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

SEPTEMBER 19, 2023

The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the. But it is not always clear which types of patents are eligible for listing in the Orange Book.

Drugs 105

Drugs Branding Drug Delivery Systems Generic Drugs 105

FDA Law Blog

MARCH 12, 2024

Failing to list the patents, as AstraZeneca points out, “may expose the reference drug sponsor to legal risks,” as “at least one generic applicant has argued that a failure to do so constitutes a violation of the antitrust laws by depriving the applicant of information that would have affected its decision whether to develop a generic product.”

Drugs 59

Drugs Drug Delivery Systems Regulation Production 59

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. Biogen’s nusinersen (brand name Spinraza) is an antisense oligonucleotide (ASO) therapy that is administered directly into the CNS by intrathecal injection through lumbar puncture.

Trials 83

Trials Drug Delivery Drugs Gene 83