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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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Hannah Balfour (European Pharmaceutical Review)
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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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CureVac recieves €75 million loan for vaccine development and manufacturing expansion
The European Investment Bank (EIB) will provide three €25 million instalments to support CureVac’s vaccine development and expansion to mRNA production facilities.
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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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FDA approves new heart rhythm devices featuring Bluetooth connectivity and continuous remote monitoring
Abbott’s Gallant™ implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices are given approval.
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Sustainable biomedical device promising for regenerative medicine, say researchers
The sustainable device, consisting of food industry by-products, had excellent biocompatibility both in vitro and in vivo.
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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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European Pharmacopoeia publishes new chapter regarding BET testing
The new chapter describes a method for bacterial endotoxins (BET) testing using recombinant factor C (rFC) instead of limulus amoebocyte lysate (LAL).