Good morning. Programming note: We'll hit your inboxes a bit later than 6 a.m. ET Monday through Wednesday while we await Nobel Prize news.

FDA approves ALS drug from Amylyx

The FDA approved a new medicine for ALS from Amylyx Pharmaceuticals yesterday, providing a desperately needed new treatment option for a devastating disease despite earlier questions. The medicine, to be sold as Relyvrio, is not a cure for ALS but in a small, 24-week study did moderately slow the progression of the neurological disease, which destroys neurons in the brain and spinal cord, resulting in weakened muscles, paralysis, and death.

Amylyx, which did not immediately say how much it will charge for Relyvrio, is conducting a larger, longer clinical trial to confirm its benefits. In a rare commitment, the company has promised to remove the drug from the market if that study is not successful. The FDA initially took a dim view of Amylyx’s supporting evidence but later reversed course at a dramatic public hearing earlier this month. STAT’s Damian Garde has more.

Who will get the call from Stockholm?

(FOX PHOTOS/GETTY IMAGES)

It’s awards season, so time to get out the crystal balls, rev up the citation calculators, and count biomedical prizes known as Nobel predictors (including the just-announced Laskers). Will mRNA Covid vaccines get the nod in medicine? How about the brilliant minds who elucidated how cells make energy, discovered the chemical chatter of bacteria, or shepherded us into the “era of the genome”? STAT’s Megan Molteni consulted experts who have this down to a science to get their picks (and add her own) for the prizes in medicine, physics, and chemistry announced Monday through Wednesday.

Here's one: Cancer biologist Jason Sheltzer of Yale is bullish on pandemic-halting mRNA vaccines winning in medicine on Monday. “It’s such a radical change in vaccine technology, at this point billions of doses have been given, and it has incontrovertibly saved millions of people from dying of Covid,” he told Megan. “To me, it’s just a slam dunk.” Read more.

U.S. coastal hospitals face rising risk of hurricane flooding

Katrina. Sandy. And now, Ian. These hurricanes devastated coastal areas, flooding hospitals and the roads that lead to them. A new study in GeoHealth asserts that even weaker storms raise the risk of floods damaging hundreds of U.S. hospitals within 10 miles of the Atlantic and Gulf coasts. That danger will increase 22% by century’s end, the analysis concludes.

The researchers say 682 acute care hospitals in 78 metropolitan statistical areas are in zones at risk, which translates to where about 1 in 4 Americans live. In 25 of those metro areas, at least half of the hospitals are at risk of flooding from a Category 2 storm. Ten areas where a Category 2 hurricane poses a threat:

Miami-Fort Lauderdale-West Palm Beach, FL
New York-Newark-Jersey City, NY-NJ-PA
Boston-Cambridge-Newton, MA-NH
Orlando-Kissimmee-Sanford, FL
New Orleans-Metairie, LA
Tampa-St. Petersburg-Clearwater, FL
North Port-Sarasota-Bradenton, FL
Jacksonville, FL
Cape Coral-Fort Myers, FL
Philadelphia-Camden-Wilmington, PA-NJ-DE-MD

Closer look: They found fungi where?

The trillions of microbes in and on our bodies — collectively known as our microbiomes — have another trick up their sleeve. Overturning the dogma saying these bugs lived only where there’s a connection to the outside world from our skin, hair, and gut, bacteria have turned up in cancerous tumors. Ravid Straussman, a cancer biologist at the Weizmann Institute of Science in Israel, made that discovery, which got him thinking about fungi. Now, two new papers published in Cell yesterday (one from his lab) trace genetic footprints of fungi in tumors across the human body.

“Some tumors had no fungi at all, and some had a huge amount of fungi,” Straussman said. Given that even a small tumor may have a billion cancer cells, Straussman said “it could still be 1 million fungal cells in a tumor, which could have a big effect on cancer biology.” STAT’s Angus Chen has more.

How Covid and cancer led to deaths in 2020

Every list of people most vulnerable to severe Covid-19 includes people with cancer. Cancer itself (particularly blood cancers) and treatments for it can weaken the immune system so much that even vaccination can’t lift immunity as high as in people without cancer. A new research letter in JAMA Oncology looked at the deaths of more than 16,000 people in the U.S. who had both cancer and Covid in 2020, during the pre-vaccine pandemic months when cancer care was disrupted.

Separating out each disease as the underlying or contributing cause, the researchers determined that 3,142 cancer deaths had Covid as a contributing cause and 13, 419 Covid deaths had cancer as a contributing cause. Familiar risk factors — older age, being American Indian or Alaska Native, Black, or Hispanic, living in large urban areas or in long-term care — were more prevalent in deaths caused by both cancer and Covid than in non-Covid-related cancer deaths.

Suicide rate rose in 2021 after two-year drop

Suicide rate, by age and sex: United States, final 2020 and provisional 2021; National Center for Health Statistics

Both the number and rate of deaths by suicide rose 4% in 2021, reversing two years of decreases recorded by the CDC’s National Center for Health Statistics, a report out today says. The number rose from 45,979 in 2020 to 47,646 in 2021 and the rate of suicides per 100,000 went up from 13.5 in 2020 to 14.0 in 2021. Those are still lower than what’s called the modern peak in 2018, when suicides climbed 35% from 1999 before dropping by 5% through 2020. Other notable numbers:

The increase in suicides was higher among males (4%) than females (2%); the suicide rate went up more for males (3%) than females (2%).
The largest increase in the suicide rate was among males ages 15-24 ( 8%).
The number of suicides was higher in nine months during 2021 compared to 2020, with the largest increase occurring in October (11%).

If you or someone you know may be considering suicide, contact the 988 Suicide & Crisis Lifeline: call or text 988 or chat 988lifeline.org. For TTY users: Use your preferred relay service or dial 711 then 988.

What we're reading

Cerebral treated a 17-year-old without his parents’ consent. They found out the day he died, Wall Street Journal
How McKinsey got into the business of addiction, New York Times
With rivals on its heels, Illumina launches a new line of high-end DNA sequencers, STAT
Johns Hopkins doctor and spouse, an Army doctor, indicted for trying to leak medical information to Russia, Baltimore Banner
States spend federal Covid aid on roads, buildings, seawalls, Associated Press
Health app companies wrestle with how to design studies to prove treatments work, STAT