MHRA approves biosimilar for vision disorders in Great Britain
A marketing authorization for Ximluci® biosimilar referencing Lucentis® (ranibizumab) in Great Britain has been issued by the Medicines and Healthcare products Regulatory Agency (MHRA).
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Potential treatment identified for septic patients
CER-001 is a potentially game-changing treatment for septic patients at high risk of acute kidney injury, suggested a ABIONYX Pharma VP.
FDA approves long-acting injectable for schizophrenia and bipolar disorder
Schizophrenia and bipolar I disorder patients can be offered Rykindo® as a bi-weekly long-acting risperidone injection, as a result of the FDA's approval.
Switzerland and US sign drug inspection agreement
To promote Good Manufacturing Practice, Switzerland and the US have signed a Mutual Recognition Agreement to improve pharmaceutical drug inspection.
Moderna joins the Association of the British Pharmaceutical Industry
To support the UK’s investments in manufacturing and R&D, Moderna has joined the Association of the British Pharmaceutical Industry (ABPI).
T-cell therapy helps overcome stem cell transplant viral infections
A T-cell therapy that targets six viruses commonly contracted by haematology patients after allogeneic stem cell transplantation, offered 95 percent response in a study.
Pre-filled asthma pen approved for self-administration in EU
Tezspire is the first biologic approved in Europe for severe asthma with no phenotype or biomarker limitation, says AstraZeneca EVP.
Ph. Eur. adopts revised general monographs after adding paragraph on N-nitrosamines
Adoption of revised general monographs 2034 and 2619 comes after inclusion of a new paragraph approaching N-nitrosamine impurities.
2022 Terra Carta Seal: three pharma companies awarded
Two Big Pharma companies and one CDMO have been awarded the Terra Carta Seal, which recognises the efforts of global companies in their commitment to sustainability.
EC approves influenza antiviral for children over one years old
Xofluza® offers the first novel mechanism of action for an influenza antiviral to be approved by the European Commission in almost 20 years.
Gut microbiome key in Parkinson’s, suggests study
A large metagenomics study determined that gut microbiome is at the centre of Parkinson’s disease pathogenesis.
Is machine learning the answer for long-acting injectable drugs?
A study from the University of Toronto is one of the first to apply machine learning to the design of polymeric long-acting injectable drug formulations.
Eisai submits MAA for lecanemab in Europe
A Marketing Authorisation Application for lecanemab to treat Alzheimer's has been submitted to the European Medicines Agency.
Promising first-in-human study results for orally inhaled antibiotic
Safety results from a first-in-human study showed that orally inhaled murepavadin, a novel macrocycle compound, was well tolerated at all dose levels.
Pharmapack Europe to launch two new zones in 2024
Two new zones will be launched at Pharmapack Europe in 2024, to support growing demand for biologics, mRNA therapeutics and contract packaging.
