Salute e Benessere

Ardena's New State-of-the-Art Nanomedicine Facility Secures Full GMP Approval…

The approval follows a €20 million investment in a state-of-the-art 45,000 sqft facility offering GMP-compliant Grade C and Grade D cleanrooms designed specifically for nanomedicine manufacturing. The fit-for-purpose cleanrooms, alongside additional GMP production spaces, dedicated laboratories for process development and analytical capabilities, and advanced warehouse facilities, reflect Ardena's commitment to meeting stringent regulatory standards, including the latest updates to Annex 1...
Nasdaq GlobeNewswire
19/11/2024

Monument Therapeutics Announces Appointment of Dr Stephen Brannan, Dr Jeff Baker…

Dr Brannan and Dr Baker join a highly accomplished team of CNS experts in the field, including Dr Michael Sand, former Senior Program Leader of CNS Research at Boehringer Ingelheim. Dr Sand's extensive expertise in schizophrenia drug development has already significantly contributed to Monument's approach in developing MT1988. Together, the SAB members will be instrumental in driving Monument's schizophrenia program and broader innovation and commercialisation strategies. Dr Brannan and Dr...
PR Newswire
19/11/2024

Augere Medical secures NOK 23M in the “first close” funding round

The proceeds will be used to strengthen the PolypAID European sales & marketing efforts and to expand the AI development capabilities The AI-driven PolypAID™ system helps clinicians and healthcare providers to augment screening of colorectal cancer. The proceeds will be used to strengthen the European sales and marketing efforts as well as hire highly skilled AI development engineers. In addition, Augere has started regulatory activities towards larger overseas markets and expects to...
Nasdaq GlobeNewswire
19/11/2024

Resolution Therapeutics Announces Approval of Clinical Trial Application by…

EDINBURGH, Scotland and LONDON, Nov. 19, 2024 /PRNewswire/ -- Resolution Therapeutics Limited ("Resolution"), a clinical-stage biopharmaceutical company pioneering regenerative macrophage therapies in inflammatory and fibrotic diseases, today announces it has received approval of a clinical trial application from the Spanish Agency of Medicines and Medical Products (AEMPS) to commence the Phase 1/2 EMERALD Study evaluating its lead candidate RTX001 in Spain. EDINBURGH…
PR Newswire
19/11/2024

Curium Completes Enrollment Early of Phase 3 SOLAR-RECUR Prostate Cancer Trial

/CT in men with suspected biochemical recurrence of prostate cancer after radical prostatectomy or radiation therapy. The additional Phase 3 trial, SOLAR-STAGE, a multicenter, open-label study to evaluate the diagnostic performance of copper Cu 64 PSMA I&T PET/CT in staging of men with newly diagnosed unfavorable intermediate-risk, high-risk or very-high-risk prostate cancer electing to undergo radical prostatectomy with pelvic lymph node dissection continues to enroll patients at sites…
Nasdaq GlobeNewswire
19/11/2024

Women's Health Company Freya Biosciences Announces Key $10.4 Million Strategic…

Freya is developing microbial immunotherapies to regulate the immune system and inflammatory responses in the vaginal tract using its DYSCOVERTM platform. Freya has identified Lactobacillus strains that are capable of engrafting in the vaginal tract thereby displacing the existing dysbiotic vaginal microbiome and reducing key inflammation biomarkers. To date the platform has yielded Freya's lead candidate, FB301 for improving pregnancy success in IVF. Freya is developing microbial...
PR Newswire
19/11/2024

Norberg Partner Sustainable Group AB has sold its holding in Aino Health AB…

Aino Health has been informed that Norberg Partner Sustainable Group AB has yesterday sold 98 748 884 shares to two Finnish investment companies. Nexit III Ky has purchased 59 249 330 shares and Tenendum Oy 39 499 554 shares. After the transactions, Norberg Partner Sustainable Group AB owns 0 percent of the shares in Aino Health AB, Nexit III Ky 29 percent and Tenendum Oy 19.3 percent. More information about the new ownersNexit Ventures Oy is an experienced Finnish Venture Capital company...
Nasdaq GlobeNewswire
19/11/2024

ZINZINO AB (PUBL.): INTERIM REPORT THIRD QUARTER 2024

Revenues in the third quarter of 2024 amounted to SEK 532.8 (436.9) million, corresponding to 22% (25%) growth compared to the corresponding period last year. In local currencies, revenues increased by 24% compared to the third quarter of the previous year. EBITDA profit amounted to SEK 63.0 (71.2) million and the EBITDA margin was 11.8% (16.3%). The EBITDA margin was compared to a very strong third quarter last year and the change was mainly due to the marginally weaker gross profit for the…
PR Newswire
19/11/2024

