BioSpace News Archive

Drug Development

Lilly’s Tirzepatide Improves Liver Fibrosis in Phase II MASH Trial

Lilly’s tirzepatide achieved an absence of metabolic dysfunction-associated steatohepatitis without the worsening of fibrosis in more than 50% of patients in a mid-stage study, the company reported Saturday.

June 10, 2024
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2 min read
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Tristan Manalac
Drug Development

Moderna’s COVID-Flu Combo Shot Beats Separate Vaccines in Phase III Study

Moderna’s combination vaccine candidate for COVID-19 and influenza outperformed licensed vaccines in older adults, according to late-stage results reported on Monday.

June 10, 2024
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2 min read
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Tristan Manalac
Drug Development

Skye Nixes Eye Disease Drug After Phase II Failure, Focuses on Metabolic Program

Skye Bioscience is putting the kibosh on its SBI-100 candidate for glaucoma, and the company’s entire ophthalmology program, after a mid-stage study did not reach its primary endpoint.

June 10, 2024
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2 min read
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Tyler Patchen
AI Enables Individualized Cancer Vaccines

The use of artificial intelligence in the development of cancer vaccines allows for individualized therapy, but the prospect of an ever-changing product poses new challenges for drug developers and regulators.

June 10, 2024
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5 min read
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Ben Hargreaves
FDA

GSK’s RSV Shot Wins Expanded FDA Approval for At-Risk Adults Aged 50 to 59

The FDA on Friday approved GSK’s application to use Arexvy to vaccinate adults aged 50 to 59 years who are at increased risk of developing severe respiratory syncytial virus.

June 10, 2024
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2 min read
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Tristan Manalac
Drug Development

Pfizer’s Paxlovid Ineffective Against Long COVID Using 15-Day Regimen: Study

While a prolonged, 15-day regimen of Paxlovid is safe, it appears to be ineffective at lowering the symptoms of long COVID, according to results of a Phase II trial funded by Pfizer and conducted by Stanford Medicine.

June 10, 2024
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2 min read
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Tristan Manalac
Deals

Alumis Files for IPO to Fund Phase III Trials of Potential Rival Drug to BMS’ Sotyktu

In an SEC filing on Friday, Alumis said it aims to start late-stage trials of a TYK2 inhibitor in plaque psoriasis this year and is seeking public funding for the studies.

June 10, 2024
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2 min read
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Nick Paul Taylor
Drug Development

Adcomm Votes Unanimously for Lilly’s Alzheimer’s Treatment Donanemab

Despite concerns raised in FDA briefing documents about Eli Lilly’s Alzheimer’s treatment, donanemab, the committee concluded that the benefits outweighed the risks.

June 10, 2024
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2 min read
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Tyler Patchen
Press Releases

Downstream Processing Market Size to Attain US$ 101.43 Billion by 2033

June 10, 2024
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1 min read
Policy

Justice Department and FDA Announce Federal Multi-Agency Task Force to Curb the Distribution and Sale of Illegal E-Cigarettes

The U.S. Department of Justice and the U.S. Food and Drug Administration announced the creation of a federal multi-agency task force to combat the illegal distribution and sale of e-cigarettes.

June 10, 2024
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6 min read