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Final results from CABINET Phase III trial reinforce efficacy benefits of…
Data demonstrated statistically significant and clinically meaningful reduction in risk of disease progression or death with Cabometyx ®(cabozantinib) versus placebo in advanced pancreatic and extra-pancreatic neuroendocrine tumors (NETs) 1 ,2 Data presented at ESMO 2024 and published in New England Journal of Medicine Ipsen has submitted an extension of indication Marketing Authorization to the European Medicines AgencyLimited approved treatment...
Nasdaq GlobeNewswire
16/09/2024
Buyback of Class B shares in Essity during week 37, 2024
The share repurchase is financed using cash flow from current operations after the ordinary dividend with the ambition to continue with share buybacks over time as a recurring part of Essity's capital allocation. The share repurchase is financed using cash flow from current operations after the ordinary dividend with the ambition to continue with share buybacks over time as a recurring part of Essity's capital allocation. Class B shares in Essity were repurchased as follows: All purchases...
PR Newswire
16/09/2024
Theriva™ Biologics Awarded Manufacturing Funding from the Spanish Government's…
Theriva Biologics and the Universitat Autònoma de Barcelona to receive a total of €2.28 Million to support the THERICEL project, a suspension cell platform for manufacturing viral-based therapies The THERICEL project is intended to establish the viability of using proprietary Theriva's A549 suspension cell platform for the clinical manufacture of adenoviral and AAV therapies. Suspension cell manufacture is expected to dramatically increase efficiency and decrease the cost of manufacturing...
Nasdaq GlobeNewswire
16/09/2024
Virbac: erratum short Press release Capital reduction_September 13, 2024
This press release rectifies the version of the press release issued by Virbac on September 13, 2024 at 5:45 pm in order to correct a typing error in the amount of Virbac's new share capital.The share capital of Virbac amounts now to €10,488,325 and not €10,448,325 as announced.Focusing on animal health, from the beginningAt Virbac, we provide innovative solutions to veterinarians, farmers and animal owners in more than 100 countries around the world. Covering more than 50 species, our...
Nasdaq GlobeNewswire
16/09/2024
PhytoHealth Corporation announced a new clinical study results published at 2024…
Results showed that patients who received PG2 in addition to CCRT experienced significantly longer overall survival compared to those who received CCRT alone. Furthermore, the combination therapy resulted in a higher tumor objective response rate. The study also found that PG2 helped strengthen the immune system by modulating the tumor immune microenvironment (TIME) and enhancing the suppression of tumor growth. Results showed that patients who received PG2 in addition to CCRT experienced...
PR Newswire
16/09/2024
Evaxion reports convincing one-year data from phase 2 trial on AI-designed…
11 out of 16 patients had objective clinical responses, equaling a 69% Overall Response Rate15 out of the 16 patients had a reduction of their tumors (target lesions)79% of EVX-01's vaccine targets triggered a targeted immune response, which compares very favorably to what is seen with other approaches A positive correlation was observed between the AI-Immunology™ platform predictions and neoantigen immune response (p=0.00013)EVX-01 as a novel potential melanoma treatment...
Nasdaq GlobeNewswire
16/09/2024
Boehringer's nerandomilast meets primary endpoint in pivotal phase-III…
Topline data from FIBRONEER™-IPF show that the investigational compound nerandomilast met its primary endpoint, which was the absolute change from baseline in Forced Vital Capacity [mL] at week 52 versus placebo. The FIBRONEER™-IPF trial is the largest trial in idiopathic pulmonary fibrosis (IPF) conducted to date. Patients were recruited in over 330 sites and in over 30 countries. 1,5 Full efficacy and safety data from the trial will be presented in the first half of 2025.Boehringer...
Nasdaq GlobeNewswire
16/09/2024
Immatics Presents Clinical Proof-of-Concept Data from Ongoing Phase 1 Dose…
TCER® IMA401 is a novel, next-generation, half-life extended bispecific T cell engager directed against an HLA-A*02-presented peptide derived from MAGEA4 and MAGEA8 with high target copy numbers on various solid cancersData from the first-in-human Phase 1 dose escalation trial demonstrate initial anti-tumor activity and a manageable tolerability profile for TCER® IMA401 monotherapy; patient population includes 35 heavily pre-treated patients across 16 different solid tumor types; dose...
