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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.
In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Key innovation: Leading companies in nanoparticles for drugdelivery. Bristol-Myers Squibb is the leading patent filer in nanoparticles for drugdelivery.
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.
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.
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.
One of the biggest challenges with developing therapies to treat CNS disorders is the delivery of systemically administered investigational products (IPs) to the brain, which is limited by the blood-brain barrier. Some methods of direct CNS administration include intrathecal, intraparenchymal and intracerebroventricular (ICV) delivery.
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.
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.
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.
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.
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.
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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