BioSpace News Archive

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

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: 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: 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: 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

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

Business

Faron Appoints Dr. Birge Berns, MD as Interim Chief Medical Officer

Faron Pharmaceuticals Ltd., a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, announces the appointment of Dr. Birge Berns, MD, as the Company’s interim Chief Medical Officer.

September 21, 2023

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6 min read

Business

Ion Channel Drug Developer Maxion Therapeutics Appoints Eva-Lotta Allan as Chair of its Board of Directors

Maxion Therapeutics, the biotechnology company developing antibody-based drugs for previously untreatable ion channel- and GPCR-driven diseases, announced the appointment of senior industry leader Eva-Lotta Allan as the Chair of its Board of Directors.

September 21, 2023

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4 min read

Pharm Country

Helius to Bring its Innovative PoNS Therapy for Improvement of Gait in People with MS, to the 2023 Academy of Neurologic Physical Therapy Conference

Helius Medical Technologies, Inc. announced that it will exhibit at the Academy of Neurologic Physical Therapy 2023 Annual Conference, September 28-30 at the Hyatt Regency Minneapolis, marking its first appearance at the conference.

September 21, 2023

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7 min read

Drug Development

Entrada Therapeutics Announces First Participant Dosed in its Phase 1 Clinical Trial of ENTR-601-44 for the Potential Treatment of Duchenne Muscular Dystrophy

Entrada Therapeutics, Inc. announced that the first participant has been dosed in its Phase 1 clinical trial evaluating ENTR-601-44 for the potential treatment of individuals with Duchenne muscular dystrophy who are exon 44 skipping amenable.

September 21, 2023

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6 min read