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WuXi Biologics, VISEN Partner to Make Lonapegsomatropin in Chengdu

The Pharma Data

This new chapter in the strategic partnership between WuXi Biologics and VISEN Pharmaceuticals underscores a shared commitment to innovation, localization, and improved patient care. VISEN Pharmaceuticals expects to obtain regulatory approval for lonapegsomatropin in China by 2025. Chen said. “By

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The Competitive Edge of Biosimilars

DrugBank

Due to the less extensive clinical trial requirements and the competitive nature of the biosimilar market, these biologics can be produced and marketed at significantly lower prices than their reference counterparts. Still, significant differences exist between these two major markets.

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2021 Biotech IPOs Get Off to a Roaring Start

The Pharma Data

Syros Pharmaceuticals – Syros announced its IPO on January 20, offering 5.4 It hopes to raise about $160 million in aggregate principal amount of 7.375% senior notes due 2025 and $270 million in aggregate principal amount of 7.250% senior notes due 2028. million shares of common stock at $14 per share, to raise $75.6

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Article EMA Thank You Proposal for IVDR extension also impacts MDR, EUDAMED

Agency IQ

For example, the European pharmaceutical trade association EFPIA expressed concern over the delays the IVDR had been causing in drug clinical application approvals. These requirements are similar to what is already required for critical pharmaceutical products. Once the E.U.

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Article EMA Thank You British regulators tease new device regulations in informative live session

Agency IQ

To keep critical devices and in vitro diagnostics (IVDs) available for patients in Great Britain (England, Scotland, and Wales), a much smaller market than the remaining 27 Member States of the E.U., government recently extended that recognition through 2028 for medical devices and 2030 for IVDs. post-market regulation here.]

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Article FDA Thank You Diagnostics landscape analysis: Key issues and a look ahead at 2024

Agency IQ

This means that the medical device frameworks – including the pre-market pathways and evidentiary requirements, as well as post-market quality system frameworks and reporting requirements – are applied to the vast majority of all (CDRH-regulated) IVD products. IVDs used in blood donation screening/processing). In the E.U.,

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Investment Trends in Pharmaceutical Research

DrugBank

Investment Trends in Pharmaceutical Research and Development Investing in the pharmaceutical sector presents a unique set of challenges and opportunities; let’s examine them in more detail.    The average cost of bringing a new drug to market is about $2.6 trillion by 2028. reported in 2021.