Clarivate

JULY 5, 2023

The month of July could see seven FDA-approved adalimumab biosimilars launch in the United States, an unprecedented situation for a market that has been relatively slow to embrace biosimilars. The Biosimilars Forum has hailed 2022 as a watershed year that could create a more competitive U.S. from 91% in 2023 to 36% by 2031.

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Clarivate

JANUARY 23, 2024

While some industry observers read this drop as a clear decline in productivity, others take a more optimistic view, attributing the decline to FDA submission calendar fluctuations and noting that 2022 numbers were not very different from the ten-year average. In fact, the number of NMEs has grown by 65% between 2013 and 2022.

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Clarivate

OCTOBER 19, 2023

the FDA offers a period of 3 years of data exclusivity for a new application of a previously approved drug. “However, drug repurposing faces multiple challenges in the regulatory area,” points out Martí Bernardo-Faura, Senior Bioinformatics Consultant at DTS Consulting Services in Clarivate. For example, in the U.S.,

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Clarivate

OCTOBER 10, 2022

Based on the TROPICS-02 trial results, Gilead has submitted a supplemental biologics license application (sBLA) to the FDA, seeking a label expansion for TRODELVY in the much larger setting of metastatic HR+/HER2-negative breast cancer. Fruquintinib will face fierce competition should it be approved in the third- and later-line setting.

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Marketing Safety Patients Competition 52

Clarivate

MAY 24, 2023

A narrow FDA AdComm vote in favor of accelerated approval for Sarepta’s first-in-class gene transfer therapy illustrates challenges faced by regulators, payers and developers as a wave of innovative genetic treatments for rare diseases comes to market.

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Clarivate

OCTOBER 7, 2021

As part of our Drugs to Watch series, which reviews therapies expected to have significant impact on healthcare markets, Clarivate oncology experts sifted through the more than 2,800 abstracts that were accepted for presentation at the ESMO 2021 Virtual Conference and selected their top picks.

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Patients Safety Marketing Physicians 91

Pharmaceutical Technology

MARCH 21, 2023

FDA and EMA decisions In January, the European Commission (EC) approved Roche’s Xofluza (baloxavir marboxil) to prevent and treat influenza in children ages one year and older. Regulatory decisions by the FDA and EMA for select therapies from late January to late February and the CMOs contracted to manufacture the therapies.

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