STAT https://www.statnews.com/ Reporting from the frontiers of health and medicine Tue, 17 Oct 2023 06:40:29 +0000 en-US hourly 1 https://wordpress.org/?v=6.3.2 https://www.statnews.com/wp-content/uploads/2023/06/cropped-STAT-Favicon-Round-32x32.png STAT https://www.statnews.com/ 32 32 STAT Copyright 2023 Measuring the long-term cost of restricting abortion access https://www.statnews.com/2023/10/17/harms-from-restricting-abortion-access-research/?utm_campaign=rss Tue, 17 Oct 2023 08:30:53 +0000 https://www.statnews.com/?p=1078318 When Diana Greene Foster and her team at the University of California, San Francisco, started their study on the lives of women who were denied abortions in 2008, they sought to investigate a rather commonly held view: That having an abortion hurt women’s mental and physical health, including by leading to PTSD and drug and alcohol use disorder.

A series of laws had been passed based on this belief, introducing compulsory counseling and waiting periods for people seeking abortions, thereby adding barriers to accessing the procedure, especially for patients with lower incomes who couldn’t afford repeated time off work, travel, and associated costs such as child care.

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Courtesy John D. and Catherine T. MacArthur Foundation Diana Foster posing for a portrait with a bookshelf in the background -- coverage from STAT 2023-10-16T18:07:10-04:00
STAT+: Our expensive obesity drugs are worth it, Novo Nordisk and Eli Lilly argue in raft of studies https://www.statnews.com/2023/10/17/ozempic-mounjaro-cost-novo-nordisk-eli-lilly/?utm_campaign=rss Tue, 17 Oct 2023 08:30:48 +0000 https://www.statnews.com/?p=1078240 DALLAS — Here at ObesityWeek, one of the largest conferences on obesity, Novo Nordisk and Eli Lilly are displaying more than a dozen studies that together carry the message: Our blockbuster weight loss treatments will be worth it for society.

But experts point out that much of this company-funded research does not include the cost of the drugs themselves, which sell at more than $10,000 per year in the U.S. and are meant to be taken indefinitely.

The two major pharmaceutical companies have seen interest skyrocket for their GLP-1-based drugs like Ozempic, Wegovy, and Mounjaro, a new generation of medications that can cut substantial amounts of weight. But insurance plans have been slow to grant wide access to obesity treatments, concerned that the vast amount of people eligible to take them, along with their high price, could lead to significant financial strain.

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Elaine Chen Wegovy, the obesity drug, was inescapable at the ObesityWeek conference in Dallas. Obesity conference attendees with a pink and blue Wegovy sign hanging from the ceiling above. -- obesity coverage from STAT 2023-10-16T20:40:58-04:00
STAT+: How one scientist’s determination made Novo Nordisk an obesity-drug powerhouse https://www.statnews.com/2023/10/17/lotte-knudsen-novo-nordisk-obesity-drug-liraglutide-ozempic-wegovy/?utm_campaign=rss Tue, 17 Oct 2023 08:30:26 +0000 https://www.statnews.com/?p=1078275 Lotte Bjerre Knudsen was still getting used to all the empty benches in her lab when she ran into a tall man with black wide-framed glasses in the hallway: Mads Krogsgaard Thomsen, the new head of research at the Danish drugmaker Novo Nordisk, and her new boss. He was just one of many changes she had found upon returning from maternity leave earlier that week — along with the departures of nearly every colleague with whom she had spent the last three years struggling to create a potential blockbuster medicine.

Thomsen got right to the point. Her team had failed to wrestle a gut hormone called GLP-1 into a new kind of drug for diabetes. Management was giving them one more shot. And by them, he meant her. “You need to figure out what to do with GLP-1,” he said. “And it has to be now.”

Knudsen went back to her office on the outskirts of Copenhagen, closed the door, and in the silence, got to work.

