Lawmakers urge scrutiny on Merck's patent plays

Sen. Elizabeth Warren and other lawmakers are urging the Biden administration to keep a close eye on Merck and its efforts to extend patent protection for its blockbuster cancer drug Keytruda. Merck is planning on securing new patents on a subcutaneous version of the drug, which could extend Keytruda's monopoly — costing consumers and taxpayers billions of dollars. The lawmakers note that Merck has a pattern of "ongoing abuse" of the patent system. Merck has 53 patents on Keytruda; although the original expires in 2028, others will expire as late as 2039.

The lawmakers call a subcutaneous version of Keytruda an "obvious use" that is meant purely to preserve the drug's high revenues. "It is not at all clear that Merck is doing anything other than extending its monopoly power over the drug," they wrote in a letter to the U.S. Patent and Trademark Office.

podcast

What makes a drug quintuple in cost?

How do you follow inventing a Covid-19 vaccine? And what did we learn from biotech's unicorn era? We cover all that and more this week on "The Readout LOUD," STAT's biotech podcast.

STAT's Ed Silverman joins us to explain how an escalating fight between Vertex Pharmaceuticals and insurance companies has left patients and families caught in the middle. We also discuss the latest news in the life sciences, including the demise of a one-time unicorn, Moderna's difficult second act, and an official biotech presidential run.

Listen here.

RSV

A CDC panel discusses the new RSV vaccines

Multiple vaccines to protect against respiratory syncytial virus or RSV are making their way through U.S. regulatory processes. On Thursday, the makers of two vaccines for seniors learned their products, if approved by the Food and Drug Administration, will likely be recommended for use in people 65 and older, but not for adults aged 60 to 64, as they'd hoped.

The RSV work group of the Advisory Committee on Immunization Practices, which advises the Centers for Disease Control and Prevention on vaccine policy, did not recommend the broader committee endorse the GSK and Pfizer vaccines for adults aged 60 to 64, suggesting cost-benefit analyses didn't support use of the vaccine in that age group.

Work group member Sarah Long, a professor of pediatrics at Drexel University College of Medicine, said there were concerns about three cases of Guillain-Barré syndrome or a GBS-like condition that were seen in the clinical trials for the vaccines. Long said the group felt it would be prudent to move conservatively until more is known about whether there is a link between receipt of the vaccine and development of the condition.

living forever

Tally Health's new epigenetics-based test

Tally Health, a company led by Harvard geneticist David Sinclair, has launched a direct-to-consumer cheek swab test that will tell you how old your body really is — not chronologically, but biologically. There are about a dozen companies offering similar tests, but what sets Sinclair's apart is that it also offers personalized action plans, such as diet, exercise, and supplement recommendations.

Sinclair's work focuses on the epigenome — the chemical modifications to DNA that turn genes on or off — and how it impacts the aging process. Tally's method, called TIME-Seq, can purportedly lower the cost of epigenetic age estimates by more than 100-fold. And Sinclair's big idea, ultimately, would be to one day reverse age-related conditions like heart disease and Alzheimer's. That's a ways off, but: "We can drive aging now forwards and backwards at will," Sinclair said.