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.

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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

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Small Molecule Laboratories Immune Response Trials 52

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028. state pharmaceutical assistance programs). Sunsetting of Coverage Gap Discount Program: The 70% coverage gap discount under the CGDP will continue until December 31, 2024. Final Guidance at 2.

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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.

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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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Agency IQ

FEBRUARY 2, 2024

The proposal will be discussed at the Council of the EU Working Party on Pharmaceuticals and Medical Devices, taking place January 30. The proposal comes after multiple stakeholders, including industry , cited major concerns about the IVDR implementation and its impact on new and already-marketed IVDs.

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The Pharma Data

JANUARY 9, 2021

This growth primarily reflects increased sales of contract development and manufacturing (CDMO) services to pharmaceutical and biotechnology innovators and government/non-government organization (NGO) customers, as well as higher product sales. Other 2021 Assumptions. FOOTNOTES. (1)

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Government Vaccine Production Licensing 52

The Pharma Data

SEPTEMBER 15, 2020

27 key programs highlighted, including assets that could potentially contribute revenue by 2025 and others in the 2026-2028 time frame. Pfizer announced several key advances in its efforts to protect humankind from the COVID-19 pandemic and prepare the pharmaceutical industry to better respond to future global health crises.

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The Pharma Data

NOVEMBER 4, 2020

As with much of the pharmaceutical industry, VASCEPA revenue and prescription growth have been adversely impacted by the COVID-19 pandemic. Amarin Corporation plc is a rapidly growing, innovative pharmaceutical company focused on developing and commercializing therapeutics to cost-effectively improve cardiovascular health. .

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Agency IQ

DECEMBER 15, 2023

EPA also proposed an additional set of CO2 standards for HD vehicles that would begin to apply in MY 2028, with progressively more stringent standards each model year through 2032. Monitoring preparations are anticipated in 2027, with sample collection between 2028-2030 and reporting concluding in 2031.

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