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Zotiraciclib granted Orphan Drug Designation by FDA and EMA
The FDA and EMA have granted Orphan Drug Designation to zotiraciclib, currently the subject of two separate Phase Ib clinical trials in glioblastoma.
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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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Priority Review granted to pemigatinib for treatment of cholangiocarcinoma
The US FDA has awarded pemigatinib Priority Review, after the drug met its primary and secondary endpoints in a Phase II trial.
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NICE approves breast cancer treatment through Cancer Drugs Fund
NICE has approved palbociclib through the Cancer Drugs Fund, meaning that women with advanced breast cancer who have already received hormone therapy will now be eligible for palbociclib on the NHS.
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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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EU marketing authorisation granted for rheumatoid arthritis treatment
Remsima SC™ is the world’s first subcutaneous formulation of infliximab and has been approved in the EU for the treatment of people with rheumatoid arthritis.
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UK leads Europe in early clinical research, says new report
According to a new report, the UK is leading the rest of Europe for early-stage clinical research into new medicines and vaccines, with more than 600 commercial clinical trials taking place in the NHS.
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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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Anti-epileptic drug XCOPRI® approved by the FDA
Based on results from two global randomised studies and a large open-label safety study, XCOPRI has been approved by the FDA as a treatment for partial-onset seizures in adults.
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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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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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Ninety-seven percent response rate reported in advanced prostate cancer treatment study
A Phase III study of oral relugolix has met its primary efficacy endpoint in men with advanced prostate cancer, supporting a New Drug Application submission to the FDA.
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Fast Track Designation received for Prader-Willi syndrome treatment
Levo Therapeutics has received Fast Track Designation from the FDA for LV-101 (intranasal carbetocin) for the treatment of Prader-Willi syndrome.