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Highlights include expansion of biotech operations in Philadelphia, acquisition of a new pharma-device facility near Dublin, Ireland, and a new Center of Excellence for advanced drugdelivery and drug-device combination product assembly in Rockford, Illinois.
Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term.
Maculus plans to raise USD3 million on a USD8 million valuation for a 12-18 month period, including initial in-vivo animal studies and completion of in-vitro / in-vivo drug elution studies. Maculus achieved the breakthrough using a patented novel tunable biodegradable proprietary product, MacuBloc.
Due to their size, cells can absorb them where they release products. The next wave came from early research into liposomes and lipid nanoparticles, both of which are used for drugdelivery. Liposomes have the same function as lipid nanoparticles in drugdelivery but have a simpler formulation.
Interest in the pulmonary route has also grown in recent years because delivering the drugs through the lungs allows direct systemic delivery and bypasses the first pass metabolism. Why is pulmonary drugdelivery a complex challenge? How can we accomplish drugdelivery to the lungs in nonclinical studies?
Becton, Dickinson and Company (BD), a pioneer in medical technology, has issued a voluntary recall notice for a trio of their intraosseous access products. Intraosseous infusion of a drug is when a drug is administered into the bone marrow cavity which facilitates the delivery of the drug through a non-collapsible vein.
DrugDelivery Devices Symposium. We have the distinct privilege of unveiling Oxford Global’s DrugDelivery Devices Symposium, taking place on the 10th of March, 2021. Discuss Combination Product Development & Engineering with leading experts such as Andrew Yum , United Therapeutics and Ning Yu , Biogen.
Amazon Pharmacy launched a pair of TV spots last month to showcase the ease of its drugdelivery service for consumers. In 2023, it introduced RxPass , a prescription drug program that offers common drugs for a flat fee of $5. According to Statista , the global online pharmacy market is predicted to hit $82.42
SHL Medical is a world-leading solutions provider for advanced drugdelivery systems with a unified purpose to further enable patient independence. The company’s most prominent products are its autoinjectors, which are seeing growing global demand. It will be high-tech, fully automated production,” Turvill adds. “A
It has combined expertise in otology, gene therapy and inner ear drugdelivery to meet the requirements of individuals with disabling hearing loss globally. AK-OTOF is the lead product candidate of the company. It is a gene therapy intended to treat hearing loss due to otoferlin gene (OTOF) mutations.
The main products used for toenail fungus treatment are available in most pharmacies, supermarkets and perhaps with the best range of products found online. Topical products, which are applied directly to the infected area, are the main products used as toenail fungus treatment.
Over the last two decades, the pharmaceutical industry has observed a paradigm shift from conventional drugdelivery strategies to the long-acting drugdelivery (LADD) of products to treat several disease indications, such as ophthalmic disorders, oncological disorders, neurological disorders and infectious diseases.
We have put in our best effort to make it easily graspable what are the intracellular drugdelivery technologies and how it can ensure effective treatment for fatal disease. Below are the highlights that we feel would be helpful to understand about the intracellular drugdelivery / intracellular non-viral drugdelivery approach.
Workshop will be on ‘Ophthalmic DrugDelivery Development – Trials and Tribulations’. Ophthalmic DrugDelivery is compelling for many reasons, including the major issue of patient compliance and tolerability of therapies. Appreciating the science and art of formulating DD products. About the workshop leader.
DUBLIN–(BUSINESS WIRE)–The “Liposome DrugDelivery Market Forecast to 2027 – COVID-19 Impact and Global Analysis by Product; Application” report has been added to ResearchAndMarkets.com’s offering. The liposome drugdelivery market is expected to reach US$ 6,992.95
Global Inhaled and Intranasal Products 2020-2030: Contract Service Providers Market – Focus on Drugs and DrugDelivery Systems – ResearchAndMarkets.com Global Inhaled and Intranasal Products 2020-2030: Contract Service Providers Market – Focus on Drugs and DrugDelivery Systems – ResearchAndMarkets.com … Continue reading (..)
Cellibre, a pioneer in sustainable biochemical manufacturing, has received a $2 million grant from the National Center for Complementary and Integrative Health (NCCIH) at the National Institutes of Health (NIH).
Therefore, medical technology is rapidly evolving, enabling more advanced and patient-friendly methods of drugdelivery. In the pursuit of creating patient-centric healthcare solutions, the medical industry has witnessed a groundbreaking advancement in drugdelivery with the emergence of large volume wearable injectors.
