BioSpace News Archive

Business

Bluebird Faces Another Delay with BLA for Sickle Cell Gene Therapy

In an earnings call Wednesday, bluebird bio revealed it is unlikely to meet its first-quarter goal to submit a Biologics License Application for sickle cell disease (SCD) gene therapy lovo-cel.

March 30, 2023
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2 min read
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Tristan Manalac
Drug Development

Biogen Successfully Targets Tau in Phase Ib Alzheimer’s Study

BIIB080 successfully reduced tau pathology in patients with early-stage disease across all six brain regions analyzed.

March 30, 2023
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3 min read
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Kate Goodwin
Policy

Court Sides with Vanda Against FDA in Freedom of Information Act Case

A federal court sided in favor of Vanda Pharmaceuticals in its Freedom of Information Act case against the FDA regarding the CRL for its sleep drug label expansion.

March 30, 2023
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3 min read
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Kate Goodwin
Drug Development

J&J Drops Out of RSV Race, Cuts Late-Stage Vaccine Candidate

The RSV race has lost one high-profile contender as Janssen announced it is discontinuing the Phase III EVERGREEN trial studying its RSV vaccine candidate.

March 30, 2023
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2 min read
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Tristan Manalac
Employer Resources

Proximity Bias: Are In-Office Workers at an Advantage Over Remote Workers?

Proximity bias, a term that describes how managers tend to favor those they see in person, may force remote and hybrid workers to work harder to keep up with their in-person counterparts.

March 30, 2023
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3 min read
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Rosemary Scott
Drug Development

GSK Expands Infectious Disease Pipeline With $593M SCYNEXIS Deal

GSK will help commercialize Brexafemme (ibrexafungerp), currently approved to treat vaginal yeast infections and vulvovaginal candidiasis (VVC).

March 30, 2023
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2 min read
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Ana Mulero
Policy

FDA approves Bioretec’s RemeOs™ trauma screw as the first bioresorbable metal implant in the U.S. market

Bioretec Ltd. has received market authorization for its RemeOs™ trauma screw in the U.S. The RemeOs™ trauma screw is the first and currently only bioresorbable metal implant approved by the U.S. Food and Drug Administration.

March 30, 2023
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4 min read
Valneva to Present on its Chikungunya Vaccine Candidate and Host a Roundtable at the 23rd World Vaccine Congress in Washington D.C.

Valneva SE, a specialty vaccine company, announced it will present on its single-shot chikungunya vaccine candidate, VLA1553, and host a roundtable on Zika vaccines next week at the 23rd World Vaccine Congress in Washington, D.C.

March 30, 2023
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5 min read
Addex Reports Full Year 2022 Financial Results and Provides Corporate Update

Addex Therapeutics, a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, reported financial results for the full-year ended December 31, 2022, and provided a corporate update.

March 30, 2023
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7 min read
AMWC 2023: Data From Sculptra® Cheek Wrinkle and Alluzience® Star Studies Reinforce Strength of Galderma’s Broad Aesthetic Portfolio

Galderma will be presenting the latest data from the Sculptra® Cheek Wrinkle and Alluzience® STAR studies at the 21st Aesthetic & Anti-Aging Medical World Congress, taking place in Monaco, from March 30 to April 1, 2023.

March 30, 2023
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8 min read