**Press Release: Ruiinno Therapeutics Receives IND Clearance for MDI-1228 Mesylate Gel to Enter Phase II Clinical Trial for Chronic Diabetic Foot Ulcers** ? North Carolina, USA, September 19, 2024 – Ruiinno Therapeutics, a joint venture between Myinno Biopharma and D2V Clinical, is proud to announce that its novel drug candidate, MDI-1228 mesylate gel, has received 30-day Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to officially advance into Phase II clinical trials. The drug candidate, a differentiated Janus Kinase (JAK) inhibitor, will focus on treating chronic non-healing diabetic foot ulcers, a condition with limited treatment options. ? This clearance marks a significant milestone in the development of MDI-1228 mesylate gel, building on the successful completion of a Phase I study in China. Ruiinno Therapeutics, officially registered in May 2024, has been strategically positioning itself for commercial success by selecting high-impact, differentiated indications. Since its inception, teams from both Myinno Biopharma and D2V Clinical have been working diligently to lay a strong foundation for Ruiinno’s future, ensuring the company is well-prepared for expansion into the U.S. market. Ruiinno’s submission to the FDA also highlights the company’s dedication to rigorous scientific inquiry and collaboration. After multiple rounds of comprehensive discussions with the FDA, Ruiinno provided compelling data and scientific rationale, resulting in the timely IND clearance for this Phase II trial. The upcoming clinical trial represents a key step forward for Ruiinno Therapeutics as it continues to develop innovative treatments for unmet medical needs in the biopharmaceutical industry. Stay tuned for further updates as Ruiinno Therapeutics embarks on this exciting new chapter. #RuiinnoTherapeutics #D2VClinical #MyinnoBiopharma #JAKInhibitor #FDAApproval #Biopharma #ClinicalTrials #DiabeticFootUlcers #INDClearance #PharmaInnovation #HealthTech
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Clinical Pharmacist | I partner with providers to optimize therapy and improve lives
Patients who are genetically predisposed to high levels of LP(a) have a higher risk of atherosclerosis, coronary heart disease, stroke, thrombosis, and aortic stenosis. Roughly 20-25 % of the world’s population is deemed to have high LP(a) levels. How do you know your levels and, consequently, your risk? LP(a) blood tests can determine levels. Although LP(a) levels should be regularly checked, the American College of Cardiology and the American Heart Association do not have LP (a) screening guidelines. Suppose there is a strong family history of premature atherosclerotic cardiovascular disease (ASCVD) in immediate relatives, a personal history of ASCVD, or severe hyperlipidemia; then LP(a) testing is warranted and strongly recommended in that case. The European Atherosclerosis Society goes even further to recommend LP(a) testing not only for the above categories but also for patients with persistent cardiovascular disease while on statin therapy, patients with >10% ten-year risk of cardiovascular disease, and a general LP(a) screen at least once per lifetime for everyone.
AstraZeneca?on Monday?entered into an exclusive licensing deal?with China-based CSPC Pharmaceutical Group to develop a preclinical lipid-lowering drug candidate, aiming to provide additional therapeutic benefits to patients with dyslipidemia. Under the terms of the agreement, AstraZeneca will pay $100 million upfront and pledge up to $1.92 billion in development and commercialization milestones. CSPC will also be entitled to tiered royalties if the molecule reaches the market. In return, AstraZeneca gains the right to advance YS2302018, an investigational oral small molecule disruptor of lipoprotein (a) (Lp(a)) that has been shown to effectively prevent its formulation. #biotech #biopharma #pharma #LpA
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Raya Therapeutics announced that its lead pipeline drug, fasudil, was well tolerated and safe, with early signs of efficacy in patients with ALS in a Phase II trial. There are currently only two drugs on the market to treat ALS:?Sanofi’s Rilutek (riluzole) and?Mitsubishi Corporation’s Radicava (edaravone). There is therefore an unmet need for more?novel candidates to come through the pipeline. Read the full article below including expert comments from Anjan Aralihalli, president and founder?of @Raya Therapeutics on Clinical Trials Arena: #clinicaltrials #globaldata #ALS #amyotrophiclateralsclerosis #drugdiscovery #biotechnology #pharmaceuticals #pharmanews https://lnkd.in/gtKcufjv
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Asahi Kasei Pharma has taken another step in its transformation into a global specialty pharmaceuticals company through a new licensing agreement with Chiome Bioscience for its humanised anti-CX3CR1 antibody. For daily news and analysis subscribe to the?https://lnkd.in/gFNEJAhc newsletter. #Pharmaceuticals #Healthcare #Biotech
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The US FDA New Drug Approvals in August 2024? PharmaShots, your go-to media platform for life science news, brings a condensed report highlighting new drug approvals in August 2024 by the US FDA.? Stay Tuned for more updates!? ?Servier Pharmaceuticals Citius Pharmaceuticals, Inc. Ascendis Pharma Galderma Gilead Sciences Incyte Johnson & Johnson #regulatory #usfda #pharma #healthcareindustry #approvals #newmolecularentities #biologic #pharmashots?
