STAT

JUNE 25, 2024

Michigan has led the nation in making inroads with its farmers as it has worked to contain spread of H5N1 bird flu infections in dairy cows. Now the state’s health authorities are trying to do the same in looking for undetected infections among farmworkers. The Michigan Department of Health and Human Services is working with an undisclosed number of farms to try to assess the risk to workers of becoming infected with the virus, which has spread to at least 25 farms in the state in the pas

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Drug Topics

JUNE 25, 2024

The Victoza generic is approved for use in adults and children aged 10 years and older.

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STAT

JUNE 25, 2024

Summer is officially here, and whether you’re relaxing in the great outdoors or riding out a heat wave inside, STAT’s annual book and podcast list has you covered with a bevy of titles to check out. Read on for recommendations from the likes of FDA Commissioner Robert Califf, former CDC Director Rochelle Walensky, and former White House Covid-19 response coordinator Ashish Jha.

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FDA 145

The Guardian - Pharmaceutical Industry

JUNE 25, 2024

Alternatives to costly Wegovy and Saxenda will make such treatments more widely available worldwide Ozempic maker invests $4bn to meet US ‘skinny jab’ demand Medicines that enable dramatic weight loss are set to experience a new boom in uptake, experts have said, as the first generic versions hit the market this week at a lower cost than the original drugs.

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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.

STAT

JUNE 25, 2024

A bipartisan group of lawmakers is urging the Biden administration to prohibit Medicare Advantage insurers from using artificial intelligence tools to deny care until it completes a systematic review of their accuracy and effects on patients. In a letter sent Tuesday, the lawmakers cited a STAT investigation in calling on the Centers for Medicare and Medicaid Services to beef up oversight of AI and algorithmic tools that discriminate against old and sick patients.

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Insurance 144

Drug Topics

JUNE 25, 2024

Drug Topics has been on site at McKesson ideaShare this week. Check out this podcast to hear a few of the exciting happenings at this year’s meeting.

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Pharmafile

JUNE 25, 2024

AstraZeneca has announced that Tagrisso (osimertinib) in combination with pemetrexed and platinum-based chemotherapy has been approved in Japan for the first line treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions or exon 21 mutations.

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Chemotherapy 119

STAT

JUNE 25, 2024

The global health toll of alcohol remains “unacceptably high” across the globe, the World Health Organization said this week. Despite alcohol’s immense health toll, however, countries are still not deploying tactics that the WHO says would help to reduce alcohol’s devastating health impacts, like access restrictions, special taxes, and prohibitions on certain types of alcohol advertising.

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Fierce Healthcare

JUNE 25, 2024

Arkansas Attorney General Tim Griffin revealed the state is filing a lawsuit against pharmacy benefit managers (PBMs) Optum and Express Scripts for their role in the state's ongoing opioid epidemic | Arkansas says Optum and Express Scripts have not adequately protected consumers from the dangers of opioids, instead using their profits to grow into vertically integrated giants.

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STAT

JUNE 25, 2024

WASHINGTON — A journal published by the American Medical Association has corrected four articles from two of the nation’s top tobacco researchers, Ray Niaura and David Abrams, after STAT uncovered undisclosed ties the New York University professors had with the e-cigarette company Juul. The articles corrected Tuesday by JAMA Network Open include a highly cited study comparing the level of toxic substances users of e-cigarettes are exposed to versus smokers of combustible cigarettes

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Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

FDA

Fierce Healthcare

JUNE 25, 2024

The Coalition for Health AI (CHAI) has released a concrete proposal for testing the quality of healthcare AI. | The Coalition for Health AI released a draft framework for assuring healthcare AI meets agreed-upon quality standards. The public will have 60 days to comment.

