FDA grants Priority Review to Pfizer’s tick-borne encephalitis vaccine TicoVac™
If approved, TicoVac would be the first vaccine in the US to help protect adults and children from tick-borne encephalitis.
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Sanofi and GSK start Phase II study of their COVID-19 vaccine candidate
The dose finding study will assess the safety, reactogenicity and immunogenicity of the companies’ investigational COVID-19 vaccine in 720 participants.
Partnership to develop a microneedle patch for delivering psychedelic pharmaceuticals
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)
FDA receives new stability data on Pfizer’s COVID-19 vaccine
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.
Patient dosed with first Lassa fever vaccine to reach human trials
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.
Upadacitinib meets all endpoints in Phase III ulcerative colitis trial
In the trial, 74 percent of participants responded to upadacitinib and 33 percent of patients achieved clinical remission.
FDA issues new guidance for developers of COVID-19 vaccines, diagnostics and therapeutics
The new recommendations address the evolving landscape of COVID-19 drug development, including the emergence of SARS-CoV-2 variants.
Scientists repair spinal cord injuries using patients’ stem cells
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.
FDA approves Libtayo® monotherapy for non-small cell lung cancer patients
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.
Janssen submits for WHO Emergency Use Listing of COVID-19 vaccine
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.
UK grants marketing authorisation to “landmark” breast cancer therapy
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.
EU doubles its COVAX contribution, promising €1bn for safe and effective COVID-19 vaccines
The addition of €500 million to the EU’s existing COVAX Facility pledge was announced at the G7 summit virtual leaders' meeting.
Gates Foundation to fund Novartis’ development of a sickle cell disease gene therapy
The Gates Foundation will fund Novartis’ discovery and development of a gene therapy for sickle cell disease that is accessible for low- and middle-income countries.
IMU-838 shows some clinical benefit in moderate COVID-19 patients
The oral treatment slightly shortened time to clinical improvement and recovery in a Phase II trial, with greatest benefits in high-risk and elderly COVID-19 patients.
CAR T therapy provides long-lasting remissions in non-hodgkin lymphoma
Study shows most non-Hodgkin's lymphoma patients who achieve a remission lasting one year remain in remission for five years after receiving Novartis’ Kymriah™.