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Christine Kao/STAT Lotte Bjerre Knudsen, a chief scientific adviser at Novo Nordisk whose passionate belief in harnessing GLP-1 biology was instrumental to the company's success in developing Ozempic and Wegovy. Photo collage illustration of Lotte Knudsen with Wegovy and Ozempic injectors positioned behind her. 2023-10-17T02:40:29-04:00
Watch: A conversation with the 2023 STAT Wunderkinds https://www.statnews.com/2023/10/17/2023-stat-wunderkinds-interviews/?utm_campaign=rss Tue, 17 Oct 2023 08:30:15 +0000 https://www.statnews.com/?p=1078161 Each year, STAT sets out to celebrate the unheralded heroes of science and medicine, poring over hundreds of nominations from across North America in search for the next generation of scientific superstars.

This year’s class of 28 Wunderkinds were selected from more than 170 brilliant researchers. In this video, we chat with Ahmed Ahmed, who studies the impact of unionization on health care workers; Josh Tycko, who’s focused on epigenetic editing; Kristine Chua, who studies how biology and social environments interact to affect pregnancy; Brenda Cabrera-Mendoza, who is interested in how genetic and socioeconomic factors that can influence mental health; and Valerie Tornini, who’s trying to understand how the evolution of key cell types in humans might happen differently in neurological disorders.

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STAT+: White House moves closer to a ban on menthol cigarettes, amid intensifying opposition from tobacco companies https://www.statnews.com/2023/10/16/white-house-ban-menthol/?utm_campaign=rss Mon, 16 Oct 2023 21:27:01 +0000 https://www.statnews.com/?p=1078287 WASHINGTON — The White House is about to feel what it’s like to go up against the world’s most powerful tobacco companies.

On Friday, the Food and Drug Administration requested White House clearance on a policy that would ultimately ban menthol cigarettes. The tobacco industry has already spent the last few months doing everything it can to drum up opposition, from drafting letters for members of Congress to rallying freedom-focused smokers, according to a review of advertising databases, leaked documents, and research reports.

The proposal, which is supported by a range of public health groups but fiercely opposed by cigarette makers, is one of the most consequential tobacco policies coming out of the FDA since the agency was given the authority to regulate tobacco in 2009. Researchers have estimated that the ban, if finalized, could prevent hundreds of thousands of premature deaths, particularly among Black smokers, who use these products at a higher rate than other racial groups.

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Mario Tama/Getty Images The tobacco industry is doing everything it can to drum up opposition to a menthol ban, from drafting letters for members of Congress to rallying freedom-focused smokers Packs of menthol-flavored and non-menthol cigarettes are displayed for sale in a smoke shop. 2023-10-16T17:59:10-04:00
Studies highlight risks of excluding people with obesity from drug trials https://www.statnews.com/2023/10/16/obesity-drug-trials-representation/?utm_campaign=rss Mon, 16 Oct 2023 19:31:34 +0000 https://www.statnews.com/?p=1078180 People with obesity often go underrepresented in drug development trials, a critical gap that researchers say leaves drugmakers and doctors unsure of efficacy or risks in that patient population.

“Patients and providers are not aware of how some drugs may act differently in people with obesity,” said Christina Chow, the head of research at Emerald Lake Safety, an institution that conducts independent research to make pharmaceuticals safer. “People with obesity are underrepresented in clinical trials for drug approval.”

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Adobe White pills against a yellow backdrop with one missing from the group. -- health coverage from STAT 2023-10-16T15:31:34-04:00
STAT+: Teva sues Colorado over ‘unconstitutional’ program to lower cost of epinephrine injectors https://www.statnews.com/pharmalot/2023/10/16/teva-colorado-epipen-allergy-injector-deductibles/?utm_campaign=rss Mon, 16 Oct 2023 19:21:52 +0000 https://www.statnews.com/?p=1078174 In the latest tussle over the cost of medicines, Teva Pharmaceuticals has filed a lawsuit alleging that a new Colorado program aimed at making epinephrine auto-injectors more affordable violates its constitutional rights.

The lawsuit was filed in response to a state law that was passed in August and requires health insurers that provide coverage for these injectors to cap out-of-pocket costs to $60 for a package of two injectors. At the same time, the law — which goes into effect Jan. 1 — requires manufacturers to make injectors available to individuals through the program, and reimburse pharmacies for their costs.

