BioCentury | Nov 25, 2020
Product Development

Nov. 25 Quick Takes: FDA approves Y-mAbs’ Danyelza; plus NIH’s ACTT-4; COVAXX, Urovant, SomaLogic, Eluminex and Liquidia

...up 17% in after-hours trading Wednesday after FDA granted accelerated approval to Danyelza naxitamab-gqgk plus GM-CSF...
BioCentury | Nov 21, 2020
Product Development

Could an approval of Biogen’s Alzheimer’s therapy still be an option?

For almost any other compound, the nearly unanimous advisory committee vote that Biogen’s Alzheimer’s therapy aducanumab suffered would make its chances of approval vanishingly small. But this mAb...
BioCentury | Nov 19, 2020

VCs back Celleron spinout with €37M to develop former Roche asset for rare joint disorder

A European VC syndicate shared Celleron’s belief that a single-asset start-up was the best place to develop emactuzumab, an asset the U.K. biotech obtained after Roche deprioritized it in 2018. The group supplied €37 million ($43.9...
BioCentury | Nov 14, 2020

Innovation in a hurry: China biotechs see a fast track to global stage – survey

The Chinese biopharma landscape in five years will see a majority of the money magnet companies commanding innovation, with first-in-class targets filling their pipelines and innovative biologics outpacing...
BioCentury | Nov 10, 2020
Product Development

First biomarker data from pioneering tau program in Alzheimer’s cloud use of antibodies for the target

Data presented at the annual CTAD meeting hint that anti-tau therapy semorinemab from Genentech and AC Immune may have engaged its target yet failed to decrease tau aggregation in a Phase II study to treat...
BioCentury | Oct 27, 2020
Product Development

Oct. 26 Quick Takes: COVID trips up Spectrum’s Rolontis at FDA; plus Jazz-SpringWorks, Novartis’ iptacopan, Kantaro, Eternygen

Delay for Spectrum due to COVID-19 travel restrictionsSpectrum Pharmaceuticals Inc. (NASDAQ:SPPI) said FDA is deferring action on the company’s BLA for its Rolontis eflapegrastim because the agency was unable to inspect Hanmi Bioplant, the drug substance...
BioCentury | Oct 24, 2020
Translation in Brief

UNC Chapel Hill Angelman gene therapy rescues motor function; plus data backing planned Pacylex, Kronos clinical trials and more

AAV gene editing therapy for Angelman syndromeUniversity of North Carolina at Chapel Hill scientists have created a CRISPR gene therapy for Angelman syndrome that ameliorated motor function deficits in a mouse model of the maternally...
BioCentury | Oct 17, 2020
Translation in Brief

SARS-CoV-2 infects brain choroid plexus, compromises CSF-blood barrier; plus Passage’s GM1 gangliosidosis gene therapy, a new COVID-19 reporter and more

SARS-CoV-2 infects brain choroid plexusA team from Medical Research Council Laboratory of Molecular Biology (MRC LMB) have found that SARS-CoV-2 infects the CSF-producing brain choroid plexus — but not...
BioCentury | Oct 14, 2020
Product Development

A third leading COVID program enters holding pattern as NIH pauses testing of Lilly’s mAb

...approved to treat plaque psoriasis. Lenzilumab is an anti-GM-CSF...
...trial is expected in November or December.TARGETSGM-CSF (CSF2...
BioCentury | Sep 19, 2020
Translation in Brief

Gene therapies from Passage Bio, Locanabio; Lava’s antitumor bispecific, health disparities in Alzheimer’s and more

Passage Bio’s frontotemporal dementia gene therapyUniversity of Pennsylvania spinout Passage Bio Inc. reported that administration of PBFT02, an AAV1-GRN vector, led to elevated levels of PGRN in the brain and cerebral spinal fluid (CSF), reduced lysosomal...
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