All Drug Development articles – Page 56
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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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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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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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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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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).
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NewsCould BioNTech's new partnership accelerate personalised mRNA therapy trials?
The UK Government and BioNTech’s new partnership aims to accelerate clinical trials of personalised immunotherapies for cancer and infectious disease vaccines.
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NewsFDA accepts Biologics License Application for RSV vaccine
The Biologics License Application for nirsevimab as the first protective option against RSV for all infants has been accepted by the the US Food and Drug Administration (FDA).
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NewsFirst-in-class telomerase inhibitor aids transfusion independence in clinical trial
Telomerase inhibitor imetelstat benefitted both major subtypes of lower risk MDS in a Phase III trial for the first time.
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NewsEMA validates Enhertu® Type II variation application for lung cancer
The Type II variation application for Enhertu® for adults with advanced non-small cell lung cancer has been validated by the EMA.
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NewsGilead’s $658.5m immunotherapy collaboration
Gilead will develop immunotherapy products through a $658.5m agreement with EVOQ Therapeutics using EVOQ’s NanoDisc technology.
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NewsJanssen submits marketing application for bispecific antibody
Approval for Janssen’s talquetamab to treat relapsed/refractory multiple myeloma has been submitted to the European Medicines Agency.
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NewsFirst patient enrolled in cisplatin-induced ototoxicity Phase II trial
A Phase II proof of concept trial evaluating SENS-401 for cisplatin-induced ototoxicity has enrolled its first patient.
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NewsFirst treatment approval for advanced ASPS
A Phase II trial has led to the FDA approval of atezolizumab for individuals over two years old with advanced alveolar soft part sarcoma.