BioSpace News Archive

Pictured: A yellow line pointing the way out of a

Policy

Mesoblast Sees Path Forward for Twice-Rejected Cell Therapy After FDA Meeting

Following a Type A meeting with the regulator, the biotech says it has clarity about the next steps in demonstrating remestemcel-L’s effectiveness in acute graft-versus-host disease.

September 21, 2023

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2 min read

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Tristan Manalac

Pictured: Eric Dube, Travere CEO/Company Courtesy

Drug Development

Travere’s Kidney Disease Drug Narrowly Misses Phase III Endpoint, Stock Tanks

The company’s treatment for IgA nephropathy, sparsentan, failed to meet statistical significance by a measure of kidney function in a head-to-head confirmatory study versus irbesartan.

September 21, 2023

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2 min read

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Connor Lynch

Pictured: FDA signage at its office in Washington, DC

Policy

Third Time Might Be a Charm for Alvotech as FDA Accepts BLA for Humira Biosimilar

Bouncing back from two Complete Response Letters, Alvotech’s BLA for its Humira biosimilar AVT02 has been accepted by the regulator with a target action date of Feb. 24, 2024.

September 21, 2023

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2 min read

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Tristan Manalac

Pictured: Genentech Headquarters/iStock, Sundry Ph

Business

Genentech Doubles Down with Orionis Deal Worth up to $2B for Glue Degraders

After announcing a $1 billion radiopharma deal with PeptiDream, Genentech signed a separate deal with Orionis Biosciences for its molecular glue degraders to target cancer and neurodegeneration.

September 21, 2023

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1 min read

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Kate Goodwin

Pictured: Capsules in a production line at a pharm

Civica Rx’s Unique Business Model Improves Drug Supply Security, Cuts Costs: Study

A new study provides the first empirical evidence that the not-for-profit manufacturer’s business model can lead to robust drug supplies and lower medicine costs.

September 21, 2023

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2 min read

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Tristan Manalac

Sensorion Announces Webconference on September 25, 2023, and its Participation in Upcoming Investor Conferences in October 2023

Sensorion is pleased to announce it is hosting a webconference on September 25, 2023, and its participation in two upcoming investor conferences in October 2023.

September 21, 2023

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4 min read

Drug Development

Travere Therapeutics Announces Confirmatory Data from the Phase 3 PROTECT Study of FILSPARI® Demonstrating Long-Term Kidney Function Preservation in IgA Nephropathy; Narrowly Missing eGFR Total Slope Endpoint versus Active Control, Irbesartan

Travere Therapeutics, Inc. announced topline two-year confirmatory secondary endpoint results from the Company’s pivotal head-to-head Phase 3 PROTECT Study of FILSPARI® in IgA nephropathy versus irbesartan.

September 21, 2023

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19 min read

Bio NC

Digital Dentistry: Dentsply Sirona and 3Shape expand their workflow integrations

Dentsply Sirona, the world’s largest manufacturer of professional dental products and technologies, and 3Shape, a leading innovator of digital solutions for dental patient care, open the next chapter in their workflow integrations.

September 21, 2023

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5 min read

Drug Development

Cybin Completes Enrollment in Phase 2 Study of CYB003 in Major Depressive Disorder

Cybin Inc. is pleased to announce that it has completed enrollment in its Phase 2 study of CYB003, a proprietary deuterated psilocybin analog program being developed for the potential treatment of major depressive disorder (“MDD”).

September 21, 2023

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8 min read

Policy

argenx Announces VYVGART (efgartigimod alfa) Authorized for Sale by Health Canada for Generalized Myasthenia Gravis

argenx SE announced that Health Canada has issued a Notice of Compliance authorizing VYVGARTⓇ for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive.

September 21, 2023

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6 min read