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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Drug Delivery Systems Production Drugs Drug Delivery 115

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.”

Drugs 59

Drugs Drug Delivery Systems Regulation Production 59

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.

Manufacturing 130

Manufacturing Drug Delivery Systems Contamination Drug Delivery 130

XTalks

MAY 30, 2023

The patch itself is made of biodegradable nanocellulose and contains no plastic additives. 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. Behfar, senior scientist at VTT, in the news release.

Drug Delivery 98

Drug Delivery Drug Delivery Systems Manufacturing Contamination 98

Roots Analysis

MAY 24, 2024

In the dynamic landscape of the healthcare sector, the evolution of drug delivery systems plays a significant role in transforming the management of chronic diseases. They are generally used in combination with primary containers, such as prefilled syringes and cartridges.

Drug Delivery 40

Drug Delivery Containment Contamination Production 40

The Pharma Data

APRIL 27, 2021

Recently the company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration based on data from the Phase 3 GEMINI 1 and GEMINI 2 clinical studies. A Minipump Continuous Drug Infusion Dog Model System to Identify Candidate Drugs and Drug Delivery Rates for Intracameral IOP-lowering Implants.

Research 40

Research Drug Delivery Systems Drug Delivery Production 40

Pharmaceutical Technology

FEBRUARY 3, 2023

In 2021, 72% of newly approved drugs were small molecules, and almost 50% of new drugs approved were OSD. While the industry is seeing advances in alternative drug delivery systems, oral solid doses, such as pills, capsules and soft gels, remain at the forefront of the industry.

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Contamination Manufacturing Containment Production 130