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Genentech’s ocular implant drugdeliverysystem for treatment of macular degeneration has received approval from the US Food and Drug Administration (FDA). Susvimo delivers ranibizumab via a port deliverysystem into a surgically placed implant in the eye, allowing for continuous delivery of the drug.
Related: Genentech’s New Ocular Implant DrugDeliverySystem for Macular Degeneration Could Be a Game Changer. The FDAapproval of Vuity exemplifies our continued pursuit of innovative new treatments that push the boundaries of what’s possible in eye care.”. Vuity is available by prescription.
These issues primarily stem from patients and healthcare providers miscalculating or incorrectly administering the drug. Compounded semaglutide products, unlike the US Food and Drug Administration (FDA)-approved ones, can vary widely in strength and packaging, making it easy for mistakes to happen.
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 drugdeliverysystem that improves the drug’s bioavailability and solubility.
Innovation S-curve for Internet of Things in the pharmaceutical industry Nanoparticles for drugdelivery is a key innovation A nanoparticle is a small particle ranging in size from 1 to 100 nanometres. Nanoparticles are used as novel drugdeliverysystems to deliver drugs to specific tissues and to provide controlled release therapy.
The team also learned about the FDAapproval of Genentech’s new ocular implant drugdeliverysystem, called Susvimo, for the treatment of neovascular, or wet, age-related macular degeneration (nAMD). Read the full articles here: FDA Authorizes Pfizer/BioNTech COVID-19 Vaccine for Kids 5 to 11.
FTC, deep in its foray into the Orange Book, filed an Amicus Brief in the case arguing that the patents do not claim any FDA-approveddrug. But FTC has been fighting hard against that position and likely will continue to do so.
Fortunately, there are FDA-approved products present in the Retinal vision occlusion drug market including Lucentis (ranibizumab), Eylea (aflibercept), and Ozurdex (dexamethasone intravitreal implant) with Avastin in use as an off-label therapy to help manage the condition and improve the vision.
The FTC expressed concern that patent listings that do not meet the statutory criteria undermine the competitive process, may disincentivize investment in developing generic and follow-on products, and reduce patient access to more affordable drugs thereby increasing costs to the healthcare system.
Looking at the potential of the pipeline therapies they hold once approved, pharmaceutical companies are charting out a seemingly exciting course in the market. Therapies such as dexamethasone drugdeliverysystem and vascular endothelial growth factor inhibitors have already pierced deeper into the market.
It’s difficult to conclude from these statements, as FTC and Congress appear to have, that device patents categorically shouldn’t be listed in the Orange Book.
Additionally, Janssen will present an update on the Phase 3 SunRISe-2 trial evaluating an investigational intravesical drugdeliverysystem, TAR-200, in combination with the programmed cell death receptor-1 (PD-1) inhibitor cetrelimab in muscle-invasive urothelial carcinoma (Abstract # MP13-17). [1]. About TAR-200.
Vornov, the use of intrathecal delivery in drug development is unexplored for small molecules and peptides besides what has already been proved. There are well-established techniques for both acute and chronic drugdelivery to the CSF. Direct CNS administration is also FDA-approved for multiple small molecules and ASOs.
XTALKS : Changes are Coming to Prefilled Injectable DrugDeliverySystems Live and On-Demand: Thursday, September 12, 2024, at 1pm EDT (10 am PDT) Register for this webinar today to learn more about the future of injectable drugdeliverysystems and the impact of blow-fill-seal technology.
Covid-19 vaccines from Moderna and Pfizer /BioNTech, which use lipid nanoparticles, became the only two FDA-approved vaccines for almost all ages. However, after a period of slow movement in the field, the FDAapproved the first nanodrug, Doxil, for Kaposi sarcoma in 1995.
This includes novel drugdeliverysystems, extended-release formulations, or unique combinations of ingredients that enhance efficacy or reduce side effects. Methods of Treatment These patents protect specific ways of using a drug to treat particular conditions.
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