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FDA approves innovative monotherapy for treatment-resistant depression
J&J’s standalone small molecule drug was approved based on evidence of improvement of depressive symptoms without the need for patients to take a daily oral antidepressant.
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Clinical Development
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Early-phase ATMP clinical trials see promising growth
Cell and Gene Therapy Catapult's (CGT Catapult) findings attest to the UK remaining “a highly attractive destination for clinical trials”.
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New guidance to aid cost-effectiveness analysis of new drugs
The report aims to support development of economic models for health technology assessment (HTA) decision making, as there has been “little change in guidance on the use of surrogate endpoints in HTA since 2018”.
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Lilly IBD biologic receives expanded US approval
The drug is the first biologic in over 15 years to have disclosed two-year Phase III efficacy data in Crohn's disease at the time of approval.
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Long-term potential revealed for novel modifier gene therapy
The positive two-year findings from the Phase I/II gene therapy trial in retinitis pigmentosa reiterate the potential of mutation-agnostic therapies.
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Potential blockbuster drugs to watch in 2025
Eleven drugs are poised to make waves in the pharmaceutical industry in 2025, according to the annual report.
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AstraZeneca’s PARP inhibitor newly recommended by NICE
The regulatory recommendation provides a targeted therapy option for eligible patients with the most common cancer in the UK.
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Could novel gel therapeutic set new standard of care in oncology?
Findings from the interim clinical study showed that the gel formulation enhanced quality of life in over half of cancer patients.
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FDA issues first recommendations on AI for drug development
The new US Food and Drug Administration (FDA) guidance will enhance credibility of AI models in drug and biological product regulatory submissions.
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Roche to advance potentially best-in-class antibody drug conjugate
As part of the collaboration and license agreement, Innovent Biologics, Inc. could receive up to $1 billion, subject to developmental success of the biologic candidate.
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The year ahead for RNA therapeutic development and manufacturing
As the industry prepares for a new year, Dr Kate Broderick, PhD, Chief Innovation Officer of Maravai Life Sciences and TriLink Biotechnologies, shares her thoughts on what the RNA therapeutics landscape of 2024 can tell us about what may be on the horizon in 2025.
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NICE makes first-of-a-kind recommendation for hearing loss drug
As a novel formulation, the “groundbreaking drug” is expected to improve the quality of life for young cancer patients with hearing loss.
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Bristol Myers Squibb licenses amyloid-beta antibody programme
The new agreement between Bristol Myers Squibb and BioArctic is set to advance development of anti-amyloid-beta antibody treatments, which have shown symptomatic benefit in Alzheimer's.
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Early allogeneic cell therapy trial results offer hope for sight condition
Based on positive outcomes of the clinical trial, a high dose of the cell therapy is expected to advance to Phase III pivotal trials.
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Antibody drug has promise as “next frontier” in inflammatory bowel disease
With its best-in-class potential, the biologic could provide a new treatment option for patients with inflammatory bowel disease (IBD), say Teva Pharmaceuticals and Sanofi.
