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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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Drug Development
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Biologic demonstrates “tremendous” potential advance in atrial fibrillation
The Phase II study validated an “incredibly safe bleeding profile” for Factor XI inhibitors as a treatment for the common cardiovascular condition.
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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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Ensuring packaging integrity of frozen biopharmaceutical products
The study’s observations offers insight for pharmaceutical professionals in choosing the appropriate primary packaging container for frozen biopharmaceutical products.
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NSF Launches ‘Compliance Unlocked’ Podcast Series
15 January 2025 | By
NSF invites pharmaceutical professionals to tune in to its new groundbreaking podcast series “Compliance Unlocked” and join the conversation on critical industry issues.
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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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HPLC method demonstrates value for quality control analysis of cardiovascular drug
The HPLC technique provides “significant improvements” over traditional methods for carvedilol determination and has broad applications for pharmaceutical quality control, research suggests.