The move came several years after EpiPen — the brand-name version of these injectors — became a symbol for unaffordable medicines thanks to large and steady price hikes taken by its manufacturer. The injectors are used to combat life-threatening food allergies, but even the arrival of generic alternatives has often failed to widen access, sometimes due to high-deductible health plans.

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Adobe Teva building 2023-10-16T15:56:53-04:00
Serotonin levels are depleted in long Covid patients, study says, pointing to a potential cause for ‘brain fog’ https://www.statnews.com/2023/10/16/long-covid-brain-fog-serotonin-interferons/?utm_campaign=rss Mon, 16 Oct 2023 15:00:20 +0000 https://www.statnews.com/?p=1077920 If you’ve been following the mystery of long Covid since it emerged in 2020, you’ll recall interferons and serotonin have been clues from the start as combatants in the body’s prolonged battles against the virus. Theories about why symptoms persist long after the acute infection has cleared often point to two suspects: viral reservoirs where SARS-CoV-2 lingers and inflammation sparked by the infection that doesn’t subside.

New research published on Monday in Cell implicates both interferons and serotonin in long Covid in a way that brings together those hypotheses and could also explain “brain fog,” or the neurocognitive difficulties people endure. A team led by researchers from the University of Pennsylvania concludes that when long Covid depletes peripheral serotonin — the kind that circulates in our bodies and not just the brain — that deficit impairs memory and other brain functions. The authors hope further research will lead to testing potential treatments.

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Adobe Silhouette of a figure against a purplish background, with clouds surrounding the head. -- health coverage from STAT 2023-10-16T10:04:06-04:00
Candor on gene therapy, Abiomed is warned, & BTK success in MS https://www.statnews.com/2023/10/16/candor-on-gene-therapy-abiomed-is-warned-btk-success-in-ms/?utm_campaign=rss Mon, 16 Oct 2023 13:53:06 +0000 https://www.statnews.com/?p=1077958 Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.

Good morning! Today, cell and gene therapy executives describe how they’re handling their sector’s contraction, we talk about how regulators are cracking down on clinical decision support software, and we look at some impressive BTK data in multiple sclerosis from Roche.

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Jonathan Wosen for STAT Cell and gene therapy sign seen at a conference. -- biotech coverage from STAT 2023-10-16T09:53:06-04:00
STAT+: Pharmalittle: Rite Aid files for bankruptcy; Alzheimer’s brain scans get broader Medicare coverage https://www.statnews.com/pharmalot/2023/10/16/riteaid-alzheimers-medicare-astrazeneca-lilly-mounjaro-avastin-covid19-rsv-vaccines-pfizer/?utm_campaign=rss Mon, 16 Oct 2023 13:16:15 +0000 https://www.statnews.com/?p=1077866 Good morning, everyone, and welcome to another working week. We hope the weekend respite was sufficiently relaxing and invigorating, because that oh-so-familiar routine of online calls and deadlines has returned. After all, the world — such as it is — continues to spin. And to nudge it in a much-needed better direction, we are quaffing cups of stimulation. Our choice today is, once again, pistachio creme. Please feel free to join us. Meanwhile, here is a menu of tidbits for you to peruse. We hope your day is meaningful and productive. And do stay in touch. …

Rite Aid filed for bankruptcy, unable to find the money to settle hundreds of federal, state, and private lawsuits alleging it oversupplied prescription opioid painkillers, The Wall Street Journal writes. The filing puts all those suits on hold. As part of the restructuring, the company will close more of its 2,100 stores and name a new chief executive. Its collapse imperils some of the roughly 47,000 jobs at the company, which just celebrated its 61st anniversary. Lenders will provide the company with about $200 million in new financing as part of a plan to restructure more than $3 billion of existing debt in chapter 11.

