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The Committee for Veterinary Medicinal Products (CVMP) recently finished its conference, which focused on enhancing animal health and welfare from July 11 to 13, 2023. The approval of a new veterinary medical treatment, demonstrating its safety and efficacy in treating a specific animal condition, was one of the primary highlights. Concerns about pharmacovigilance were also raised, highlighting the significance of monitoring and reporting adverse effects to guarantee product safety. The forum also stressed the need for legislation and procedures to be harmonized in order to improve access to veterinary pharmaceutical goods inside the European Union and stimulate worldwide collaboration in the field. Overall, the CVMP's focus to promoting animal healthcare and its recent accomplishments indicate their commitment to developing veterinary medicine and enhancing animal well-being. https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-11-13-july-2023

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In response to an ongoing review, the European Medicines Agency (EMA) has issued a statement regarding GLP-1 receptor agonists. These medications are commonly used in the treatment of type 2 diabetes. The review is being conducted to assess the potential risk of pancreatic adverse events associated with the use of GLP-1 receptor agonists. The EMA highlights the importance of balancing the benefits and risks of these medications and emphasizes that patients should continue to follow their prescribed treatment until further information is available. The EMA reassures healthcare professionals and patients that they are actively monitoring the situation and will provide updates as necessary, ensuring the safety and well-being of individuals receiving GLP-1 receptor agonist therapy. https://www.ema.europa.eu/en/news/ema-statement-ongoing-review-glp-1-receptor-agonists

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The European Medicines Agency (EMA) recently issued an essay outlining the main points of the Pharmacovigilance Risk Assessment Committee (PRAC) conference, which took place from July 3-6, 2023. The PRAC is in charge of evaluating the safety and monitoring of medical products throughout the European Union. Several key subjects were discussed during the discussion, including a review of safety concerns regarding certain drugs. The committee reviewed available data and made suggestions for regulatory actions, such as product information updates and risk-mitigation strategies. Furthermore, the PRAC assessed and advised on a variety of pharmacovigilance operations, such as signal management and risk communication. The article highlights the EMA's dedication to guaranteeing the safety of pharmaceutical goods and encouraging effective pharmacovigilance methods to protect public health. https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-3-6-july-2023

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The European Medicines Agency (EMA) has officially declared the gradual discontinuation of exceptional regulatory flexibilities that were put in place during the COVID-19 pandemic. These flexibilities have been implemented to streamline the process of developing, authorizing, and making medicines and vaccines available for combating the virus. As the ongoing pandemic continues to develop and vaccination campaigns make progress, the European Medicines Agency (EMA) is focused on resuming regular regulatory procedures while also ensuring the essential flexibility to effectively address any potential future challenges. The agency emphasizes the significance of maintaining the ongoing safety, quality, and effectiveness of medicinal products, while also recognizing the persistent requirement for attentiveness in monitoring and addressing emerging COVID-19 variants. The European Medicines Agency (EMA) would like to assure the public that their dedication to safeguarding public health remains unwavering. They are committed to continuously adjusting their regulatory approach, as needed, to ensure the protection and well-being of individuals throughout the European Union. https://www.ema.europa.eu/en/news/phasing-out-extraordinary-covid-19-regulatory-flexibilities

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The European Medicines Agency (EMA) has released a review highlighting the use of real-world evidence (RWE) in regulatory decision-making. Real-world evidence refers to data collected outside of traditional clinical trials, such as from observational studies, patient registries, and electronic health records. The review demonstrates the EMA's commitment to harnessing the potential of RWE to support regulatory assessments and decision-making processes. It emphasizes the importance of robust methodologies, data quality, and transparency in utilizing real-world evidence effectively. The EMA acknowledges the value of RWE in complementing clinical trial data, especially in areas such as safety monitoring, effectiveness evaluation, and understanding the real-world impact of treatments. The review provides insights into the EMA's ongoing efforts to promote the use of real-world evidence, ensuring that regulatory decisions are evidence-based, patient-centered, and reflect the real-world healthcare setting. https://www.ema.europa.eu/en/news/use-real-world-evidence-regulatory-decision-making-ema-publishes-review-its-studies

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The Federal Institute for Drugs and Medical Devices (BfArM) has released important information regarding the pharmacovigilance of Voxzogo® (vosoritide). The latest update pertains to a change in the administration syringe and needle, resulting in product administration now measured in Units (U) instead of mL. This change is aimed at enhancing the precision and accuracy of dosage administration. BfArM, being the authority responsible for drug safety in Germany, would like to ensure that this vital information reaches all healthcare professionals directly.  Read more here: https://www.bfarm.de/SharedDocs/Risikoinformationen/Pharmakovigilanz/EN/RHB/2023/rhb-voxzogo.html?nn=968840

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The European Medicines Agency (EMA) has released a workshop report outlining recommendations to enhance clinical trials during public health emergencies in the EU. The report suggests actions to address challenges faced during events like the COVID-19 pandemic, focusing on improving regulatory processes for large trials and establishing a funding framework. It highlights the need for larger, faster trials across multiple countries, involving better coordination among regulators and ethics committees, accelerated assessment, and use of the EU Clinical Trials Information System. The report also suggests expanding the role of EMA's Emergency Task Force (ETF) to include voluntary involvement of ethics committees. The proposed actions aim to create a conducive research environment and will guide the EU's efforts in improving clinical trials during emergencies. The Accelerating Clinical Trials in the EU (ACT EU) initiative will drive implementation of trial approvals, while funding mechanisms will be discussed in conjunction with the European Commission and Member States. Read more here: https://www.ema.europa.eu/en/news/paving-way-towards-coordinated-clinical-trials-public-health-emergencies-eu

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Youth-led campaigns have been instrumental in finding fresh and innovative ways to communicate about public health issues. These campaigns have the ability to make complex topics accessible and engaging, reaching a broad audience through various mediums such as podcasts, social media challenges, and short videos. One example is the initiative by members of the International Pharmaceutical Students' Federation across Europe to raise awareness about blood donation. They challenged their friends to donate blood, share a selfie with a special social media filter, and tag their friends. This simple yet powerful campaign showcased the importance of blood donation and encouraged more life-saving donations. As we celebrate International Youth Day and recognize the contributions of young people to society, it is crucial to support and encourage youth-led campaigns. They are paving the way for a better world by creating accessible, engaging, and informative content about public health issues.  

