Wed.Jun 12, 2024

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Vitamin D Testing: Uncovering Potential Inaccuracies

Drug Topics

CDC researchers reported on the improvements and inaccuracies of assays within the Vitamin D Standardization-Certification Program.

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Michigan stands out for its aggressive bird flu response. Will other states follow its lead?

STAT

For weeks now, as the H5N1 bird flu has been spreading into dairy cattle herds in more and more places, one state continues to lead the pack. With reports of infections in 25 herds, Michigan currently accounts for about one-third of the country’s confirmed cases in livestock. And of the three people known to have contracted the H5N1 virus from sick cows since the outbreak began, two of them are farmworkers in Michigan, including one who experienced respiratory symptoms.

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Stopping the Syndemic: Pharmacy at the Intersection of HIV and Injection Drug Use

Drug Topics

As the opioid crisis and injection drug use continue, pharmacists can look to previous outbreaks to guide their responses to the HIV–injection drug use syndemic.

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Opinion: The J&J lawsuit should be a wakeup call to the PBM industry — and to companies everywhere

STAT

The ongoing legal dispute involving Johnson & Johnson has again thrust the topic of pharmacy benefit managers (PBMs) into the spotlight. Ann Lewandowski, a J&J employee, sued the company for overpaying for its employees’ prescription drugs through its PBM, Express Scripts, claiming that these overpayments resulted in higher health insurance premiums and out-of-pocket drug costs for employees.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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2024 shaping up to be a big year for healthcare AI companies. But some investors remain cautious

Fierce Healthcare

AI deal activity is dominating healthcare investment with one in four dollars invested in healthcare going toward companies leveraging AI, according to a new report. | So far, in 2024, $2.8 billion has already been invested in AI healthcare companies, with SVB projecting the sector to see $11.

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World Trade Center responders exposed to more dust saw higher risk of early dementia

STAT

Nearly a quarter of a century after the 9/11 attacks in New York City, first responders continue to face steep health consequences for their exposure to particulate matter in the aftermath of the World Trade Center’s collapse. More than 10,000 people who were in the area have been diagnosed with cancer , with an incidence 30% higher than in the general population, and more first responders have died from long-term health issues associated with the collapse than during the attack.

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STAT+: Pfizer’s gene therapy for Duchenne muscular dystrophy fails in phase 3 trial

STAT

Pfizer said Wednesday afternoon that a closely watched gene therapy for Duchenne muscular dystrophy failed to slow the disease’s progression in a phase 3 trial. This is now the second large, randomized, placebo-controlled trial of a Duchenne gene therapy to fail to reach its primary endpoint, a composite scale of muscle function designed specifically for the rare disease.

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Amid FTC crackdown, judge says Teva inhaler patents are 'improperly listed' in FDA Orange Book

Fierce Pharma

After being called out on some intellectual property claims late last year, Teva has fallen victim to the Federal Trade Commission’s (FTC’s) ongoing crusade against questionable drug patents. | A federal judge in New Jersey ruled that five of Teva’s patents on the metered dose inhaler for its asthma med ProAir HFA are “improperly listed” in the FDA’s Orange Book.

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NIH wanted to make cancer research more diverse. The effort turned out to be a costly failure

STAT

Government researchers hoped to attract a more diverse group of patients for clinical research by paying for the travel expenses of cancer patients seeking to volunteer for trials. It didn’t work. Patients don’t pay for the care they receive as part of clinical trials run by the National Institutes of Health. But patients, and often their caregivers, incur other costs such as travel, food and lodging, child care, and absences from work.

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Junshi, Coherus' PD-1 inhibitor Loqtorzi scores in phase 3 liver cancer trial

Fierce Pharma

Junshi revealed that a phase 3 trial of Loqtorzi plus Avastin prolonged the survival of first-line patients with hepatocellular carcinoma.