Two new immunizations promise to protect babies from respiratory syncytial virus – if people can find them, CNBC says. Providers are scrambling to offer a Pfizer vaccine, Abrysvo, to pregnant patients and a Sanofi monoclonal antibody, Beyfortus, to babies. The immunizations, both of which protect infants from complications of RSV, were recently approved and are starting to roll out just as the respiratory virus season gets underway. The tight timeline leaves little room to resolve logistical hurdles like insurance coverage, and the steep price is making some providers wary of stocking up without a guarantee they will get paid for administering them.

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Alex Hogan/STAT an anthropomorphized red and blue pill illustrated in the style of the famous american gothic painting 2023-10-16T09:16:15-04:00
STAT+: Cell and gene therapy CEOs share survival strategies amid biotech slump https://www.statnews.com/2023/10/16/cell-gene-therapy-biotech-slump-strategies/?utm_campaign=rss Mon, 16 Oct 2023 08:30:55 +0000 https://www.statnews.com/?p=1077757 CARLSBAD, Calif. — Biotech CEOs leading cell and gene therapy companies spoke frankly at a conference here last week about the tough choices they’re making to preserve limited cash amid the industry’s ongoing slowdown.

The company leaders said that they’ve felt added pressure to use smaller teams to work quickly on fewer projects, and at times to partner with outside firms that have specific manufacturing and research expertise. Not all of these changes are bad, they added, noting that efficiency is a good trait for a biotech company in any market.

The candid conversation on Thursday was part of Meeting on the Mesa, an annual cell and gene therapy conference held in Carlsbad, in the north of San Diego County. And it provided a glimpse into discussions happening across the life science industry as biotech markets continue a sharp slump that dates back to late 2021.

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Jonathan Wosen for STAT Cell and gene therapy sign seen at a conference. -- biotech coverage from STAT 2023-10-13T17:52:33-04:00
STAT+: FDA’s warning to J&J’s Abiomed signals a crackdown on digital health tools https://www.statnews.com/2023/10/16/fda-johnson-johnson-abiomed-warning-letter/?utm_campaign=rss Mon, 16 Oct 2023 08:30:53 +0000 https://www.statnews.com/?p=1077688 The Food and Drug Administration is following through on its promise to regulate more health software tools, starting with a public reprimand of Johnson & Johnson’s heart pump company, Abiomed.

Abiomed, which was bought by Johnson & Johnson late last year for $16.6 billion, sells devices for heart failure patients as well as patient monitoring software. The FDA published a warning letter on Wednesday telling the company it should have submitted its software for approval before putting it on the market. The agency also took issue with Abiomed’s failure to report various problems with its heart pumps.

The letter comes a year after the Food and Drug Administration announced its intention to regulate more health software tools, sending the industry into an uproar.

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Business Wire Abiomed, which was bought by Johnson & Johnson late last year for $16.6 billion, sells devices for heart failure patients as well as patient monitoring software. Patient treated with Impella in the heart. -- health tech coverage from STAT 2023-10-16T15:24:51-04:00
Opinion: Doctors — and patients — must seek alternatives to long-term steroids https://www.statnews.com/2023/10/16/long-term-prednisone-steroids-ibd-side-effects-chronic-illness-alternatives/?utm_campaign=rss Mon, 16 Oct 2023 08:30:44 +0000 https://www.statnews.com/?p=1077538 Steroids were once the only treatment option for some chronic conditions. Today, many other treatments exist, but doctors often stick with the tried-and-true steroids. There are good reasons for this: They are low-cost and readily approved by insurance companies.

But while generally safe for short-term use, long-term steroids pose significant dangers. When weeks on steroids turn into months, or years, the risks grow, and patients should ask questions.

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Flickr Long-term use of prednisone and other steroids for chronic conditions can pose risks to patients. Prednisone prescription pills and bottle. -- first opinion coverage from STAT 2023-10-13T14:37:02-04:00
Is there a nursing shortage in the United States? Depends on who you ask https://www.statnews.com/2023/10/16/nursing-shortage-us-hospitals-unions/?utm_campaign=rss Mon, 16 Oct 2023 08:30:10 +0000 https://www.statnews.com/?p=1077547 Hospitals are frustrated with a nationwide nursing shortage that’s only gotten worse since the pandemic. In 2022, the American Hospital Association quoted an estimate that half a million nurses would leave the field by the end of that year, bringing the total shortage to 1.1 million.

