Salute e Benessere

Bavarian Nordic Submits Supplemental BLA Seeking U.S. FDA Approval of…

COPENHAGEN, Denmark, May 31, 2024– Bavarian Nordic A/S (OMX: BAVA) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a freeze-dried formulation of JYNNEOS ®for prevention of smallpox and mpox disease in adults 18 years of age and older.The liquid-frozen formulation of JYNNEOS ®was approved by the FDA in September 2019. It remains the only approved mpox vaccine anywhere in the world...
Nasdaq GlobeNewswire
31/05/2024

AB Science is providing a summary of the live webcast held on May 30, 2024…

PRESS RELEASESUMMARY OF THE WEBCAST HELD ON MAY 30, 2024, PROVIDING AN UPDATE ON THE APPLICATION FOR CONDITIONAL MARKETING AUTHORISATION OF MASITINIB IN THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSISParis, May 31, 2024, 4.30pm CETAB Science SA(Euronext - FR0010557264 - AB) is providing a summary of the live webcast held on May 30, 2024, giving an update on the application for conditional marketing authorization of masitinib in the treatment of amyotrophic lateral sclerosis (ALS)...
Nasdaq GlobeNewswire
31/05/2024

DBV Technologies Announces Plan to Implement ADS Ratio Change

DBV Technologies Announces Plan to Implement ADS Ratio Change DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT—CUSIP: 23306J101), a clinical-stage biopharmaceutical company focused on treatment options for food allergies and other immunologic conditions with significant unmet medical need, previously announced plans to change the ratio of its American Depositary Shares (“ADSs”) to its ordinary shares (the “ADS Ratio”), nominal value €0.10 (ten cents) per...
Nasdaq GlobeNewswire
31/05/2024

Hansa Biopharma Completes Randomization in Pivotal Phase 3 US ConfIdeS Trial

The ConfIdeS trial is evaluating kidney function in 64 highly sensitized (cPRA ≥99.9%) kidney transplant patients with positive crossmatch against a deceased donor, comparing desensitization using imlifidase with standard of care. A total of 24 US sites are participating in the trial and its primary endpoint is kidney graft function at 12 months, measured by eGFR (estimated Glomerular Filtration Rate). The ConfIdeS trial is evaluating kidney function in 64 highly sensitized (cPRA ≥99.9%)…
PR Newswire
31/05/2024

Kinomica Announces Multiple Abstracts on its KScan® Precision Oncology…

"We are delighted to be able to showcase multiple elements of the KScan® platform and illustrate how these components coalesce into a biomarker discovery capability that provides insights that would otherwise be unobtainable," said Arran Dokal PhD, CTO of Kinomica. "It's well accepted that quantitative phosphoproteomics provides unique biological information that is not captured by other technologies, but any clinical utilization of the technology has been considered challenging…
PR Newswire
31/05/2024

As the second European Myasthenia Gravis Awareness Day unfolds, 'All United for…

BRUSSELS, May 31, 2024 /PRNewswire/ -- There is a notable gap in the understanding and recognition of the severity of MG In Europe, resulting in disparities in patient care. Many patients are left underserved, highlighting the need for heightened awareness about this rare autoimmune neuromuscular disease and its implications for patients and their caregivers. BRUSSELS,May 31, 2024/PRNewswire/ -- There is a notable gap in the understanding and recognition of the severity of MG In Europe,...
PR Newswire
31/05/2024

Novartis Scemblix® Phase III data first to show superior efficacy with a…

Phase III ASC4FIRST trial met both primary endpoints with clinically meaningful and statistically significant results; Scemblix ®(asciminib) demonstrated superior MMR rates at week 48 vs. investigator-selected SoC TKIs (imatinib, nilotinib, dasatinib and bosutinib) (67.7% vs. 49.0%) and imatinib alone (69.3% vs. 40.2%) 1 Scemblix also demonstrated a favorable safety and tolerability profile vs. imatinib and 2G TKIs, with fewer grade ≥3 AEs, dose adjustments, and half the...
Nasdaq GlobeNewswire
31/05/2024

Press Release: Sanofi launches 2024 global Employee Stock Purchase Plan

Sanofi launches 2024 global Employee Stock Purchase Plan Paris, May 31, 2024.Sanofi's global employee shareholder plan, Action 2024, opens on June 4, 2024, to around 80,000 employees in 56 countries. Now in its 10 thyear, the program demonstrates the ongoing commitment of Sanofi and its Board of Directors to secure that employees benefit from the company growth and success.Paul Hudson Chief Executive Officer of Sanofi “This plan underscores our ongoing commitment to unite the...
Nasdaq GlobeNewswire
31/05/2024

