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Based on new stability data, the US regulator will allow COMIRNATY® to be transported and stored at standard pharmaceutical freezer temperatures for up to two weeks.
KarXT significantly reduced both positive and negative of symptoms of schizophrenia without the common problematic side effects of current antipsychotic therapies.
Moderna has shipped the trial material for its mRNA-1273.351 vaccine candidate to the US National Institutes of Health for Phase I trials.
BMS and bluebird bio have applied to the FDA for approval of ide-cel as a standard therapy for relapsed or refractory multiple myeloma based on positive Phase II trial results.
If approved, TicoVac would be the first vaccine in the US to help protect adults and children from tick-borne encephalitis.
The dose finding study will assess the safety, reactogenicity and immunogenicity of the companies’ investigational COVID-19 vaccine in 720 participants.
The Terasaki Institute is partnering with PharmaTher to adapt a microneedle drug delivery patch for the micro-dosing of psychedelics.
![Lines of vials labelled 'COVID-19 Vaccines' [Credit: Dimitris Barletis/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Covid-19-vaccines-2-1-300x278.jpg)
![Lines of vials labelled 'COVID-19 Vaccines' [Credit: Dimitris Barletis/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Covid-19-vaccines-2-1-e1614176959561.jpg)
New stability data could allow Pfizer and BioNTech’s COMIRNATY® COVID-19 vaccine to be stored at normal refrigerated temperatures for up to two weeks.
The first trial participant has been given INO-4500 in Ghana - INO-4500 is a DNA vaccine candidate being developed to protect against Lassa fever.
In the trial, 74 percent of participants responded to upadacitinib and 33 percent of patients achieved clinical remission.
The new recommendations address the evolving landscape of COVID-19 drug development, including the emergence of SARS-CoV-2 variants.
In a Phase II trial, all 13 patients who received an intravenous infusion of their own mesenchymal stem cells had improvements in neurological function six months later.
The approval was based on a Phase III trial in which Libtayo reduced risk of death by 43 percent in non-small cell lung cancer patients with ≥50 percent PD-L1 expression in their tumours.
If granted Emergency Use Listing by the World Health Organization (WHO), up to 500 million doses of Janssen’s single-dose COVID-19 vaccine could be distributed under COVAX.
Seagen's Tukysa® (tucatinib) was approved in the UK as part of a combination regimen for the treatment of adults with locally advanced or metastatic HER2-positive breast cancer.