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In a proactive response to the increasing number of hospital admissions attributed to anaphylactic reactions, the Medicines and Healthcare products Regulatory Agency (MHRA) has reinforced its emergency guidance. According to the Uk government website, the most recent NHS figures show nearly 26,000 admissions in 2022-23 (25,721 admissions), more than double the 12,361 admissions in 2002-03 (a 108% increase). For food-related anaphylaxis and other adverse reactions, the rise is even higher, going from just under 2,000 admissions twenty years ago (1,971 admissions) to over 5,000 last year (5,013 admissions, a 154% increase). Individuals who are susceptible to anaphylaxis should consistently have two auto-injectors on hand, regularly verify their expiration dates, and be certain they are familiar with the proper usage of the specific brand prescribed to them. By equipping oneself with the knowledge of how to effectively handle an emergency situation, whether it involves oneself or another person, the goal is to enhance the likelihood that individuals with allergies can navigate anaphylactic episodes with fewer severe outcomes and consequently lower the frequency of hospital admissions. Read more here: https://www.gov.uk/government/news/mhra-reinforces-anaphylaxis-emergency-guidance-as-hospital-admissions-rise

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Exciting news in healthcare innovation! The FDA has granted clearance to the groundbreaking V-PRO maX 2 Low Temperature Sterilization System. This cutting-edge system is a game-changer, as it's the first FDA-cleared solution with a specialty cycle designed specifically to sterilize 3D printed devices in healthcare facilities. Gone are the challenges of ensuring the safety of complex 3D printed surgical instruments and anatomical models. The V-PRO maX 2 system's specialty cycle is tailored to effectively sterilize patient-specific surgical guides, including those for osteotomy, shoulder, hip, knee, and spine procedures. These instruments, as well as anatomical models, are fabricated using 3D printing processes and are intended for single-use during surgical procedures. Read more here: https://www.fda.gov/news-events/press-announcements/fda-roundup-august-11-2023

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Abu Dhabi Global Healthcare Week is set to be held from May 13-15, 2024, at the Abu Dhabi National Exhibition Centre. Organized by the Department of Health - Abu Dhabi, the event will gather healthcare leaders and stakeholders from around the world to address global healthcare perspectives and challenges. The theme of the event is "Transforming the Future of Global Healthcare" and will focus on four key pillars: reimagining healthcare, diverse and inclusive health, trailblazing medical breakthroughs, and disruptive healthcare. The event will feature a trade exhibition showcasing the latest technologies in health-tech innovation, finance, genomics, and patient engagement. The aim of the event is to foster collaboration, knowledge sharing, and investment in healthcare. It will also include awards programs to recognize philanthropy and innovation in healthcare. Managed by dmg events, the event aims to position Abu Dhabi as a leading force in the global healthcare ecosystem and shape the future of healthcare worldwide. Read more here: https://www.doh.gov.ae/en/news/under-the-patronage-of-khaled-bin-mohamed-bin-zayed-inaugural-abu-dhabi-global-healthcare-week

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The Dubai Health Authority (DHA) successfully concluded its summer training program for Emirati students. The program aimed to provide students with valuable practical experience and skills development in a diverse and specialized work environment. Noura Almidfa, Director of the Human Resources Department at DHA, highlighted the authority's commitment to Emiratisation and ensuring the training program had a real impact on students' educational and professional growth. The students expressed their appreciation for the opportunity, noting the supportive and innovative work atmosphere at DHA. The program's success further reflects DHA's dedication to nurturing talent and fostering a sense of family within the organization.  Read more here: https://www.dha.gov.ae/en/media/news/837

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The Gulf Health Council has launched an educational guide titled "Antimicrobial Resistance." This guide addresses the significant health issue of antimicrobial resistance, aiming to raise awareness and provide proper guidance on handling antimicrobials. It reflects the commitment of the Gulf Cooperation Council countries to enhancing health and tackling global challenges related to antimicrobial resistance. The guide explains the concept of "One Health" and its impact on individual health, emphasizing the interconnectedness of humans, animals, plants, and the environment. It discusses antimicrobials, their role in fighting infections, and the problem of antimicrobial resistance. The guide emphasizes the misuse of antibiotics as a major contributing factor and promotes wise use of these drugs. It highlights prevention measures such as proper handwashing, vaccinations, and the judicious use of antibiotics only when prescribed. The aim is to increase awareness of the risks of antimicrobial resistance and encourage a healthy lifestyle. Read more here: https://www.ghc.sa/en/blog/post-news/the-gulf-health-council-has-launched-an-educational-guide-titled-antimicrobial-resistance/

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In a recent assessment, the European Medicines Agency (EMA) investigated the impact of paternal exposure to Valproate, a medication used for epilepsy and bipolar disorder. While Valproate's risks during pregnancy are well-documented, this review aimed to uncover potential risks linked to paternal exposure. Key Findings: The EMA's analysis found limited evidence suggesting a connection between paternal Valproate use and increased risks of congenital malformations or developmental disorders in offspring. It's crucial to note that available data remains somewhat limited, requiring further research for conclusive results. Recommendations: Healthcare professionals should advise male Valproate users on the importance of contraception to prevent potential pregnancy exposure. Careful monitoring of children born to fathers with Valproate exposure is also recommended. Patient Guidance: Patients, particularly those of childbearing potential, should be informed about potential risks and discuss concerns with their healthcare provider. Effective contraception is vital when on Valproate treatment. While the EMA's review indicates limited paternal exposure risks associated with Valproate, caution is warranted. Patients and healthcare providers should collaborate to make informed decisions based on individual circumstances and available evidence. Read more here: https://www.ema.europa.eu/en/news/ema-review-data-paternal-exposure-valproate

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A groundbreaking advancement in the fight against polio has emerged, offering the potential to cut detection times in half. Recent research, as highlighted by the UK government, introduces a scientific detection method that could revolutionize how we identify and respond to polio outbreaks.   Polio, a highly contagious viral disease, demands swift detection and containment to prevent its spread. Traditional methods rely on time-consuming stool sample analysis. This new technique, however, leverages cutting-edge technology to detect poliovirus in sewage samples. By analyzing wastewater, it allows for rapid identification of poliovirus circulation within a community.   The implications for global health are profound. Reducing detection times significantly enhances our ability to respond promptly to polio outbreaks, limiting their impact. It also provides a valuable tool for evaluating the effectiveness of vaccination campaigns, aiding in the ultimate goal of polio eradication.   This breakthrough underscores the importance of collaborative research and innovation in our shared mission to rid the world of this debilitating disease. Read more here: https://www.gov.uk/government/news/polio-detection-times-could-be-halved-using-a-scientific-detection-method-new-research-shows

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The UK government has announced a monumental commitment of £210 million to address one of the most pressing global health threats: antimicrobial resistance (AMR).  The Challenge of Antimicrobial Resistance AMR occurs when bacteria, viruses, and other microbes become resistant to the drugs used to treat them. This poses a grave risk, making common infections untreatable and potentially leading to increased mortality rates. It's a growing concern worldwide. The Commitment The £210 million pledge encompasses a comprehensive approach, including research into new antibiotics, therapies, and diagnostics. It will also support global efforts to reduce the overuse of antibiotics in healthcare, agriculture, and the environment. By investing in research and global collaboration, the UK government demonstrates its unwavering commitment to preserving the effectiveness of antibiotics and securing a healthier future for all. Read more here: https://www.gov.uk/government/news/210-million-to-tackle-deadly-antimicrobial-resistance

