Pink Sheet

NICE, the health technology appraisal institute for England and Wales, acknowledges the challenges that companies are facing in relation to US most favored nations pricing polices, said the organization’s director of medicines evaluations, Helen Knight.

As the trilogues between the European Parliament and Council of the EU are underway for the much anticipated Critical Medicines Act, the Pink Sheet offers an infographic that covers the act’s key features and highlights what industry wants to see moving forward.

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

The Indian government is reported to be considering curbs like the Essential Commodities Act - last put to use during COVID – for pharma amid the ongoing war between the US-Israel coalition and Iran. What is prompting the move and what does industry have to say?

The health technology assessment institute, NICE, has recommended making Novo Nordisk’s drug available via England’s National Health Service for more than a million people to help reduce the risk of major adverse cardiovascular events.

Participants in the qualification process for BMD in osteoporosis are optimistic future uses of the US FDA pathway will be less time consuming, but staff resources still are a major challenge for the agency.

Policy experts assess the viability of exemptions from the Medicare Most Favored Nation payment demonstrations that companies that have sealed voluntary MFN deals with the Administration believe they are entitled to.

The Germany-based family-owned company, which has posted a decent set of financials for 2025 driven by Jardiance and Ofev, is particularly concerned about the red tape involved in getting clinical trials off the ground.

Country still trying to encourage shots after nationwide probe into post symptoms led to a long halt, but rates remain low.

Jiuyuan Gene’s semaglutide biosimilar hits unexpected regulatory roadblock on its way to market in China for type 2 diabetes over data protection provisions under "agreements between Chinese and foreign governments."

April opens with US FDA goal dates for cell therapies from Replimune and Orca Bio, then momentum moves to the drugs center with Merck HIV combo, Axsome's Auvelity for Alzheimer's agitation and a trio of Sanofi applications including a hyaluronidase-free subcutaneous Sarclisa

340B hospitals are preparing for the US Medicare program to reduce payments for drugs purchased at the discounted price next year, as well as planning for a potential revival of a rebate model.

Marketing authorization holders for selected critical medicines will face new data submission requirements as the European Medicines Agency rolls out an analytics‑based framework to assess supply chain vulnerabilities in 2026.

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include one new product – Anktiva, Immunitybio's treatment for adults with non-muscle invasive bladder cancer.

The European Medicines Agency says that three-dimensional printing is an emerging technology with great potential in pharmaceutical applications.

The US Government Accountability Office urged the FDA to publish long‑required guidance explaining how it evaluates advisory committee member conflicts of interest, spotlighting a transparency gap that has persisted despite a congressional mandate.

Vanda has asked a federal appeals court to set aside Principal Deputy Commissioner Sara Brenner's decision denying Vanda a hearing on the agency's refusal to approve tradipitant.

Pink Sheet editors discuss the highlights and challenges of FDA Commissioner Martin Makary’s first year in office and consider possibilities for year two.

The European Medicines Agency has backed five new medicines for EU approval, with orphan drugs for lung cancer and a rare immunodeficiency disorder in the mix.

The UK drug regulator will review preliminary data from studies that use non-animal models before it assesses a drug marketing authorization application to help developers adopt alternative testing methods.