2024

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USDA, FDA turf battles hamper responses to outbreaks like H5N1 bird flu

STAT

WASHINGTON — On a bright June day in 2018, one of the nation’s top regulators waved groceries in the air, quizzing the secretary of agriculture on which agency is charged with monitoring different types of food. Scott Gottlieb, the commissioner of the Food and Drug Administration at the time, grinned widely as he held liquid egg whites and a carton of eggs.

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Traditional gene therapies are uber-niche. Ocugen hopes to change that.

PharmaVoice

The biotech is developing a ‘gene-agnostic’ approach to expand the patient pool for gene therapies.

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Ajax, aiming for a better JAK drug, raises $95M to begin first tests

BioPharma Dive

Goldman Sachs and Eli Lilly are among those backing the startup, which claims its prospect could be more potent than the myelofibrosis therapies that have come to market in recent years.

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An open letter: Concerns on electoral bonds and pharma industry

Express Pharma

Chandru Chawla, a pharma veteran writes an open letter to those CEOs of Pharmaceutical companies who have NOT purchased Electoral Bonds and have NOT made political donations through other means Dear Pharma CEO who did NOT make political donations Compliments from an ordinary soon-to-be senior citizen and a consumer of medicines. Recently, ordinary folks like me have been bombarded with this alleged scam being referred to as Chanda Do Dhanda Lo.

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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AstraZeneca admits Covid-19 vaccine may cause blood clots in “very rare” cases

Pharmaceutical Technology

AstraZeneca has maintained that while the vaccine may, in “very rare” cases, cause TTS, the casual mechanism for this effect remains unknown.

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Cannabinoids show promise in acute migraine clinical trial

pharmaphorum

Inhaled cannabinoids have been shown to perform better than placebo in providing pain relief for people suffering from acute migraine in a clinical trial

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More Trending

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My rendezvous with the raw milk black market: quick, easy, and unchecked by the FDA

STAT

WASHINGTON — It’s Friday May 10, and I’m on my way to what feels like the world’s weirdest drug deal. I received a text the day before from a man named Karl. My order would be arriving from Maryland between 2 and 4 p.m. at the northwest D.C. drop site. It’ll be safely wrapped in ice packs, he assured me.

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CDC launching wastewater dashboard to track bird flu virus spread

STAT

Reluctance among dairy farmers to report H5N1 bird flu outbreaks within their herds or allow testing of their workers has made it difficult to keep up with the virus’s rapid spread , prompting federal public health officials to look to wastewater to help fill in the gaps. On Monday, the Centers for Disease Control and Prevention is expected to unveil a public dashboard tracking influenza A viruses in sewage that the agency has been collecting from 600 wastewater treatment sites around the

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Farmers resist push for workers to wear protective gear against bird flu virus

STAT

WASHINGTON — The Centers for Disease Control and Prevention recommended this week that dairy and poultry farms with infected animals supply protective gear to workers in a bid to stave off human transmission of the H5N1 virus. The challenge now is making it happen. The CDC has no legal authority to order those protective measures, and health officials in some of the nine states with reported outbreaks in cattle have had little luck getting farmers to take them up on offers of free persona

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Federal officials will fund farms’ protective measures to contain H5N1 bird flu

STAT

WASHINGTON — The federal government will provide livestock farms as much as $28,000 apiece to bolster protective measures and testing for the avian flu virus spreading among dairy cows, officials said Friday. The Agriculture Department also allotted $98 million to aid states restricting the interstate movement of affected cattle, and health officials announced they would put an additional $101 million toward expanded surveillance, tests, treatments, and vaccines for the virus, which has n

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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STAT+: Sanofi enters vaccine licensing deal with Novavax, giving beleaguered biotech a lifeline

STAT

LONDON — Novavax, the beleaguered maker of a Covid-19 vaccine, just got a boost of its own.   The French pharma company Sanofi on Friday said it had reached a licensing deal to sell Novavax’s Covid shot going forward as well as to try to combine the vaccine with Sanofi’s own flu shot. The pact includes a $500 million upfront payment, with up to $700 million more on the table if certain regulatory and launch milestones are reached.

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Bird flu keeps rewriting the textbooks. It’s why scientists are unsettled by the U.S. dairy cattle outbreak

STAT

Twenty-seven years ago today, a 3-year-old boy in Hong Kong developed a sore throat, spiked a fever, and started to cough. Six days later, he was hospitalized; six days after that, he died of acute respiratory distress caused by viral pneumonia. Testing showed the toddler, who’d had contact with sick chickens before becoming ill, had been infected with H5N1 bird flu.

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Large amount of bird flu virus in milk suggests asymptomatic cows are infected with H5N1

STAT

Since March, when the first reported cases of H5N1 bird flu began showing up in dairy cattle in Texas, the Food and Drug Administration has been asking farmers to discard any milk from infected animals. Initially, spotting tainted milk was believed to be fairly easy because cows that get sick with H5N1 begin producing milk that is thick and yellowish.

