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J&J to provide 200,000 Ebola vaccine regimens to Rwanda
Johnson & Johnson has announced that it will be contributing vaccines to support the Rwandan immunisation programme to combat Ebola.
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FDA grants Orphan Drug Designation to Epidermolysis Bullosa treatment
The US Food and Drug Administration has awarded APR-TD011 Orphan Drug Designation, for the treatment of a rare disease.
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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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Medical cannabis: face-to-face with Dr Mikael Sodergren
Dr Sodergren explores the uses of medical cannabis, describing its applications. He also discusses the future of cannabinoid research in the short- and long-term.
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FDA update: additional testing of ranitidine and nizatidine ordered
To further its investigation into the cause of the NDMA impurities found in ranitidine and nizatidine, the FDA has asked manufacturers of these products to expand their testing to include all lots of the medication.
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Once-a-month oral contraceptive pill one step closer
A new slow-release formulation and delivery system for the oral contraceptive pill has shown success in pre-clinical trials and could be taken once a month.
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Astellas enters into definitive agreement to acquire Audentes Therapeutics
Astellas has announced that it will be acquiring Audentes Therapeutics at a total cost of $3 billion.
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NICE approves new tablet formulation for olaparib drug
The UK NICE has extended its approval for olaparib, updating its formulation from eight capsules twice a day to two tablets twice daily.
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Strategies developed for improving drug delivery for brain tumour treatment
Scientists have proposed combining ultrasound with other techniques to improve drug transport into brain tumours.
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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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Dr Richard Torbett named as new ABPI Chief Executive
The ABPI’s board has unanimously appointed Dr Richard Torbett as Chief Executive, commencing 1 January 2020.
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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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Political parties focus on R&D and mental health ahead of UK election
The three largest UK political parties have published their manifestos for the upcoming election which focus on various pharma initiatives including the NHS, R&D, drug prices and mental health.
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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.