2026 Documentation Drug Development 
Putting Patients First Blog
JUNE 26, 2025
Rutta Chief Executive Officer 1 Centers for Medicare & Medicaid Services, “Medicare Program; Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program Draft Guidance; Comment Request,” Federal Register 90, no. Food and Drug Administration, FDA Patient-Focused Drug Development Guidance Series , March 21, 2025.
Pharmaceutical Technology
JULY 16, 2025
Robert Barrie July 16, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Shares in London-listed GSK closed 1.19% down following the document release. Experts also identified poor tolerability of regimens and resulting uncertainty regarding proposed dose, as per a briefing document published on 15 July.
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Pharmaceutical Technology
JULY 15, 2025
The net payment made by Sino to acquire LaNova will be approximately $500.9m, a figure that excludes the estimated cash and bank deposits, according to a company document outlining the terms of the transaction. LaNova’s drug development focuses on tumour immunity and the tumour microenvironment. by market close.
Pharmaceutical Technology
JULY 18, 2025
Comstock said it is not yet clear if the report will be turned into an official agency guidance document, but it will be made publicly available. However, the PRV program for rare pediatric diseases is at risk of expiry in September 2026, and is pending renewal.
Pharmaceutical Technology
JULY 18, 2025
The concern of ocular toxicity was first highlighted in a document published ahead of the ODAC meeting that took place on 17 July. The recommendation given by ODACs is usually followed by the FDA when deciding if a drug should be approved.
FDA Law Blog: Biosimilars
OCTOBER 13, 2024
We have heard over and over again how the potential for a priority review voucher has allowed small companies with limited resources to invest in the development of drugs for rare pediatric diseases. No rare pediatric disease vouchers could be awarded even to designated applications after September 30, 2026.
Putting Patients First Blog
APRIL 14, 2023
Driven by the work of the Food and Drug Administration on patient-focused drug development (PFDD), many companies in the biopharmaceutical community have devoted significant resources to better understand patient populations and are working to bring to market products that best suit their needs. Sincerely, Randall L.
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