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The Department of Health – Abu Dhabi (DoH) has closed a medical laboratory in the Emirate for violating regulations. The laboratory, which is located in Al Ain, was found to be non-compliant with DoH's standards for medical laboratories, as well as its regulations, policies, and circulars. Specifically, the laboratory was found to be: Not following proper procedures for sample collection and testing. Not maintaining accurate records of its testing results. Not reporting its test results to DoH in a timely manner. The closure of the laboratory is a regulatory measure taken by DoH to protect the health and safety of community members. DoH will continue to monitor all health facilities in the Emirate to ensure that they are complying with its standards and regulations. "The closure of this laboratory is a clear message to all healthcare providers that DoH will not tolerate non-compliance with our regulations," said Dr. Muwaffaq Al-Hammadi, Director of DoH's Health Regulation and Quality Assurance Department. "We are committed to ensuring the highest standards of care for patients in Abu Dhabi, and we will take all necessary measures to protect the public's health." DoH urges all healthcare providers to comply with its regulations and policies to ensure the quality and safety of healthcare services in Abu Dhabi. Read more here: https://www.doh.gov.ae/en/news/the-department-of-health-abu-dhabi-closes-a-medical-laboratory-for-violating-regulations

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The European Medicines Agency (EMA) is taking proactive steps to safeguard the health of expectant mothers and their unborn children by recommending new measures to avoid exposure to the medication topiramate during pregnancy. Topiramate is a drug commonly prescribed to treat epilepsy, migraines, and other medical conditions. However, it has been associated with an increased risk of birth defects when used during pregnancy. To address this concern, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has conducted a thorough review of available data and proposed essential measures. The PRAC recommends that healthcare professionals inform women of childbearing age about the potential risks associated with topiramate and consider alternative treatments for conditions, such as epilepsy or migraines, before prescribing this medication. Additionally, they suggest that women using topiramate should use effective contraception to avoid unintended pregnancies. This proactive approach reflects the EMA's commitment to patient safety. By raising awareness and promoting responsible prescribing practices, the EMA aims to reduce the risk of birth defects associated with topiramate exposure during pregnancy. The agency continues to monitor the safety of medications, ensuring that healthcare decisions are well-informed and prioritize the well-being of both patients and their offspring. Read more here: https://www.ema.europa.eu/en/news/prac-recommends-new-measures-avoid-topiramate-exposure-pregnancy

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In a progressive move towards safeguarding the public's health and interests, the UK government has officially commenced a consultation on unregulated cosmetic procedures. This significant step is aimed at garnering insights from both the public and experts regarding the status quo of unregulated cosmetic treatments, which have gained immense popularity in recent years. Unregulated cosmetic procedures, encompassing treatments such as dermal fillers and Botox injections, have generated growing concerns over patient safety and the qualifications of practitioners. This consultation is designed to address these pressing issues by seeking feedback on prospective regulations and industry standards. By actively participating in this consultation, individuals can voice their opinions and contribute to shaping policies that enhance safety, transparency, and accountability within the cosmetic industry. The invaluable input provided by the public will play a pivotal role in crafting regulations that prioritize consumer protection and uphold the highest standards of care.   Read more here: https://www.gov.uk/government/news/consultation-launched-into-unregulated-cosmetic-procedures

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We would like to bring to your attention an important recall notice regarding certain products manufactured by Sun Pharma UK Ltd. Specifically, this alert pertains to Gemcitabine 10mg/ml Solution for Infusion (PL 31750/0062) and Single Dose Infusion Bag 2000mg/200ml (CLMR 23/A/06).   Background Information: Sun Pharma UK Ltd. has initiated a company-led recall of the aforementioned medicines due to concerns related to quality control. This recall is being conducted in cooperation with the Medicines and Healthcare products Regulatory Agency (MHRA), which ensures that medicines and medical devices meet appropriate standards of safety, quality, and effectiveness.   Potential Risks: While there have been no reported adverse effects associated with the affected products, it is imperative to follow the guidance provided in the official recall notice. The recall is being undertaken as a precautionary measure to prevent any potential risks to patients.   Next Steps for Patients: If you have been prescribed Gemcitabine 10mg/ml Solution for Infusion or Single Dose Infusion Bag 2000mg/200ml, please consult with your healthcare provider immediately. They will be able to provide you with further guidance regarding alternative treatment options or discuss any necessary adjustments to your current treatment plan.   Next Steps for Healthcare Professionals: Healthcare professionals are advised to stop dispensing and using the affected products. Please refer to the official recall notice for detailed instructions on returning the recalled medicines and obtaining replacement stock.   Contact Information: For any questions or concerns related to this recall, please contact Sun Pharma UK Ltd. directly via the contact information provided in the official recall notice linked here: https://www.gov.uk/drug-device-alerts/company-led-medicines-recall-sun-pharma-uk-ltd-gemcitabine-10mg-slash-ml-solution-for-infusion-pl-31750-slash-0062-single-dose-infusion-bag-2000mg-slash-200ml-clmr-23-a-slash-06 Ensuring patient safety and providing accurate information is our top priority. We encourage all patients and healthcare professionals to stay informed about recalls and take appropriate action when necessary.   Please share this information with anyone who may be affected by this recall.

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We would like to bring to your attention an important recall notice regarding Ketofall 0.25 mg/ml Eye Drops Solution in single-dose containers.   Background Information: The Health Products Regulatory Authority (HPRA) has issued a recall notice for Ketofall 0.25 mg/ml Eye Drops Solution in single-dose containers, with the authorization number PA1815/002/001. This recall has been initiated due to concerns related to product quality and safety.   Potential Risks: While there have been no reported adverse effects associated with the affected product, it is crucial to follow the guidance provided in the official recall notice. The recall is being undertaken as a precautionary measure to prevent any potential risks to patients.   Next Steps for Patients: If you have been prescribed Ketofall 0.25 mg/ml Eye Drops Solution, please consult with your healthcare provider immediately. They will be able to provide you with further guidance regarding alternative treatment options or discuss any necessary adjustments to your current treatment plan.   Next Steps for Healthcare Professionals: Healthcare professionals are advised to stop dispensing and using the affected product. Please refer to the official recall notice for detailed instructions on returning the recalled medicine and obtaining replacement stock.   Contact Information: For any questions or concerns related to this recall, please contact the relevant authority as provided in the official recall notice linked here : http://www.hpra.ie/homepage/medicines/safety-notices/item?t=/recall-notice-for-ketofall-0.25-mg-ml-eye-drops-solution-in-single-dose-container-pa1815-002-001&id=c4ca1426-9782-6eee-9b55-ff00008c97d0   Ensuring patient safety and providing accurate information is our top priority. We encourage all patients and healthcare professionals to stay informed about recalls and take appropriate action when necessary.  