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STAT

JUNE 25, 2024

Continuous positive airway pressure “is here to stay,” sleep medicine doctor Atul Malhotra declared in a May 2024 editorial published in the Lancet. But after Eli Lilly reported the full results of its obesity drug in sleep apnea patients last week, industry watchers are now debating the lasting power of CPAP machines. The trial, run by Malhotra himself, demonstrated that Zepbound reduced the number of sleep apnea episodes in patients both who were using the machines and those who

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Pharmacy Times

JUNE 25, 2024

The supplemental new drug application (sNDA) for brexpiprazole is accepted by the FDA for treatment of patients with post-traumatic stress disorder (PTSD).

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FDA 113

STAT

JUNE 25, 2024

Awareness of the harms to patients caused by errors in diagnosis and treatment has been front and center for nearly 25 years. A different kind of harm, this one affecting patients and clinicians, is only now getting the recognition it deserves. Called administrative harm, it directly influences patient care and outcomes, professional practice, and organizational efficiencies.

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Patient Care 125

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European Pharmaceutical Review

JUNE 25, 2024

The European Commission has approved the first twice-yearly injection for relapsing and primary progressive multiple sclerosis (RMS and PPMS). Roche highlighted that as a 10-minute injection, OCREVUS ® (ocrelizumab) subcutaneous has the same twice-yearly schedule as the intravenous (IV) infusion, which was the first therapeutic to be approved for both RMS and PPMS.

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Immunization 111

STAT

JUNE 25, 2024

AliveCor has spent years battling with Apple over the market for consumer heart monitoring technology. Now it’s hoping to make its imprint on professional health care with its new device, which recently received clearance from the Food and Drug Administration. The 12-lead electrocardiogram device, called the Kardia 12L ECG System, is a hand-held version of the standard ECG device usually found in hospitals and used to diagnose heart conditions.

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FDA Documentation Hospitals 137

Fierce Pharma

JUNE 25, 2024

A little over a year after being slapped with an FDA rejection, AbbVie has hit another regulatory wall in its bid to debut a more convenient Parkinson’s disease successor to its established fo | A little over a year after being slapped with an FDA rejection, AbbVie has hit another regulatory wall in its bid to debut a more convenient Parkinson’s disease successor to its established formulation of carbidopa and levodopa.

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FDA 112

STAT

JUNE 25, 2024

When you get sick, your path to wellness depends on more than your health care. For someone diagnosed with diabetes, for example, access to nutritious food can be just as important as insulin. Health care providers and policymakers are increasingly recognizing the health impacts of social drivers such as access to healthy food, transportation, and safe housing.

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PharmaVoice

JUNE 25, 2024

A COVID and flu duo could ease manufacturing and administration, potentially driving higher vaccination rates, said Moderna’s VP of North American medical affairs.

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Vaccines 110

STAT

JUNE 25, 2024

Drug discovery has quickly become the most enticing place to apply artificial intelligence. Billions of dollars are being invested in AI-driven “techbios.” In an industry where nothing changes overnight, even large biopharma companies are touting AI as key to how they’re transforming their discovery engines. But in the race to integrate AI into drug discovery, investing so heavily in scaling one part of the system overlooks the rest.

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Fierce Pharma

JUNE 25, 2024

On the market for three years in China, Novo Nordisk’s diabetes drug Ozempic (semaglutide) is racing toward blockbuster sales in the world’s second most populous country. | China’s National Medical Products Administration (NMPA) has blessed Novo Nordisk's Wegovy with marketing approval to treat people with a body mass index (BMI) of at least 30 or between 27 and 30 for those with one weight-related risk factor.

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STAT

JUNE 25, 2024

Not much sets the world of transplant medicine abuzz. But in the early 2000s, a creative idea in Missouri got everyone in the field talking. For the first time, organ donors who were declared brain-dead were moved out of the hospital and into an independent, freestanding center to have their organs removed. With these patients out of the precious and limited ICU beds, the hospital could devote its time and resources to living patients.

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Hospitals 115

Fierce Healthcare

JUNE 25, 2024

U.S. Surgeon General Vivek Murthy declared firearm violence a public health crisis, as gun deaths and injuries punctuate daily life in America. | The nation’s top doctor called on policymakers to consider gun safety measures such as bans on assault weapons and universal background checks for all firearm purchases.

