Drug Discovery World

SEPTEMBER 6, 2022

As is always the case with pharmaceuticals, the industry’s capabilities to manufacture and produce these potentially life-saving therapies will be of concern. . The challenge for the market then, according to Boissel, is how much can a payor afford to pay upfront? . Manufacturing . Workforce .

Therapies 130

Therapies Clinical Trials Vaccine Disease 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. and the E.C.

FDA 40

FDA Science Regulations Biosimilars 40

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 125

Engineering Virus DNA Therapies 125

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. Any CMC changes (e.g.,

Biosimilars 40

Biosimilars Science FDA Licensing 40

The Pharma Data

DECEMBER 12, 2020

12, 2020– AstraZeneca and Alexion Pharmaceuticals, Inc. 1 The global rare disease market is forecasted to grow by a low double digit percentage in the future. AstraZeneca intends to build on its geographical footprint and extensive emerging markets presence to accelerate the worldwide expansion of Alexion ‘s portfolio.

Regulations 75

Regulations International Disease Small Molecule 75

Drug Discovery World

FEBRUARY 26, 2024

For example, Vertex Pharmaceuticals’ stem-cell treatment for sickle-cell disease and transfusion-dependent β-thalassemia was authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) in November 2023, making it the first licensed therapy that uses the gene-editing tool CRISPR to help treat patients.

Therapies 130

Therapies Treatment Engineering Disease 130

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. state pharmaceutical assistance programs). Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year.

Compliance 105

Compliance Pharmacy Drugs Licensing 105