XTalks

OCTOBER 27, 2021

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.

Drug Delivery Systems 104

Drug Delivery Systems Drug Delivery FDA Approval Drugs 104

FDA Law Blog

JUNE 13, 2024

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-approved drug. The Court addressed Teva’s valid argument that the Inhaler Patents are drug product patents and thus listable. that is described in the pending or approved NDA ” (emphasis added).

Drug Delivery Systems 116

Drug Delivery Systems Drugs Production Drug Delivery 116

FDA Law Blog

SEPTEMBER 19, 2023

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

Drugs Branding Drug Delivery Systems Generic Drugs 105

FDA Law Blog

MARCH 12, 2024

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 45

Drugs Drug Delivery Systems Regulation Production 45

XTalks

AUGUST 30, 2022

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 drug delivery to the CSF. Direct CNS administration is also FDA-approved for multiple small molecules and ASOs.

Trials 83

Trials Drug Delivery Drugs Gene 83

Pharmaceutical Technology

APRIL 24, 2023

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.

Drug Delivery 147

Drug Delivery Vaccination Vaccine Research 147

Drug Patent Watch

DECEMBER 19, 2024

This includes novel drug delivery systems, 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.

Drugs 92

Drugs Marketing Licensing Licensing 92