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Transitioning to eCTD v4.0

The Premier Consulting Blog

offers significant advancements in the way that sponsors and regulatory bodies handle submissions, and adapting to these improvements will be mandatory across all major regulatory authorities by 2028 (earlier, in many regions). This blog post gives an overview of the changes that eCTD v4.0 As of April 2023, the FDA is overseeing its eCTD v4.0

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The Competitive Edge of Biosimilars

DrugBank

The EMA's stringent requirements aim to ensure that biosimilars are as safe and effective as their reference products, thus safeguarding patient health and maintaining the integrity of the pharmaceutical market. billion by 2028. Understanding the financial implications of biosimilars is important for investors and analysts.

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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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Analysis Chemical Thank You California publishes draft regulations for landmark plastic pollution reduction act

Agency IQ

California implements a variety of extended producer responsibility (EPR), programs, including programs to address paint, carpet, mattress, pharmaceutical and battery waste. Improving recycling: SB 54 contains a set of recycling targets that increase between 2028 and 2032. That amount will increase to 40% in 2030 and 65% in 2032.

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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

government recently extended that recognition through 2028 for medical devices and 2030 for IVDs. An example: For GSPR 12 on devices that incorporate medicinal products, rather than citing the European pharmaceutical regulations (Directive 2001/83/EC), the U.K. government continued to recognize CE-marked products for a limited time.

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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.  Pharmaceutical Market Analysis The global pharmaceutical market revenue in 2024 is projected to be 1.15 billion by 2030.