BioSpace News Archive

Drug Development

Pfizer’s Gene Therapy for Duchenne Muscular Dystrophy Fails Phase III Trial

Pfizer’s investigational Duchenne muscular dystrophy gene therapy, fordadistrogene movaparvovec, failed in a late-stage study to significantly improve motor function in patients versus placebo.

June 13, 2024
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2 min read
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Tristan Manalac
Policy

Opinion: Regulatory Flexibility Can Accelerate Rare Disease Drug Development

Shifts in the FDA’s approach present an unprecedented opportunity to solve problems with patient access and trial design.

June 13, 2024
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6 min read
Foresite Raises $900M in Sixth Fund to Invest in Life Science Startups

Among the biggest raises this year, Foresite Capital’s $900 million fund will support biotech companies working in precision medicine and life science infrastructure.

June 13, 2024
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2 min read
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Tristan Manalac
Drug Development

Moderna’s Next-Gen COVID Vaccine Beats Current Shot in Pivotal Adult Efficacy Trial

Moderna said Thursday it plans to talk to regulators about the next steps after showing its next-generation candidate is more efficacious in adults than the biotech’s existing Spikevax COVID-19 shot.

June 13, 2024
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2 min read
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Nick Paul Taylor
Drug Development

Coherus, Junshi’s PD-1 Blocker Loqtorzi Aces Phase III Liver Cancer Trial

Coherus BioSciences and Junshi Biosciences’ PD-1 inhibitor Loqtorzi significantly boosted progression-free and overall survival in a late-stage study of patients with advanced hepatocellular carcinoma.

June 13, 2024
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2 min read
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Tristan Manalac
Drug Development

Secondary Cancer Risk Is Low After CAR T Cell Treatment: Stanford Study

Results of a large Stanford Medicine study, published Wednesday in The New England Journal of Medicine, finds CAR-T therapies carry a low risk of secondary malignancies not related to the T cells.

June 13, 2024
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2 min read
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Tristan Manalac
Business

Santa Ana Bio Launches With $168M, Targets Autoimmune and Inflammatory Diseases

With Versant Ventures as a founding investor, Santa Ana Bio emerged from stealth Thursday with $168 million in combined Series A and B funding to support plans to have two programs in the clinic by next year.

June 13, 2024
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2 min read
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Tyler Patchen
FDA

UroGen Announces Unprecedented 82.3% Duration of Response at 12 Months in the ENVISION Trial Investigating UGN-102 as Potentially the First FDA-Approved Non-Surgical Treatment for LG-IR-NMIBC

UroGen Pharma Ltd. announced 82.3% 12-month duration of response data by Kaplan-Meier estimate from its Phase 3 ENVISION trial in patients who achieved complete response at three months after the first instillation of investigational drug UGN-102 for intravesical solution.

June 13, 2024
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8 min read
Genetown

Pressure BioSciences, Inc. to Host Business and Financial Update on Wednesday, June 19th at 4:30pm ET

Pressure BioSciences, Inc. announced that the Company will host a teleconference to update investors and other stakeholders in the Company on a number of business and financial topics.

June 13, 2024
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4 min read
Lone Star Bio

FibroBiologics Set to Join Russell 2000® Index - June 13, 2024

FibroBiologics, Inc. announced it is set to join the Russell 2000® Index at the conclusion of the 2024 Russell US Indexes annual reconstitution, effective at the open of US equity markets on Monday, July 1, according to a preliminary list of additions posted Friday, May 24.

June 13, 2024
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5 min read