Drug Patent Watch

DECEMBER 12, 2024

Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. In this comprehensive guide, we’ll explore the intricacies of identifying such drugs and leveraging them for successful in-licensing opportunities.

Licensing 96

Licensing Licensing Branding Drugs 96

Camargo

DECEMBER 13, 2021

A biologics license application (BLA) is required for biological products subject to licensure under the PHS Act, and FDA approval to market a biologic is granted by issuance of a biologics license. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

Development 161

Development Production Immune Response Licensing 161

The Pharma Data

DECEMBER 17, 2020

With experiences attained in licensing and business development functions from Amgen, Baxter and Johnson & Johnson, Mr. Bliss introduced himself in Mandarin Chinese. SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Dec. TLC is consistently ranked top 5% among all listed companies in Taiwan’s Corporate Governance Evaluations.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Containment 40

The Pharma Data

AUGUST 5, 2020

In February, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted the company’s Supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab for the treatment of relapsing forms of multiple sclerosis in adults. J Neurol Sci. 2003;206(2):165–71.

Trials 52

Trials Medicine Production Containment 52

XTalks

FEBRUARY 8, 2021

Crucially, biosimilars manufacturers must also demonstrate that their product’s safety and efficacy profile won’t go down if a patient switches back and forth between the biosimilar and the reference product during the course of treatment. Because most biologics are mixtures of variants, they really can’t be copied exactly.”.

Production 78

Production Insulin Branding Generic Drugs 78

Druggist

MARCH 25, 2021

Although the active ingredient is the same, there are differences in non-active components (the core of the tablet and coating), which reflect both pills’ manufacturing process. As with other drugs, once a patent expires, other manufactures start to produce generic or new brands of the same pill (desogestrel). Cerazette**.

Branding 98

Branding Bioequivalency Pharmacy Generic Drugs 98