News – Page 75
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NewsMHRA 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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NewsPotential 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.
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NewsFDA 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.
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NewsSwitzerland 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.
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NewsModerna 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).
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NewsT-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.
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NewsPre-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.
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NewsPh. 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.
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News2022 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.
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NewsEC 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.
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NewsGut microbiome key in Parkinson’s, suggests study
A large metagenomics study determined that gut microbiome is at the centre of Parkinson’s disease pathogenesis.
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NewsIs 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.
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NewsEisai submits MAA for lecanemab in Europe
A Marketing Authorisation Application for lecanemab to treat Alzheimer's has been submitted to the European Medicines Agency.
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NewsPromising 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.
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NewsPharmapack 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.
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NewsPotential blockbuster drugs to watch in 2023
Lecanemab for Alzheimer's and the first potential gene therapy primed for US launch for haemophilia A are two potential blockbuster Drugs to Watch™, says a 2023 report.
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NewsAstraZeneca to acquire CinCor in nearly $2b deal
For a transaction value of nearly $2b, AstraZeneca is set to acquire CinCor Pharma, Inc., including rights to hypertension drug baxdrostat.
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NewsFDA grants accelerated approval for Leqembi
Alzheimer’s drug Leqembi has been accepted via the US Food and Drug Administration (FDA)’s Accelerated Approval pathway.
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NewsMajor M&A deals on 2023 agenda, says report
Subin Baral, EY Global Deals Leader, Life Sciences, recounts the global M&A trends in 2022 and predicts activity for 2023 in EY’s 2023 M&A Firepower report.
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NewsFDA grants priority review of glofitamab for lymphoma
Glofitamab for relapsed or refractory large B-cell lymphoma has been granted priority review by the US Food and Drug Administration (FDA).