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  Advancements in Device Safety Communication:    The FDA's Center for Devices and Radiological Health (CDRH) has released a comprehensive report to Congress on Postmarket Device Safety-Related Communications. This initiative aims to equip healthcare providers, patients, and consumers with current information on the benefits and potential risks of medical devices in the market. CDRH's commitment to safety and transparency underscores its dedication to public health.   New Guidance on Biological Evaluation of Medical Devices:    The FDA has issued final guidance on the use of International Standard ISO 10993-1, focusing on the biological evaluation of medical devices. This guidance includes Attachment G, which outlines recommendations for biocompatibility information in premarket submissions for devices in contact with intact skin. The FDA will host a webinar on October 12, 2023, to provide further insights on this guidance.   Breakthrough Device to Reduce Esophageal Injury Risk:    The FDA has granted marketing authorization to the S4 Medical Corp.'s Esolution Esophageal Retractor. This catheter-based device is designed to mitigate the risk of esophageal injuries during ablation procedures for treating atrial fibrillation (Afib). Although not a treatment for Afib itself, this device plays a crucial role in minimizing potential complications during ablation procedures.   Grants for Pediatric Device Development:    The FDA's Pediatric Device Consortia (PDC) Grants Program has awarded a total of $6.75 million to five non-profit consortia. These grants will support research, production, and distribution of pediatric medical devices over the next five years. This initiative aims to address the unique challenges in pediatric medical device development and enhance access to safe and effective devices for young patients.   Strengthening the 510(k) Program:    The FDA has released three draft guidances to bolster and modernize the 510(k) Program. These efforts are crucial as medical devices become increasingly complex and innovative. Starting October 1, 2023, all 510(k) submissions must be made electronically through eSTAR, a move aimed at enhancing efficiency and compliance.   Workshop on PET Product Quality and Regulatory Framework:    The FDA has announced a public workshop focused on Positron Emission Tomography (PET) drug manufacturing. This event will serve as a platform for sharing insights and information on the regulatory and compliance framework for PET drug production. The workshop will be held both on-site and virtually on November 13 and 14, 2023.   Outbreak Advisory for Listeria Monocytogenes:    The FDA issued an update on September 1 regarding an outbreak of Listeria monocytogenes linked to Soft Serve On The Go cups. The Ice Cream House initiated a recall of all affected dairy and non-dairy frozen dessert products manufactured at their facility in Brooklyn, N.Y.   Ultraviolet Germicidal Light System Authorization:    On September 1, the FDA granted marketing authorization to the Xenex Disinfection Services, Inc., LightStrike+ system. This system utilizes ultraviolet germicidal light to reduce microbial presence on non-porous, non-critical medical device surfaces in clinical settings. It is intended for use in unoccupied rooms after manual cleaning and disinfection.   For more detailed information, please refer to the official FDA statement here: https://www.fda.gov/news-events/press-announcements/fda-roundup-september-8-2023

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Introduction: In a move to ensure the safety and efficacy of weight management medications, the European Medicines Agency (EMA) has recently launched a comprehensive review of Mysimba (naltrexone/bupropion). This medication, designed for adults grappling with obesity or overweight concerns, is prescribed as an adjunct to a balanced diet and regular exercise regimen. The impetus for this review arises from lingering concerns surrounding the potential long-term cardiovascular risks associated with Mysimba, and how they may influence the overall benefit-risk profile of the drug. Background: At the time of Mysimba’s authorization, uncertainties about its impact on the cardiovascular system were acknowledged. Notably, two studies investigating cardiovascular risk with this medication were terminated prematurely, prompting the necessity for a third study to align with the stipulations of the marketing authorization. However, as of the review commencement, this third study, pivotal in evaluating the potential cardiovascular risk, had not yet commenced. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) expressed reservations regarding the proposed study designs put forth by the marketing authorization holder (MAH). These designs were deemed inadequate in probing the long-term cardiovascular safety of Mysimba. Furthermore, the risk minimization measures proposed by the MAH, aimed at mitigating potential risks for patients undergoing extended Mysimba treatment, were not deemed robust enough to obviate the need for a dedicated study. The Path Forward: The EMA will now embark on a comprehensive evaluation of all available data concerning the potential long-term cardiovascular safety risk associated with Mysimba within its approved indication. This rigorous assessment aims to determine whether any amendments to the medicine’s marketing authorization in the European Union are warranted. The potential outcomes of this review include amendments to existing authorizations, suspension of marketing activities, or in extreme cases, the revocation of the medicine's approval. Ensuring Patient Safety and Well-being: The EMA's commitment to rigorously reviewing medicines like Mysimba underscores its unwavering dedication to safeguarding public health. This review serves as a testament to the agency's proactive approach in addressing potential concerns, especially when it comes to medications designed to address critical health issues like obesity and overweight. Conclusion: As the EMA commences its comprehensive review of Mysimba, patients and healthcare professionals alike can rest assured that every effort is being made to ensure the highest standards of safety and efficacy. This process not only reaffirms the agency's commitment to evidence-based medicine but also underscores its dedication to the well-being of individuals navigating the challenges of obesity and overweight. Stay tuned for updates as we navigate this important milestone in the pursuit of optimal healthcare for all.   You can read more about it here: https://www.ema.europa.eu/en/medicines/human/referrals/mysimba

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We want to bring to your attention an urgent recall affecting two specific batches of Lipocomb capsules, Lipocomb 10 mg/10 mg (batch PPA0465/460/001) and Lipocomb 20 mg/10 mg (batch PPA0465/460/002). This recall is being executed at the patient level due to a product mix-up issue stemming from incorrect labeling. It is imperative that patients and pharmacists take immediate action to ensure safety and accuracy in medication usage. Product Details and Recall Information: Lipocomb 10 mg/10 mg hard capsules, PPA0465/460/001 Batch Number (on carton): 5466A0722::RN220 Batch Number (on blister sticker label): 5466A0722 Expiry Date: 07/2025 Lipocomb 20 mg/10mg hard capsules, PPA0465/460/002 Batch Number (on carton): L803D0822::RN228 Batch Number (on blister sticker label): L803D0822 Expiry Date: 08/2025 Authorized Holder: PCO Manufacturing Ltd. Prescription Required: Yes Recall Classification: Patient-level recall Target Audience: Patients and Pharmacists Actions To Be Taken: For Pharmacists: Immediate Quarantine: Isolate any units from the specified batches in your pharmacy or those returned to you. Dispensing Records Check: Review your dispensing records to identify patients who received packs of the affected products since 8th August 2023 (Lipocomb 10 mg/10 mg) and since 24th August 2023 (Lipocomb 20 mg/10 mg). Patient Contact: Get in touch with identified patients or their caregivers. Advise them to check the batch number on the carton or blister sticker. Instruct them not to use the affected pack and to return it to your pharmacy for replacement from an unaffected batch. Contact PCO’s Sales Support Team: Call 01-8356700 to arrange the uplift of quarantined units within the next 14 days. For Patients: Check Batch Number: Inspect the batch number on the carton or the sticker on the product blisters. Do Not Use Affected Pack: If you have a pack from the impacted batches, refrain from using it. Return it to your pharmacy as soon as possible to receive a replacement from an unaffected batch. Further Assistance: For any queries related to the recall, please reach out to Niamh Clarke at 01-8356700.   Read more about this recall here: http://www.hpra.ie/homepage/medicines/safety-notices/item?t=/recall-notice-for-lipocomb-10-mg-10-mg-hard-capsules-ppa0465-460-001-and-lipocomb-20-mg-10mg-hard-capsules-ppa0465-460-002&id=b7d81426-9782-6eee-9b55-ff00008c97d0

