BioCentury | Aug 11, 2020
Product Development

Remdesivir heads for FDA review as Gilead continues to build manufacturing pipeline

As Gilead continues to expand its manufacturing capabilities for Veklury, the company has moved a step closer to gaining full approval of the therapy in the U.S. for COVID-19. The company announced its NDA submission for...
BioCentury | Jun 20, 2020

Clinical scorecard for COVID-19: lessons from the first wave of controlled trials

Breaking through the noise of poor-quality clinical studies are the first clear signals of a treatment paradigm for COVID-19, indicating how and when to use the two major therapeutic approaches -- attacking the virus and...
BioCentury | Jun 11, 2020
Product Development

J&J picks up pace for Warp Speed COVID-19 vaccine

One Operation Warp Speed finalist is advancing its COVID-19 vaccine into the clinic two months earlier than planned as the U.S. initiative looks to a 170-year-old company to produce glass packaging for countermeasures. Meanwhile, a...
BioCentury | May 15, 2020
Translation in Brief

Passage’s mouse, dog data for Krabbe disease; plus a predictive model of COVID-19 mortality, Sorrento’s COVID-19 antibody candidate and more

Efficacy for Passage’s Krabbe disease gene therapy Passage Bio Inc. (NASDAQ:PASG) has presented data supporting an IND it plans to submit next half for PBKR03 to treat Krabbe disease. In mouse and dog models of...
BioCentury | Apr 2, 2020
Product Development

COVID-19 roundup: EMA seeks to rein in chloroquine use; plus cash for CEPI, WHO’s SOLIDARITY grows, CytoDyn, EUSA, Chembio, PCR Biosystems and more

EMA said Wednesday that chloroquine and hydroxychloroquine should only be used to treat COVID-19 in clinical trials or national emergency use programs to preserve availability for autoimmune indications, such as lupus. The agency’s statement came...
BioCentury | Apr 1, 2020
Product Development

Chinese data propel InflaRx anti-complement mAb into clinic for severe COVID-19 pneumonia

Backed by preclinical and clinical data that support blocking complement to mitigate coronavirus-mediated respiratory distress, InflaRx has begun a clinical study of its own complement inhibitor to treat COVID-19 patients with severe pneumonia. InflaRx N.V....
BioCentury | Dec 9, 2019
Company News

Novartis downsizing internal efforts on CAR T in solid tumors

Novartis is pivoting away from internal development of CAR Ts in solid tumors, it said Thursday at its R&D day. The company is, however, pressing forward with the modality via partnerships, and plans to use...
BioCentury | Dec 5, 2019
Tools & Techniques

Using exosomes to switch myeloid cells

Driven by the natural biology of exosomes, Codiak has moved beyond diagnostics and targeted cancer therapies to embrace myeloid switching as a strategy to treat cancer. The biotech presented preclinical data Nov. 18 at the...
BioCentury | Nov 19, 2019

Combining Arava with HIF1A inhibition to treat RA

DISEASE CATEGORY: Autoimmune disease INDICATION: Rheumatoid arthritis (RA) Inhibiting HIF1A could enhance the efficacy of Arava leflunomide for RA-associated bone erosion in patients with high C-reactive protein levels. In a rat model of RA, Arava...
BioCentury | Nov 12, 2019
Company News

FDA: Mineral oil unlikely culprit in REDUCE-IT outcome

FDA sliced and diced the CVOT data for Amarin’s Vascepa and found little reason to think the mineral oil control arm may have confounded the positive outcome. Now, the agency is asking its Endocrinologic and...
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