Moderna to pay major settlement in Roivant patent case

Moderna has agreed to pay Roivant up to $2.25 billion to settle claims that it infringed on Roivant's patents with its Covid-19 shot.

Roivant will receive $950 million and then another $1.3 billion if Moderna's attempts to have parts of its liability offloaded to the federal government fail upon appeal. If the full amount is paid, it will be among the largest patent settlements in history.

The news comes less than a week before the companies were set to go to a jury trial in Delaware, where legal experts say Moderna may have faced an uphill battle.

regulation

FDA warns more telehealth firms about compounded GLP-1s

The FDA has sent another batch of warning letters to 29 telehealth companies, saying they've made false or misleading statements about compounded GLP-1 products.

The companies — including Zappy, SkinnyRx, and GoodGirlRx — make claims on their site implying their products have been FDA-approved or evaluated when they have not, the FDA said. It had sent a similar batch of letters to different firms last September.

The FDA last month said it would take steps to combat misleading marketing of compounded GLP-1s, after Hims & Hers attempted to sell what it claimed was a compounded version of Novo Nordisk's Wegovy pill — a move that the drug industry and regulators saw to be especially egregious.

However, it's not clear how much of an impact these warnings letters will have. The FDA had sent Hims a warning letter in September, but Hims continued to market compounded GLP-1s and draw comparisons to the brand-name drugs.

gene editiing

Prime Medicine's drug will test bounds of FDA flexibility

The FDA has said it wants to speed new gene therapies to the market, but has also recently come under scrutiny from patients and the drug industry for spurning a string of rare disease treatments that appeared to be on track for approval.

The latest test of the agency's flexibility will come from Prime Medicine, which said yesterday it will ask the FDA to approve a gene-editing treatment that has been given to only two patients.

Prime's drug is the first to employ prime editing, a CRISPR-based tool for making virtually any small change to DNA. The treatment is designed to insert two missing DNA letters into the blood cells of people with a form of chronic granulomatous disease, which leaves patients susceptible to life-threatening infections and debilitating inflammatory disorders.

drug pricing

Virginia wants to go further than other states in containing drug costs

A growing number of states have created affordability boards to address rising drug costs. Virginia lawmakers are now proposing a board that, if approved, would appear to adopt the most stringent measures so far in limiting costs.

The Virginia board would target the same drugs that have been chosen by Medicare for price negotiations under the Inflation Reduction Act and also set upper payment limits for drugs.

Of the other nine states that have boards, none is using Medicare as a baseline for choosing drugs to target, and only four have the authority to set upper payment limits.