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Teva Prolia® (Denosumab) Biosimilar Candidate is Accepted for Review by U.S. FDA…
Prolia ®(denosumab) is indicated to treat certain conditions that lead to high risk for fracture, including osteoporosis in postmenopausal women TVB-009P, Teva's proposed biosimilar to Prolia, showed Phase 3 clinical results in osteoporosis and is part of Teva's robust biosimilar portfolio – 7 approved biosimilars and 16 in the pipeline – across critical therapeutic areas such as oncology, immunology and respiratory medicineAnticipated decision by both agencies is expected...
Nasdaq GlobeNewswire
08/10/2024
MolecuLight Announces Groundbreaking Study on Antimicrobial Stewardship in Wound…
Dr. Serena, a dedicated advocate in the fight against antimicrobial resistance, shares his insights: "Antimicrobial resistance is a critical challenge across all areas of medicine, including wound care. Our study represents a significant advancement in tackling this issue. We discovered that using fluorescence imaging during patient assessments reduced the average number of concurrent medications prescribed—from 1.4 per patient with standard clinical examination to just 1 per patient…
PR Newswire
08/10/2024
Novo Nordisk launches new initiative to prevent childhood obesity in…
The initiative will launch in six cities across five continentsInterventions aim to increase physical activity and healthy eating among childrenThe three-year initiative comes with an investment of more than 250 million Danish kroner Bagsværd, Denmark, 8 October 2024– Novo Nordisk today announced a new global initiative to prevent obesity in children. The Childhood Obesity Prevention Initiative aims to accelerate the prevention of childhood obesity in disadvantaged urban...
Nasdaq GlobeNewswire
08/10/2024
Adcendo Announces US FDA Clearance of IND Application for Phase I/II…
Dr. Lone Ottesen, Chief Medical Officer of Adcendo, said: "uPARAP is a highly attractive target for the development of an ADC in mesenchymal cancers including soft tissue sarcoma, as it is highly overexpressed in multiple STS subtypes, has unique internalization properties and shows only very low expression in healthy tissues. The IND clearance of ADCE-D01 is an important milestone for our program and our company, and we look forward to initiating patient enrolment for this study and…
PR Newswire
08/10/2024
Zealand Pharma announces that Boehringer receives U.S. FDA Breakthrough Therapy…
Company announcement – No. 47 / 2024 Zealand Pharma announces that Boehringer receives U.S. FDA Breakthrough Therapy designation and initiates two Phase III trials in MASH for survodutide The U.S. FDA Breakthrough Therapy designation is for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate or advanced fibrosis, based on survodutide's groundbreaking results from Phase II study Boehringer launches two Phase III studies of...
Nasdaq GlobeNewswire
08/10/2024
Boehringer receives U.S. FDA Breakthrough Therapy designation and initiates two…
The U.S. FDA Breakthrough Therapy designation is for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate or advanced fibrosis, based on survodutide's groundbreaking results from Phase II study 1 Boehringer launches two Phase III studies of survodutide, LIVERAGE in adults with MASH and moderate or advanced fibrosis, and LIVERAGE-Cirrhosis in those with MASH and cirrhosisBoehringer Ingelheim announced today that the U.S...
Nasdaq GlobeNewswire
08/10/2024
Clean Food Group partners with THG LABS to harness the power of cutting-edge…
This collaboration leverages the expertise of THG LABS Innovation and R&D teams, drawing on their extensive insight from over 30 years of experience in creating award-winning skincare, haircare and suncare, as the manufacturing partner of choice for world-leading beauty brands. Their support will guide the innovation and directly influence the cosmetic product pipeline. This collaboration leverages the expertise of THG LABS Innovation and R&D teams, drawing on their extensive insight…
PR Newswire
08/10/2024
MONCYTE Health Raises EUR 1 Million Seed Capital to Advance Personalized…
Cardiovascular disease is the primary cause of death worldwide, with high cholesterol being one of most important risk factors of the disease. High blood cholesterol can lead to the formation of atherosclerotic plaques, which are fat deposits in arterial walls that can block the blood flow and lead to heart attack and stroke. Currently, a significant proportion of high-risk patients do not achieve optimal blood cholesterol levels and remain at elevated risk for cardiovascular disease...
