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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.
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Clinical Trials
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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.
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AstraZeneca 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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FDA 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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FDA 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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Could 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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FDA 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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First-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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EMA 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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Janssen 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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First 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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First 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.
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EC approves Zynlonta® for large B-cell lymphoma
Antibody drug conjugate Zynlonta® (loncastuximab tesirine) is approved in the European Union for treatment of relapsed or refractory diffuse large B-cell lymphoma.
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FDA approves first capsid inhibitor for HIV
Gilead’s Sunlenca (lenacapavir) is the first capsid inhibitor to be FDA-approved for treating HIV-1.
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Moderna finalises plans for UK mRNA vaccine manufacturing centre
Moderna is to build an mRNA vaccine manufacturing centre in the UK after finalising a ten-year agreement with the UK government.