Neurizon's NUZ-001 Reduces Aggregation of Key ALS Disease Target TDP-43 in…

Two separate preclinical studies were conducted in collaboration with Ncardia, a leading human induced pluripotent stem cell (iPSC) technology company. The first study evaluated the ability of NUZ-001 and its major active metabolite (NUZ-001 Sulfone) to reduce TDP-43 aggregation in M337V Motor Neurons co-cultured with astrocytes in response to a stressor. TAR DNA-binding protein 43 (TDP-43) is a known driver of ALS pathology. The results show NUZ-001 and NUZ-001 Sulfone significantly and…
PR Newswire
19/11/2024

Essity expands its athletics tape production in France

The new fully automated production line is located at Essity's site in Vibraye, France and will fivefold the production capacity of Leukotape K. The investment amounted to EUR 1m. The new fully automated production line is located at Essity's site in Vibraye,Franceand will fivefold the production capacity of Leukotape K. The investment amounted to EUR 1m. "We are proud to announce that we are expanding the production at our Vibraye site, dedicated to producing high-quality medical...
PR Newswire
19/11/2024

Nagase Viita to Launch Injectable-grade Pharmaceutical Excipient "SUCROSE SG" in…

Sucrose is widely used as a stabilizer in biopharmaceuticals, a rapidly growing market. It helps maintain the quality of antibody drugs and lipid nanoparticles (LNPs) formulated with nucleic acid, such as COVID-19 vaccines. Sucrose is widely used as a stabilizer in biopharmaceuticals, a rapidly growing market. It helps maintain the quality of antibody drugs and lipid nanoparticles (LNPs) formulated with nucleic acid, such as COVID-19 vaccines. Since its founding, sustainability and...
PR Newswire
19/11/2024

ONWARD Medical Awarded Grant to Study Potential for ARC-BCI Therapy to Restore…

Grant supports the first clinical trials studying the potential for brain-computer interface (BCI) and artificial intelligence (AI) technology to restore thought-driven movement after strokeFunding also supports technology development of ARC-BCI System and ARC-IM LeadApproximately 15 million people worldwide experience a stroke each year EINDHOVEN, the Netherlands, Nov.19, 2024(GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating...
Nasdaq GlobeNewswire
19/11/2024

Nicox Announces Publication of the Adaptive Design Period of the NCX 470 Mont…

Press ReleaseNicox Announces Publication of the Adaptive Design Period of the NCX 470 Mont Blanc Phase 3 Trial An adaptive design is a useful clinical trial design tool which allowed identification of the optimal dose of NCX 470 in the Mont Blanc trial, the first Phase 3 trial of NCX 470Both doses of NCX 470 ophthalmic solution tested, 0.065% and 0.1%, lowered intraocular pressure more than the comparator, latanoprost 0.005% ophthalmic solutionThe 0.1% NCX 470...
Nasdaq GlobeNewswire
19/11/2024

Dapirolizumab Pegol Phase 3 Data Presented at the American College of…

Dapirolizumab pegol (DZP) met its primary endpoint, demonstrating statistically and clinically significant improvement across all organ systems as measured by BICLA, an endpoint measuring disease activityA greater response was observed across multiple clinical endpoints among participants treated with DZP including 50% less severe disease flares compared to participants on standard of care aloneSystemic Lupus Erythematosus is a chronic, debilitating autoimmune disease affecting multiple...
Nasdaq GlobeNewswire
19/11/2024

Invitation to attend the special shareholders' meeting of the Company to be held…

REGULATED INFORMATIONNovember 19, 2024, 7:00am CET / 1:00am ET NYXOAH SA(Euronext Brussels/Nasdaq: NYXH)Rue Edouard Belin 12, 1435 Mont-Saint-Guibert, Belgium (hereinafter the “ Company ”) Invitation to attend the special shareholders' meeting of the Companyto be held on December 19, 2024 The board of directors of the Company is pleased to invite its securities holders to attend the special shareholders' meeting of the Company, to be held on Thursday, December 19, 2024 at 3:00 p...
Nasdaq GlobeNewswire
19/11/2024

BIOVAXYS ANNOUNCES PRIVATE PLACEMENT OFFERING

Each Unit consists of one (1) common share in the capital of the Company (each, a "Share") and one (1) whole Share purchase warrant (each, a "Warrant"), whereby each Warrant shall be convertible into an additional Share at an exercise price of $0.15 for a period of 24 months from the date of issuance. Each Unit consists of one (1) common share in the capital of the Company (each, a " Share ") and one (1) whole Share purchase warrant (each, a " Warrant ")…
PR Newswire
19/11/2024