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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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Opinion: Getting farmworkers to use PPE is hard, but it’s the best way to stop an H5N1 bird flu epidemic

STAT

Although a third U.S. dairy worker has been confirmed to be infected with the H5N1 bird flu, many dairy farms are still unwilling to use even freely offered personal protective equipment (PPE). This is cause for alarm. Working with a pathogen assigned a biosafety level of 3 — meaning it “can cause serious or potentially lethal disease through respiratory transmission” — with at best BSL 2 level protections is playing with fire.

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AMA, lawmakers aim renewed prior authorization crackdown on insurers

Fierce Healthcare

The American Medical Association (AMA) and a bipartisan group of Congressional leaders are looking to stop unfair prior authorization practices from health plans. | A large coalition of bipartisan lawmakers and national advocacy organizations are renewing their efforts in reforming prior authorization.

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Watch: How pharmacy benefit managers influence drug pricing

STAT

This is Part 2 of “Behind the Counter,” an in-depth video series demystifying the complex world of patents and drug pricing. The point of prescription drugs is to help people improve their quality of life. When a doctor writes a prescription and sends it along to the pharmacy, oftentimes they’re more focused on the drug’s effectiveness than its cost.

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CMS projects national health spending grew 7.5% in 2023 to $4.8T

Fierce Healthcare

National health spending is estimated to have outpaced the rest of the country’s economy in 2023, growing by 7.5% with projected expenditures of $4.8 trillion, according to newly published calculat | Record-high insurance coverage rates from pandemic policies alongside other trends like high utilization pushed health spending past the nominal GDP growth rate in 2023, according to new projections from government actuaries.

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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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Watch: The role of PBMs, patents, and public health in drug pricing

STAT

This is Part 1 of “Behind the Counter,” an in-depth video series demystifying the complex world of patents and drug pricing. Prescription drug costs are remarkably higher in the United States than in other countries, so it’s no surprise that more than half of U.S. adults say they are worried about being able to afford their medications.

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Valoctocogene Roxaparvovec-Rvox Demonstrates Long-Term Safety and Efficacy in 4-Year Clinical Trial Data

Pharmacy Times

A 1-time infusion of valoctocogene roxaparvovec had demonstrated sustained bleed control and factor VIII expression in patients with hemophilia A.

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Senators slam the FDA’s new vape enforcement plan: ‘What in the hell have you been waiting for?’

STAT

WASHINGTON — The Food and Drug Administration and the Department of Justice claim they’re getting serious about clearing store shelves of illegal vapes. Lawmakers made clear Wednesday they aren’t buying it.

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Luspatercept Reduces Transfusion Burden Compared With Epoetin Alfa

Pharmacy Times

Individuals with very low- to intermediate-risk myelodysplastic syndromes treated with luspatercept (Reblozyl; Bristol Myers Squibb) achieved improvements in hemoglobulin levels.

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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+: New AI for biopsies can analyze microscopic images, talk to pathologists about your tumor

STAT

To non-pathologists, the histology slide looked, as all histology slides do, like a sea of mottled lilac and burgundy. Oblong pink spots, like sprinkles on a cookie at a Barbie-themed birthday party, spotted the left side of the image. To LLaVA 1.5, an open-source artificial intelligence mode, the cells looked like they were from the cheek. LLaVA-Med, a version of LLaVA trained on medical information, told researchers the cells were from breast tissue.

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Sens. Warren, Markey introduce bill to jail executives who 'loot' healthcare system

Fierce Healthcare

Massachusetts’ progressive senators have debuted a federal bill that would introduce criminal and civil penalties for executives who “loot” healthcare organizations to the detriment of patient care | Citing Steward Health Care as a paradigm, the progressive lawmakers say the civil and criminal penalties in their bill will prevent private equity firms that "steal from America's healthcare system to feed their corporate greed.

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Opinion: FDA: Do your job and stop letting companies sell illicit vapes to kids

STAT

If it were common knowledge that a company was targeting kids to consume highly addictive and dangerous products, you’d expect the government to do something about it. Yet millions of illegal vapes are being smuggled into the U.S. and sold widely — mainly to kids — and the Food and Drug Administration is doing little about it. The FDA needs to step up and end this scourge before the country finds itself in another vaping epidemic , this one caused by government inaction.

