whitepaper
Whitepaper: Are nitrosamines a concern for biologic manufacturers?
Nitrosamine genotoxins in several pharmaceuticals has led to monitoring of manufacturing practices for products considered at risk.
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Biologics
whitepaper
Whitepaper: Navigating nitrosamine impurity testing
Nitrosamine impurities have become a concern in the bio/pharmaceutical industries, due to their carcinogenic properties and presence in medications.
whitepaper
ebook: Benefits of liquid-filled capsules for pharmaceutical development
Discover the benefits of liquid-filled capsules for the formulation of highly potent APIs and drugs that benefit from slow or extended release.
news
Sandoz to file for approval of aflibercept biosimilar
Sandoz intends to seek regulatory approval for its aflibercept biosimilar in the US and EU in the coming months.
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Multiple myeloma bispecific antibody granted accelerated approval
Accelerated US approval of a first-in-class bispecific antibody (BsAb) therapy offers a new option for a difficult-to-treat blood cancer.
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FDA warning letters highlight CAPA concerns
Several FDA warning letters distributed to pharmaceutical manufacturers in 2023 have warned of numerous corrective and preventive action (CAPA) compliance concerns.
news
Will Novartis provide new oral option for chronic hives?
If approved, Novartis’ remibrutinib has potential to be the first of a new class of chronic spontaneous urticaria (CSU) treatment in a decade.
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AstraZeneca’s tezepelumab and dapagliflozin accepted for use in Scotland
The Scottish Medicines Consortium (SMC)’s acceptance means eligible patients across the UK can now benefit from AstraZeneca's Tezspire (tezepelumab) for severe asthma and Forxiga (dapagliflozin) for chronic heart failure.
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Next-gen sustainable inhalers on the horizon
Global development and manufacture of the next generation of green inhalers is positioned to be accelerated by a new joint £33 million government-industry investment.
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Adalimumab biosimilars shaping market, research states
GlobalData has shared research on how the loss of exclusivity of AbbVie’s Humira (adalimumab) is shaping the biosimilars market.
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Treating Alzheimer’s: regulatory hurdles in an anti-amyloid revolution
In this article, Gareth Morgan, a life sciences partner at Pinsent Masons discusses how Leqembi validates the anti-amyloid approach for treating Alzheimer’s, and whether its recent regulatory authorisations could support fast-tracking approvals of other promising Alzheimer’s therapies.
news
Approval expanded for generalised myasthenia gravis medicine
Extended EU approval of Soliris to paediatric generalised myasthenia gravis (gMG) patients is based on Phase III data which demonstrated improvement in disease severity through 26 weeks.
news
Innovative solid-state storage for biologics developed
A new method enabling biological materials to be stored in a solid-state means medicines such as insulin could be administered orally in the future.
news
Novel antibody therapeutic demonstrates potential in GVHD
Key data from a Phase II trial of a potentially first-in-class CSF-1R monoclonal antibody for chronic graft-versus-host disease (GVHD) has been released.
whitepaper
ebook: Key biomarkers of immunomodulation
Altasciences has published an ebook sharing comprehensive information about testing biomarkers of immunomodulation as part of your drug development program.