At the same time, National Nurses United insists there isn’t a nurse shortage at all. There are plenty enough nurses for the country, they say — merely a shortage of nurses who want to work under current conditions.

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Justin Sullivan/Getty Images Striking Kaiser Permanente workers in California hold signs as they march in front of the Kaiser Permanente San Francisco Medical Center on Oct. 4. Striking Kaiser Permanente workers hold signs as they march in front of the Kaiser Permanente San Francisco Medical Center on October 04, 2023 in San Francisco. The sign reads, "Respect and value healthcare works." -- coverage from STAT 2023-10-13T18:20:10-04:00
STAT+: Dana-Farber’s divorce from Brigham is the culmination of decades of change https://www.statnews.com/2023/10/15/dana-farber-brigham-cancer-boston/?utm_campaign=rss Sun, 15 Oct 2023 16:39:19 +0000 https://www.statnews.com/?p=1077856 On the Southeast Expressway, at the edge of the city, two billboards advertising cancer care loomed on the side of the road — one advertising Dana-Farber Cancer Institute, the other touting the work of Mass General Cancer Center.

The advertisements, posted in January, were rare public evidence of the increasingly awkward relationship between two of the region’s most prominent cancer programs. Dana-Farber provides care in partnership with Brigham and Women’s Hospital, which has the same parent company as Mass General.

Not only had that corporate relationship produced competing billboards, it had also spurred competing visions. And by September, those festering differences led to an apparently permanent split. Dana-Farber announced it would break with the Brigham to partner with Beth Israel Deaconess Medical Center — a deal with huge implications for cancer care in Boston.

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Bill Brett/The Boston Globe Dana Faber Cancer 2023-10-15T12:39:19-04:00
STAT+: What to know about this year’s Medicare open enrollment period https://www.statnews.com/2023/10/15/medicare-open-enrollment-period/?utm_campaign=rss Sun, 15 Oct 2023 11:00:35 +0000 https://www.statnews.com/?p=1077404 It’s the middle of October — the time of year that’s filled with pumpkin spice lattes, jumbo-sized bags of Halloween candy, and endless advertisements to sign up for Medicare.

Medicare’s annual enrollment period kicked off Sunday and runs through Dec. 7, allowing eligible older adults and people with disabilities to sign up for traditional Medicare coverage or Medicare Advantage, the alternative option that is run by health insurance companies.

A lot is changing during this year’s enrollment window. The federal government is cracking down on deceptive TV ads and other messaging that exaggerate the benefits of, or hide the potential flaws of, Medicare Advantage plans. The Senate Finance Committee is holding a hearing this week on that same topic. Prescription drug plan premiums also are fluctuating a lot in many areas in response to provisions embedded in the Inflation Reduction Act.

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Adobe Mini people figurines stand in line beside a stethoscope. -- health business coverage from STAT 2023-10-13T13:14:46-04:00
Opinion: Why Gaza health care facilities and workers have suffered so much violence https://www.statnews.com/2023/10/14/gaza-israel-hospitals-health-care-warzones/?utm_campaign=rss Sat, 14 Oct 2023 23:35:04 +0000 https://www.statnews.com/?p=1077851 In a mere week, the fifth major conflict in the past 15 years between Hamas and Israel became its most catastrophic. Hamas’ slaughter of more than 1,200 Israelis represents the largest instance of the murder of Jews since the Holocaust. Hamas wounded another 3,700 Israelis and took more than 100 of them hostage.

Israel has responded with massive airstrikes that, as of this writing, have killed more than 1,900 Palestinians, including more than 450 children, and wounded more than 7,700 others, according to the Ministry of Health in Gaza, though this figure may include both fighters and civilians. More than 350,000 Gazans were displaced even before Israel ordered more than 1 million people to leave northern Gaza. The expected Israeli ground invasion will surely multiply the number of deaths and injuries to people living there.

