COMMUNIQUÉS West-GlobeNewswire

Ipsen’s Iqirvo® (elafibranor) approved in the European Union as first new treatment for primary biliary cholangitis in nearly a decade
20/09/2024
European Commission grants conditional marketing authorization for Iqirvo ® (elafibranor), first-in-class new treatment for primary biliary cholangitis (PBC), a rare liver disease Approval follows positive CHMP opinion [...]
Le médicament Iqirvo® (élafibranor) d’Ipsen est approuvé dans l’Union européenne comme premier nouveau traitement contre la cholangite biliaire primitive depuis près d’une décennie
20/09/2024
La Commission européenne accorde une autorisation de mise sur le marché conditionnelle à Iqirvo ® (élafibranor), nouveau traitement premier de sa classe thérapeutique contre la cholangite biliaire primitive (CBP), une [...]
Novo Nordisk A/S: Monlunabant phase 2a trial in obesity successfully completed
20/09/2024
Bagsværd, Denmark, 20 September 2024 – Novo Nordisk today announced headline results from a phase 2a clinical trial with monlunabant, a small molecule oral cannabinoid receptor 1 (CB1) inverse agonist. Monlunabant, [...]
Fortress Biotech Announces Pricing of $8 Million Registered Direct Offering and Concurrent Private Placements
20/09/2024
MIAMI, Sept. 20, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress” or “Company”), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for [...]
Autonomix Selected to Present at the 2024 Octane Medical Innovation Forum
20/09/2024
THE WOODLANDS, TX, Sept. 20, 2024 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company focused on advancing precision nerve-targeted treatments, today [...]
Alpha Tau Announces FDA Approval of IDE to Initiate Multi-Center Investigator-Initiated Study of Alpha DaRT® in Immunocompromised Patients with Recurrent cSCC
20/09/2024
-Trial to focus on particularly vulnerable subset of patients, following strong clinician interest in use of the Alpha DaRT in this patient population - JERUSALEM, Sept. 20, 2024 (GLOBE NEWSWIRE) -- Alpha Tau Medical [...]
Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron KP.2-adapted COVID-19 Vaccine in the European Union
20/09/2024
Upon authorization by the European Commission, the Omicron KP.2-adapted COVID-19 vaccine will be available for individuals 6 months of age and older Data demonstrate that the Omicron KP.2-adapted COVID-19 vaccine [...]
Samsung Bioepis and Biogen Receive Positive CHMP Opinion for Aflibercept Biosimilar, OPUVIZ™
20/09/2024
OPUVIZ™, a biosimilar referencing Eylea 1 (aflibercept), is Samsung Bioepis and Biogen’s second ophthalmology biosimilar to be recommended for marketing authorization by the European Medicines Agency INCHEON, South [...]
Dupixent® (dupilumab) Recommended for EU Approval by the CHMP to Treat Eosinophilic Esophagitis (EoE) in Children as Young as 1 Year Old
20/09/2024
Recommendation based on a Phase 3 trial showing a significantly greater proportion of children on Dupixent achieved histological remission compared to placebo, consistent with improvements seen in adults and adolescents [...]
Press Release: Dupixent recommended for EU approval by the CHMP to treat eosinophilic esophagitis in children as young as 1 year old
20/09/2024
Dupixent recommended for EU approval by the CHMP to treat eosinophilic esophagitis in children as young as 1 year old Recommendation based on a phase 3 study showing a significantly greater proportion of children on [...]
Communiqué de presse : Le CHMP recommande l’approbation du Dupixent dans l’UE pour le traitement de l’œsophagite à éosinophiles de l’enfant à partir de 12 mois
20/09/2024
Le CHMP recommande l’approbation du Dupixent dans l’UE pour le traitement de l’œsophagite à éosinophiles de l’enfant à partir de 12 mois Recommandation fondée sur une étude de phase III ayant montré qu’une proportion [...]
DARZALEX® (daratumumab)-based quadruplet regimen receives positive CHMP opinion for transplant-eligible patients with newly diagnosed multiple myeloma
20/09/2024
Recommendation supported by findings from quadruplet therapy PERSEUS study with daratumumab subcutaneous (SC) formulation in the frontline setting Findings showed 60 percent reduction in risk of disease progression or [...]
Traws Pharma, Inc. Appoints Luba Greenwood to Board of Directors
20/09/2024
Experienced Life Sciences Executive Brings Strategic Expertise to Support Traws’ Further Transformation and Growth Director James J Marino Also to Step Down from Traws Board After a Decade of Service NEWTOWN, Pa., Sept [...]
Press Release: Tolebrutinib demonstrated a 31% delay in time to onset of confirmed disability progression in non-relapsing secondary progressive multiple sclerosis phase 3 study
20/09/2024
Tolebrutinib demonstrated a 31% delay in time to onset of confirmed disability progression in non-relapsing secondary progressive multiple sclerosis phase 3 study Data presented at ECTRIMS show that tolebrutinib, a [...]
CP : Le tolebrutinib a permis d’allonger de 31 % le délai avant progression confirmée du handicap dans le cadre d’une étude de phase III menée chez des personnes présentant une sclérose en plaques secondairement progressive non active
20/09/2024
Le tolebrutinib a permis d’allonger de 31 % le délai avant progression confirmée du handicap dans le cadre d’une étude de phase III menée chez des personnes présentant une sclérose en plaques secondairement progressive [...]
Inbiome, developing a new PCR technology capable of simultaneous identification of hundreds of bacterial pathogens in a single test, welcomes Professor Dr. Carl Wittwer to its Advisory Board
20/09/2024
Amsterdam, The Netherlands, September 20, 2024. Inbiome, a pioneer in advanced molecular diagnostics, today announced the appointment of Professor Dr. Carl Wittwer ( picture ), a global authority in PCR technology and [...]
Apellis Receives Negative CHMP Opinion for Pegcetacoplan for Geographic Atrophy (GA) in the EU Following Re-Examination
20/09/2024
WALTHAM, Mass., Sept. 20, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has [...]
213,285 Orion Corporation A shares converted into B shares
20/09/2024
ORION CORPORATION STOCK EXCHANGE RELEASE – OTHER INFORMATION DISCLOSED ACCORDING TO THE RULES OF THE EXCHANGE 20 SEPTEMBER 2024 at 9.30 EEST 213,285 Orion Corporation A shares converted into B shares In accordance with [...]
Financière de Tubize - Transparency notification
20/09/2024
Publication concerning a transparency notification (article 14, first paragraph of the law of 2 May 2007 concerning the publication of significant participating interests) Press release - Regulated information Brussels [...]

Pages