Nasdaq GlobeNewswire
16/09/2024
Novartis Kisqali® shows deepening benefit in new analysis, reducing the risk of…
Invasive disease-free survival benefit continued to increase after completion of the three-year treatment period across all patient subgroups, including those with node-negative disease 1 Results remain consistent across secondary endpoints, including distant disease-free survival, with a trend for improved overall survival* 1 Safety is in line with previously reported results with generally low-grade symptomatic adverse events, reinforcing well-tolerated profile 1 People...
Nasdaq GlobeNewswire
16/09/2024
Remedee Labs' Solution becomes the first CE marked medical device (class IIa)…
"Obtaining European medical device status for the indication fibromyalgia is a major milestone for Remedee Labs, but above all for people living with fibromyalgia, who previously lacked access to any approved and dedicated treatments for their condition," says Dr. David Crouzier (PhD), co-founder, CEO of Remedee Labs. "Obtaining European medical device status for the indication fibromyalgia is a major milestone for Remedee Labs, but above all for people living with fibromyalgia…
PR Newswire
16/09/2024
FDA approves OCREVUS ZUNOVO™ as the first and only twice-a-year 10-minute…
OCREVUS ZUNOVO™ has the potential to expand treatment options to centres without IV infrastructure or with IV constraints, like at a doctor's officeThis approval is backed by a decade of proven safety and efficacy data of Ocrevus® IV, with over 350,000 people treated globallyOCREVUS ZUNOVO™ offers people with multiple sclerosis (MS) more options to access treatment based on their individual needs Basel, 16 September 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the...
Nasdaq GlobeNewswire
16/09/2024
China patent notification boosts PolTREG's development of Treg cell therapy in…
China's National Intellectual Property Administration has issued notification to grant patent to PolTREG Chinese patent covers intrathecal administration of PolTREG's PTG-007 Treg cell therapy to treat multiple sclerosisIntrathecal administration demonstrated promising result in Phase I clinical trialPolTREG set to launch one Phase 2 study in each of two types of MS: relapsing-remitting (RRMS) and primary progressive (PPMS) in Q4 2024 Gdańsk, Poland – 16 September 2024– PolTREG S...
Nasdaq GlobeNewswire
16/09/2024
Ipsen provides update on CONTACT-02 Phase III trial in metastatic…
Trial investigating Cabometyx ®(cabozantinib) in combination with atezolizumab demonstrated a positive trend towards improvement for one of the primary endpoints of overall survival, but did not meet statistical significanceIpsen will not pursue regulatory submissions for the combination regimen in countries where we have commercialization rights (outside of the US and Japan)We remain confident in the proven profile of Cabometyx as a monotherapy and in combination with...
Nasdaq GlobeNewswire
15/09/2024
Investigational Rinatabart Sesutecan (Rina-S) Shows Promising Anti-Tumor…
Media ReleaseCOPENHAGEN, Denmark; September 15, 2024 Treatment with rinatabart sesutecan(Rina-S) showed encouraging response rate in heavily pretreated patients with ovarian cancer in dose expansion cohortResponses with Rina-S were observed across FRα expression levels Phase 3 trial will further evaluate the safety and efficacy of Rina-S at 120 mg/m 2in patients with advanced ovarian cancer Genmab A/S(Nasdaq: GMAB)announced today new data from the Phase...
Nasdaq GlobeNewswire
15/09/2024
Breakthrough Therapy designation for Sanbexin sublingual tablets granted by the…
The Breakthrough Therapy designation is based on the significant improvement in efficacy metrics demonstrated by the sublingual tablets in a previous clinical study. The data from a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III clinical study in China for the treatment of AIS demonstrated that Sanbexin sublingual tablets significantly improved neurological recovery and independent living ability in patients with AIS compared to placebo, meeting the expected…
PR Newswire
14/09/2024
Gan & Lee Pharmaceuticals Presented Two Positive Clinical Results of Once-weekly…
Phase Ia Study Results Phase Ia Study Results This placebo-controlled and active-comparator-controlled, single-center, single-dose, randomized, dose-escalation study aimed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GZR4 in healthy adult male participants. The study was conducted following a dose-escalation design, starting from lower doses and progressively increasing to higher doses. Participants in cohorts 1-4 randomly receiving a...
