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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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NICE requests more data on Keytruda for head and neck cancer treatment
NICE has asked for more information on Keytruda (pembrolizumab) for untreated metastatic or unresectable recurrent squamous cell head and neck cancer due to uncertainty over clinical trial evidence.
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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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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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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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FDA approves sNDA for candidiasis treatment in paediatric patients
Supplemental new drug application (sNDA) has been approved for an expanded indication of MYCAMINE® for the treatment of invasive candidiasis in paediatric patients under four months old.
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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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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.
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Acute myeloid leukemia treatment receives FDA Orphan Drug Designation
Orphan drug designation has been approved by the FDA for PRGN-3006 UltraCAR-T™ for patients with acute myeloid leukemia (AML).
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Funding for AI in drug development, clinical trials and information synthesis hits $5.2bn
A study has suggested that while funding for artificial intelligence in pharma was $5.2bn in 2019, overall investment is slowing.
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Adopting new guidelines could get medicines from CID trials to patients faster
The ECMC has published guidelines for Complex Innovative Design trails which could improve the conduct, quality and acceptability of oncology studies, enabling patients to get access to new medications more quickly.