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Brain worms are more common than you think. Here’s what doctors who’ve treated them say.

STAT

Yes, it’s possible to have a worm living in your brain — in fact, it’s far more common than you might think, said Dr. David Hamer, a professor of global health and medicine at the Boston University School of Public Health, who also directs a travel clinic at Boston Medical Center. Brain worms became a topic of public fascination Wednesday after the  The New York Times  reported that presidential candidate Robert F.

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STAT+: Gene therapy trial targeting rare form of deafness shows ‘jaw-droppingly good’ results

STAT

Two congenitally deaf children can hear for the first time after being treated with gene therapy, according to data presented at a conference Wednesday. The results are “jaw-droppingly good, just shocking how good. It exceeded the wildest expectations of anybody who started this work,” said Larry Lustig, an otolaryngologist at Columbia University and an investigator on the study.

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STAT+: CRISPR edits fail to cure HIV patients in early test

STAT

BALTIMORE — An ambitious effort to cure HIV with CRISPR genome editing fell short in an early clinical trial, investigators announced Friday morning. In the study, run by Excision BioTherapeutics, researchers tried to use the gene editing tool to address a chief reason HIV has been so hard to cure. While antiviral drugs can clear patients of replicating virus, HIV is able to worm its way into a patients’ own DNA in certain cells.

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STAT+: Young boy dies in trial for Pfizer Duchenne gene therapy

STAT

A young boy died in a trial for Pfizer’s experimental gene therapy for Duchenne muscular dystrophy, the company told patient advocates Tuesday. The boy was enrolled in Daylight, a trial studying the treatment in boys aged 2 or 3. The boy had received the therapy early last year, Pfizer told the advocates in a note posted online by Parent Project Muscular Dystrophy.

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Opinion: Measles is coming back. My sister Marcie isn’t

STAT

At the end of February 1960, my healthy, precocious sister Marcie was halfway through the fourth grade when she contracted measles from a classmate who lived down the street. Their cases were among the nearly 500,000 that year , before the measles vaccination program began in the U.S. in 1963. For every 1,000 people who get measles, one develops measles encephalitis , which can cause permanent brain damage.

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STAT+: No, alcohol isn’t good for you. Will new dietary guidelines be shaped more by health or industry interests?

STAT

In 1995, when Marion Nestle was on the committee drafting the Dietary Guidelines for Americans, things were run differently. She and other experts handled it all: deciding on nutrition-related research questions, collecting the evidence, issuing a scientific report, and then writing guidance for how Americans should eat. When it came time for that last part — the writing — Nestle and two co-authors got together at a bar, ordered glasses of wine, and got to work.

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STAT+: NYU professors who defended vaping didn’t disclose ties to Juul, documents show

STAT

WASHINGTON – Two New York University professors collaborated directly with executives of the vaping company Juul without disclosing those relationships to academic journals or Congress, a STAT investigation reveals. At the height of the youth vaping crisis, when many public health experts were calling for sweeping action that could upend the entire industry, David Abrams and Ray Niaura emerged as two authoritative voices willing to defend vaping — despite its growing popularity amo

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Texas dairy farm worker’s case may be first where bird flu virus spread from mammal to human, scientists say

STAT

A new report on the first human bird flu case tied to the outbreak in cows in the United States suggests that the Texas man may be the first detected case of the H5N1 virus transmitting from a mammal to a person. Nearly 900 people in 23 countries have been infected with the H5N1 bird flu virus since it started spreading from Southeast Asia in late 2003.

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CDC’s top flu scientist says the risk to the public from H5N1 is low, but she isn’t sleeping well. Here’s why

STAT

Vivien Dugan isn’t getting much sleep these days. The director of the influenza division at the Centers for Disease Control and Prevention, Dugan is leading the team of CDC scientists that is working with partners — in the U.S. Department of Agriculture, the Food and Drug Administration, and state and local health departments — to respond to the H5N1 bird flu outbreak in dairy cattle.

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Scientists spot an orangutan using a plant to treat his own wound in the wild

STAT

When male Sumatran orangutans let out a long call, they’re usually trying to grab female attention. But the sounds — a booming blend of roars and grunts — can end up attracting unwanted attention from other males, too. Things can get tense. Which is likely how Rakus, an adult male orangutan frequently seen in Gunung Leuser National Park in South Aceh, Indonesia, acquired a face wound in June 2022.

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After decades fighting Big Tobacco, Cliff Douglas now leads a foundation funded by his former adversaries

STAT

“Does it trouble you to answer that question?” one of New York’s highest paid attorneys asked Cliff Douglas, then a 36-year-old activist who had found himself at the center of a $10 billion libel lawsuit brought by the cigarette giant Philip Morris. Philip Morris’ lawyer Herbert Wachtell demanded to know: Were cigarette companies intentionally killing people?

