Tue.Jun 25, 2024

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Michigan launches first effort of its kind to detect silent bird flu infections in farmworkers

STAT

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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Teva Pharmaceuticals Launches Liraglutide Injection 1.8 mg, First Generic GLP-1 in the US

Drug Topics

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

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Surgeon general declares gun violence a public health crisis

STAT

Firearm violence is officially a public health crisis in the U.S. — Surgeon General Vivek Murthy says so. In a new advisory published on Tuesday, Murthy calls attention to the health toll of gun violence, describing the size of the crisis while laying out a roadmap of research and policy interventions to curb its effects. “My hope is that framing just the profound impact and pervasive impact of gun violence in our country … can firmly take it out of the realm of politics and

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‘Skinny jabs’: weight-loss drugs set for new boom as generic versions emerge

The Guardian - Pharmaceutical Industry

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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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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The 42 best books and podcasts on health and science to check out this summer

STAT

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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Welcome to McKesson ideaShare

Drug Topics

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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More Trending

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CHAI releases draft framework of quality assurance standards for healthcare AI

Fierce Healthcare

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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Stop blindly allowing MA plans to use AI to deny care, lawmakers urge Biden administration

STAT

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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FDA Accepts sNDA for Brexpiprazole for Adult Patients With PTSD

Pharmacy Times

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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STAT+: Experts split on whether Eli Lilly’s Zepbound will hamper CPAP sales

STAT

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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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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AstraZeneca’s Tagrisso approved in Japan for lung cancer treatment

Pharmafile

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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STAT+: AliveCor gets FDA nod for portable 12-lead, AI-powered ECG device

STAT

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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Novo Nordisk wins approval in China for GLP-1 obesity drug Wegovy

Fierce Pharma

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+: Former Moderna executive launches genome editing company

STAT

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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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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Arkansas files opioid epidemic lawsuit against PBMs Optum, Express Scripts

Fierce Healthcare

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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WHO warns global health toll of alcohol remains ‘unacceptably high’

STAT

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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AbbVie's Duopa successor in Parkinson's rejected again after FDA flags third-party manufacturer issues

Fierce Pharma

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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Cell and gene therapies and the tricky question of patient support

pharmaphorum

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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Drugmakers dig in their heels amid FTC's latest patent crackdown. What happens next?

Fierce Pharma

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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Generative AI in clinical trials: Practical use cases and common concerns

pharmaphorum

Discover practical use cases and common concerns surrounding the implementation of generative AI (GenAI) in clinical trials. Learn how this technology is transforming the landscape of medical research.

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Opinion: Could billions of dollars in AI funding lead to the same number of new drugs?

STAT

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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LGBTQ+ fertility and family building

Fierce Healthcare

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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Mistrust in healthcare is hitting clinical trial enrolment

pharmaphorum

A survey of pharma industry executives has found that a third of them believe mistrust in the healthcare system has become a significant barrier to getting a diverse range of people to sign up for clinical trials.

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Can Moderna’s COVID-flu combo shot improve flagging vaccination rates?

PharmaVoice

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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Standalone organ donor centers have sprouted all over the U.S. Do they work better than hospitals?

STAT

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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U.S. surgeon general declares gun violence ‘a public health crisis’

Fierce Healthcare

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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Opinion: Tackling administrative harm can yield better decisions for better care

STAT

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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New multiple sclerosis treatment option granted in EU

European Pharmaceutical Review

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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Can screening for food insecurity make a difference for patients? The jury is out

STAT

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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Moderna’s RSV Vaccine Could Have Further Implications for mRNA Technology

Pharmacy Times

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

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Merck cans head and neck cancer drug once hailed as big hope

pharmaphorum

Two years ago, Merck KgAA was talking up xevinapant as a leap forward in head and neck cancer and one of the brightest stars in its late-stage pipeline, Now, the drug has been abandoned after failing a phase 3 trial.The TrilynX study was testing xevinapant with chemoradiotherapy in patients with unresected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN), but according to an interim look at the data was unlikely to meet its goal of extending event-free survival.

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Novavax seeks EMA approval for updated JN.1 Covid-19 vaccine

Pharmaceutical Technology

Novavax has sought EMA approval for its updated JN.1 Covid-19 vaccine, NVX-CoV2705, for people aged 12 years and above.

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What’s the best time to take famotidine?

The Checkup by Singlecare

Famotidine is an over-the-counter (OTC) heartburn medication. Sold under the brand names Pepcid AC, Pepcid Complete, and Zantac 360, it belongs to a class of drugs called histamine-2 (H2) receptor blockers , which work by reducing the amount of acid that your stomach produces. If you have a condition that can cause severe acid reflux—such as gastroesophageal reflux disease (GERD), hiatal hernia, or Zollinger-Ellison syndrome—your provider might prescribe a stronger dose.

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Vizient acquiring fellow healthcare industry advisor Kaufman Hall

Fierce Healthcare

Healthcare financial and strategic advisory firm Kaufman Hall is being acquired by minority stakeholder Vizient, a healthcare data and improvement company. | Vizient has been a minority stakeholder since a 2021 strategic investment, in which the pair collaborated on their advisory offerings.

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