Trading by management and close relations of management

In accordance with article 19 in Regulation (EU) No 596/2014 of 16 April 2014 on market abuse (the Market Abuse Regulation) and commission delegated regulation (EU) 1052/2016 of 8 March 2016, Novozymes A/S, part of Novonesis Group reports the following transactions under ISIN DK0060336014, Novonesis (Novozymes) B shares under the symbol NSIS B. Investor Relations Tobias Bjorklund+45 3077 8682 [email protected] Anders Enevoldsen+45 5350 1453 [email protected] ...
Nasdaq GlobeNewswire
31/05/2024

Clarivate Expands Real-World Data Offering with Addition of Social Determinant…

Crucial determinants such as income, education, ethnicity and smoking activity, coupled with unique predictive models around health conscientiousness and lifestyle habits, are known to significantly influence health outcomes and are captured within HealthWise Data's SDoH attributes. Through the partnership with HealthWise Data, these non-medical factors are integrated within the Clarivate Real-World Data Product, providing nuanced insights into patient populations, facilitating targeted…
PR Newswire
31/05/2024

SIFI receives positive CHMP opinion for AKANTIOR® (polihexanide 0.08%) in…

The CHMP recommendation will now be reviewed by the European Commission (EC), which may decide on the marketing authorisation (MA) for AKANTIOR® in August 2024. The decision will then be applicable to all member states of the European Union as well as to Iceland, Liechtenstein and Norway. The CHMP recommendation will now be reviewed by the European Commission (EC), which may decide on the marketing authorisation (MA) for AKANTIOR ®inAugust 2024. The decision will then be applicable to all...
PR Newswire
31/05/2024

Announcement of change in the total number of votes in AB SKF

AB SKF does not hold any own shares. AB SKF does not hold any own shares. Aktiebolaget SKF (publ) Information in this press release contains information that AB SKF is obliged to make public pursuant to the Financial Instruments Trading Act. The information was submitted for publication on31 May 2024at 08.00 CEST. For further information, please contact: Press Relations:Carl Bjernstam, +46 31-337 2517; +46 722 201 893;[email protected] Investor Relations:...
PR Newswire
31/05/2024

SciBase: Interim report

Important events during the quarter Important events during the quarter Important events after the end of the period This information is information that SciBase Holding AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 08.00 CET onMay 31, 2024. This year-end report has not been subject to review by the Company's auditors Contact person:Michael...
PR Newswire
31/05/2024

SciBase: Today is the first day of trading in the new shares and warrants of…

Number of shares and share capitalThrough the Capital Raising, the number of shares in SciBase has increased by 99,706,967 shares, from 119,831,437 shares to 219,538,404 shares. Through the Capital Raising, the share capital in the Company has increased by SEK 4,985,348.35, from SEK 5,991,571.85 to SEK 10,976,920.20. The Capital Raising has entailed a dilution of approximately 45 percent of the number of shares in the Company. Upon full exercise of the warrants of series TO 2, the Company's…
PR Newswire
31/05/2024

NX Europe Exhibits at LogiPharma 2024

Photo: NX Europe's boothhttps://cdn.kyodonewsprwire.jp/prwfile/release/M103866/202405281403/_prw_PI1fl_nezZwWzb.jpg Photo: NX Europe's boothhttps://cdn.kyodonewsprwire.jp/prwfile/release/M103866/202405281403/_prw_PI1fl_nezZwWzb.jpg LogiPharma is one ofEurope'slargest international pharmaceutical trade shows, focusing on issues, trends and the latest technologies in pharmaceutical and biopharmaceutical supply chains. The exhibition attracted approximately 2,000 participants from a...
PR Newswire
31/05/2024

Nyxoah Announces Closing of Offering and Partial Exercise of Option to Purchase…

INSIDE INFORMATION REGULATED INFORMATIONNyxoah Announces Closing of Offering and Partial Exercise of Option to Purchase Additional SharesMont-Saint-Guibert, Belgium – May 31, 2024, 8:00am CET / 2:00am ET – Nyxoah SA (Euronext Brussels/ Nasdaq: NYXH)(“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced the closing of its previously announced...
Nasdaq GlobeNewswire
31/05/2024

