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Ractigen Announces U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to RAG-18 for the treatment of Duchenne Muscular Dystrophy

SUZHOU, China, July 25, 2024 /PRNewswire/ — Ractigen Therapeutics, a pioneering developer of small activating RNA (saRNA) therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to RAG-18, one of the company’s lead saRNA product candidates for the treatment of Duchenne Muscular Dystrophy (DMD). RAG-18 could represent a novel and translatable therapeutic strategy for DMD and Becker Muscular Dystrophy (BMD) caused by any mutation of the DMD gene. The RPDD is granted by the FDA to drugs that treat serious or life-threatening diseases primarily affecting children under 18 years of age with a prevalence of fewer than 200,000 in the United States. If a New Drug Application (NDA) for RAG-18 is approved, Ractigen may be eligible to receive a Priority Review Voucher (PRV), which can be used to expedite the review of a subsequent marketing application for a different product or ...
- Source: drugdu
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- July 30, 2024
Sanyou Bio Congratulates Eluminex Biosciences and Foreseen Biotechnology on Major Breakthroughs in Innovative Drug Project

SHANGHAI, July 26, 2024 /PRNewswire/ — On July 15, Eluminex Biosciences announced that their tri-specific fusion antibody drug, EB-105, has administered its first dose to a diabetic macular edema patient in the United States. This clinical trial, known as LOTUS, is an open-label, multicenter, single-dose, dose-escalation clinical trial via intravitreal injection, currently being conducted in four hospitals across the United States. On July 22, 2024, Foreseen Biotechnology announced the exclusive global licensing of their ADC targeted drug, FS001, to Ipsen Pharma SAS of France. Ipsen will have exclusive rights to develop, manufacture, and commercialize FS001 worldwide. The total licensing fee, including upfront payments, milestone payments, and sales royalties, amounts to US$1.03 billion. Eluminex Biosciences’s preclinical studies have shown that EB-105 can effectively inhibit signal transduction pathways such as VEGF-A/VEGFR-2, Ang-2/Tie-2, and IL-6/IL-6R. In addition to targeting vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2), EB-105 also inhibits intracellular inflammation-related signal ...
- Source: drugdu
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- July 30, 2024
study

Dive Brief A recent study showed that a version of ChatGPT analyzes medical images at an expert level but frequently reached the right answer with incorrect reasoning. The results, which were published Tuesday in the peer-reviewed journal npj Digital Medicine, show OpenAI’s artificial intelligence GPT-4 with vision is as good at answering multiple-choice questions about medical images as physicians who lack access to external resources. However, the model made mistakes in image comprehension, while still reaching the right answer, 27% of the time. The researchers said the errors show the need for further study before the AI models are integrated into clinical workflows. Dive Insigh GPT-4 with vision, called GPT-4V, is a version of the ChatGPT large language model that can analyze images and text at the same time. Pilot medical studies found the model outperformed medical students and physicians in closed-book settings. However, those studies looked at the answers ...
- Source: drugdu
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- July 29, 2024
Abbott recalls Freestyle Libre 3 sensors due to incorrect glucose readings

Dive Brief Abbott has recalled a small number of Freestyle Libre 3 sensors distributed in the U.S. in the first half of May, the company said Wednesday. Internal testing found a subset of three lots of the continuous glucose monitor (CGM) sensors may provide incorrect high glucose readings, the company said. The false readings could lead to incorrect treatment decisions, such as taking insulin when not required. Abbott is sending free replacements to affected users. A spokesperson for Abbott said via email the recall “may impact less than 1% of Libre 3 users in the U.S.” but did not specify the number of devices affected when asked. Dive Insight Abbott’s Freestyle Libre 3 CGM product consists of a wearable sensor, a reader and an app. The recall affects only the sensor component. Abbott has “received a small number of reports from consumers regarding the issue,” the spokesperson wrote. The company ...
- Source: drugdu
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- July 29, 2024
Integrity Partners With Gosen Insurance Group to Bring New Solutions to Hispanic Communities in Florida

By Mike Hollan The partnership will allow both group to expand their operations and provide more solutions to underserved communities. Integrity Marketing Group and Gosen Insurance Group are partnering to provide more benefit to underserved markets.1 Gosen is an independent insurance company located in Kissimmee, Florida, that focuses on providing Medicare solutions to the Hispanic community in the area. One of the company’s strengths is its ability to provide education of Medicare and coverage options in the native language of many of the community members. In a press release, Integrity CEO and co-founder Bryan W. Adams said, “Katiry and Alex embody a strong spirit of empathy, compassion, and service. They are true servant-leaders within the Hispanic community and bring a deep commitment to improve the lives of the clients and agents they serve. With Integrity’s world-class resources and groundbreaking technology alongside them, Katiry and Alex can support their diverse community ...
- Source: drugdu
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- July 29, 2024
Talent Management Strategies for Post-Milestone Growth