Peripheral Nerve Injuries Market to Show Remarkable Growth at a CAGR of 6.19% by…

Key Takeaways from the Peripheral Nerve Injuries Market Report Key Takeaways from the Peripheral Nerve Injuries Market Report Discover which therapies are expected to grab the major peripheral nerve injuries market share @ Peripheral Nerve Injuries Market Report Peripheral Nerve Injuries Overview Peripheral nerve injuries involve damage to the nerves outside the brain and spinal cord, which can disrupt motor function, sensory perception, and autonomic processes in the affected areas...
PR Newswire
18/11/2024

Publication relating to transparency notifications

REGULATED INFORMATIONPublication relating to transparency notificationsMont-Saint-Guibert(Belgium), November 18, 2024 , 10:30 pm CET / 4:30 pm ET –In accordance with article 14 of the Act of 2 May 2007 on the disclosure of large shareholdings, Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) announces that it received a transparency notification as detailed below.On November 15, 2024, Nyxoah received a transparency notification from ResMed Inc. following the...
Nasdaq GlobeNewswire
18/11/2024

PHAXIAM Presented its IVD Phagogram test and updated phage susceptibility…

PHAXIAM Presented its IVD Phagogram test and updated phage susceptibility tracking at the first "Phagogram Day" This event, organized in collaboration with Phage Canada and bringing together international experts, highlighted the growing interest in phage therapy and the urgent need for a reference method for phagogram on an international scalePHAXIAM phages demonstrated outstanding performance against clinical bacterial strains Lyon (France) – November 18, 2024, at 06:00 p.m...
Nasdaq GlobeNewswire
18/11/2024

EQT Life Sciences leads €54 Million Series A Financing of ATB Therapeutics

The investment will enable ATB to expand and enhance the ATBioFarm platform, as well as to accelerate development of its unique weaponized antibodies for oncology and immunology applications. ATB's research and development operations will be extended to Ghent and will continue in Marche-en-Famenne, where the Company is setting up a cutting-edge pilot manufacturing facility. The investment will enable ATB to expand and enhance the ATBioFarm platform, as well as to accelerate development of its...
PR Newswire
18/11/2024

Novo Nordisk A/S - share repurchase programme

Bagsværd, Denmark, 18 November 2024– On 11 November 2024, Novo Nordisk initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules"). This programme is part of the overall share repurchase programme of up to DKK 20 billion to be executed during a 12-month period beginning 6 February 2024.Under…
Nasdaq GlobeNewswire
18/11/2024

VelaVigo Announces Exclusive Option Agreement with Avenzo to License a Potential…

Since its inception in 2021, VelaVigo has built an extensive pipeline of over ten FIC/BIC multi-specific antibodies and ADC molecules for oncology and autoimmune diseases. It has also set up VelaVigo Bio, Inc. in the US to drive clinical development and partnership globally. Since its inception in 2021, VelaVigo has built an extensive pipeline of over ten FIC/BIC multi-specific antibodies and ADC molecules for oncology and autoimmune diseases. It has also set up VelaVigo Bio, Inc. in the US…
PR Newswire
18/11/2024

Vaderis Receives FDA Fast Track Designation for VAD044 for the Treatment of…

Dr. Hanny Al-Samkari, the Peggy S. Blitz Endowed Chair in Hematology/Oncology at Massachusetts General Hospital and Associate Professor of Medicine at Harvard Medical School (USA) commented, "The FDA's decision to designate VAD044 as a Fast Track product for the treatment of HHT underscores its potential to be the first ever approved treatment for this debilitating genetic disease." Dr.Hanny Al-Samkari, the Peggy S. Blitz Endowed Chair in Hematology/Oncology at Massachusetts General…
PR Newswire
18/11/2024

Vaderis Receives FDA Fast Track Designation for VAD044 for the Treatment of…

Dr. Hanny Al-Samkari, the Peggy S. Blitz Endowed Chair in Hematology/Oncology at Massachusetts General Hospital and Associate Professor of Medicine at Harvard Medical School (USA) commented, "The FDA's decision to designate VAD044 as a Fast Track product for the treatment of HHT underscores its potential to be the first ever approved treatment for this debilitating genetic disease." Dr.Hanny Al-Samkari, the Peggy S. Blitz Endowed Chair in Hematology/Oncology at Massachusetts General…
PR Newswire
18/11/2024
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