FDA grants Fast Track designation to two COVID-19 vaccines
Two investigational SARS-CoV-2 vaccine candidates, BNT162b1 and BNT162b2, currently in clinical trials have been granted Fast Track designation by the FDA.
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NICE recommends Adcetris (brentuximab vedotin) for treatment of rare lymphoma
The recommendation of Adcetris (brentuximab vedotin) represents the first new frontline therapy for systemic anaplastic large cell lymphoma (sALCL) in several decades.
Inhaled formulation of remdesivir enters clinical trials
Gilead reveals the novel inhaled formulation of remdesivir entered Phase I trials to establish if it could be used to treat mild to moderate COVID-19.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
