BioCentury | Jun 19, 2020
Product Development

InflaRx, Kiniksa anti-inflammatory mAbs yield trend toward lower COVID-19 mortality, plus Sinopharm reports antibody readout from vaccine trial

After dexamethasone set a new bar for mortality reduction in COVID-19 patients this week, InflaRx and Kiniksa reported data from their anti-inflammatory mAbs showing trends toward a survival benefit. InflaRx N.V. (NASDAQ:IFRX) announced on Wednesday...
BioCentury | Jun 2, 2020

Personalized kidney play Chinook rounds out pipeline, lands on NASDAQ via Aduro deal

By uniting with publicly traded Aduro, Versant Ventures-incubated kidney company Chinook will gain a clinical asset for IgA nephropathy while also delivering liquidity to a VC syndicate that is committing additional capital to fund the...
BioCentury | May 21, 2020
Product Development

May 20 Quick Takes: Filgotinib meets in ulcerative colitis; broader labels for Lynparza, Tecentriq, plus updates from Eiger, eGenesis and more

High dose filgotinib meets ulcerative colitis endpoints  A 200 mg dose of filgotinib from Gilead Sciences Inc. (NASDAQ:GILD) and Galapagos N.V. (Euronext:GLPG; NASDAQ:GLPG) met the primary endpoints in the placebo-controlled Phase IIb/III SELECTION trial to...
BioCentury | May 9, 2020
Targets & Mechanisms

Connecting COVID-19 antibody responses to disease protection, one data set at a time

Reports that most if not all COVID-19 survivors have antiviral antibodies are beginning to set benchmarks for immunity, but understanding how much protection different levels and types of antibodies provide will be critical for determining...
BioCentury | May 2, 2020
Product Development

Good test hunting: FDA authorizations point to benchmarks for COVID-19 serology

The critical role of COVID-19 antibody testing in reopening society -- combined with controversy around the regulatory flexibility these tests have received and reports that some are performing poorly -- have put all eyes on...
BioCentury | Apr 30, 2020
Product Development

NIH competition to encourage COVID-19 diagnostic innovation, pad U.S. testing capacity

As dozens of leading biopharmas, research institutes and health agencies embrace precompetitive coalitions and master protocols to speed development of COVID-19 therapies and vaccines, NIH has created a competition to accelerate diagnostics. The organization today...
BioCentury | Apr 25, 2020
Product Development

Mesoblast’s stem cells boost survival to 83% in COVID-19 patients with ARDS; Arch also taking aim at respiratory distress

Two weeks after Mesoblast announced a randomized controlled trial of its stem cell therapy to treat COVID-19 patients with acute respiratory distress syndrome, it has revealed compassionate use data backing the study. Also targeting ARDS...
BioCentury | Apr 18, 2020
Product Development

Roche latest heavy hitter to scale up serological tests

COVID-19 serological testing capacity is set to surge as diagnostic giant Roche joins the ranks of companies offering assays to detect antiviral antibodies. The ramp up in volume comes amidst ongoing uncertainty about the accuracy...
BioCentury | Apr 16, 2020
Product Development

Ortho becomes second to receive EUA for COVID-19 antibody assay

Ortho has become the second company after Cellex to receive Emergency Use Authorization from FDA for a COVID-19 antibody assay. Ortho Clinical Diagnostics Inc.’s test can be run on its VITROS systems. The company said...
BioCentury | Apr 14, 2020
Product Development

New U.S. policies complicate regulatory calculus for COVID-19 antibody tests

Guidelines released by CMS, HHS and FDA over the past week raise further questions about the flood of antibody tests that have come on the U.S. market without FDA review. At issue is whether the...
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