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OTC Hearing Aids: “Nothing to See Here” Says GAO Report

The FDA Law Blog

By Sara W. Koblitz & Jeffrey N. Gibbs — It’s been over a year and a half since Over-the-Counter (“OTC”) hearing aids became legal, and it’s not clear that they’ve made the difference in hearing loss treatment that Congress anticipated. (FDA once estimated that OTC hearing aids would save patients over $3000.) A recent GAO Report hasn’t found that OTC hearing aids have had much impact.

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STAT+: Avidity Biosciences says its experimental drug showed potential against form of muscular dystrophy

STAT

Avidity Biosciences said Wednesday morning that an experimental medicine successfully knocked down the gene behind a form of muscular dystrophy being pursued by a fleet of drug companies. The early-stage study examined patients with facioscapulohumeral muscular dystrophy, or FSHD, who generally experience slowly progressive muscle loss in the face, shoulder blades, arms, or lower legs.

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Understanding Depression: Risk Factors and Evolving Treatments

Pharmacy Times

At ASHP Pharmacy Futures 2024, Mei T. Liu, PharmD, BCPP, highlights the global prevalence and multifaceted nature of depression, its bidirectional relationship with medical conditions, and the need for diverse, evidence-based treatment options.

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Three scientists win Kavli Prize for nanoscience in biomedicine

STAT

Three scientists — Robert Langer, Paul Alivisatos, and Chad Mirkin — were awarded the 2024 Kavli nanoscience prize for their seminal work in biomedicine, the Norwegian Academy of Sciences and Letters announced Wednesday. The $1 million Kavli Prize recognizes scientists for significant contributions and breakthroughs in astrophysics, nanoscience, and neuroscience once every two years.

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FDA Approves Dapagliflozin For Pediatric Patients With Type 2 Diabetes

Pharmacy Times

The indication is for the improvement of glycemic control in pediatric patients aged 10 and older with type 2 diabetes and comes after positive results from the phase 3 T2NOW clinical trial.

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What do Parkinson’s and obesity have in common?

STAT

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. STAT is running a promo this week — you can get 40% off an annual subscription with the discount code STAT40. Learn more  here.

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Developing the EU’s first intestinal microbiota-based biologic

European Pharmaceutical Review

Since 2018, biotech company Mikrobiomik has been researching, development and producing innovative biological medicines based on the human microbiome. We are proud to be the first company planning to market MBK-01, the EU’s first biologic based on intestinal microbiota, full spectrum purified intestinal microbiota (FSPIM), in the form of lyophilised capsules for oral administration.

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STAT+: Pharmalittle: We’re reading about Sanders dogging Novo Nordisk, Teva patents, and more

STAT

Hello, everyone, and how are you today? We are doing just fine, thank you, especially since the middle of the week is already upon us. After all, we have made it this far, so we are determined to hang on — hang in? — for another couple of days. And why not? The alternatives — at least those we can identify — are not so appetizing.

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FDA Gives Clearance to 2 OTC Continuous Glucose Monitoring Systems

Pharmacy Times

Continuous glucose monitoring systems offer timely biofeedback for patients with type 2 diabetes.

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NICE declines to look again at depression drug Spravato

pharmaphorum

Johnson & Johnson has slammed a decision by NICE not to carry out a new appraisal of its antidepressant Spravato, claiming it has “grave concern” about access to new mental health treatments through NHS England.

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Does exercise help acid reflux?

The Checkup by Singlecare

Acid reflux is a burning sensation that rises from your stomach to your throat, leaving a sour and bitter taste in your mouth. Acid reflux occurs when the lower esophageal sphincter (LES), a muscular valve at the lower end of your esophagus, relaxes at the wrong time, says G.S. Ramesh, MD , a board-certified gastroenterologist at Digestive Health Associates in Houston, Texas.

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Pharma Pulse 6/12/24: The Healthcare System is Changing—So How Should We Respond?, What the Apple-OpenAI Deal Means for Four Tech Titans & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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