The Pharma Data
JUNE 9, 2025
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
The Premier Consulting Blog
APRIL 27, 2023
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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DrugBank
SEPTEMBER 26, 2024
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.
The Pharma Data
JANUARY 19, 2021
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
Agency IQ
MARCH 15, 2024
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.
Agency IQ
JANUARY 26, 2024
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.
Agency IQ
MARCH 7, 2024
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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