Latest news with #ANSM
Time of India
6 days ago
- Business
- Time of India
Gland Pharma shares in focus after subsidiary Cenexi gets 11 observations from French regulator
Gland Pharma shares will be in focus on Thursday after the company announced that its material subsidiary, Cenexi, received 11 observations from France's drug regulator, Agence nationale de sécurité du médicament et des produits de santé (ANSM), following a Good Manufacturing Practices (GMP) inspection at its Fontenay manufacturing facility. In a stock exchange filing, Gland Pharma stated: 'The ANSM, France, has issued its final report citing 11 observations pursuant to the GMP inspection of Cenexi's Fontenay manufacturing facility conducted between December 9 and December 19, 2024.' In response, Cenexi has submitted a Corrective and Preventive Action (CAPA) plan, outlining measures to be implemented over a 3- to 12-month period, depending on the nature of each observation. The plan has been accepted by ANSM. Also Read: MRF snatches India's highest-priced stock crown back from Elcid Investments Live Events The company clarified that the observations will not impact manufacturing operations at the Fontenay site. Gland Pharma added that Cenexi is committed to resolving the issues in coordination with the French regulator and will continue to update stock exchanges on further developments. Also Read: These 10 Nifty microcap stocks can rally 70-200% in the next 12 months Gland Pharma Share Price Target and Performance According to Trendlyne, the average target price for Gland Pharma is Rs 1,678, implying a potential upside of 3% from current levels. Of the 12 analysts tracking the stock, the consensus rating is 'Hold'. On Wednesday, Gland Pharma shares closed 1.88% higher at Rs 1,623.7 on the BSE, while the Sensex gained 0.32%. The stock has rallied 16% in the last one month but remains down 43% over the past three years. The company's market capitalisation stands at Rs 26,751 crore. Also Read: Ola Electric, Kalyan Jewellers among 10 firms where promoters pledge increased in Q4 ( Disclaimer : Recommendations, suggestions, views and opinions given by the experts are their own. These do not represent the views of the Economic Times)
Yahoo
6 days ago
- Business
- Yahoo
French ANSM authorises FineHeart's device trial for heart failure
The French National Agency for the Safety of Medicines and Health Products (ANSM) has authorised FineHeart to commence a nonrandomised first-in-human trial in the country to assess the FlowMaker device in heart failure patients. This prospective trial aims to evaluate the feasibility of device implantation alongside its preliminary clinical performance and safety. It comes after the initial implantations of the device at the Institute for Clinical and Experimental Medicine in Prague, Czech Republic, last year. The latest trial will be carried out across several cardiac surgery-specialising centres in France. According to the company, the fully implantable left ventricular assist device operates in synergy with the natural contraction of the heart. It is less invasive than current devices and is designed to enhance an individual's quality of life by preserving native cardiac function. Designed by French rhythmologists and electrophysiologists, the device claims to be the first implantable cardiac output accelerator. It adapts to the pathology's progression and can be removed with no risk to the patient. It does not necessitate aortic bypass. The device utilises less energy and operates without percutaneous connections to external batteries, as it is recharged through a transcutaneous energy transfer system, aiding in the elimination of infection risks. The implantation procedure is performed on a beating heart and typically lasts around 90 minutes. FineHeart said that the device offers a therapeutic option for over 200,000 individuals annually with advanced heart failure and those who are ineligible for existing treatments. FineHeart co-founder and CEO Arnaud Mascarell said: "ANSM approval marks a key strategic step for FineHeart. It validates the quality and solidity of our preclinical work and confirms the relevance of our initial clinical results. 'This green light paves the way for the acceleration of our clinical roadmap, with the ambition of responding to a major unmet medical need. It also sends a strong signal to the entire medtech ecosystem, and to all our partners and investors, whom we thank for their confidence.' In 2023, the company secured two patents from the China National Intellectual Property Administration for FlowMaker. "French ANSM authorises FineHeart's device trial for heart failure" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
03-06-2025
- Business
- Yahoo
FineHeart Receives ANSM1 Authorization to Deploy Its First-In-Human Clinical Study in France
Patients with advanced heart failure will be treated with FlowMaker®, an innovative, fully implantable device for restoring cardiac output. BORDEAUX, France, June 03, 2025--(BUSINESS WIRE)--FineHeart S.A., a clinical-stage medical technology company specializing in the development of innovative solutions for cardiology, announces that it has received authorization from the French National Agency for the Safety of Medicines and Health Products (ANSM) to initiate its First-In-Human (FIH) clinical trial in France. This prospective, non-randomized study is designed to assess the safety, implant feasibility and preliminary clinical performance of the FlowMaker® device in patients with advanced heart failure. It follows the first successful implantations carried out in 2024 at IKEM (Institute for Clinical and Experimental Medicine) in Prague, whose initial results have been presented at several international scientific congresses. Conducted in several French centers specializing in cardiac surgery, this study represents a decisive step in the clinical development of FlowMaker®. FlowMaker® is a new-generation, fully implantable left