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FDA approves first gene therapy for high-risk early bladder cancer
The first gene therapy for high-risk non-muscle-invasive bladder cancer has been approved by The US Food and Drug Administration (FDA).
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CHMP meeting highlights – December 2022
A total of five drugs were recommended for approval at the CHMP’s December meeting, including a gene therapy and two cancer drugs.
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Alzheimer’s therapeutics market to reach $6.8 billion by 2032
A large patient population and limited treatment options are expected to expand the Alzheimer’s therapeutics market at a CAGR of 9.3 percent, suggested a report.
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WHO updates guidelines for treating drug-resistant tuberculosis
A historic change to guidelines for treating drug-resistant tuberculosis has been published by the World Health Organization.
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CHMP adopts positive opinion for haemophilia B gene therapy
Gene therapy etranacogene dezaparvovec has been granted a positive opinion by the CHMP as a haemophilia B treatment for adults in Europe.
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First targeted delivery of siRNA into muscle
A Phase I/II trial demonstrated the first successful targeted delivery of siRNA into muscle, using monoclonal antibody AOC 1001.
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Lilly and EVA Pharma to aid affordable insulin access in Africa
Insulin for at least one million diabetics in low- and middle-income countries, mainly in Africa, is the aim of Eli Lilly and EVA Pharmaceutical's new collaboration.
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European Commission approves first medicine for prurigo nodularis
Dupixent®, the first and only targeted medicine for prurigo nodularis has been approved by the EC for adults with a moderate-to-severe form of the condition.
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Takeda’s $4 billion acquisition to address autoimmune diseases
Takeda will acquire Nimbus Therapeutics for $4 billion and gain rights to its allosteric TYK2 Inhibitor to address multiple immune-mediated diseases.
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New collaboration could advance small molecule epilepsy therapy
UCB and Praxis Precision Medicines, Inc. will collaborate to advance Praxis’ PRAX-020 small molecule programme for KCNT1 related epilepsies.
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Application note: Workflow for antibody aggregate and fragment analysis
Protocol for heat stressing and SEC-UV analysis of monoclonal antibody aggregates and fragments.
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mRNA vaccine plus KEYTRUDA® improve melanoma survival
An mRNA vaccine plus KEYTRUDA® significantly improved recurrence-free survival in a Phase II trial for advanced melanoma patients.
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European Commission approves Pluvicto® for prostate cancer
The European Commission has approved Pluvicto® as the first targeted radioligand therapy for advanced prostate cancer, based on significant results from the Phase III VISION trial.
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Canadian and US developers to trial psychedelic medicines in UK
Canadian and US developers of psychedelic medicines for complex mental health conditions have signed with a UK-based CMO to trial their drugs in London.
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European Pharmaceutical Review Issue 6 2022
This issue includes articles on Raman mapping of pharmaceutical tablets, delivery options for mRNA therapeutics, the use of high-throughput analytics for clonal cell selection and much more...
