Saint Herblain (France), July, 11 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Medicines Agency (EMA) will lift the temporary restriction on vaccinating people aged 65 years and above after concluding a thorough review of Valneva’s single-dose chikungunya vaccine IXCHIQ® by EMA’s safety committee (PRAC). The committee initiated its review at the beginning of May following the occurrence of serious side effects mainly in elderly people ...

Saint Herblain (France), July, 11 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Medicines Agency (EMA) will lift the temporary restriction on vaccinating people aged 65 years and above after concluding a thorough review of Valneva’s single-dose chikungunya vaccine IXCHIQ® by EMA’s safety committee (PRAC). The committee initiated its review at the beginning of May following the occurrence of serious side effects mainly in elderly people ...

VANCOUVER, British Columbia, July 10, 2025 (GLOBE NEWSWIRE) -- AVRICORE HEALTH INC. (TSXV: AVCR) (the "Company" or "Avricore") is pleased to announce the expansion of its HealthTab™ platform into pharmacies in North Central London—making it the second NHS Integrated Care Board (ICB), after North East London, to join this groundbreaking initiative aimed at tackling health inequalities through cholesterol screening. Six (6) new HealthTab™ systems were deployed in this phase, expanding the UK network to thirte ...

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FORWARD-LOOKNG STATEMENTS & DISCLOSURES MAY 3, 2022 © 2022 Esperion. All Rights Reserved – For investor audience only WHEN DO YOU PLAN TO GET YOUR NEXT CHOLESTEROL TEST? This presentation contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding marketing strategy and commercialization plans, current and planned operational expenses, future operations, commercial products, clinical development, including the timing ...

Key Takeaways CHMP recommends updating Ozempic's EU label based on positive STRIDE PAD outcomes in T2D patients. Ozempic showed improved walking capacity in patients with T2D and PAD in the late-stage STRIDE study. NVO expects EC approval of the PAD label update within two months; FDA review is underway in the U.S.Novo Nordisk (NVO) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending that Ozempic’s (once-weekly se ...

Financial Data and Key Metrics Changes - The company is executing a Fit for Growth program aimed at optimizing its cost structure, with a target of achieving $800 million in net cost savings by the end of the year [44] - The company has successfully executed activities necessary to yield $1 billion in growth and $800 million in net savings [44] Business Line Data and Key Metrics Changes - The company has shifted its focus from primarily neuroscience to include immunology and nephrology, with significant investments in four ongoing product launches [4][9] - The company has nine programs in phase three or phase three ready, indicating a robust pipeline for future growth [7] Market Data and Key Metrics Changes - The U.S. launch of Skyclaris is in a steady growth phase, while initial launches in Europe are progressing similarly [48] - The company has received approval in Brazil for Skyclaris, which is expected to be an important market [49] Company Strategy and Development Direction - The company is focused on redeploying capital from its MS business to support new growth opportunities in nephrology and immunology [5] - The company is actively pursuing business development opportunities, including the acquisition of Hai Bio, to enhance its pipeline [7][8] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the foundational position of the company for future capital deployment and growth opportunities [6] - The company is monitoring potential changes in drug pricing policies and tariffs, which could impact negotiations in the EU [14][15] Other Important Information - The company is excited about the potential of its pipeline assets, particularly in rare diseases and kidney diseases, as highlighted in an upcoming investor presentation [40][41] - The company is leveraging AI technology to identify patients for its therapies, indicating a focus on innovative approaches in patient engagement [49] Q&A Session Summary Question: How is the firm balanced now in terms of various disease areas? - The company is leveraging existing expertise in rare diseases while expanding into nephrology and immunology through strategic acquisitions [10] Question: What is the comfort level among PCP providers with the use of blood-based biomarker tests for Alzheimer's? - PCP providers are already using blood-based biomarkers alongside PET scans, indicating a growing acceptance of these tests [26] Question: What are the expectations for the upcoming readouts from the company's trials? - The company anticipates steady progression in growth and is optimistic about the potential for inflection points with new diagnostic tests and treatment methods [27]

Esperion Therapeutics (ESPR) 2025 Conference May 08, 2025 12:30 PM ET Speaker0 I guess take a step back and Primary. I guess take a step back and go go through the data that went into those new labels. Can you just walk us through the clear outcome study and the findings there? Speaker1 So the clear outcome study was a 14,000 patient outcome study which measured MACE four, MACE three in a variety of endpoints in both a, in a non statin population in both a primary and secondary prevention patient population ...

Core Viewpoint - Theriva Biologics is presenting interim blinded safety and pharmacokinetic data for SYN-004 at the ESCMID Global Congress, focusing on its potential to prevent acute graft-versus-host disease in allogeneic hematopoietic cell transplant recipients [1][3]. Group 1: Clinical Trial Details - The ongoing Phase 1b/2a clinical trial is randomized, double-blinded, and placebo-controlled, evaluating the safety and tolerability of oral SYN-004 in allogeneic HCT recipients receiving IV antibiotics [3]. - The trial is being conducted at Washington University School of Medicine and aims to enroll up to 36 participants across three cohorts, each receiving different IV beta-lactam antibiotics [3]. - Safety and pharmacokinetic data are reviewed by an independent Data and Safety Monitoring Committee to determine the progression to the next cohort [3]. Group 2: About SYN-004 - SYN-004 (ribaxamase) is designed to degrade certain IV beta-lactam antibiotics in the gastrointestinal tract, maintaining gut microbiome balance and preventing Clostridioides difficile infection and acute graft-versus-host disease [4][6]. - A previous Phase 2b clinical trial with 412 patients showed that SYN-004 protected the gut microbiome from antibiotic-mediated dysbiosis, leading to better maintenance and recovery of the microbiome [4]. Group 3: Company Overview - Theriva Biologics is a diversified clinical-stage company focused on developing therapeutics for cancer and related diseases, with a subsidiary working on an oncolytic adenovirus platform [5][6]. - The company's lead candidates include VCN-01, SYN-004, and SYN-020, targeting various aspects of cancer treatment and microbiome protection [6].

Tarsus Pharmaceuticals (TARS) Q4 2024 Earnings Call February 25, 2025 08:00 AM ET Company Participants David Nakasone - Head of Investor Relations (IR)Bobak Azamian - Co-Founder, President, CEO & ChairmanAziz Mottiwala - Chief Commercial OfficerSesha Neervannan - COOJeff Farrow - CFOCory Jubinville - Managing Director, Equity ResearchJason Gerberry - MD & Equity ResearchEddie Hickman - Vice PresidentAndrea Newkirk - Biotechnolgy Equity Research Conference Call Participants François Brisebois - Managing Dire ...