BioSpace News Archive

Pictured: Illustration of a base nucleotide being

Beam Launches Early-Stage Study of Allogeneic, Base-Edited CAR-T Therapy

Biotech Beam Therapeutics has dosed the first patient in a Phase I/II study of its base-edited CAR-T therapy in relapsed or refractory T-cell acute lymphoblastic leukemia/T-cell lymphoblastic lymphoma.

September 6, 2023

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Tristan Manalac

Pictured: Moderna COVID-19 Vaccine/iStock, carmeng

Drug Development

Moderna Says Updated COVID-19 Vaccine is Effective Against Newer Variants

The vaccine maker reported new trial data confirming an 8.7 to 11-fold increase in neutralizing antibodies against circulating strains, including the highly watched BA.2.86, EG.5 and FL.1.5.1 variants.

September 6, 2023

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Kate Goodwin

External view of AstraZeneca's production plant in Sweden

Policy

FDA Rejects AstraZeneca’s Ultomiris Label Expansion in NMOSD

Citing the need to improve its Risk Evaluation and Mitigation Strategy, the regulator has declined AstraZeneca’s bid to get its C5 complement inhibitor approved in neuromyelitis optica spectrum disorder.

September 6, 2023

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Tristan Manalac

Pictured: An elderly man with his hand over his he

Drug Development

BioCardia’s Cell Therapy Unlikely to Meet Primary Endpoint in Phase III Heart Failure

Interim data from the company’s late-stage clinical trial suggests its cell therapy treatment for heart failure likely won’t meet the primary efficacy endpoint, BioCardia announced on Tuesday.

September 6, 2023

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Connor Lynch

Pictured: Medicines on dollar bills/iStock, Julia_

Policy

CMS Should Monitor Effects of Drug Rebates with Eye Towards IRA: GAO

Monitoring rebates from drugmakers will be critical as provisions of the Inflation Reduction Act are implemented, including drug price negotiations, the Government Accountability Office contends.

September 6, 2023

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Tristan Manalac

Pictured: Illustration of money exchanging hands/i

Genetown

Nimbus Secures $210M in Private Funding on Heels of $4B Takeda Deal

Led by new investor Google Ventures, it is one of 2023’s larger fundraising efforts and comes less than a year after a $4 billion deal with Takeda for a Nimbus autoimmune disease treatment.

September 6, 2023

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Connor Lynch

Sequana Medical Notice of 2023 Half-year Results and Business Update

Sequana Medical NV, a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, will announce its half-year results ended 30 June 2023 on Thursday, 14 September 2023.

September 6, 2023

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3 min read

Drug Development

Tetra Pharm Technologies concludes preclinical testing of TPT0301 in preparation of First-in-Human clinical trials

Following convincing results from a recent In-Vitro study, the Danish biotech company, Tetra Pharm Technologies, announces successful In-Vivo study results of its candidate compound, TPT0301.

September 6, 2023

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Policy

IND for ATA-100, a Gene Therapy for the Treatment of Limb-Girdle Muscular Dystrophy Type 2I/R9 (LGMD2I/R9), cleared to proceed by FDA

Atamyo Therapeutics announced that the U.S. Food & Drug Administration has cleared its Investigational New Drug application for ATA-100 to proceed in a Phase 1b/2b clinical trial.

September 6, 2023

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Pharm Country

Immunic to Participate in Industry and Investor Conferences in September 2023

Immunic, Inc., a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, announced participation in the following industry and investor conferences in September:

September 6, 2023

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4 min read