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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.
Researchers may develop nanodrugs due to their smaller surface area to allows drugs to dissolve faster, or nanoparticles may encapsulate drugs, so they last longer in the body. Due to their size, cells can absorb them where they release products. Lipid nanoparticle drugdelivery was in the spotlight during the Covid-19 pandemic.
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.
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?
Amazon Pharmacy launched a pair of TV spots last month to showcase the ease of its drugdelivery service for consumers. Related: Eli Lilly Partners with Amazon Pharmacy for Home Delivery of Drugs Through Amazon Pharmacy, customers can manage their prescriptions, including refills and dosage information, through their Amazon account.
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.
US-based development-stage biopharmaceutical firm Satsuma Pharmaceuticals is developing STS101, a unique nasal powder formulation of the anti-migraine drug dihydroergotamine mesylate, for the treatment of acute migraine. In March 2023, Satsuma submitted a new drug application for STS101 to the US Food and Drug Administration (FDA).
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.
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.
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
Similarly, the target delivery approach in healthcare would take the drugs directly to right where it’s needed: the disease site, icing apt treatment. 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.
SMi presents the 4 th Annual Ophthalmic Drugs Conference taking place on the 23 rd -24 th November 2020, in London. Workshop will be on ‘Ophthalmic DrugDelivery Development – Trials and Tribulations’. Appreciating the science and art of formulating DD products. Regulatory landscape for product approval.
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.
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 (..)
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
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.
According to GlobalData, Phase I drugs for Adrenal Insufficiency have a 67% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Hydrocortisone’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
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.
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 →
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.
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.
LillyDirect Pharmacy Solutions, Eli Lilly’s direct-to-consumer (DTC) drugs website, is teaming up with Amazon Pharmacy to deliver select medications to people’s homes. The drugs include Lilly’s newly approved GLP-1 obesity drug Zepbound (tirzepatide), around a dozen of the company’s insulins and migraine drug Emgality (galcanezumab).
When it comes to vaccines and other high-value biologics, it is essential that effective formulations go hand in hand with safe delivery. By having the drug already dosed inside the chamber and no need to draw it from a vial into a syringe, the process is streamlined and the risk of a potential dosing error is eliminated.
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).
This year, Matt Cooper, PhD , our Executive Director, Therapeutic Strategy Lead, Oncology, attended and found the presentations around antibody-drug conjugates (ADCs) and tumor-infiltrating lymphocytes (TILs) to be of great interest to the future of oncology therapeutics.
has been formed so biopharma clients can receive end-to-end drug substance and drugproduct manufacturing solutions. An alliance between KBI Biopharma Inc., and Argonaut Manufacturing Services Inc.,
CPhI Worldwide will see Gerresheimer showcase its latest developments in primary packaging, drugdelivery systems for newly developed biologics along with medical and diagnostic products.
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.
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.
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.
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.
Though some drug companies have been reluctant to delist certain patents from the Orange Book, the District Court of New Jersey just ordered Teva to delist 5 of its patents that it deemed improperly listed. The Court addressed Teva’s valid argument that the Inhaler Patents are drugproduct patents and thus listable.
According to GlobalData, Phase I drugs for Hepatocellular Carcinoma have an 81% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Decoy-20’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
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.
SMi Group’s 14 th Annual Conference and Exhibition: Pre-Filled Syringes and Injectable Drug Devices 2022 – 12 th – 13 th January 2022. Sustainability for Drug Devices Focus Day – 14 th January 2022. The Future of DrugDelivery and Combination Product Device Design.
Pharmaceutical solid dosage forms are the most popular in the pharmaceutical industry and are one of the most used drugdelivery methods across patient groups. Drug manufacturers have been investing significantly in the R&D of more effective and patient-friendly solid forms.
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