BioSpace News Archive

FDA

Verona Wins FDA Approval for COPD Drug, Eyes Q3 Launch With $1B Financing for Rollout

Verona Pharma on Wednesday secured the FDA’s approval for Ohtuvayre, which the company contends is the first inhaled chronic obstructive pulmonary disease medicine with a new mechanism of action in over 20 years.

June 27, 2024
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2 min read
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Tristan Manalac
Psychiatric Drug Developers Make Recommendations Following Lykos Adcomm

Industry experts provide clinical trial design and protocol suggestions for psychedelic drug developers after an advisory committee voted against approving Lykos’ MDMA-assisted PTSD therapy.

June 27, 2024
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7 min read
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Gail Dutton
Drug Development

Novo Ends Phase III Kidney Disease Trial, Incurs More Than $800M Q2 Impairment Loss

Novo Nordisk on Wednesday announced it is stopping a late-stage study after its candidate ocedurenone, which the pharma acquired last year in a potential $1.3 billion deal with KBP Biosicences, failed to meet the primary endpoint.

June 27, 2024
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2 min read
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Tyler Patchen
Policy

CDC Narrows RSV Vaccine Recommendations for Seniors

New recommendations from the Centers for Disease Control and Prevention call for the use of respiratory syncytial virus vaccines in adults aged 75 and older, but limited its use in 60- to 74-year-olds.

June 27, 2024
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2 min read
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Tristan Manalac
FDA

AbbVie, Genmab Secure FDA Label Expansion for Epkinly in Follicular Lymphoma

AbbVie and Genmab on Wednesday announced the FDA has expanded the label of their bispecific antibody Epkinly, allowing it to be used in patients with relapsed or refractory follicular lymphoma.

June 27, 2024
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2 min read
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Tristan Manalac
Employer Resources

With Latest Expansion in Ohio, Resilience Can Best Serve Partners and Patients

Expansion across its network will mean hundreds of new employees in Cincinnati, increased ability to get complex medicines to patients and more.

June 27, 2024
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5 min read
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BioSpace Insights
Drug Development

Genflow Biosciences PLC Announces Strengthening of Pre-Clinical Efforts

Genflow Biosciences Strengthens Pre-Clinical Efforts with FDA Guidance and CDMO and CRO Selection

June 27, 2024
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6 min read
Fostrox + Lenvima® holds promise of greatly improved outcomes for advanced liver cancer patients, reveals new data from Medivir at ESMO GI

Medivir AB presented positive new data from its ongoing phase Ib / IIa study of fostroxacitabine bralpamide + Lenvima® in advanced hepatocellular carcinoma at the ESMO GI Cancers Congress in Munich, Germany.

June 27, 2024
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6 min read
Drug Development

GenVivo Announces Initiation of Patient Dosing in a US Phase I/Ib Clinical Trial Evaluating GEN2, a Personalizing, Gene Vector Immunotherapy, in Patients with Advanced Solid Tumors

GenVivo, Inc. announced that it has dosed the first US patient in a Phase I/Ib, open-label, dose-escalation and expansion clinical trial of GEN2.

June 27, 2024
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5 min read
Biotech Bay

Nkarta Initiates Clinical Trial of NKX019 in Lupus Nephritis with First Patient in Screening and Announces Pipeline Expansion to Additional Autoimmune Indications

Nkarta, Inc. announced the initiation of Ntrust-1, a multi-center clinical trial of NKX019 in lupus nephritis, with the first patient in screening.

June 27, 2024
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9 min read