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Global distribution partnership established for Strontium89
Q Biomed entered into a Named Patient Programme distribution agreement for Strontium89, a non-opioid metastatic bone cancer pain drug.
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EMA issues opinion on nitrosamines in medicines
The agency’s opinion will require companies to take measures to reduce nitrosamine impurities in medicines and carry out and action the results of risk assessments.
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TXA127 enters multiple Phase II trials in COVID-19 patients
A pharmaceutical formulation of the human angiotensin peptide, TXA127, will enter Phase II trials in hospitalised COVID-19 patients not in intensive care.
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Phase III COVID-19 antibody trials initiated in Americas
Simultaneous Phase III trials evaluating Regeneron’s REGN-COV2 antibody as both a prophylactic and a treatment have begun in US and some South American locations.
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Cervical dysplasia treatment device approved for global Phase III trial
The cervical dysplasia drug-device product, APL-1702 (Cevira®), offers an alternative to surgery and has been approved to start a clinical trial in China and several other countries.
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A new model for enhancing microparticle injectability
Scientists unveil their model, which other researchers can use to test the injectability of their drug delivering microparticle designs in silico.
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Long-acting injectable HIV PrEP outperforms commercially available daily pill
Extensive analysis of interim data finds patients given cabotegravir injection had a 66 percent lower incidence of HIV acquisition than those taking Truvada pills.
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India approves remdesivir for restricted emergency use in COVID-19 patients
The Drug Controller General of India (DCGI) approved remdesivir lyophilised powder for emergency use in patients hospitalised with severe COVID-19.
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Expanded access for compassionate use of remestemcel-L in COVID-19 infected children
US expands access to remestemcel-L for compassionate use in COVID-19 infected children with complications of multisystem inflammatory syndrome.
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How to start up an ATMP clinical trial
Advanced therapy medicinal products (ATMPs) are medicines based on genes, tissues or cells. They offer revolutionary opportunities for the treatment of disease and injury; however, developers face a complex regulatory and developmental landscape to bring ATMPs to market. Here Magdalena Czarnecka offers guidance and advice on effectively initiating an ATMP…
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New next-generation research platform launched by Genomics England
The genomic research platform will initially be used to help fast-track COVID-19 drug research and development, before being leveraged against other diseases, such as cancer.
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US trial testing Kevzara® (sarilumab) as a COVID-19 treatment stopped
Companies leading trial announce Kevzara failed to meet primary and secondary endpoints in critically ill COVID-19 patients, so the trial has been halted.
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EMA recommends Idefirix (imlinfidase) is granted marketing authorisation
The European Medicines Agency (EMA) recommended Idefirix is granted conditional marketing authorisation for highly sensitised patients awaiting kidney transplant.
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CHMP recommends cystic fibrosis treatment Kaftrio is granted marketing authorisation
The European Medicines Agency's human medicines committee (CHMP) said the treatment would offer a therapeutic option for certain cystic fibrosis phenotypes that are currently untreatable.
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Gilead prices remdesivir at $2,340 per patient for developed countries
Gilead has announced that the potential COVID-19 drug remdesivir will cost $390 per vial for developed countries, with treatment courses costing $2,340 per patient.