Treatment for rare Duchenne muscular dystrophy mutation approved by FDA26 February 2021 | By Hannah Balfour (European Pharmaceutical Review)The FDA conditionally approved Sarepta’s Amondys 45 (casimersen) after interim Phase III results indicated the treatment is reasonably likely to be of clinical benefit.
EMA COVID-19 treatment evaluations update26 February 2021 | By Hannah Balfour (European Pharmaceutical Review)The EMA has begun a rolling review of Celltrion’s regdanvimab (CT-P59) antibody for COVID-19 and assessing new data on Veklury (remdesivir).
FDA approves more flexible transportation conditions for Pfizer-BioNTech COVID-19 vaccine26 February 2021 | By Hannah Balfour (European Pharmaceutical Review)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.
Novel anti-psychotic shows promise in Phase II schizophrenia trial25 February 2021 | By Hannah Balfour (European Pharmaceutical Review)KarXT significantly reduced both positive and negative of symptoms of schizophrenia without the common problematic side effects of current antipsychotic therapies.
New variant-specific mRNA COVID-19 vaccine to enter clinical trials25 February 2021 | By Hannah Balfour (European Pharmaceutical Review)Moderna has shipped the trial material for its mRNA-1273.351 vaccine candidate to the US National Institutes of Health for Phase I trials.
Ide-cel provides lasting remissions in multiply-relapsed myeloma25 February 2021 | By Hannah Balfour (European Pharmaceutical Review)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.
FDA grants Priority Review to Pfizer’s tick-borne encephalitis vaccine TicoVac™25 February 2021 | By Hannah Balfour (European Pharmaceutical Review)If approved, TicoVac would be the first vaccine in the US to help protect adults and children from tick-borne encephalitis.
Sanofi and GSK start Phase II study of their COVID-19 vaccine candidate24 February 2021 | By Hannah Balfour (European Pharmaceutical Review)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 pharmaceuticals24 February 2021 | By Hannah Balfour (European Pharmaceutical Review)The Terasaki Institute is partnering with PharmaTher to adapt a microneedle drug delivery patch for the micro-dosing of psychedelics.
FDA receives new stability data on Pfizer’s COVID-19 vaccine24 February 2021 | By Hannah Balfour (European Pharmaceutical Review)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 trials24 February 2021 | By Hannah Balfour (European Pharmaceutical Review)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 trial23 February 2021 | By Hannah Balfour (European Pharmaceutical Review)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 therapeutics23 February 2021 | By Hannah Balfour (European Pharmaceutical Review)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 cells23 February 2021 | By Hannah Balfour (European Pharmaceutical Review)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 patients23 February 2021 | By Hannah Balfour (European Pharmaceutical Review)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.
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![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)