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In a critical advisory, healthcare professionals are being urged to exercise utmost caution when prescribing fluoroquinolone antibiotics (ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, ofloxacin). This class of antibiotics, while effective, carries a substantial risk of enduring and potentially irreversible side effects. It is imperative that these medications are reserved for specific cases, and that patients and practitioners remain vigilant to safeguard against serious adverse reactions. Understanding the Risks: Fluoroquinolones, whether administered orally, by injection, or inhalation, have been associated with prolonged, often persisting for months or even years, disabling side effects. These adverse reactions can impact a range of bodily systems, organs, and senses. Despite new restrictions and precautions implemented in 2019, recent data shows a consistent prescribing pattern of fluoroquinolones in the UK, prompting a call for heightened awareness among healthcare providers. Guidance for Healthcare Professionals: Early Intervention is Crucial: It is imperative to discontinue fluoroquinolone treatment at the earliest signs of a serious adverse reaction, including any indications of tendon pain or inflammation. Avoidance in Specific Cases: Avoid prescribing fluoroquinolones for non-severe or self-limiting infections, and for mild to moderate infections (e.g., acute exacerbation of chronic bronchitis, chronic obstructive pulmonary disease) unless other antibiotics specifically recommended for these conditions are deemed unsuitable. Patient Considerations: Special care should be exercised when prescribing fluoroquinolones to individuals over 60 years of age, those with renal impairment, or those who have undergone solid-organ transplants due to their heightened risk of tendon injury. Cautious with Co-administration: Avoid pairing corticosteroids with fluoroquinolones, as the combination may exacerbate fluoroquinolone-induced tendinitis and tendon rupture. Report Adverse Reactions: Any suspected adverse reactions to fluoroquinolone antibiotics should be promptly reported through the Yellow Card website or app. Empowering Patients: Patients taking fluoroquinolone antibiotics (ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, ofloxacin) are advised to be vigilant for potential side effects and promptly notify their healthcare provider if any alarming symptoms arise. If any of the following signs emerge, immediate medical attention is advised: Tendon pain or swelling. Joint pain or swelling. Abnormal sensations, weakness, or difficulty walking. Severe fatigue, mood changes, or sleep disturbances. Changes in vision, taste, smell, or hearing. Conclusion: As healthcare professionals, it is our collective responsibility to prioritize patient safety. By heeding this advisory and carefully considering the use of fluoroquinolones, we can mitigate the risk of long-lasting and irreversible side effects, ensuring the well-being of those under our care. The importance of informed and thoughtful prescription practices cannot be overstated, and together, we can make a significant impact on patient outcomes. You can read more about this update here: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1181257/August-2023-DSU.pdf

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Dear Healthcare Providers, We are writing to inform you of an important safety notice regarding Terumo Platelet Additive Solution+ (T-PAS+). Please carefully review the following information: Device Details: Device Type: Terumo Platelet Additive Solution+ (T-PAS+) Commercial Name: Terumo Platelet Additive Solution+ (T-PAS+) Primary Clinical Purpose: The T-PAS+ solution is a platelet additive solution intended to partially replace plasma in the preparation and storage of a buffy coat-derived platelet concentrate or apheresis platelet unit. Device Model/Catalogue/Part Numbers: 40853, 40855, 40856 Affected Serial or Lot Number Range: C/N 40853 - 23052020, 23052021 C/N 40855 - 23054013, 23054014 C/N 40856 - 23055009 Reason for Field Safety Corrective Action (FSCA): 1. Product Problem Description: The T-PAS+ lots listed above may contain oil residue on the luer connectors used to mix additive solution with collected platelet products, including the frangible connector that is in direct contact with the additive solution. 2. Hazard and Probability: There is a possibility that this oil residue may transfer into the fluid pathway of the additive solution and into the final collected product. This residue has been identified as Renolin B 15 VG 46, which is not intended for use in medical applications. Terumo Blood and Cell Technologies has received no reports of adverse events or injuries related to the presence of oil residue on T-PAS+ products. 3. Predicted Risk: There is potential for adverse consequence due to pulmonary oil microembolism (POME) in the population at greatest risk in the event the residue transfers into a platelet product and is subsequently transfused. The population at greatest risk is defined as neonates, pediatrics, critically ill patients, and those with impaired lung function. In the general population, this potential degree of oil residue is not likely to cause an adverse health consequence. We strongly advise healthcare providers to take immediate action to identify and quarantine affected lots. For further guidance on how to proceed, please contact the terumo team at https://www.terumobct.com/contact-us?showAddresses=true  Your patients' safety is our top priority, and we appreciate your prompt attention to this matter.

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In a recent development, the European Medicines Agency's (EMA) human medicines committee (CHMP) has recommended against renewing the conditional marketing authorization for Blenrep (belantamab mafodotin), a medicine primarily used in the treatment of multiple myeloma, a form of cancer affecting the bone marrow. This decision comes after a thorough review of available data, including results from the DREAMM-3 study, which did not confirm the effectiveness of Blenrep as initially agreed upon when the conditional marketing authorization was granted. Conditional Marketing Authorization: A Brief Overview Conditional marketing authorization is granted to medicines that address unmet medical needs for serious diseases. This type of authorization allows a medicine to be approved based on less comprehensive data than normally required. It is considered when the benefits of providing the medicine outweigh any potential risks associated with its use while waiting for further evidence. Medicines under conditional marketing authorization are subject to specific post-authorization obligations, such as conducting additional studies, to generate comprehensive data. Blenrep's Conditional Authorization and Obligations Blenrep received its conditional marketing authorization in August 2020 due to its potential to address a critical unmet need for patients who had received at least four prior treatments, and for whom the disease did not respond to certain other types of cancer treatment. At the time of authorization, comparative data for Blenrep were not available. The CHMP therefore required the company marketing Blenrep to conduct a study comparing its safety and effectiveness with pomalidomide plus low-dose dexamethasone, another authorized treatment for relapsed/refractory multiple myeloma. Study Results and Implications The study, known as DREAMM-3, aimed to assess the effectiveness of Blenrep in comparison to the established treatment regimen. Unfortunately, the results did not show a significant difference in progression-free survival between the two groups. This measure of effectiveness was pivotal in confirming the medicine's authorized use. Consequently, the CHMP concluded that the effectiveness of Blenrep could not be confirmed, leading to the recommendation for non-renewal of its marketing authorization in the European Union. Implications for Patients and Healthcare Professionals For patients currently using Blenrep, it is crucial to consult with their healthcare providers to discuss suitable alternative treatment options. Healthcare professionals are advised not to initiate any new patients on Blenrep, and to inform existing patients about the discontinuation of the medicine. The Verdict The decision to not renew the conditional marketing authorization for Blenrep reflects the EMA's commitment to ensuring the safety and efficacy of medicines used in the treatment of serious diseases. While this may be a setback for some patients, it underscores the importance of rigorous evaluation and ongoing research in the field of medical treatment. The EMA will now forward the CHMP’s opinion to the European Commission, which will issue a final legally binding decision applicable in all EU Member States. This decision serves as a reminder of the continuous efforts to provide the best possible care and treatment options for patients facing challenging medical conditions.   You can read more about it here: https://www.ema.europa.eu/en/news/ema-recommends-non-renewal-authorisation-multiple-myeloma-medicine-blenrep

