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Vaccines Europe launches first pipeline review
In its first pipeline review, Vaccines Europe has set out four key actions to ensure adults are protected from vaccine-preventable diseases.
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Biopharmaceuticals
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FDA approves Rezlidhia™ for leukaemia
Rezlidhia™ has been approved for adults with mIDH1 relapsed/refractory acute myeloid leukaemia by the US Food and Drug Administration (FDA).
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Pfizer’s €1.2 billion manufacturing site expansion
Pfizer’s €1.2 billion investment in its Grange Castle site in Dublin is expected to double the plant’s capacity for manufacturing biologics.
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mRNA non-vaccine therapeutics to generate $2 billion by 2028
Driven by the approval of pipeline agents, mRNA non-vaccine therapeutics are set to reach $2 billion in sales by 2028, says GlobalData.
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Could acoziborole eliminate sleeping sickness in Africa?
Acoziborole showed significant success in clinical studies, suggesting it could simplify treatment and help eradicate sleeping sickness.
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First faecal microbiota product approved for C. diff
The first faecal microbiota product to prevent recurrence of Clostridioides difficile infection in adults has been approved by the FDA.
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First paediatric EC approval of HIV drug
The European Commission has granted the first paediatric marketing authorisation for Gilead's low-dose Biktarvy® HIV tablet.
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NEJM publishes lecanemab Alzheimer’s study results
Full study results of Eisai’s Phase III Alzheimer's study suggest lecanemab could slow disease progression.
whitepaper
Application note: Middle-up mass analysis of protease digested cetuximab
Protocol for purification, proteolysis, reduction and UHPLC-MS analysis of unlabelled and labelled monoclonal antibodies
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CPI opens £88 million manufacturing innovation centre
CPI has opened its Medicines Manufacturing Innovation Centre in Scotland to focus on efficient, sustainable manufacturing and advance medicine research.
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First adaptive clinical trial for flu
A £2.9 million trial, the first adaptive platform trial studying flu treatments, could reduce serious illness in patients.
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AstraZeneca to acquire Neogene for $320 million
AstraZeneca is set to acquire Neogene Therapeutics to advance T-cell receptor therapies for hard-to-treat cancers like solid tumours.
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On-demand webinar: Get your aseptic facility ready for EU GMP Annex 1
Available on-demand: experts discussion and Q&A on the recent annex 1 revision, in the context of Microbiological Environmental Monitoring.
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FDA Fast Track designation for photodynamic cancer therapy
REM-001, a photodynamic therapy for cutaneous metastatic breast cancer has been given Fast Track designation by the US Food and Drug Administration (FDA).
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Nasal spray could help prevent depression relapse
SPRAVATO® nasal spray helped treatment-resistant depression patients remain remission and relapse free in a Phase III trial.