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Ali Mahmoud/AP Palestinian children wounded in Israel strikes are brought to Shifa Hospital in Gaza City on Wednesday, Oct. 11, 2023. Palestinian children wounded in Israel strikes are brought to Shifa Hospital in Gaza City on Wednesday, Oct. 11, 2023. 2023-10-14T19:35:04-04:00
STAT+: Eye docs urge Medicare to lower insurance hurdles amid shortage of repackaged Avastin https://www.statnews.com/pharmalot/2023/10/13/medicare-eyes-avastin-vision-shortage/?utm_campaign=rss Fri, 13 Oct 2023 17:07:10 +0000 https://www.statnews.com/?p=1077212 Due to a shortage of a widely used compounded medicine for serious eye diseases, two leading ophthalmologic groups want Medicare contractors to halt practices that limit coverage of other — albeit costlier — treatments over concerns about patient access.

At issue is Avastin, an older cancer medicine that is often used by physicians to treat age-related macular degeneration and macular edema, among other ailments. The injectable medication was never approved for these purposes, but has proven effective, and so vials are often repackaged. Moreover, it is much cheaper than treatments that were approved by regulators for those uses.

Earlier this month, though, a company that is the largest supplier of repackaged Avastin began recalling its supplies after the U.S. Food and Drug Administration inspected its facilities and found sterility issues. In Oct. 2 letters to customers, Pine Pharmaceuticals, which also compounds medicines, did not offer a timeline for when it could resume repackaging and shipping Avastin.

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STAT+: UnitedHealth’s profit jumps as medical costs come in lower than expected https://www.statnews.com/2023/10/13/unitedhealth-third-quarter-optum-profits/?utm_campaign=rss Fri, 13 Oct 2023 16:01:10 +0000 https://www.statnews.com/?p=1077556 UnitedHealth Group has made it clear that more people, especially older adults, are seeing their doctors and getting more medical care this year. But that is certainly not dragging down the company’s profits.

In the third quarter of this year, UnitedHealth’s net profit increased by more than 11%, to more than $5.8 billion, the company reported Friday.

UnitedHealthcare, the health insurance division of the conglomerate, registered a medical loss ratio of 82.3% in the quarter. That means for every $100 in premiums the company collected, it paid out $82.30 to hospitals, doctors, and other providers — and kept the rest as profit and to cover its own expenses. That ratio was lower than the 82.8% that Wall Street had predicted for the quarter.

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PATRICK T. FALLON/AFP via Getty Images UnitedHealthcare (UHC) health insurance company signage is displayed on an office building in Phoenix, Arizona 2023-10-13T12:01:10-04:00
STAT+: HHS dispatches millions to next-generation Covid targets, including intranasal vaccine https://www.statnews.com/2023/10/13/covid-vaccines-castlevax-codagenix-gritstone/?utm_campaign=rss Fri, 13 Oct 2023 15:27:58 +0000 https://www.statnews.com/?p=1077523 WASHINGTON — The Biden administration announced Friday that it is investing in three potential vaccines and a range of new technologies aimed at staying ahead of Covid-19.

The $500 million investment across 13 projects is the latest installment in the federal government’s Project NextGen, a $5 billion plan to develop new Covid-19 treatments, vaccines, and ways of delivering them. The Health and Human Services Department this summer channeled $1.4 billion to similar goals.

Friday’s announcement includes $8.5 million for New York-based CastleVax to develop an intranasal vaccine and $10 million to Codagenix, also in New York, for a live-attenuated intranasal vaccine that it is working on with the Serum Institute of India, one of the largest vaccine producers in the world. HHS also allotted $10 million to Gritstone Bio, the first installment of what could be a massive $433 million investment in the small California biotech’s plans for a “self-amplifying mRNA” vaccine.

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Adobe Multiply white nasals sprays/vaccines against an orangish background. -- health policy coverage from STAT 2023-10-13T11:27:58-04:00