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Introducing the Vaccine Monitoring Platform (VMP) research agenda The European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) have introduced the Vaccine Monitoring Platform (VMP) research agenda, a pivotal step in ensuring the safety and effectiveness of vaccines in EU/EEA immunization programs. This comprehensive agenda outlines crucial areas for expanding research, providing a framework for academia, public health bodies, and the pharmaceutical industry to generate essential knowledge for both current and future vaccines. The Significance of the Research Agenda The research agenda serves as a blueprint for studies needed to gather additional knowledge about vaccines in use and those in development. Its primary audience includes academia, public health organizations, and the pharmaceutical industry, acting as a vital resource before embarking on research initiatives. Moreover, the agenda aims to raise awareness among national competent authorities and patient organizations. Supporting Regulatory Decision-Making A key objective of the research agenda is to provide data to aid regulators and EU Member States in making informed decisions regarding study planning, immunization programs, and vaccination policy. By addressing specific categories of research topics, the agenda targets critical areas of focus: Data gaps for authorized vaccines Diseases requiring post-authorization monitoring due to changes in vaccine composition (e.g., flu and COVID-19) Enhancing existing vaccines for use during public health emergencies Vaccine preparedness, including understanding disease burden Post-authorization monitoring to confirm benefit/risk profiles Endorsement and Evolution of the Research Agenda The VMP steering group officially endorsed the research agenda in July 2023. It is a dynamic document, continually updated and reviewed annually to align with evolving research priorities and resource availability. Background and Scope The VMP is a collaborative effort between EMA and ECDC, aiming to generate independent real-world evidence on vaccine safety and effectiveness. The research agenda provides thematic prioritization, guiding the selection of VMP studies. It supports decision-making processes for regulators and Member States regarding study planning, immunization programs, and vaccination policy. Conclusion The Vaccine Monitoring Platform research agenda marks a significant milestone in vaccine safety and effectiveness research. By delineating critical areas for further investigation, it empowers stakeholders to make well-informed decisions that safeguard public health. This dynamic agenda reflects EMA and ECDC's commitment to ongoing research and continual improvement in vaccine safety. Stay tuned for updates as the research agenda evolves to meet the evolving needs of vaccine safety monitoring.   You can find the research questions in the document provided by the EMA: https://www.ema.europa.eu/en/documents/other/vaccine-monitoring-platform-vmp-research-agenda_en.pdf

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 The U.S. Food and Drug Administration (FDA) has taken a monumental step towards combating rare diseases. In a recent announcement, the agency disclosed the allocation of $27 million in grants to fund 10 new clinical trial studies. This funding, generously provided by Congress through the Orphan Products Grants Program, is poised to catalyze the development of medical products targeted at rare diseases over the next four years. Sandra Retzky, D.O., J.D., MPH, director of the Office of Orphan Products Development, emphasized the gravity of this initiative, stating, “Millions of people in the U.S. suffer from a rare disease or condition. Currently, treatment options for many rare diseases are often limited or non-existent. The Orphan Products Grants Program invests in new research that will help enhance our understanding of rare diseases and advance therapies to improve the lives of those affected.” The FDA's Office of Orphan Products Development received a staggering 35 grant applications for this program, illustrating the pressing need for advancements in rare disease treatments. The proposals submitted aimed to evaluate the safety and efficacy of new indications or changes in labeling to address unmet needs in rare diseases or conditions. Each of the funded studies showcases collaborative, efficient, and innovative designs. Moreover, they demonstrate early and ongoing patient engagement along with the utilization of established infrastructure. This year's recipients cover a diverse range of critical areas in the field of rare diseases: Treatment for Children with Severe Heart Failure: This groundbreaking study holds promise for children grappling with severe heart failure, a condition with limited therapeutic options. Antidote for Snake Venom: This project addresses a pressing concern for regions with high incidences of snakebites, offering hope to countless individuals affected by this life-threatening predicament. Innovations in Cancer Treatments: The grants will contribute to pioneering research in the field of oncology, potentially revolutionizing the landscape of cancer care. Treatment for Complications Linked to Bone Marrow Transplants: This study targets an often-overlooked aspect of transplant medicine, providing potential relief for patients enduring the aftermath of bone marrow transplants. These initiatives represent a significant leap forward in the fight against rare diseases. With these grants, the FDA has not only provided crucial financial support but also underscored its commitment to catalyzing advancements in medical science. As the studies progress, the medical community and the public eagerly anticipate the potential breakthroughs that could transform the lives of millions. This bold move by the FDA exemplifies the power of collective effort in addressing some of the most challenging health issues of our time. For more information on the Orphan Products Grants Program and other FDA initiatives, visit FDA.gov.

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The Pharmacovigilance Risk Assessment Committee (PRAC) convened from September 25th to 28th, 2023, to review critical safety data. Among the significant outcomes was the decision to update the product information for medicines containing Omega-3-acid ethyl esters.   Atrial Fibrillation Identified as a Common Side Effect   The PRAC has endorsed the addition of atrial fibrillation - characterized by irregular, rapid contractions of the heart - to the list of common side effects associated with medicines containing Omega-3-acid ethyl esters. These medications are prescribed for the management of hypertriglyceridemia, a condition in which dietary and lifestyle modifications alone are insufficient to regulate levels of triglycerides in the blood. Notably, hypertriglyceridemia poses a risk factor for coronary artery disease, and patients on these medications often grapple with concurrent conditions such as cardiovascular diseases and diabetes.   Evidence-Based Decision Making   The PRAC based its decision on a thorough examination of systematic reviews and meta-analyses of randomized controlled clinical trials. These analyses revealed a dose-dependent increase in the risk of atrial fibrillation among patients with established cardiovascular diseases or cardiovascular risk factors who were treated with Omega-3-acid ethyl esters as compared to those who received a placebo. The highest observed risk was associated with a daily dose of 4 grams. Importantly, if atrial fibrillation does develop, treatment with these medicines should be permanently discontinued.   Informing Healthcare Professionals and Patients   In light of these findings, the PRAC has recommended an update to the product information to ensure that healthcare professionals and patients are informed about the risk of atrial fibrillation. A Direct Healthcare Professional Communication (DHPC) will be dispatched shortly to furnish doctors with further details.   Next Steps   Upon adoption, this DHPC will be forwarded to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh). Subsequently, following the CMDh's opinion, the DHPC will be distributed to healthcare professionals by the marketing authorization holder, in accordance with an agreed-upon communication plan. It will also be made available on the Direct Healthcare Professional Communications page and in national registers across EU Member States.   This decision underscores the PRAC's commitment to patient safety and its dedication to ensuring that the benefits of medications outweigh any potential risks. Healthcare professionals are encouraged to stay vigilant for updates and to incorporate this critical information into their practice.   For more detailed information, please visit  https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-25-28-september-2023  

