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UK accounts for 12 percent of global cell and gene therapy clinical trials
New research has found that the cell and gene therapy clinical environment in the UK has encouraged commercial sponsorship from around the world.
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Summarising 2019: a year of firsts for the EMA
The EMA was a proactive force in 2019, granting marketing authorisation for a range of drugs. This article highlights some of the most important advancements made by the agency last year.
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HIV treatment Dovato (dolutegravir/lamivudine) approved in Japan
The Japanese Ministry of Health, Labour and Welfare (#MHLW) has granted marketing approval for Dovato, a treatment for HIV-1 infection.
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Phase III STRENGTH trial for Epanova in mixed dyslipidaemia will close
On recommendations by an independent committee, AstraZeneca will close its STRENGTH trial for Epanova, which has shown low likelihood of being beneficial to patients with mixed dyslipidaemia.
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FDA grants Avatrombopag Orphan Drug Designation for thrombocytopenia
The US FDA has granted avatrombopag (Doptelet) ODD as around 10 percent of US cancer patients per year experience chemotherapy-induced thrombocytopenia (CIT) with no available treatment.
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Novartis and NHS partner to improve manufacture of oligonucleotides
A partnership between Novartis and NHS England includes a proposal to investigate processes that can increase the scale and efficacy of oligonucleotide manufacture.
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FDA approves Keytruda for patients with high-risk, non-muscle invasive bladder cancer
Keytruda is the first anti-PD-1 monoclonal antibody therapy approved for patients with BCG-unresponsive, high-risk, non-muscle invasive bladder cancer.
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MS treatment trial to compare stem cell transplantation to biologic drugs
The BEAT-MS trial aims to compare the experimental autologous hematopoietic stem cell transplantation (AHSCT) therapy to the best available biologic therapies for multiple sclerosis (MS).
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T-cell lymphomas treatment trial update announced by Innate Pharma
Enrolment of new patients in the TELLOMAK trial, which has been evaluating the efficacy and safety of lacutamab in patients with advanced T-cell lymphomas, has been suspended.
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US study investigates how medicines can be removed from wastewater
New research has shown that technologies are available for US treatment plants to remove medicines from wastewater but that upgrades can be expensive.
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FDA approves Ayvakit, the first targeted gastrointestinal stromal tumour treatment
The FDA has approved Ayvakit for the treatment of GISTs with platelet-derived growth factor receptor alpha mutations, following 84 percent response rate in clinical trials.
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Nanoparticle gene therapy drug delivery for paediatric brain cancer tested in mice
A study has shown that PBAE nanoparticles could replace viral vectors in gene therapies and provide a safe treatment option for paediatric brain cancer patients.
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NICE argue for more histology-independent cancer drug evidence
Staff at NICE have co-authored a paper which suggests that new, histology-independent cancer treatments require more clinical evidence before approval recommendation by the institution.
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Cancer immunotherapy market to hit $115bn by 2023, says report
New research analysis has predicted that immunotherapy will become the oncology treatment of choice, with the market reaching $115 billion by 2023.
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MHRA approves cerebral palsy spasticity drug to treat children
Dysport®, a therapy for spasticity in cerebral palsy patients has been granted a license update to treat children aged two years and older.