Each week we highlight five things affecting the life sciences industry. Here’s the latest.
UK eyes hiking NHS drug price threshold to counter proposed US tariff
- The UK government is reportedly considering a 25% increase in the National Institute for Health and Care Excellence’s cost-effectiveness threshold to give the National Health Service room to pay more for medicines amid looming U.S. tariffs.
- Critics warn the move could strain public health budgets and argue that higher thresholds don’t always yield better population health outcomes, writes Fierce Pharma.
Generic drugs excluded from tariffs
- The Trump administration announced it will not impose tariffs on generic drugs, despite months of deliberation under a national security investigation using Section 232 of the Trade Expansion Act of 1962; however, the decision is not final and could change in the coming weeks.
- By sparing generic drugs from tariffs, the administration aims to maintain affordable access to medications and protect the flow of imports from key suppliers like India, which provides nearly half of generics used in the U.S., reports The Wall Street Journal.
Biopharma market shows signs of revival
- A biotech company developing treatments for schizophrenia and Alzheimer’s psychosis filed to go public on Nasdaq, despite the government shutdown, aiming an initial public offering of $227 million.
- This IPO would be only the second major U.S. biotech listing since February. Recent positive clinical results, acquisitions and market recovery have somewhat boosted industry morale, according to Endpoints News.
FDA approval of first IPF drug in over a decade
- A global pharmaceutical company received U.S. Food and Drug Administration approval for its drug, marking it the first new treatment for idiopathic pulmonary fibrosis (IPF), a hard-to-treat lung disease, in over a decade. The drug showed improved lung function and tolerability compared to older treatments, potentially reshaping the IPF treatment landscape.
- While the drug did not meet statistical survival benefit criteria, it showed a nominal reduction in death risk and is expected to see solid uptake. Analysts view its approval as a turning point in IPF drug development, according to Fierce Pharma.
FDA launches pilot to boost domestic generic drug production
- A just-launched abbreviated new drug application pilot program will fast-track reviews for generic drugs made with U.S.-sourced active pharmaceutical ingredients and tested domestically, aiming to reduce reliance on foreign manufacturing.
- According to Endpoints News, while the FDA and government push for U.S.-based production, industry economics and tight profit margins make domestic manufacturing challenging, potentially risking drug shortages if generics exit the market.
For more insights in life sciences, check out RSM’s industry outlook.