ventricular assist device designed to work in synergy with the heart's natural contraction. Less invasive than current devices, this technology aims to preserve native cardiac function while significantly improving patients' quality of life. Pr Pascal Leprince, Head of the Thoracic and Cardiovascular Surgery Department at Hôpital Universitaire Pitié-Salpêtrière (AP-HP) Sorbonne Université and principal investigator of the clinical trial in France, commented: "The launch of this trial in France represents a highly promising step forward for patients with advanced heart failure. Thanks to its pulsatile operation, synchronized with the heart's electrical activity, the FlowMaker® could transform the treatment of these patients, offering them a less invasive and potentially more durable solution than current devices. We look forward to starting this clinical study and confirming these benefits." "ANSM approval marks a key strategic step for FineHeart. It validates the quality and solidity of our preclinical work and confirms the relevance of our initial clinical results. This green light paves the way for the acceleration of our clinical roadmap, with the ambition of responding to a major unmet medical need. It also sends a strong signal to the entire MedTech ecosystem, and to all our partners and investors, whom we thank for their confidence" says Arnaud Mascarell, CEO and co-founder of FineHeart. 1 ANSM: French National Agency for the Safety of Medicines and Health Products About FineHeart - FineHeart View source version on Contacts Europe Media RelationsAnnie-Florence Loyerafloyer@ +33 (6) 88 20 35 59 FineHeart Communications James +33 (0) 7 60 92 77 72
Business Wire
03-06-2025
- Business
- Business Wire
FineHeart Receives ANSM 1 Authorization to Deploy Its First-In-Human Clinical Study in France
BORDEAUX, France--(BUSINESS WIRE)--FineHeart S.A., a clinical-stage medical technology company specializing in the development of innovative solutions for cardiology, announces that it has received authorization from the French National Agency for the Safety of Medicines and Health Products (ANSM) to initiate its First-In-Human (FIH) clinical trial in France. This prospective, non-randomized study is designed to assess the safety, implant feasibility and preliminary clinical performance of the FlowMaker® device in patients with advanced heart failure. It follows the first successful implantations carried out in 2024 at IKEM (Institute for Clinical and Experimental Medicine) in Prague, whose initial results have been presented at several international scientific congresses. Conducted in several French centers specializing in cardiac surgery, this study represents a decisive step in the clinical development of FlowMaker®. FlowMaker® is a new-generation, fully implantable left ventricular assist device designed to work in synergy with the heart's natural contraction. Less invasive than current devices, this technology aims to preserve native cardiac function while significantly improving patients' quality of life. Pr Pascal Leprince, Head of the Thoracic and Cardiovascular Surgery Department at Hôpital Universitaire Pitié-Salpêtrière (AP-HP) Sorbonne Université and principal investigator of the clinical trial in France, commented: " The launch of this trial in France represents a highly promising step forward for patients with advanced heart failure. Thanks to its pulsatile operation, synchronized with the heart's electrical activity, the FlowMaker® could transform the treatment of these patients, offering them a less invasive and potentially more durable solution than current devices. We look forward to starting this clinical study and confirming these benefits." "ANSM approval marks a key strategic step for FineHeart. It validates the quality and solidity of our preclinical work and confirms the relevance of our initial clinical results. This green light paves the way for the acceleration of our clinical roadmap, with the ambition of responding to a major unmet medical need. It also sends a strong signal to the entire MedTech ecosystem, and to all our partners and investors, whom we thank for their confidence" says Arnaud Mascarell, CEO and co-founder of FineHeart. About FineHeart - FineHeart
Local France
07-05-2025
- Health
- Local France
30,000 boxes of heart and blood pressure tablets recalled in France
France's national authority for regulating medicine, the Agence nationale de sécurité du médicament (ANSM) published a statement recalling thousands of boxes of Lisinopril, a medicine that treats high blood pressure. In a statement published on Tuesday, the ANSM explained that the recall was due to a printing defect. "We have been informed by the Viatris laboratory of a printing defect on the blister packs of several batches of Lisinopril 5mg breakable tablets, which may lead to a risk of overdose. "The inscription on the aluminium blister pack may be confusing, as it suggests that several tablets should be taken on certain days (...) There is therefore a risk of patients taking too many tablets," they wrote. According to the ANSM, risks in the event of an overdose include fatigue, balance problems, hypotension, and impaired kidney function. A total of four batches of Lisinopril 5mg, or 32,640 boxes, are being recalled. These are batch number 8172295 (28 tablets expiring in January 2026), 8189879 (28 tablets expiring in March 2027), 8172296 (84 tablets expiring in January 2026) and 8192737 (84 tablets expiring in March 2027). Patients are asked to return affected boxes to their pharmacy. Advertisement ANSM also said 'the quality of the tablets [in the affected batches] is not in question'. The recall was solely to prevent possible overdoses prompted by the misprinted packaging. If you are concerned your medication could be affected by a recall, you can always take it to your local pharmacy and ask the pharmacist for their advice. READ MORE: How you can check for food contamination warnings in France