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Pasteurization inactivates H5N1 bird flu in milk, new FDA and academic studies confirm

STAT

Extensive testing of pasteurized commercially purchased milk and other dairy products from 38 states has found no evidence of live H5N1 bird flu virus, Food and Drug Administration officials said at a press briefing Wednesday. The results confirmed findings of earlier testing of a more limited number of samples and add weight to the FDA’s conclusion that pasteurized milk products are safe for consumption despite a widespread outbreak of cows infected with H5N1.

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After private equity firms gobbled up wheelchair makers, users pay the price in long repair times

STAT

When Maureen Amirault purchased her first electric wheelchair in 2020, she had been living with muscular dystrophy for decades. Braces and a cane helped, but walking became too arduous, so she got a chair through a company called Numotion. The first few months were great. The headrest fell off, but Numotion fixed it in a matter of days.

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New Medicaid rule expected to lower wait times for home-based care, raise caregiver wages

STAT

Caregivers for older adults and people with disabilities could see a bump in their wages in the coming years, thanks to a forthcoming rule by the Centers for Medicare and Medicaid Services. The new rule brings sweeping changes to a bevy of Medicaid programs throughout the country, including fee-for-service and managed care delivery systems. One of the most notable changes applies to the home and community-based services (HCBS) industry.

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What we’re starting to learn about H5N1 in cows, and the risk to people

STAT

The H5N1 bird flu virus has been around for decades, and the damage it wreaks on chickens and other poultry is well documented. But the recent discovery that the virus has jumped into dairy cattle — whose udders seem to be where the virus either infects or migrates to — has dumbfounded scientists and agricultural authorities. Questions for which there are pretty clear answers when it comes to birds are suddenly unsettled science in cows.

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STAT+: CVS is willing to dump 10% of its Medicare Advantage members next year

STAT

CVS Health is preparing to make significant changes to its 2025 Medicare Advantage plans, which could potentially drive away 10% of its membership, the company’s chief financial officer said at an investment banking conference Tuesday. “The goal for next year is margin over membership,” CVS CFO Tom Cowhey said at the conference, hosted by Bank of America.

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There’s never a good time to drink raw milk. But now’s a really bad time as bird flu infects cows

STAT

Scientists who know about the types of pathogens — E. coli and Salmonella among them — that can be transmitted in raw milk generally think drinking unpasteurized milk is a bad idea. But right now, they believe, the danger associated with raw milk may have gone to a whole new level. “If I were in charge, for the moment I would forbid the selling of raw milk,” said Thijs Kuiken, a pathologist in the department of viroscience at Erasmus Medical Center in Rotterdam,

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Opinion: Medical students lose in the research arms race for residency slots

STAT

“Going to medical Spanish class really isn’t worth my time. I’d rather use the time to do research,” one of my classmates told me during the first week of my first year of medical school. Such a comment was my introduction to the publish-or-perish environment that is increasingly pervasive amongst medical students. Before then, I had known publish-or-perish as something for those seeking tenure at universities.

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Opinion: H5N1 communication has been strictly for the birds. Didn’t the federal government learn anything from Covid?

STAT

When it comes to federal agencies communicating to the public about H5N1 bird flu, it feels like a classic case of Yogi Berra’s déjà vu all over again. In the wake of pointed criticism about its failure to release new information about the growing H5N1 outbreak in livestock, the Animal and Plant Health Inspection Service of the U.S.

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With younger women getting breast cancer, national panel lowers mammogram screening age to 40

STAT

A national advisory panel significantly lowered the age recommendations for screening mammography on Tuesday, saying that all women should start breast cancer screening at age 40, rather than 50, and continue every other year until age 74. The previous recommendations from the panel, the United States Preventive Services Task Force, suggested that women make an individual choice on getting mammography from ages 40 to 49.

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Opinion: It shouldn’t be easy to buy synthetic DNA fragments to recreate the 1918 flu virus

STAT

It should be hard — exceedingly hard — to obtain the synthetic DNA needed to recreate the virus that caused the deadly 1918 influenza pandemic without authorization. But my lab found that it’s surprisingly easy, even when ordering gene fragments from companies that check customers’ orders to detect hazardous sequences. Our experiment demonstrates that the immense potential benefits of biotechnology are profoundly vulnerable to misuse.

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Opinion: Colorectal cancer is increasing among young people. It’s time to boost research on it

STAT

I am not writing here to talk about my husband, Chadwick Boseman, who died far too young from colorectal cancer. I am not here to give any glimpses into our obviously private life and his obviously private battle with this cancer, which is affecting far more young lives than it should. The legacy he created is not about cancer and I hope you don’t remember him that way.

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