Nasdaq GlobeNewswire
08/10/2024
Selonterra Awarded Second Grant from The Michael J. Fox Foundation for…
This new research funding from The Michael J. Fox Foundation enables Selonterra to strengthen the link of our novel targets to clinical dysfunctions in Parkinson's disease and to progress our small molecules towards clinical candidates. This new research funding from The Michael J. Fox Foundation enables Selonterra to strengthen the link of our novel targets to clinical dysfunctions in Parkinson's disease and to progress our small molecules towards clinical candidates. "We are very…
PR Newswire
08/10/2024
The Positive Topline Results From Phase III Study of UCB/Biogen's Dapirolizumab…
As per the estimates, the prevalence of systemic lupus erythematosus in the United States is approximately 500K cases in 2023. In females, prevalence rates are observed to be much greater than that of males, constituting more than 90% of the total prevalent cases in the US. In 2023, among the treated SLE patients, nearly 40% of patients became relapsed or refractory after the first line of therapy. As per the estimates, the prevalence of systemic lupus erythematosus inthe United Statesis...
PR Newswire
07/10/2024
Nyxoah Raises $27 Million through its At-the-Market Offering
INSIDE INFORMATION REGULATED INFORMATIONNyxoah Raises $27 Million through its At-the-Market OfferingInvestment by a new U.S.-based healthcare investor, strengthening the balance sheet and reinforcing U.S. focus Mont-Saint-Guibert, Belgium – October 7, 2024, 11:00pm CET / 5:00pm ET – Nyxoah SA(Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through...
Nasdaq GlobeNewswire
07/10/2024
Simtra BioPharma Solutions Expands Capabilities with $14M Investment in ADC…
Enhancing End-to-End Service Offering for Accelerated Development and Manufacturing of Antibody-Drug Conjugates (ADCs) as part of the scaling of its Development Services Business /finish, accelerating time to market for its customers. The new clinical suite at Simtra's Halle/Westfalen, Germany site will support ADC development by offering key capabilities, including: Conjugation mixingSingle-use tangential flow filtrationDiafiltration and buffer exchangeThe Halle/Westfalen site...
Nasdaq GlobeNewswire
07/10/2024
The U.S. Fish and Wildlife Service Rejects Petition to List Long-Tailed Macaques…
Long-tailed macaques are used extensively throughout the world in biomedical research given their close approximation to human beings. Six of the 25 most used prescription drugs were developed with the help of long-tailed macaques.1 Research with long-tailed macaques has been crucial for advances in regenerative medicine,2 immunology,3 cancer,4 vaccine development,5 and pharmacology.6 The National Institutes for Health (NIH) recently published a review confirming the importance of LTMs in…
PR Newswire
07/10/2024
EssilorLuxottica: Third-Quarter 2024 Revenue Conference Call Invitation
Third-Quarter 2024 Revenue Conference Call Invitation Mr STEFANO GRASSI, Chief Financial Officer, and Mr GIORGIO IANNELLA, Head of Investor Relations,have the pleasure of inviting you to our Third-Quarter 2024 Revenue Conference Call on: Thursday, October 17, 2024, at 6:30 pm CEST Dial-in telephone access:If you wish to dial into the conference call, please pre-register at the following link to receive the personal credentials (Dial-in numbers, Conference ID and User ID):...
