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Good morning. About a month ago, when I first started writing this newsletter, I shared the devastating news that the famed rat hole here in Chicago was being removed. But as summer approaches, it appears there now may be a new animal-shaped indentation for us all to obsess over — the Chicago cicada hole.
Now let’s get into the biotech news of the day.
The need-to-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 unsure if Guardant’s 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 must first decline other available options like colonoscopy or stool-based tests, according to briefing documents the agency released ahead of an advisory committee meeting this Thursday.
Guardant’s sequencing-based test, known as Shield, detects chemical modifications to DNA that are telltale signs of colon cancer. If the FDA ultimately decides that Shield must be used after patients decline other traditional screening options, then that would limit the test’s use — and Guardant’s revenue prospects.
Guardant published results earlier this year that showed Shield could catch colorectal cancer at stages 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 test’s usefulness compared with existing screening methods.
Our reporters will be tuning into the advisory meeting Thursday — stay tuned for our coverage then.
AstraZeneca’s ‘new era of growth’
Yesterday, during AstraZeneca’s first investor day in a decade, CEO Pascal Soriot laid out the company’s ambitious goals for the next few years: it aims to nearly double its revenue to $80 billion by 2030, banking on the launch of 20 new drugs and continued growth of its cancer and rare disease therapies.
Soriot noted there will be headwinds, like the loss of exclusivity on its 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 hub in Cambridge, England. AstraZeneca is focusing especially on next-generation chemotherapies called antibody-drug conjugates.
Read more from STAT’s Drew Joseph on what else Soriot had to say about the company’s plans in obesity and its interest in China.
Maryland takes first steps to cap drug costs
From STAT’s Rachel Cohrs: Back in 2019, Maryland was a pioneer when it created a prescription drug affordability board to help give state officials more tools to control prescription drug costs in the state. The board had some hiccups over the past few years and its progress was overtaken by Colorado’s affordability board, but the Maryland program is finally getting up and running.
The Maryland board this week voted to advance cost reviews for six out of the eight drugs it considered, including Novo Nordisk’s Ozempic, Eli Lilly’s Trulicity, Boehringer Ingelheim’s Jardiance, and AstraZeneca’s Farxiga, Bloomberg Law reports. The board hasn’t decided whether to put cost caps on the medicines yet.
Colorado’s board is already facing a lawsuit from a pharmaceutical company it’s targeting, so similar action could follow in Maryland if the state decides to pursue upper payment limits.
A surprising off-label benefit of anti-seizure drugs
Though there are three FDA-approved drugs for treating alcohol use disorder, a different type of medication, one that’s frequently used off-label, may actually provide greater benefit to patients with alcohol-associated liver disease, a new study found.
Looking at health records, researchers compared acamprosate, sold under the brand name Campral to treat alcohol dependence, against gabapentinoids, a class of anti-seizure drugs. They found that a smaller percentage of patients on gabapentinoids progressed to advanced liver scarring.
Rates of alcohol-associated liver disease have surged, making it the leading cause of liver transplants in the U.S.
Read more from STAT’s Isa Cueto.
The complicated calculus behind making H5N1 vaccine
If the H5N1 bird flu virus ever acquires the ability to transmit to and among people, the world would need a lot of vaccine. But when should drugmakers actually start scaling up production of such a vaccine?
Some manufacturers that have been working on vaccines for H5N1 viruses for years have already produced small batches that have undergone early human testing. And some millions of doses in the low double digits have even been stockpiled by the U.S. government.
But it’s a different story when thinking about producing vaccine at the massive quantities needed to vaccinate the world. That’s a high-cost, high-risk endeavor.
Read more from STAT’s Helen’s Branswell on the questions surrounding this decision and the manufacturing constraints at play.
More reads
- CDC asks states and cities to keep flu surveillance at peak levels because of bird flu threat, STAT
- Senators strike bipartisan tone on more pharma patent reforms, Endpoints
- In pharma tax probe, Wyden puts Pfizer in hot seat with CEO letter, Fierce Pharma
- Opinion: What clinical real-world data can deliver, STAT