Agency IQ

JANUARY 4, 2024

Swissmedic reorg adds new focus on medical device market surveillance The Swiss regulator, Swissmedic, just announced a reorganization, with a new head of the medicinal product authorization and vigilance sector, but also a new and discrete medical devices surveillance sector. KAROLINE MATHYS is the head of the new sector.

Marketing 40

Marketing Regulations Clinical Trials International 40

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. The Discount Program is similar to the CGDP with respect to several requirements and operational processes, and CMS will implement it in a similar manner.

Compliance 104

Compliance Drugs Pharmacy Licensing 104

The Pharma Data

SEPTEMBER 7, 2021

0.750% due August 31, 2026. 0.750% due August 31, 2026. 0.750% due August 31, 2026. 0.750% due August 31, 2026. and Citigroup Global Markets Inc. toll-free at +1 (888) 292-0070 or collect at +1 (980) 387-3907 or to Citigroup Global Markets Inc. 3.950% Notes due 2049. 532457 BT4. 1,500,000,000. 532457 AM0.

Licensing 52

Licensing Licensing Marketing 52

Agency IQ

JULY 26, 2024

BY LAURA DIANGELO, MPH , RACHEL COE, MSC | JUL 23, 2024 9:54 PM CDT Biosimilarity and interchangeability: A quick recap The Biologics Price Competition and Innovation (BPCI) Act of 2009 intended to increase the number of biologic products on the market by creating two types of approvals for biosimilar products.

Biosimilars 40

Biosimilars Science FDA Production 40

The Pharma Data

APRIL 1, 2021

Sanofi expects this new facility to be operational in 2026, following design, construction, testing and qualification of the facility and equipment. The vaccine has received marketing authorizations in 25 countries in Europe (under the name Efluelda ® outside of the UK) for use in adults 60 years of age and older.

Vaccine 52

Vaccine Government Science Production 52

Codon

SEPTEMBER 29, 2024

2026 Another lab, one with a greater appreciation for what machine learning could pull from noisy, high-throughput biological data, stumbled across the 2025 paper and discussed it in a Monday morning lab meeting. At best, the corporations with the best models released weak versions to the public under non-commercial licenses.

Engineering 130

Engineering Virus DNA Therapies 130

Agency IQ

AUGUST 2, 2024

While generic drugs technically pre-dated the law (look up “Paper NDAs” if you’re interested), the law turbocharged the ability of generics to come to market. While this would not affect existing vouchers, it would prevent FDA from issuing new ones after September 2026. Read the full list of documents on FDA’s Unified Agenda here.]

FDA 40

FDA Science Regulations Biosimilars 40