PR Newswire
14/09/2024
Avacta Reports Updated Phase 1 Clinical Data of AVA6000 at the European Society…
This announcement contains inside information for the purposes of Article 7 of the UK version of Regulation (EU) No 596/2014 which is part of UK law by virtue of the European Union (Withdrawal) Act 2018, as amended ("MAR"). Upon the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain. 14 September 2024 Avacta Group plc (“Avacta” or “the Group” or...
Nasdaq GlobeNewswire
14/09/2024
iTeos Announces Clinically Meaningful Objective Response Rate Observed at Every…
- Clinically meaningful objective response rate (ORR) of 63.3-76.7% observed with belrestotug + dostarlimab combinations, with confirmed ORR (cORR) at ~60% for every dose - >30% cORR difference between belrestotug + dostarlimab vs dostarlimab monotherapy - Belrestotug + dostarlimab safety profile broadly consistent with known safety profile of checkpoint inhibitor combinations - GALAXIES Lung-301, global Phase 3 registration study, enrolling in same indication and setting -…
Nasdaq GlobeNewswire
14/09/2024
Fagron completes share buy-back program
Regulated information Nazareth (Belgium)/Rotterdam (The Netherlands), 13 September 2024 – 6PM CET Fagron completes share buy-back program Fagron has successfully completed its share buy-back program today. In the last period from 9 September 2024 through 13 September 2024, Fagron purchased 45,000 of its owns shares at an average price of € 19.10 per share corresponding to a total amount of € 859,324.10. A total of 150,000 Fagron shares have been repurchased under the buy-back program at...
Nasdaq GlobeNewswire
13/09/2024
Virbac : Half-yearly financial report 2024
Please find attached 2024 Half-yearly financial report of Virbac Attachment Half-Yearly Financial Report_2024 for publication
Nasdaq GlobeNewswire
13/09/2024
Virbac : Public release of the Half-Year Financial Report at 30 June 2024.
Public release of the Half-Year Financial Report at 30 June 2024.The Group released and filed its 2024 half-year financial report with the French “Autorité des marchés financiers”.The document is also available on the corporate website, at corporate.virbac.com, under “Investors”, “Financial Reports”. Attachment Public release of the Half-Year Financial Report_06.24
Nasdaq GlobeNewswire
13/09/2024
Virbac : the board of directors announces a capital reduction through…
During the meeting held on September 13, 2024, the board of directors, acting on the authorization granted by the combined shareholders' meeting on June 20, 2023, decided to reduce the share capital of Virbac by canceling 67,340 treasury shares. These shares were acquired during 2023 under the share buyback program authorized by the same shareholders' meeting.As of today, the share capital of Virbac amounts to €10,448,325, represented by 8,390,660 shares of €1.25, fully...
Nasdaq GlobeNewswire
13/09/2024
Virbac: Information on the departure of Sébastien Huron
At its meeting on September 13, 2024, the board of directors acknowledged the resignation of Sébastien Huron, effective as of September 27, 2024, from his positions as chief executive officer of Virbac and director of Virbac Limited (UK).On the recommendation of the appointments and compensation committee, the board of directors has decided on the financial terms of Sébastien Huron's departure, as set out below.Fixed compensation for 2024 In accordance with the compensation policy...
Nasdaq GlobeNewswire
13/09/2024
Virbac 2024 half-year results
Exceptional business momentum in the first half, with revenue up 16.1% at constant exchange ratesStrong growth in adjusted current operating income 1 +3.4 points compared with 2023 to reach a record level at 21.4% of revenue2024 targets confirmed Revenue growth expected between 7% and 9% at constant exchange rates and scopeAdjusted current operating income 1expected to be around 16% compared with 15.1% in 2023 CONSOLIDATED FIGURES AS AT JUNE 30...
Nasdaq GlobeNewswire
13/09/2024
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