PolyActiva’s Post

PBC Biomed are delighted to announce the launch of our client Mochida Pharmaceutical Co., Ltd. innovative new nerve repair product – ReFeel® Nerve Repair Solution. ReFeel® is #biocompatible in nature and uses a proprietary alginate and PGA formula to create a bridge for #nerve #regeneration. The freeze-dried alginate sheet suppresses the migration and proliferation of cells that make up granulation tissue; providing a protected environment which facilitates the natural healing process of the nerve. The PBC Biomed Design & Development, Clinical, Regulatory and Commercial teams have been working alongside Mochida Pharmaceutical Co., Ltd. for the last four years; preparing this technology for commercial release. ReFeel® will officially be launched at the American Society for Surgery of the Hand (ASSH) conference in Minneapolis this week. Visit booth #210 for more information on this exciting new technology! Caution: Prescription use only. Federal law (USA) restricts this device to sale by or on the order of a physician. #acceleraratingmedicalinnovation #ASSH24

Nanosuspensions enhance the solubility and bioavailability of poorly soluble drugs, offering a promising solution to formulation challenges and improving clinical efficacy. #drug #clinical #nanomedicine Nano Biomed. Eng. https://lnkd.in/gazz45hP

Exciting news to come from Genentech as they roll out a game-changer for wet AMD sufferers! 🚀 Susvimo, the first-of-its-kind eye implant, has received the green light from the FDA for updates, promising renewed hope for nearly 1.5 million Americans grappling with this condition. Imagine maintaining your vision with just two refills a year, rather than the frequent eye injections that have been the norm until now 💉 This innovative treatment, which involves a one-off implant procedure, is set to revolutionize how we manage wet AMD. Streamlining treatment to semi-annual refills, Susvimo offers a less intrusive, more manageable approach to preserving eyesight 👀✅ #Ophthalmology #Genentech #Susvimo #WetAMD #HealthInnovation #ClinicalResearch #ClinicalTrials #Biotechnology #LifeScience #ElixirAssociates #StaffingPartner

MEDICAL DEVICES WEEKLY ROUND-UP 📌 😷 Qnovia, Inc. announced the FDA clearance of IND application for lead asset RespiRx™ Nicotine inhaler as a prescription smoking cessation therapy. The device is the first truly inhalable nicotine replacement therapy (NRT). Over half the approximately 28 million smokers in the US attempt to quit each year. Less than one in ten is successful. Qnovia aim to address this unmet need and are proud to lead the charge. 🧪 Bruker announced the acquisition of Dynamic Biosensors, a pioneer of single-cell interaction Cytometry systems for drug delivery. This acquisition strengthens Bruker's biophysical portfolio for the analysis of molecular interactions and kinetics, offering deeper insights into both inter-molecular and molecule-single cell interactions in drug delivery and research. 💉 Tactile Medical launched the next-generation Nimbl™ Lymphedema Platform. Nimbl, which is significantly smaller and lighter than previous device iterations, is indicated as a treatment option for patients with both upper and lower extremity lymphedema, chronic edema, venous insufficiency and wound healing. 🔬 Conformal Medical announced the launch of the GLACE Study with next-generation CLAAS® AcuFORM™ left atrial appendage occlusion device. The study aims to assess the use of intracardiac echocardiography(ICE) imaging of the left atrial appendage during appendage closure procedures with the next-gen device. The GLACE study allows Conformal to validate the use of ICE with this innovative technology. #medicaldevices #usmedicaldevices #medicaldevicemanufacturing #usmedicaldevicemanufacturing

#Researchers, there is a pressing need to develop efficient, long-lasting drug delivery systems in ophthalmology, that reduce patient discomfort and increase compliance. With this call for proposals, we invite you to explore and progress drug delivery systems for intravitreal administration, with a particular focus on implantable/injectable formulation approaches and applicators. The goal is to create systems capable of maintaining therapeutic drug levels for at least three months, thereby reducing the frequency of drug administration. Discover more on #opnMe https://lnkd.in/ej2VPV6Z

