News
Viglya wishes to establish transparent and open communication with its stakeholders. This section offers new and updated information regarding the company and the life science sector.
FDA Approves New Indication for Drug Containing an Active Ingredient Derived from Cannabis to Treat Seizures in Rare Genetic Disease
Today, the U.S. Food and Drug Administration approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older. Epidiolex was previously [...]
EMA: Global regulatory workshop on COVID-19 therapeutics #2: agreement on acceptable endpoints for clinical trials
International regulators have published a report today on the acceptability of various primary endpoints in the clinical trials conducted for the development of treatments for COVID-19. The report summarises the main outcomes of the second workshop on COVID-19 therapeutics [...]
EMA: Global regulatory workshop on COVID-19 real-world evidence and observational studies
Vaccines surveillance and vigilance, collaboration on pregnancy studies and building international patient cohorts were the main topics discussed during the 3rd workshop on observational studies of real-world data in the context of COVID-19. The workshop, [...]
Infarmed: Suspensão da atividade do distribuidor por grosso Steinbock Apotheke OG (Áustria)
A autorização da atividade de distribuição por grosso de medicamentos da entidade Steinbock Apotheke OG foi suspensa após a deteção de não-conformidades com as boas práticas de distribuição, conforme divulgado pela autoridade competente austríaca. Face [...]
UK MHRA: New synthetic datasets to assist COVID-19 and cardiovascular research
The Medicines and Healthcare products Agency (MHRA) has announced the creation of two innovative synthetic datasets which will support the development of cutting-edge medical technologies to fight coronavirus (COVID-19) and cardiovascular disease. These datasets have been generated [...]
ANSM: Défaut qualité de la Protamine Choay 1000 UAH/ml: recommandations pour les professionnels de santé
Des lots[1] du médicament Protamine Choay 1000 UAH/ml (solution injectable) présentent une activité de neutralisation de l’héparine réduite d’environ 25% par rapport à l’activité attendue (environ 755 UAH/ml au lieu de 1000 UAH/ml). Nous demandons donc [...]