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Genentech’s New Ocular Implant Drug Delivery System for Macular Degeneration Could Be a Game Changer

XTalks

Genentech’s ocular implant drug delivery system for treatment of macular degeneration has received approval from the US Food and Drug Administration (FDA). Susvimo delivers ranibizumab via a port delivery system into a surgically placed implant in the eye, allowing for continuous delivery of the drug.

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Drugs Companies Clap Back at Congress…Then Get Sued

FDA Law Blog

As Abbvie wrote: “While your letter refers to ‘sham’ patents and concerns about ‘abusing the patent system,’ the FTC’s letter makes no assertions that these patents were ill-gotten or are otherwise illegitimate. In fact, federal law and regulation appear to require AbbVie to list these patents.”

Drugs 59
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To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

FDA Law Blog

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.

Drugs 105
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Considerations for Neuroscience Trials with Intrathecal Delivery and Other Methods of Direct CNS Administration

XTalks

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.

Trials 83
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Covid-19 vaccine success bolsters nanoparticle drug delivery research

Pharmaceutical 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 FDA approved the first nanodrug, Doxil, for Kaposi sarcoma in 1995.