Pharmaceutical Technology

FEBRUARY 13, 2023

Elyxyb is a prescription nonsteroidal anti-inflammatory drug (NSAID) used for acute migraine treatment in adult patients with or without aura. It is formulated using a self-micro-emulsifying drug delivery system that improves the drug’s bioavailability and solubility.

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Drug Delivery Systems FDA Approval Bioavailability Drug Delivery 130

Pharmaceutical Technology

FEBRUARY 14, 2023

Innovation S-curve for Internet of Things in the pharmaceutical industry Nanoparticles for drug delivery is a key innovation A nanoparticle is a small particle ranging in size from 1 to 100 nanometres. Nanoparticles are used as novel drug delivery systems to deliver drugs to specific tissues and to provide controlled release therapy.

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Drug Delivery Drugs Drug Delivery Systems FDA Approval 147

Drug Discovery World

AUGUST 9, 2023

The new acquisition gives Biogen rights to Reata’s portfolio of products for neurological diseases, including the FDA-approved Skyclarys (omaveloxolone), the only approved treatment for Friedreich’s ataxia (FA) in the United States.

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Drugs Drug Delivery Systems Drug Delivery Life Science 52

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.

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Drug Delivery Systems Drug Delivery FDA Approval Drugs 104

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.”

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Drugs Drug Delivery Systems Regulation Production 59

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.

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Drugs Branding Drug Delivery Systems Generic Drugs 105

The Pharma Data

AUGUST 31, 2021

Vice President, Late Development and Global Medical Affairs, Janssen Research & Development, LLC. “We FDA approval for nmCRPC in February 2018, and was approved for mCSPC in September 2019.2To date, more than 40,000 patients worldwide have been treated with ERLEADA ®. 2] ERLEADA ® received U.S.

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Drug Delivery Systems Drug Delivery Trials Drugs 52