🧑💼 The Business of Biotech (2nd Edition): Gatekeepers Of Innovation 🏛️ The Food and Drug Administration (FDA) is a formidable force in the biotech industry. Here’s what it takes to be successful and avoid common mistakes that leave drug development programs stuck in the regulatory mud. ⚔️ Gatekeeper Of Innovation Traditionally, the FDA has been revered as the protector of public health and the adversary of unethical medicine. But that does not mean that it is beyond scrutiny. Congress (and the public) frequently flips between criticism of the FDA for granting approvals too quickly and then retracts and disapproves of delayed approval rates. In recent years, the public has been increasingly skeptical of the Administration as the complexity of the political relationships between other government agencies and the private sector grows. To the pharmaceutical industry, the FDA is a powerful gatekeeper that can make or break their business. The value of public and private clinical-stage companies is wholly dependent on clinical trial data and the FDA’s final stamp of approval. Clearly, intimate knowledge of the regulatory process is an absolute must for every biotech. Understand the FDA approval process like a biotech CEO: https://lnkd.in/eFZ4Uy6F #biotechnology #arthritis #osteoarthritis #investing #crowdfunding #venturecapital #healthcare #drugdevelopment #clinicaltrials #regenerativemedicine #orthopedics #orthopaedics #surgery #investor #FDA #medicine #lifesciences #researchanddevelopment #capitalmarkets

We are thrilled to announce the publication of our latest research paper, titled "Design and development of dual drug-loaded nanofibrous inserts for ophthalmic sustained delivery of AMK and VAN: Pharmacokinetic study in rabbit’s eye" in the prestigious journal, International Journal of Pharmaceutics, Volume 656. This paper can be the first to discuss the preparation of ophthalmic inserts using vancomycin and amikacin delivery nanofibers manufactured based on polycaprolactone and polyvinylalcohol polymers. Our research introduces a groundbreaking approach to enhancing the bioavailability and efficacy for ocular drug delivery. We aim to overcome the challenges associated with traditional ocular therapies, offering new hope for patients worldwide. The designed inserts offer specific benefits, including a sustained drug release, being non-invasive and safe.  For those interested in exploring the potential of novel ocular drug delivery systems, we invite you to read our paper. Free access is available through https://lnkd.in/d5GnPjk9 for 50 days. #OcularDrugDelivery #ResearchPublication #DrugDeliverySystem #Nanofiber #SustainedDelivery #Keratitis #Antibiotic

US fast track drug development news from Market Scope: Priovant Therapeutics, of Durham, North Carolina, reported Sept. 23 that the US FDA had granted fast track designation for #brepocitinib in non-infectious intermediate or posterior uveitis or panuveitis. Brepocitinib is a potential first-in-class dual selective inhibitor of TYK2 and JAK1 under evaluation for multiple autoimmune diseases. It is administered as a once-daily oral therapy. #uveitis #retina #developmentpipeline #fasttrack

🧑💼 The Business of Biotech (2nd Edition): Gatekeepers Of Innovation 🏛️ The Food and Drug Administration (FDA) is a formidable force in the biotech industry. Here’s what it takes to be successful and avoid common mistakes that leave drug development programs stuck in the regulatory mud. ⚔️ Gatekeeper Of Innovation Traditionally, the FDA has been revered as the protector of public health and the adversary of unethical medicine. But that does not mean that it is beyond scrutiny. Congress (and the public) frequently flips between criticism of the FDA for granting approvals too quickly and then retracts and disapproves of delayed approval rates. In recent years, the public has been increasingly skeptical of the Administration as the complexity of the political relationships between other government agencies and the private sector grows. To the pharmaceutical industry, the FDA is a powerful gatekeeper that can make or break their business. The value of public and private clinical-stage companies is wholly dependent on clinical trial data and the FDA’s final stamp of approval. Clearly, intimate knowledge of the regulatory process is an absolute must for every biotech. Understand the FDA approval process like a biotech CEO: https://lnkd.in/dJ8faE5P #biotechnology #arthritis #osteoarthritis #investing #crowdfunding #venturecapital #healthcare #drugdevelopment #clinicaltrials #regenerativemedicine #orthopedics #orthopaedics #surgery #investor #FDA #medicine #lifesciences #researchanddevelopment #capitalmarkets

Are you facing challenges with your clinical trial timelines or searching for a reliable, experienced CRO partner? At Altasciences, we understand the importance of streamlining your drug development process while ensuring the highest quality results. We provide a comprehensive, North American solution that can significantly enhance your clinical trials. Have a look at these resources: 1- Podcast—Benefits of Conducting a Clinical Trial in Canada: https://lnkd.in/gjgVUmMq 2- Video—Follow Your Sample From the Clinic to the Lab: https://lnkd.in/gTXfp_Mp 3- The Altascientist—Phase I Ethnobridging Clinical Trials: https://lnkd.in/gTAD8y9x 4- The Altascientist—Studying the Effects of Drugs on Driving: https://lnkd.in/gC6ngXHp 5- The Altascientist—Human Abuse Potential Studies: https://lnkd.in/gJnzJZpC 6- Video—Specialized Ophthalmology Expertise: https://lnkd.in/giPybUAb #ClinicalTrials #DrugDevelopment #ResearchAndDevelopment