FDA delivers split decision on GSK's Blenrep

The Food and Drug Administration yesterday delivered a split decision on GSK's blood cancer drug Blenrep, approving its use in combination with a medicine called Velcade, but rejecting it when used with a different treatment called Pomalyst.

It's the latest twist in the turbulent history of the multiple myeloma drug.

The FDA and its advisers in July raised concerns about the sometimes-serious eye issues Blenrep can cause and about whether GSK had done enough to identify a safe dose that maintained the drug's efficacy. The agency also criticized the pivotal trials for including so few participants in the U.S.

obesity

Ro wants to measure 'food noise' in obesity care

Ro, one of the biggest telehealth companies in the obesity space, has launched a questionnaire to measure "food noise," a term that people with obesity often use to describe incessant and debilitating thoughts about food. Many patients said that new GLP-1 drugs have helped "quiet" their food noise.

Already, one biotech is using it in a trial of an investigational therapy, and Ro plans to license the scale to other drugmakers as well.

The issue, some experts said, is that food noise is still not well characterized or understood, and Ro has a vested interest in funding the development of the questionnaire.

"That makes me deeply concerned that a diagnosis is being created to be able to sell the solution," one researcher told me.

access

Patients form a buyer's club to get generic versions of Vertex drug

Patient advocacy groups are working with a generic manufacturer to revive a buyer's club and distribute Vertex's cystic fibrosis drug in countries where the cost is out of a reach.

The generic version of the drug, Trikafta, will be priced at $6,375 for a child and $12,750 for an adult per year, compared with a list price that exceeds $300,000 annually in the U.S.

Even though the World Health Organization has classified Trikafta as an essential medicine, patients in various countries have struggled to obtain it.

Pricing

Report finds prices of new drugs haven't matched their value

A new analysis from the Institute for Clinical and Economic Review finds that the price of new drugs has rapidly increased without offering sufficient value.

The report found the median net price for 154 newly launched medicines, when adjusted for inflation and discounts, rose by 51% between 2022 and 2024.

When looking at 23 of the 154 drugs it had previously reviewed, ICER found that 16 had annual net prices that exceeded the upper limits of its benchmark for cost-effectiveness.