Biogen, Guardant, AstraZeneca, H5N1 vaccine

Want to stay up to date on the science and politics driving biotechnology today? Sign up to receive our biotech newsletter in your inbox.

Good morning. About a month ago, when I first started writing this newsletter, I shared the devastating news about the famous rat hole here in Chicago has been removed. But as summer approaches, it looks like a new animal-shaped notch is now emerging that we can all become obsessed with: the Cicada hole from Chicago.

Now let’s take a look at the biotech news of the day.

The must-know this morning

• Biogen is acquiring Human Immunology Biosciences, a privately held developer of drugs for immune-related diseases, for $1.15 billion and up to $650 million in additional payments if certain milestones are met.

FDA is unsure if the Guardant test can be used for first-line cancer screening

From STAT’s Jonathan Wosen: The FDA is seeking guidance on whether Guardant’s blood-based colon cancer screening test could be a first-line screening option or whether patients should first decline other available options, such as colonoscopy or stool-based tests, the FDA said. briefing papers the agency released this Thursday ahead of an advisory committee meeting.

Guardant’s sequencing-based test, known as Shield, detects chemical modifications in DNA that are telltale signs of colon cancer. If the FDA ultimately decides that Shield should be used after patients have rejected other traditional screening options, it would limit the test’s use – and Guardant’s revenue prospects.

Guardant published results earlier this year showing that Shield could catch colorectal cancer at stage 2 or later, but was less effective at detecting stage 1 cancer and advanced adenomas, precursors to colon cancer. This has raised concerns about the usefulness of the test compared to existing screening methods.

Our reporters will tune in to the advisory meeting on Thursday – then stay tuned for our coverage.

AstraZeneca’s ‘new era of growth’

Yesterday, at AstraZeneca’s first investor day in a decade, CEO Pascal Soriot laid out the company’s ambitious goals for the coming years: it aims to nearly double sales to $80 billion by 2030, banking on the launch of twenty new drugs and continued growth. of its cancer and rare disease therapies.

Soriot noted there will be headwinds, such as the loss of exclusivity of his blockbuster diabetes drug Farxiga and the Inflation Reduction Act, but he said he still sees a “new era of growth” as he showed off the company’s flashy new research center the company in Cambridge. England. AstraZeneca focuses mainly on next-generation chemotherapeutics, so-called antibody-drug conjugates.

Read more from STAT’s Drew Joseph on what else Soriot had to say about the company’s plans for obesity and its interest in China.

Maryland is taking first steps to limit drug costs

From STAT’s Rachel Cohrs: In 2019, Maryland was a pioneer when it created a Prescription Drug Affordability Board to give state officials more tools to control prescription drug costs in the state. The board had some problems in recent years and progress was overtaken by the Colorado affordability board, but the Maryland program is finally up and running.

The Maryland board voted this week to advance the cost review for six of the eight drugs it was considering, including Novo Nordisk’s Ozempic, Eli Lilly’s Trulicity, Boehringer Ingelheim’s Jardiance and AstraZeneca’s Farxiga. Bloomberg Law reports this. The board has not yet decided whether there will be cost ceilings on the medicines.

The Colorado board is already facing a lawsuit from a drug company it is targeting, so similar action could follow in Maryland if the state decides to pursue higher payment limits.

A surprising off-label benefit of antiepileptic drugs

Although there are three FDA-approved medications for treating alcohol use disorders, a different type of drug, one often used off-label, may actually provide more benefit to patients with alcohol-related liver disease, a new study shows.

Looking at health records, researchers compared acamprosate, sold under the brand name Campral to treat alcohol addiction, with gabapentinoids, a class of anti-seizure medications. They found that a smaller percentage of patients receiving gabapentinoids progressed to advanced liver scarring.

The rate of alcohol-associated liver disease has skyrocketed, making it the leading cause of liver transplants in the US

Read more from STAT’s Isa Cueto.

The complicated calculus behind creating an H5N1 vaccine

If the H5N1 bird flu virus ever gains the ability to spread to and between humans, the world would need this a lot of of vaccine. But when should drugmakers actually start scaling up production of such a vaccine?

Some manufacturers who have been working on vaccines against H5N1 viruses for years have already produced small batches that have been tested in humans early on. And several million doses in the low double digits have even been stockpiled by the US government.

But it’s a different story when you think about producing vaccines in the enormous quantities needed to vaccinate the world. That is an undertaking with high costs and risks.

Read more from STAT’s Helen’s Branswell about the questions surrounding this decision and the production restrictions involved.

Read more

• CDC asks states and cities to maintain flu surveillance at peak levels due to bird flu threat, STAT
• Senators strike a bipartisan tone on more pharmaceutical patent reforms, Endpoints
• In a pharmaceutical tax investigation, Wyden puts Pfizer on the line with a letter from the CEO, Fierce Pharma
• Opinion: What Clinical Practice Data Can Provide, STAT