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FDA reviews GSK's new Shingrix vaccine for expanded protection against shingles ?? Know complete story - https://lnkd.in/dvrtQGqT Rigel Pharmaceuticals Inc.’s R289 gains Orphan Drug Status for rare autoimmune conditions ?? Know complete story - https://lnkd.in/dh9ZU6x5 UCB and XtalPi Inc. collaborate to transform biologics development with AI technology ?? Know complete story - https://lnkd.in/dBe3FjFS Genenta Science (Nasdaq: GNTA) expands cancer therapy manufacturing to accelerate clinical trials ?? Know complete story - https://lnkd.in/dUX-XPab #GSK #Shingrix #Vaccine #Rigel #R289 #OrphanDrugStatus #UCB #XtalPi #AIinPharma #Genenta #CancerTherapy #Biologics
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Asahi Kasei Pharma has taken another step in its transformation into a global specialty pharmaceuticals company through a new licensing agreement with Chiome Bioscience for its humanised anti-CX3CR1 antibody. For daily news and analysis subscribe to the?https://lnkd.in/gnuy4bKp newsletter. #Biopharma #Pharmaceuticals #Healthcare
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Kicking-off 2025 and the #JPMorgan conference with major catalysts on the horizon. Thank you?#ALSNewsToday?for highlighting our recent milestone! Read more on NeuroSense Therapeutics signing a binding term sheet with a global pharmaceutical company and our plans to advance PrimeC into a Phase 3 clinical trial mid-year: #als #businessdevelopment #phase3
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Pharos iBio is advancing its AI-driven drug discovery platform with strong Phase 1 results for its #leukemia drug, PHI-101. The company is expanding global collaborations and receiving inquiries from pharma giants. #JPM25 https://lnkd.in/gpzXm7UQ
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Regeneron Pharmaceuticals recently received a complete response letter (CRL) from the FDA regarding the biologics license application (BLA) for linvoseltamab, a promising treatment for relapsed or refractory (R/R) multiple myeloma. The CRL was issued not due to concerns over the drug's safety or efficacy but rather because of issues identified during a pre-approval inspection at a third-party fill/finish manufacturer unrelated to linvoseltamab. Despite this setback, Regeneron remains committed to bringing this innovative therapy to patients as quickly as possible. Linvoseltamab has shown encouraging results in clinical trials, with a 71% objective response rate and a favorable safety profile. The company is working closely with the FDA and the third-party manufacturer to address the issues and is optimistic about the path forward. This decision highlights the complexities and challenges of the drug approval process, where external factors can delay the availability of potentially life-saving treatments. Regeneron is also continuing to explore linvoseltamab's potential in earlier stages of myeloma, including smoldering myeloma and MGUS, which could further expand its impact in the oncology field. Read more here: https://lnkd.in/ehhAqXDC #MultipleMyeloma #FDA #Regeneron #Oncology #Biopharma #DrugDevelopment