Nasdaq GlobeNewswire
07/10/2024
GBI Biomanufacturing and Allterum Therapeutics Announce Strategic Collaboration…
"We are honored to be chosen by Allterum as their trusted partner on this important project," said Karl Pinto, Chairman and CEO of GBI. "Our team is dedicated to providing the highest quality development and manufacturing services for drug substance and drug product, ensuring the success of this promising treatment. This collaboration is a testament of our commitment to advancing the field of oncology and making a meaningful difference in the lives of patients." "We are…
PR Newswire
07/10/2024
Lab Consumables Market to Hit USD 20.51 Billion by 2029 with 7.3% CAGR |…
Browse in-depth TOC on "Lab Consumables Market" Browse in-depth TOC on "Lab Consumables Market" 178 - Tables62 - Figures283 - Pages Moreover, in recent years, the market players are also focusing on providing sustainable and eco-friendly consumables due to its growing demand amongst various end users in the market. Also, there is an increasing demand for molecular diagnostics and growth potential in the emerging markets. All these factors are expected to drive provide...
PR Newswire
07/10/2024
Curia Unveils Brand Refresh at CPHI WW in Milan
The refined brand highlights Curia's key capabilities and personalized approach across small molecules, generic APIs and biologics The brand refresh includes:Three distinct commercial service logos– Curia has established brand logos for each of its three key service offerings across small molecules, generic APIs and biologics. This new hierarchy of service logos clearly communicates Curia's robust portfolio of services and solutions.Revamped website – Curia is pleased to...
Nasdaq GlobeNewswire
07/10/2024
Dark Horse Consulting Launches Initiative for Certification of Manufacturing…
Initiative for Certification of Manufacturing Capabilities (“ICMC™”) , a groundbreaking offering designed to close a critical gap in the CGT CDMO market.ICMC was conceptualized as a way to meet the growing demand for transparency and consistency in the rapidly expanding CGT CDMO landscape. Currently, new service providers are entering a market where their claims of providing compliant and scalable manufacturing services are not proactively verified by the relevant regulatory bodies...
Nasdaq GlobeNewswire
07/10/2024
EVERSANA Expands Global Commercialisation Operations With Berlin, Germany Office
"Over the years we have made smart strategic investments in the services, talent, and locations needed to transform the global commercialisation of life-changing therapies. Germany represents the fourth-largest pharmaceutical market in the world and is often the first country in which our clients strategically launch new therapies in Europe. We have the local expertise and operations in Germany to help our clients and their products thrive," said Jim Lang, CEO, EVERSANA. "Over the…
PR Newswire
07/10/2024
Novo Nordisk A/S – Share repurchase programme
Bagsværd, Denmark, 7 October 2024– On 7 August 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 the...
Nasdaq GlobeNewswire
07/10/2024
COSRX Announces Prime Big Deal Days Promotion Featuring the Advanced Snail Duo…
A Skincare Must-Have for #MirrorSkin A Skincare Must-Have for #MirrorSkin TheAdvanced Snail 96 Mucin Power Essencedelivers deep hydration, locking in moisture to enhance the skin's natural radiance. With 96% snail mucin, it works to smooth skin texture and boost elasticity, making it an essential step in your skincare routine. To take your skincare routine one step further, follow with theAdvanced Snail 92 All in one Cream. This cream intensifies the moisture barrier, seals in...
PR Newswire
07/10/2024
NTC Launches Imperial, the new eye drops product line on THE PATIENT'S SIDE
NTC is going to present the Imperial line during CPhI in Milan, supporting with evidence the innovation of this device characterized by exceptional drop control for precise dosing, elongated tip for a greater accuracy in instillation, and advanced ergonomics to assure a low squeeze force bottle. NTC is going to present the Imperial line during CPhI inMilan, supporting with evidence the innovation of this device characterized by exceptional drop control for precise dosing, elongated tip for a...
PR Newswire
07/10/2024
Buyback of Class B shares in Essity during week 40, 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
07/10/2024
Sai Life Sciences releases Sustainability Report 2024
Contract Research, Development and Manufacturing Organization (CRDMO) [1] , published itsSustainability Report for 2023-2024. Aligned with the Global Reporting Initiative (GRI) Universal Standards 2021 framework, this fifth edition of the Sustainability Report is based on the theme,'Synergising Sustainability, Performance and Growth.'The full report can be readhere.Making the announcement,Krishna Kanumuri, CEO & Managing Directorof Sai Life Sciences,...
Nasdaq GlobeNewswire
07/10/2024
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