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In a recent update, the Medicines and Healthcare products Regulatory Agency (MHRA) has released important information regarding statins and their potential link to myasthenia gravis. This announcement comes after a thorough review and assessment by the Pharmacovigilance Risk Assessment Committee (PRAC) from September 25th to 28th, 2023.   Understanding Myasthenia Gravis Myasthenia gravis is a rare autoimmune neuromuscular disorder characterized by fluctuating weakness in voluntary muscles. This condition affects various functions such as eye movements, facial expression, speech, swallowing, limb movement, and breathing. Common symptoms include drooping eyelids, double vision, difficulties with chewing or swallowing, speech disturbances, limb weakness, and shortness of breath. Although myasthenia gravis can develop at any age, it is more prevalent in women under 40 and men over 60.   Statins and Myasthenia Gravis: What You Need to Know The MHRA has observed a very small number of reports globally associating atorvastatin, pravastatin, lovastatin, fluvastatin, simvastatin, rosuvastatin, and pitavastatin (single-ingredient and fixed-dose combination products) with new-onset or aggravation of pre-existing myasthenia gravis. Given the extensive use of statins, these reports are considered to be very infrequent.   Key Recommendations for Healthcare Professionals: Suspected cases of new-onset myasthenia gravis after initiating statin therapy should be referred to a neurology specialist. Depending on individual assessments of benefits and risks, discontinuation of statin treatment may be necessary. Patients with pre-existing myasthenia gravis should be vigilant for any aggravation of symptoms while on a statin. Again, treatment discontinuation might be considered based on individual assessments. All suspected adverse drug reactions associated with statins should be reported through the Yellow Card scheme. Advice for Patients and Carers:   Statins are vital medications to lower the risk of cardiovascular events. Most individuals taking statins do not experience significant side effects. If you do, consult a healthcare professional. Do not stop statin treatment without consulting your doctor. Inform your doctor of any history of myasthenia gravis or ocular myasthenia before starting statin therapy. Seek immediate medical attention if you experience severe breathing or swallowing difficulties. Review and Recommendations A recent European review led to recommendations for new warnings about the risk of myasthenia gravis associated with multiple statins. The Pharmacovigilance Expert Advisory Committee (PEAG) of the Commission on Human Medicines (CHM) endorsed these recommendations. As a result, product information for all statins will be updated to include myasthenia gravis and ocular myasthenia gravis as adverse drug reactions with a frequency listed as 'not known'.   For more information about this notice please visit: https://www.gov.uk/drug-safety-update/statins-very-infrequent-reports-of-myasthenia-gravis   The MHRA remains committed to ensuring that healthcare professionals and patients have access to the most up-to-date safety information for medications. We encourage all healthcare professionals, patients, and caregivers to report any suspected adverse drug reactions through the Yellow Card scheme.   For further information and to access the Yellow Card reporting platform, please visit the Yellow Card website. https://yellowcard.mhra.gov.uk/ Your contributions are invaluable in maintaining the safety of pharmaceutical products.   Disclaimer: This article is for informational purposes only and does not constitute medical advice. Please consult a qualified healthcare professional for personalized medical guidance.

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Today, the U.S. Food and Drug Administration announced the creation of a new Digital Health Advisory Committee to help the agency explore the complex, scientific and technical issues related to digital health technologies (DHTs), such as artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software. The Digital Health Advisory Committee will advise the FDA on issues related to DHTs, providing relevant expertise and perspective to help improve the agency’s understanding of the benefits, risks, and clinical outcomes associated with use of DHTs. The committee should be fully operational in 2024.  To support the development of safe and effective digital health technologies while also encouraging innovation, the FDA will solicit views from the committee, which will consist of individuals with technical and scientific expertise from diverse disciplines and backgrounds. This will help ensure digital health medical devices are designed and targeted to meet the needs of diverse populations. “As one of our strategic priorities, our goal is to advance health equity in part through expanding access by bringing prevention, wellness and healthcare to all people where they live – at home, at work, in big cities and rural communities,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Digital health technologies are critical for achieving this transformation in care delivery. As digital health technologies advance, the FDA must capitalize on knowledge from inside and outside of the agency to help ensure we appropriately apply our regulatory authority in a way that protects patient health while continuing to support innovation.”  Digital health is a rapidly evolving, cross-cutting space that spans a wide range of technologies. In addition to the technologies mentioned above, it also includes issues such as decentralized trials, patient-generated health data and cybersecurity. “Technology moves at an incredible pace, and we’re excited to have a committee of experts throughout the field who can help ensure our regulation of these exciting tools maintains an appropriate pace while working within parameters of safety and effectiveness standards,” said Troy Tazbaz, director of the FDA’s Digital Health Center of Excellence. “Many of these technologies are novel and tend to rapidly change; it’s our duty to seek as much knowledge on them as possible as we determine and implement appropriate regulation to encourage innovation while protecting public health.”  The committee will consist of a core of nine voting members including the chair. The number of temporary members selected for a particular meeting will depend on the meeting topic.    For more information click here: https://www.fda.gov/news-events/press-announcements/fda-establishes-new-advisory-committee-digital-health-technologies