Aptar Enters into Agreement with Weihai Hengyu Medical Products to Add Elastomeric and Plastic Component Manufacturing Capabilities in China for Injectable DrugDelivery Aptar Enters into Agreement with Weihai Hengyu Medical Products to Add Elastomeric and Plastic Component Manufacturing Capabilities … Continue reading →
Satsuma shareholders will receive the CVR subject to the future sale, licence or any other monetisation events related to Satsuma’s new investigational therapeutic product, STS101. In March 2023, Satsuma submitted a new drug application for STS101 to the US Food and Drug Administration (FDA). in cash per share.
Elyxyb is a prescription nonsteroidal anti-inflammatory drug (NSAID) used for acute migraine treatment in adult patients with or without aura. It is formulated using a self-micro-emulsifying drugdelivery system that improves the drug’s bioavailability and solubility.
Antares Pharma overview Antares Pharma is a specialty pharmaceutical company engaged in the development, manufacturing, and commercialization of pharmaceutical products and technologies. It also develops products to reduce the risk of preterm birth in pregnant women.
When it comes to vaccines and other high-value biologics, it is essential that effective formulations go hand in hand with safe delivery. This could equate to significant savings when considering the large-scale production and distribution of major vaccines. Lower materials usage and easier storage and disposal are further advantages.
The FDA has issued a warning about dosing errors and subsequent adverse events related to compounded semaglutide injectable products. These issues primarily stem from patients and healthcare providers miscalculating or incorrectly administering the drug. These errors have led to some patients being hospitalized due to overdoses.
The production of commercial dose non-sterile products such as tablets, capsules, ointments, creams, and powders is rising due to their growing global demand, attributed to increasing demand for anti-ageing products, hereditary factors, genetic mutations, exposure to harmful radiation, and rising geriatric population.
Research agreement to investigate the feasibility of a proprietary biotechnology process for the industrial production of psilocybin API.
XPhyto is currently focused on securing industrial scale production of psychedelic APIs and the standardization of drug formulations for the delivery of such APIs.
Bayer recently announced that it has received US Food and Drug Administration (FDA) clearance for its MEDRAD Centargo computed tomography (CT) injection system, a multi-patient injector that aims to improve workflow efficiency in CT imaging procedures.
Novaliq, a biopharmaceutical company specializing in ocular therapeutics, recently announced that their product Vevye (cyclosporine ophthalmic solution) 0.1 percent received approval from the US Food and Drug Administration (FDA) to treat dry eye disease. As a water-free product, it does not have an associated pH value or osmolarity.
Linker Stability : The stability of the linker, which attaches the chemotherapy agent to the antibody, is essential for efficient and precise drug-delivery. Researchers are actively looking for ways to solve these problems with the goal of finding the optimal balance between efficacy and toxicity for many of these drugs.
This morning, Sandoz announced it has acquired medical and drugdelivery device specialist Coalesce Product Development, bolstering its capabilities for the development of respiratory medicines and ‘complex’ generics.
Multiple guidance documents have been released in the last several years outlining the FDA’s current thinking on specific digital health products, such as software as a medical device (SaMD) and mobile medical applications. ANDA applications rely on an approved product, provided in the FDA’s Orange Book as the Reference Listed Drug (RLD).
Pharmaceutical solid dosage forms are the most popular in the pharmaceutical industry and are one of the most used drugdelivery methods across patient groups. Pharmaceutical solid dose manufacturing companies in contract marketing segment have gained a vital position in pharmaceutical formulations.
CPhI Worldwide will see Gerresheimer showcase its latest developments in primary packaging, drugdelivery systems for newly developed biologics along with medical and diagnostic products.
They are where innovative companies can look to access research and tap into networks, cross-pollinating ideas and talent and testing products to accelerate development. The company is using the site to produce medical-grade silicones designed for a range of healthcare applications, from drugdelivery to implantables.
SAE Media Group's 11th Annual Pre-Filled Syringes East Coast Conference will return to Boston in April 2024 to bring you the latest advances in the combination productdrugdelivery space.
While the industry is seeing advances in alternative drugdelivery systems, oral solid doses, such as pills, capsules and soft gels, remain at the forefront of the industry. Tablet manufacturing, which is the most common OSD form, takes an API dry powder ingredient and compresses it to form tablets, which can be coated or uncoated.
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