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M&A outlook for pharma in 2025
For a strong 2025, dealmaking should be central to the life sciences strategy, says EY’s annual M&A report.
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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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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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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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ePI rollout backed in new paper by pharmaceutical bodies
The industry associations uphold that adopting digital formats for medicine information will simplify supply chain and improve patient safety.
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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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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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CHMP recommends novel long-acting HIV treatment
The positive opinion means HIV patients could overcome challenges of taking daily oral regimens, says ViiV Healthcare's Chief Medical Officer.
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Innovative biologic prefilled syringe approved in EU
The new treatment option provides a convenient alternative to currently available vials of the bispecific antibody for EU patients with common vision conditions.
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Legislative milestone for UK clinical trials
The amended regulatory framework will foster clinical trial design innovation and provide UK life sciences with faster trial approvals.
