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FDA updates guidance for adaptive clinical trial reporting
The US Food and Drug Administration has announced new guidance for drug applications that include results from adaptive clinical trials.
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Avacopan Phase III trial meets primary endpoints
A study to demonstrate the safety and efficacy of avacopan has produced topline results, according to the pharmaceutical company developing the drug.
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Enzalutamide treatment approved for use in China
The Chinese National Medical Products Administration has given its approval to XTANDI® to treat prostate cancer, following a successful Phase III trial.
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Broadly neutralising antibody to be developed for HIV-1 treatment
The investigational broadly neutralising antibody, N6LS, is to be developed by ViiV Healthcare for the treatment and prevention of HIV-1.
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Medical device design – a key consideration when entering biosimilars market
A recent industry report projects a boom in the biosimilars market over the next three years and highlights key considerations for meeting its potential.
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First treatment for inherited rare disease approved by the FDA
Givlaari (givosiran) has been approved by the FDA for the treatment of adult patients with the rare genetic disorder, acute hepatic porphyria.
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EC approves two new regimens of Keytruda for HNSCC
The European Commission has given its approval to Keytruda to treat head and neck squamous cell carcinoma as a monotherapy or in combination with a chemotherapy.
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UK authorisation granted for first in-human CAR-Treg cell therapy study
Authorisation has been granted in the UK for the STEADFAST clinical study of TX200, which is the first-in-human trial to evaluate a CAR-Treg cell therapy.
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Primary endpoint met in drug study for worsening chronic heart failure
A study evaluating the efficacy and safety of vericiguat, a treatment for patients with worsening chronic heart failure, has met the primary efficacy endpoint.
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Therapy approved for patients with sickle cell disease complication
Adakveo has been approved by the FDA to reduce the frequency of vaso-occlusive crisis, a painful complication of sickle cell disease.
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Dengue fever vaccine shown to have 80 percent efficacy
A dengue fever vaccine candidate has demonstrated a high level of success in a Phase III trial, meeting its primary endpoints.
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Expert view: Biologics driving innovation in LC-MS analytical chemistry
Over the last few years, biologics have continued to make up an increasing proportion of biopharmaceutical sales and pipeline candidates. Cory E Muraco and Wayne Way discuss current trends in biologics analysis.
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Treating ulcerative colitis with a safe and effective biologic
Janssen has recently received marketing authorisation from the European Commission for Stelara to treat ulcerative colitis. Dr Jaime Oliver discusses the mode of action and why the treatment is needed.
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Marketing authorisation recommended to be withdrawn for preterm birth drug
A vote by an FDA committee has resulted in the suggestion that marketing authorisation is revoked for preterm birth treatment Makena.
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Candidate vaccine shows sustained protection against pulmonary TB
A candidate TB vaccine’s efficacy level and acceptable safety profile have been confirmed in a three-year clinical trial.