Drug Delivery Systems Drugs Regulation 
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.
FDA Law Blog
JUNE 13, 2024
Though some drug companies have been reluctant to delist certain patents from the Orange Book, the District Court of New Jersey just ordered Teva to delist 5 of its patents that it deemed improperly listed. The Court addressed Teva’s valid argument that the Inhaler Patents are drug product patents and thus listable.
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Pharmaceutical Technology
OCTOBER 26, 2022
Nano-based delivery systems are on the rise, as they enable manufacturers to deliver therapeutic agents to specific targeted tissue in a more controlled manner. Data indicates that the global nanopharmaceutical drugs market size reached USD 53.85 Billion in 2021 and is expected to reach USD 102.4 Billion in 2030.
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. Of course, the statute says that only drug formulation, composition, or method of use patents are listable, but FDA has not defined the scope of the “drug” that must be covered by the patent.
XTalks
MAY 30, 2023
The healthcare industry has one of the heaviest environmental footprints, and manufacturers are increasingly faced with regulations to make more sustainable products,” said Mohammad H. The patch itself is made of biodegradable nanocellulose and contains no plastic additives. Behfar, senior scientist at VTT, in the news release.
XTalks
AUGUST 24, 2022
By the end of this year, the EPA plans to propose an air pollution regulation to address EtO emissions at commercial sterilizers and to protect public health. As a result, the EPA is providing new information on specific facilities where lifetime risk levels are the largest to nearby communities.
FDA Law Blog
MARCH 12, 2024
Koblitz — After years of silence from FDA on whether certain patents could be listed in the Orange Book, some manufacturers of drug and device combination products have had a rude awakening lately. In fact, federal law and regulation appear to require AbbVie to list these patents.”
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