BioSpace News Archive

FDA

Combination Vaccines Are Coming for Respiratory Diseases

Pfizer, Moderna, Novavax and more are working to combine preventative shots for COVID-19, flu, RSV and other illnesses. Will convenience be enough to overcome vaccine fatigue?

October 31, 2023
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4 min read
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Kate Goodwin
Drug Development

Novartis’ $3.2B Chinook Buy Pays Off with Promising Phase III IgAN Data

Following the recent Chinook Therapeutics acquisition, the Novartis experimental IgA nephropathy therapeutic atrasentan significantly reduced protein in the urine of patients compared to placebo.

October 31, 2023
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2 min read
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Tristan Manalac
Business

Amgen Axes Prostate Cancer Drug, Takes $650M Write-Down as Q3 Profit Drops

In its third-quarter results Tuesday, Amgen announced a $650 million write-down after discontinuing AMG 340, a prostate cancer candidate acquired in the $900 million buy of Tenobio in 2021.

October 31, 2023
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2 min read
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Kate Goodwin
Drug Development

Sarepta Fails Confirmatory Trial for DMD Therapy, Still Eyes Label Expansion

Despite failing to hit the primary endpoint in the Phase III EMBARK study, the company plans to file for a label expansion for its Duchenne muscular dystrophy gene therapy Elevidys.

October 31, 2023
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2 min read
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Tristan Manalac
Business

Pfizer Continues COVID Cliff in Q3 with First Quarterly Loss Since 2019

Third-quarter revenues for antiviral treatment Paxlovid dropped 97% operationally compared with the prior-year period, while vaccine Comirnaty revenues declined 70% in the quarter.

October 31, 2023
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2 min read
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Tyler Patchen
Policy

Opinion: 7 Ways Leveraging Fractional Executives Can Grow Your Biotech Startup

Here’s how expanding companies can benefit from executive-level strategic experience in key areas while staying lean and nimble.

October 31, 2023
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5 min read
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Carina Clingman
Biotech Bay

Verge Genomics and the Pritzker Neuropsychiatric Disorders Research Consortium Form Cutting Edge Schizophrenia Research CollaborationResearch to analyze data from schizophrenia patient brain tissue with Verge’s AI-powered platform

Verge Genomics announced that it has entered into a collaboration with the Pritzker Neuropsychiatric Disorders Research Consortium to further the company’s cutting-edge research on schizophrenia.

October 31, 2023
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3 min read
Biotech Beach

Glaukos Technologies Featured in Numerous Scientific Abstracts at the 2023 American Academy of Ophthalmology Annual Meeting

Glaukos Corporation (NYSE: GKOS) announced today that its technologies will be featured in various scientific programming at the American Academy of Ophthalmology (AAO) annual meeting, being held November 3-6, 2023 in San Francisco, CA.

October 31, 2023
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6 min read
Genetown

Access Vascular to Ramp Production With $22 Million Series C Financing

Access Vascular, Inc. announced that it raised a Series C round worth $22 million from a consortium of new and existing investors.

October 31, 2023
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2 min read
Policy

XOMA Earns $5 Million Milestone Upon FDA Acceptance of Day One’s Tovorafenib NDA for Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG)FDA has granted Priority Review and assigned a PDUFA target action date of April 30, 2024

XOMA Corporation, the biotech royalty aggregator, announced it has earned a $5 million milestone related to the U.S. Food and Drug Administration’s acceptance of Day One Biopharmaceuticals’ New Drug Application for tovorafenib as a monotherapy for relapsed or progressive pediatric low-grade glioma.

October 31, 2023
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4 min read