BioCentury | Jun 24, 2020
Finance

AsclepiX aims for basket of retinal indications with $35M series A

AsclepiX intends to use its $35 million series A round for proof-of-concept studies of its lead product in three retinal disease indications, while also developing peptides into therapeutic candidates for oncology. Spun out of The...
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 19, 2020
Deals

Lyell, Pact combine T cell techs to take on solid tumors

Lyell and Pact think the union of their T cell engineering technologies could overcome the roadblocks hampering cell therapies for solid tumors. While the partners are still pursuing independent pipelines, the joint program could ultimately...
BioCentury | Jun 17, 2020
Emerging Company Profile

Lightspeed, Klausner back Stanford cell therapy spinout Orca in new $192M round

With the completion of a new $192 million series D round, Stanford spinout Orca Bio has now raised nearly $300 million to develop and manufacture allogeneic cell therapies that use controlled formulations designed to reduce...
BioCentury | Jun 13, 2020
Translation in Brief

OSE identifies myeloid checkpoint target; plus a call from NCI for COVID-19 test proposals, Sinopharm vaccine data and more

mAbs against new myeloid checkpoint  OSE Immunotherapeutics S.A. (Euronext:OSE) has identified CLEC1A, a carbohydrate-binding protein, as a tumor myeloid checkpoint target, and has generated mAbs that prevent CLEC1A from binding its ligand on tumor cells....
BioCentury | May 5, 2020
Product Development

As FDA tightens reins on COVID-19 antibody testing, Roche unveils test specs via EUA

FDA’s reversal of its hands-off policy on antibody tests for the novel coronavirus, coupled with its authorization of a highly anticipated test from Roche, is raising the bar for COVID-19 serology. Yet accessing enough patient...
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 | May 2, 2020
Product Development

Comparing COVID-19 antibody tests

The performance metrics for the serological tests FDA has authorized so far serve as guideposts for sizing up the next wave of tests to come to market. FDA has granted Emergency Use Authorization to nine...
BioCentury | Apr 29, 2020
Politics, Policy & Law

U.S. blueprint highlights sequential COVID-19 antibody testing as route to minimizing false positives

In its COVID-19 Testing Blueprint unveiled Monday, the Trump administration made its latest push to improve the accuracy of serological tests on the U.S. market, this time by doubling them up. But banking on sequential...
BioCentury | Apr 25, 2020
Politics, Policy & Law

FDA is wrong on self-validation of COVID-19 tests

While the world waits for vaccines and therapies, smart use of public health measures is critical for beating COVID-19. Testing is the essential tool for guiding public health. FDA, America’s premier public health agency, contributed...
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1 - 10 of 1355
BioCentury | Jun 24, 2020
Finance

AsclepiX aims for basket of retinal indications with $35M series A

AsclepiX intends to use its $35 million series A round for proof-of-concept studies of its lead product in three retinal disease indications, while also developing peptides into therapeutic candidates for oncology. Spun out of The...
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 19, 2020
Deals

Lyell, Pact combine T cell techs to take on solid tumors

Lyell and Pact think the union of their T cell engineering technologies could overcome the roadblocks hampering cell therapies for solid tumors. While the partners are still pursuing independent pipelines, the joint program could ultimately...
BioCentury | Jun 17, 2020
Emerging Company Profile

Lightspeed, Klausner back Stanford cell therapy spinout Orca in new $192M round

With the completion of a new $192 million series D round, Stanford spinout Orca Bio has now raised nearly $300 million to develop and manufacture allogeneic cell therapies that use controlled formulations designed to reduce...
BioCentury | Jun 13, 2020
Translation in Brief

OSE identifies myeloid checkpoint target; plus a call from NCI for COVID-19 test proposals, Sinopharm vaccine data and more

mAbs against new myeloid checkpoint  OSE Immunotherapeutics S.A. (Euronext:OSE) has identified CLEC1A, a carbohydrate-binding protein, as a tumor myeloid checkpoint target, and has generated mAbs that prevent CLEC1A from binding its ligand on tumor cells....
BioCentury | May 5, 2020
Product Development

As FDA tightens reins on COVID-19 antibody testing, Roche unveils test specs via EUA

FDA’s reversal of its hands-off policy on antibody tests for the novel coronavirus, coupled with its authorization of a highly anticipated test from Roche, is raising the bar for COVID-19 serology. Yet accessing enough patient...
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 | May 2, 2020
Product Development

Comparing COVID-19 antibody tests

The performance metrics for the serological tests FDA has authorized so far serve as guideposts for sizing up the next wave of tests to come to market. FDA has granted Emergency Use Authorization to nine...
BioCentury | Apr 29, 2020
Politics, Policy & Law

U.S. blueprint highlights sequential COVID-19 antibody testing as route to minimizing false positives

In its COVID-19 Testing Blueprint unveiled Monday, the Trump administration made its latest push to improve the accuracy of serological tests on the U.S. market, this time by doubling them up. But banking on sequential...
BioCentury | Apr 25, 2020
Politics, Policy & Law

FDA is wrong on self-validation of COVID-19 tests

While the world waits for vaccines and therapies, smart use of public health measures is critical for beating COVID-19. Testing is the essential tool for guiding public health. FDA, America’s premier public health agency, contributed...
Items per page:
1 - 10 of 1355