the JAK inhibitor can build upon standard of care’s ability to reduce COVID-related death among hospitalized patients even as...
BioCentury | Apr 3, 2021
Product Development

Digging beyond the headlines at AACR 2021

BioCentury’s analysis of this year’s AACR meeting unearths orthogonal approaches to high-wattage targets KRAS and TIGIT, details on allogeneic and personalized cell therapies, and targeted protein degradation players beyond the usual suspects. In the run-up...
BioCentury | Mar 1, 2021
Deals

With Phase III started in head and neck cancer, Debiopharm partners lead program with Germany’s Merck

Debiopharm will bank €188 million ($226.6 million) for pipeline development now that the biotech has partnered lead program xevinapant with Merck KGaA, adding the German biopharma’s resources to the molecule’s evaluation in a Phase III...
BioCentury | Feb 13, 2021
Product Development

Short of reaching high bar, Amicus’ Pompe treatment still headed for FDA review

Amicus still believes its two-component therapy can become a new standard of care in Pompe disease, but nearly a third of the company’s value has vaporized after it said the treatment missed the primary endpoint...
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....
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