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Scientific journal: Complete your clinical research 6 to 9 weeks faster
Discover how completing your trials in Canada can accelerate your early phase clinical research by six to nine weeks compared to an IND submission.
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Regulation & Legislation
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The Unified Patent Court: assessing the impact on European life sciences patent litigation
Paul England, senior counsel in Taylor Wessing's Patents Group, examines the burgeoning influence of the Unified Patent Court and unitary patents within the life sciences sector. How popular are unitary patents and do they have potential to reshape European life sciences patent litigation?
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MHRA authorises new treatment for rare lung cancer
A “potential best-in-class treatment” for adults with KRASG12C-mutated non-small cell lung cancer (NSCLC) has been authorised in the UK.
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MHRA authorises alopecia treatment
UK patients with severe alopecia areata could access Pfizer's enzyme inhibitor, Litfulo (ritlecitinib), to help treat their condition.
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Video: Ami Polymer: Setting new bioprocessing standard
Our dedication to quality and prompt service has earned us several awards. You can trust us for top-notch service and reliability.
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FDA approves first Stelara biosimilar, Wezlana
The US FDA has approved Amgen’s Wezlana (ustekinumab-auub) as the first biosimilar to reference blockbuster drug Stelara (ustekinumab).
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Mitigating medicines shortages in Europe
The pharmaceutical industry must work together, applying new initiatives and harnessing digital tools to address Europe’s medicines shortages in 2023 and beyond, regulators and other organisations assert.
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European approval for third adapted COVID-19 vaccine
The European Commission has authorised the first protein-based adapted vaccine for COVID-19.
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Under the microscope: QC compliance and environmental isolates
In this Q&A Microbiologics’ Brianna DeWitt explores how to make QC with environmental isolates simple and reliable while conquering compliance with regulations and standards.
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Sustainable biosimilar competition in Europe: can it be achieved?
The Biosimilar Medicines Group has reflected on a new report by IQVIA that outlines factors for achieving sustainable levels of biosimilar competition in Europe.
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New Bill could enhance UK clinical trial regulation
According to a report on policy development in the UK, the Future Clinical Trials Bill will mandate transparent trial registration and facilitate quicker regulatory approval.
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UK Clinical Trial Application submitted for amyloid-targeting drug
The Clinical Trial Application sent to the MHRA is for a combination drug with the potential to become a cost-effective treatment against early Alzheimer’s disease.
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NICE recommends first Parkinson’s treatment
A new, easy-to-use treatment option for advanced Parkinson’s could benefit around 900 adult patients on the NHS, according to National Institute for Health and Care Excellence (NICE) final draft guidance.
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FDA approves new therapy for myelodysplastic syndromes
The first targeted therapy for certain adults with the rare blood cancer myelodysplastic syndromes, has been approved by the US Food and Drug Administration (FDA).
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Guidance on machine learning-enabled medical devices published
The Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada have issued guidelines to reduce the regulatory burden for machine learning-enabled medical devices.