By Tracy Duberman, PhD Insights from Takeda, Jazz, Nestlé Health Sciences, Humana, and other healthcare executives Milestones such as major acquisitions, FDA approvals for new therapies, or obtaining Series C funding are transformative events for pharmaceutical organizations. These triumphs come with nuanced challenges including how to integrate new teams while retaining core talent and how to sustain morale during rapid scaling. Pharma leaders managing talent post milestones need to focus on assessing future talent needs, implementing strategic talent acquisition, onboarding new hires to the company’s culture, leveraging internal talent mobility, prioritizing DE&I initiatives, recognizing employee performance, and focusing on employee well-being. Below are talent management strategies to consider for post-milestone growth. Projecting talent needs for future success: It is important to assess the impact of any large-scale change on both current and future talent and to have a data-informed approach to effectively manage talent during transformative phases. Understanding current talent ...
- Source: drugdu
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- July 29, 2024
FDA committee proposes overhaul of perioperative lung cancer trials

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has called for changes in how clinical trials are conducted for treatments involving surgery for early-stage non-small cell lung cancer (NSCLC). In the 25 July meeting, the ODAC highlighted that it’s important to separately evaluate the effectiveness of each part of the treatment process, which includes pre-operative and post-operative phases. The committee meeting – which ended with a 11–0 vote in favour of changing how perioperative trials are run– came after AstraZeneca proposed to use Imfinzi (durvalumab) as a treatment with chemotherapy both before and after surgery. The pharma giant conducted the Phase III AEGEAN study (NCT03800134) to support this label expansion. The committee did not vote on Imfinzi’s approval in this indication, but the overall majority suggested that it should be approved. Following a lengthy discussion as to whether there should be another trial, Ravi Madan, medical ...
- Source: drugdu
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- July 29, 2024
EMA backs Wegovy cardiovascular label update as Novo seeks EU coverage

The European Medicines Agency (EMA) has offered a positive opinion to Novo Nordisk, which should pave the way for the company to update the label for its blockbuster weight loss drug Wegovy (semaglutide 2.4mg). The new label will reflect the therapy’s positive effects on cardiovascular health, potentially improving its chances for reimbursement in Europe. Under the new label, healthcare providers will be able to prescribe Wegovy to patients to reduce the risk of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal heart attack or non-fatal stroke in adults with established cardiovascular disease. If approved, this will be available for patients who are overweight or obese (initial BMI ≥27kg/m²) without having diabetes. The EMA’s Committee for Medicinal Products for Human Use (CHMP) supported the label update based on data from the Phase III SELECT (NCT03574597) study. The trial demonstrated that Wegovy decreased the incidence of MACE, in a statistically significant ...
- Source: drugdu
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- July 29, 2024
FDA approves Sun Pharma’s JAK inhibitor for alopecia

Sun Pharmaceutical Industries has secured the US Food and Drug Administration (FDA) approval for its oral Janus kinase (JAK) Inhibitor Leqselvi (deuruxolitinib) to treat severe alopecia areata. Originally developed by Concert Pharmaceuticals, Sun Pharma inherited the asset when it purchased Concert Pharmaceuticals in January 2023 for $576m. Alopecia areata is an autoimmune condition where the immune system attacks hair follicles, leading to sudden, patchy hair loss. JAK inhibitors such as Leqselvi block the activity of Janus kinase enzymes, which are involved in the signalling pathways that drive inflammation and immune responses. The FDA approval is based on data gathered from two Phase III studies—THRIVE-AA1 and THRIVE-AA2 (NCT04518995 and NCT04797650)—where Leqselvi restored scalp hair coverage by at least 80% in more than 30% of patients after 24 weeks. The 1,220 patients enrolled across the two studies had alopecia areata with at least 50% scalp hair loss as measured by Severity of ...
- Source: drugdu
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- July 29, 2024
Bavarian Nordic wins positive CHMP opinion to amend Imvanex approval

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended adjusting the marketing authorisation of Bavarian Nordic’s smallpox and mpox vaccine Imvanex (MVA-BN), based on the inclusion of real-world effectiveness data. The recommendation is following a type II variation request by the Danish vaccine maker, as per a 26 July press release. A type II variation is when a major change is needed in the marketing authorisation for a medicine approved in Europe. Bavarian Nordic originally received approval for the vaccine, also known under the brand names Jynneos and Imvamune, in 2013 for smallpox prevention, which was then extended in 2022 to include mpox. The approval was before the mpox outbreak in 2022 and was therefore based on data in non-human primates and immunogenicity insights from healthy volunteers. The results demonstrated that Imvanex had a good safety profile and induced immune responses that were non-inferior to ...
- Source: drugdu
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- July 29, 2024

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