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In a significant development, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended against renewing the marketing authorization for Translarna (ataluren), a medicine designed to treat patients suffering from Duchenne muscular dystrophy caused by a specific genetic defect known as a 'nonsense mutation' in the dystrophin gene, and who retain the ability to walk. This recommendation comes after an extensive re-evaluation of the medicine's benefits and risks during the process of renewing its marketing authorization. The assessment included the results of a recent study that failed to confirm the effectiveness of Translarna. Given the critical unmet medical need for a serious disease, Translarna was granted a conditional marketing authorization in July 2014. This type of authorization allows for a medicine to be approved based on less comprehensive data than usual, with the understanding that the benefits of early availability outweigh any associated risks. Medicines with a conditional marketing authorization are subject to specific post-authorization obligations aimed at generating comprehensive data. In 2016, during the renewal of Translarna’s marketing authorization, the CHMP scrutinized new data from a study requested as part of the specific obligations. At that time, there were still uncertainties regarding the medicine’s beneficial effects. Consequently, the committee urged the company to conduct an additional study focusing primarily on a subgroup of patients with a progressive decline in their walking ability, as they were expected to derive greater benefit from Translarna treatment than the broader patient population. In this subgroup, the study did not demonstrate a statistically significant difference between Translarna and a placebo in terms of the distance patients could walk in six minutes after 18 months of treatment, suggesting that the observed difference could be due to chance. Furthermore, the results in the broader patient population failed to replicate the effect seen in the initial study that supported the marketing authorization. As part of the current marketing authorization renewal, the CHMP meticulously re-evaluated all available data on the benefits and risks of Translarna. This encompassed an analysis of patient registry data comparing health outcomes of patients treated with Translarna for an average of 5.5 years with those who had not received the treatment. Although the CHMP acknowledged Translarna's impact in terms of delaying the loss of walking ability, methodological issues and uncertainties associated with indirect comparison prevented conclusive findings. Additionally, there was no discernible benefit of Translarna for other assessed outcomes. During this re-evaluation, the CHMP sought input from a panel of neurology experts as well as patient representatives, factoring in their perspectives in its final recommendation. Based on a comprehensive assessment of the available data, the committee concluded that the efficacy of Translarna has not been substantiated in patients with nonsense mutation Duchenne muscular dystrophy, including those anticipated to have a more favorable response to treatment. Therefore, the committee recommended against renewing the marketing authorization in the EU. EMA will now forward the CHMP's opinion to the European Commission, which will issue a final legally binding decision applicable in all EU Member States. Information for Patients and Carers: If you or your child is currently receiving Translarna, it is imperative to consult your doctor on the appropriate steps to discontinue treatment. Recent studies have not confirmed the beneficial effects of Translarna in patients with nonsense mutation Duchenne muscular dystrophy, even in those with a progressive decline in their walking ability who were expected to benefit the most from treatment. Information for Healthcare Professionals: In light of the comprehensive review, it has been determined that Translarna's conditional marketing authorization will not be renewed, rendering the medicine unavailable in the EU. Healthcare professionals are advised against initiating new patients on Translarna. For patients currently using Translarna, discussions should be held regarding the cessation of treatment and consideration of suitable supportive therapies. Translarna was granted conditional marketing authorization in July 2014 for the treatment of patients with Duchenne muscular dystrophy caused by a 'nonsense mutation' in the dystrophin gene. This debilitating genetic disease gradually leads to muscle weakness and loss of function. Patients afflicted with this condition lack normal dystrophin, a crucial protein in muscles that safeguards them during contraction and relaxation. In patients with Duchenne muscular dystrophy resulting from a nonsense mutation, the production of a normal dystrophin protein is prematurely halted, resulting in a truncated dystrophin protein that functions inadequately. The active component in Translarna, ataluren, facilitates the cellular protein-making machinery to bypass the genetic mutation, allowing for the production of a functional dystrophin protein. The results of study 041, which were submitted as part of a variation application requesting a switch to standard marketing authorization, and the renewal of the marketing authorization application for Translarna were assessed by EMA’s Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which has adopted EMA’s opinions. EMA will now send the CHMP opinions on the variation application and on the renewal application to the European Commission, which will issue a final legally binding decision applicable in all EU Member States. The company that markets Translarna may ask for re-examination within 15 days of receiving the opinions.   For more information visit the EMA website: https://www.ema.europa.eu/en/news/ema-recommends-non-renewal-authorisation-duchenne-muscular-dystrophy-medicine-translarna

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In a groundbreaking stride towards revolutionizing the field of stem cell therapy, the Head of the Medicines and Healthcare products Regulatory Agency’s UK Stem Cell Bank (UKSCB) has heralded the advent of automation as the future of stem cell manufacturing. This proclamation comes on the auspicious occasion of the UKSCB's 20th Anniversary, a momentous event being celebrated at the esteemed Medicines and Healthcare products Regulatory Agency’s South Mimms Laboratories. This gathering of experts and UKSCB alumni not only commemorates two decades of unyielding support for innovation in research and clinical applications but also propels our gaze towards a future laden with advanced therapeutics. At the heart of this scientific revolution lie human embryonic stem cells, endowed with the remarkable potential to mend and rejuvenate various parts of the human body post-illness or disease. Their applications span a wide spectrum of diseases ranging from blindness to blood cancer and heart disease, offering a glimmer of hope for countless patients. Fueled by the invaluable support from national partners such as the Medical Research Council (MRC), Biotechnology and Biological Sciences Research Council (BBSRC), and National Institute for Health Research (NIHR), the UKSCB stands as the beacon of hope, providing high-quality stem cells for pioneering research. With an impressive roster of 30 stem cell lines available for clinical application, the UKSCB proudly holds the mantle of being the largest source of clinical grade human embryonic stem cells worldwide. On the global stage, the UKSCB has played an instrumental role in advancing stem cell research and applications, having supplied stem cells to 25 different countries. The demand for clinical grade stem cell lines has seen a meteoric rise, accounting for 54% of the total requests in 2022, a testament to the growing significance and trust in this field. Dr. Lee Carpenter, the Head of the UK Stem Cell Bank, aptly articulates the pivotal role automation can play in overcoming the labor-intensive and cost-prohibitive nature of stem cell manufacturing. By leveraging automation and machine learning, the UKSCB envisions a future where patients can gain swifter access to more cost-effective and safer stem cell therapies, potentially transforming the landscape of medical treatments. Dr. Marc Bailey, MHRA Chief Science and Innovation Officer, emphatically underscores the tangible impact of their work in advancing treatments for degenerative diseases like Parkinson’s. He highlights that the UKSCB's pioneering efforts in curating and supplying the foundation of cell-based therapeutics have the potential not only to treat but one day even cure these debilitating conditions. Two decades ago, the MHRA’s UK Stem Cell Bank was established with a singular purpose - to curate and distribute all human embryonic stem cells produced in the UK. Today, it stands as a global powerhouse, recognized for its indispensable role in the realm of advanced therapeutics. With over 180 different human embryonic stem cell lines at its disposal, many of which hold promise for patient treatment, the UKSCB's impact on the field is immeasurable. A recent milestone was achieved with the successful trial of the CellQualia Intelligent Cell Processing System, a cutting-edge robot-based stem cell growth platform. This system, located at the MHRA South Mimms Laboratories, is a testament to the possibilities that automation holds for the future of stem cell production. It is a pioneering step forward, opening the doors to further studies comparing automation with manual production techniques. As we stand on the cusp of a new era in stem cell therapy, the UKSCB's commitment to innovation and excellence shines brighter than ever. With automation as its guiding star, it aspires to redefine the boundaries of what is possible, offering renewed hope to patients around the world. The journey of the UKSCB over the last two decades is a testament to the power of human ingenuity and the boundless potential of stem cell research. Together, we look forward to a future where stem cell treatments are not just a possibility, but a reality accessible to all who need them.   For more information, visit: https://www.gov.uk/government/news/patients-could-have-faster-access-to-ground-breaking-stem-cell-treatment-with-manufacturing-innovation

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