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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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Big Pharma
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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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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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How automation and digital technologies will unlock the full potential of advanced therapies
Automation and digital technologies, combined with workforce training and regulatory advancements, hold the key to transforming the production of advanced therapies. Dr Stephen Ward, Executive Director at CGT Catapult, shares how leveraging these innovations can facilitate the delivery of life-changing therapies to patients at scale, opening new possibilities for treating…
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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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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.
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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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ASH 2024: CAR T-cell therapy demonstrates durable benefit in lymphoma
The cell therapy could increase survival in certain lymphomas without requiring patients to undertake subsequent therapy, the new analysis suggests.
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£16 million to fund UK-Switzerland life sciences research
The joint agreement between two key global players in life sciences, the UK and Switzerland, marks a long-term commitment to strengthening research in the sector.
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Restoring regulatory excellence “central” to UK life science competitiveness
The Association of the British Pharmaceutical Industry (ABPI) asserts that the recommendations will help generate confidence and predictability in medicine regulation in the UK.
whitepaper
Understanding and Applying Updated FDA Guidance
Understanding and Applying the Updated FDA Guidance: Inspection of Injectable Products for Visible Particulates.
