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New multiple sclerosis treatment option granted in EU
The newly authorised formulation of the anti-CD20 therapy provides certain multiple sclerosis patients with another treatment option comparable to intravenous infusion.
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Drug Markets
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Big potential for small molecule drugs in cancer treatment
With recent recommendation of Takeda’s fruquintinib by the European Medicines Agency (EMA), EPR spoke to Dr Sebastian Stintzing, Professor of Medicine, Head of the Department of Hematology, Oncology, and Tumor Immunology (CCM) of The Charité University Hospital in Berlin and investigator on the FRESCO-2 trial, to find out more about…
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AbbVie to advance TL1A antibody for IBD
The new, potentially multi-billion-dollar deal will help bring a next-generation therapy to patients with inflammatory bowel disease (IBD), an autoimmune condition.
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Innovative radioligand manufacturing facility inaugurated
Following advancements at a similar European facility, the new manufacturing facility in the US is set to produce lead-212 radioligand therapies.
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First-in-class telomerase inhibitor approved for blood cancer
The FDA’s regulatory approval of the telomerase inhibitor is welcome, considering the high unmet need for many lower-risk myelodysplastic syndromes (LR-MDS) patients, according to Geron.
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Advancing targeted treatments for multiple myeloma
Edmond Chan, Senior Director, EMEA Therapeutic Area Lead, Haemato-Oncology, Johnson & Johnson Innovative Medicines, offers insight into the promising evidence of cell therapies and biologic-based treatments for patients with multiple myeloma.
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Innovating small molecule injectables: market forecast to 2033
Key trends in the global small molecule injectable drugs market up to 2033 include advancements in technology, drug delivery systems and fast-track approvals of new drug formulations, research predicts.
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Two novel biosimilars approved in EU and US
The first omalizumab biosimilar in allergic diseases is approved by the European Commission and the US Food and Drug Administration (FDA) has authorised the fifty third biosimilar in the US.
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Major manufacturing investment to support API production for tirzepatide
Eli Lilly and Company has committed the largest US investment in synthetic medicine active pharmaceutical ingredient (API) manufacturing.
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Sanofi releases new data for innovative oral asthma treatment
New findings from a Sanofi trial highlight promise for the potential first advanced oral treatment for moderate-to-severe asthma.
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European Commission grants first-of-a-kind biosimilar approval
The approval means Sandoz’s Wyost® and Jubbonti® are the first biosimilars of denosumab authorised in Europe.
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European authorities recognised for leading medicine regulatory oversight
Expansion of the WLA framework means that the largest number of regulatory agencies for medical products are approved as WHO Listed Authorities.
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UK clinical trial regulation may support haemophilia treatment access
The new Notification scheme by the MHRA helps to reduce the time it takes for the lowest-risk clinical trials to commence, while maintaining patient safety.
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Takeda agrees to develop active immunotherapy for Alzheimer’s
As part of the agreement, AC Immune SA will be eligible for an option exercise fee and extra potential milestones of up to approximately $2.1 billion from Takeda.
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Sanofi adds to biomanufacturing investment in France
The pharmaceutical company shared that its new investment adds to the current €2.5 billion planned for major building projects in France.