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STAT

JUNE 25, 2024

Pharmaceutical companies in the U.K. have increasingly violated a voluntary industry marketing code but complaints are also taking longer to review, according to a new analysis. As a result, the researchers argue that the growing number of infractions and inadequate policing are harming public health due to unsafe or unethical business practices. Between 2004 to 2021, the Prescription Medicines Code of Practice Authority, a self-regulatory body overseen by the Association of the British Pharmace

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Pharmaceutical Companies Pharmaceutical Companies 111

Fierce Healthcare

JUNE 25, 2024

An increasing number of employers are now offering fertility benefits. This is not only a cost-saving for employees but also serves as a way to attract and retain talent. | This week on "Podnosis," Fierce Healthcare’s Anastassia Gliadkovskaya chats with Carrot Fertility’s chief product officer, James Wong, about his personal family-building story and the challenges faced by the LGBTQ+ community when building families.

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STAT

JUNE 25, 2024

As chief medical officer of Moderna, Tal Zaks used to be skeptical of genome editing. Why repair a patient’s broken gene, he would ask, with all the havoc CRISPR can wreak on DNA, when a company like Moderna can just replace that gene with regular, transient doses of mRNA? (One reason: Moderna was having immense difficulty doing just that.) On Tuesday, though, Zaks emerged after years outside the spotlight as, of all things, acting CEO of a new genome editing company.

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Fierce Pharma

JUNE 25, 2024

In the U.S. Federal Trade Commission’s (FTC) latest campaign against what the agency views as “junk” drug patents listed at the FDA, drugmakers have decided not to play ball. | In the U.S. Federal Trade Commission’s latest campaign against what the agency views as “junk” drug patent listings in the FDA’s database, drugmakers have decided not to play ball.

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FDA 113

STAT

JUNE 25, 2024

You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine.  Sign up here  to receive it in your inbox on Tuesdays and Thursdays. Exclusive: Senators ask Medicare for a pay bump for drugs used with PET scans Sen. Marsha Blackburn (R-Tenn.) is leading a bipartisan group of senators to ask Medicare officials to bump payment for drugs paired with diagnostic scans that are used for, among other things,

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Pharmacy Times

JUNE 25, 2024

The recent approval could further the use of mRNA technology across other indications.

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Vaccines 138

STAT

JUNE 25, 2024

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, STAT published our  annual list of the top books and podcasts  to check out this summer. Take a look — we’ve sourced recommendations from Robert Califf, Rochelle Walensky, and also our staff and readers.

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FDA 110

pharmaphorum

JUNE 25, 2024

Explore the complexities of patient support in the realm of cell and gene therapies. Learn about the challenges and strategies for providing effective patient assistance in this cutting-edge field.

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STAT

JUNE 25, 2024

Top of the morning to you, and a fine one it is. Clear blue skies and cool breezes are wafting over the Pharmalot campus, where the official mascots have returned from their jaunt around the grounds and are now snoozing comfortably in their respective corners. This means we are free to focus on the matters at hand — rummaging through our to-do list and making cups of stimulation.

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Pharmafile

JUNE 25, 2024

ILiAD Biotechnologies has announced that it has selected Emmes Group to conduct the upcoming phase 3 trials of its lead pertussis vaccine candidate, BPZE1. The two companies are currently working to finalise a definitive agreement for the collaboration. The post ILiAD Biotechnologies announces collaboration with Emmes Group on phase 3 pertussis vaccine trial appeared first on Pharmafile.

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Vaccines 97

STAT

JUNE 25, 2024

Many people have interpreted as a setback the “no” vote by an advisory committee to the Food and Drug Administration on Lykos Therapeutics’ new drug application for MDMA-assisted psychotherapy for post-traumatic stress disorder. We believe it is an opportunity to build upon Lykos’ success and rally support for better-funded, well-controlled clinical trials to determine the safety and efficacy of a promising PTSD treatment.

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Documentation FDA 106