Press Release: Dupixent recommended for EU approval by the CHMP to treat…

Dupixent recommended for EU approval by the CHMP to treat patients with COPD Recommendation for adults with uncontrolled COPD with raised blood eosinophils based on data from two landmark Phase 3 trials demonstrating Dupixent significantly reduced exacerbations and improved lung function If approved, Dupixent would be the first-ever targeted therapy for COPD in the EU and the first new treatment approach for this disease in more than a decadeParis and Tarrytown, N.Y. May 31, 2024...
Nasdaq GlobeNewswire
31/05/2024

Press Release: Update on FDA priority review of Dupixent for the treatment of…

Update on FDA priority review of Dupixentfor the treatment of COPD patients with type 2 inflammationParis and Tarrytown, NY May 31, 2024. The US Food and Drug Administration (FDA) has extended by three months the target action date of its priority review of the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The revised target action...
Nasdaq GlobeNewswire
31/05/2024

Addex Therapeutics to Release Q1 2024 Financial Results and Host Conference Call…

Geneva, Switzerland, May 31, 2024 - Addex Therapeutics(SIX and Nasdaq: ADXN), a clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders, announced today that it will issue its Q1 2024 Financial Results on June 6, 2024. Tim Dyer, CEO and Mikhail Kalinichev, Head of Translational Science, will provide a business update and a review of the Addex product pipeline during a teleconference and webcast for...
Nasdaq GlobeNewswire
31/05/2024

dsm-firmenich implements a cross guarantee agreement to mitigate structural…

The cross-guarantee agreement will be made available on the company website, in the Investors/Debt & credit section. The cross-guarantee agreement will be made available on the company website, in the Investors/Debt & credit section. For more information, please contact: dsm-firmenich investor relations enquiries: Email:[email protected] dsm-firmenich media enquiries: Email:[email protected] About dsm-firmenichAs innovators in nutrition,...
PR Newswire
31/05/2024

BioSenic S.A. : Information on the total number of voting rights and shares

PRESS RELEASE – REGULATED INFORMATION Mont-Saint-Guibert, Belgium, May 31, 2024, 7.00 am CEST –BIOSENIC (Euronext Brussels and Paris: BIOS), the clinical-stage company specializing in serious autoimmune and inflammatory diseases and cell therapy, today announces an increase in the total number of voting rights and shares as a result of the issuance of new shares. The following information is published in accordance with Article 15 of the Belgian law of 2 May 2007 on the publication of...
Nasdaq GlobeNewswire
31/05/2024

Data from the PRECISION study of aprocitentan to be presented at the European…

Allschwil, Switzerland – May 31, 2024Idorsia Ltd (SIX: IDIA) today announced that data from the Phase 3 study of aprocitentan, Idorsia's endothelin receptor antagonist, will be presented by Prof. Krzysztof Narkiewicz, MD, PhD, at the European Society of Hypertension's 33 rd European Meeting of Hypertension and Cardiovascular Protection, taking place in Berlin, Germany, May 31 – June 3, 2024.An oral presentation is scheduled for Sunday, June 2 (09:05 – 09:15 CEST) in Convention Hall I...
Nasdaq GlobeNewswire
31/05/2024

FutureBridge set to engage with industry leaders at 2024 ASCO® Annual Meeting…

"At these conferences, we look forward to sharing our expertise on the future of medicines, healthcare solutions, disruptive trends, emerging technologies, and therapeutic platforms," said Shivali Jasrotia, Senior Consultant at FutureBridge. "We aim to strengthen relationships with existing clients and establish new collaborations with industry, academia, patient advocates, innovators, and key opinion leaders." "At these conferences, we look forward to sharing our…
PR Newswire
31/05/2024

One in Six Globally Concerned About Colorectal Cancer Screening Costs

CRC Screening Gaps Vary Globally: Nearly half (49.3%) of global respondents have never undergone CRC screening, with the highest proportions in Saudi Arabia (62.0%) and Poland (61.0%). CRC Screening Gaps Vary Globally : Nearly half (49.3%) of global respondents have never undergone CRC screening, with the highest proportions inSaudi Arabia(62.0%) andPoland(61.0%). Preference for Fecal Testing Over Colonoscopy : Although colonoscopies are more recognized (33.4%), fecal tests at...
PR Newswire
31/05/2024
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