Wed.May 01, 2024

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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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As AI proliferates in pharma, regulators look to catch up in clinical trials

PharmaVoice

The FDA’s newly launched Center for Clinical Trial Innovation potentially opens the door for more efficient and expanded AI use, but leaves pharmas wanting more guidance.

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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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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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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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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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Injectable Weight Loss Drugs Illegally Sold Online Pose Danger to Patients

National Association of Boards of Pharmacy

Almost 75% of Americans are clinically defined as overweight or obese, and over 11% have diabetes. America’s obsession with weight loss and dieting is well-documented, with a staggering $30 billion spent each year on diet products. Because of this, it is no surprise that drugs like semaglutide , liraglutide , and tirzepatide have “gone viral.” This class of drugs, with brand names like Ozempic, Wegovy, and Mounjaro, are approved to treat patients with diabetes and obesity.

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GSK raises forecasts on strong vaccine, HIV drug sales

BioPharma Dive

Sales of the shingles vaccine Shingrix and the RSV shot Arexvy helped fuel quarterly revenue totals that surpassed analyst expectations, though the company warned momentum could slow in the months ahead.

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STAT+: Brain biopsies on ‘vulnerable’ patients at Mount Sinai set off alarm bells at FDA, documents show

STAT

NEW YORK — By the time Peter Bauman considered deep brain stimulation, he was desperate. Early onset Parkinson’s disease, diagnosed at age 49, had disabled him, ended his bartending career, and led him to consider suicide. He hoped that the treatment, known as DBS, in which an electrode connected to an external battery is inserted into the brain and emits electrical impulses, would ease his Parkinson’s tremors.

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FTC targets ‘junk patents’ on Ozempic, other top drugs

BioPharma Dive

The move broadens the antitrust regulator’s campaign against allegedly “improper or inaccurate” patent listings by drugmakers to include top-selling medicines for weight loss, diabetes, asthma and COPD.

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STAT+: Lawmakers grill UnitedHealth CEO on Change cyberattack: ‘Your company let the country down’

STAT

On Wednesday, UnitedHealth CEO Andrew Witty appeared before Congress to answer for what lawmakers called a “single attack [that] kicked off a cascading series of crises that are unmasking some deep vulnerabilities in the core of our health care system”: the February Change Healthcare cyberattack that is still disrupting payment processing across the country.

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Why Every Small Business Needs an HCM Solution: A Comprehensive Guide

Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.

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Weight loss treatments bring in billions but capacity remains an issue

pharmaphorum

Explore the challenges in weight loss treatments despite the billions spent on clinical trials for weight loss drugs. Discover why capacity remains a critical issue in the industry.

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STAT+: To regrow blood vessels after heart attack, a little transplant of mitochondria goes a long way in mice

STAT

Blood vessels in the legs or heart sustain considerable damage when they are narrowed by poor circulation from diabetes or blocked in a heart attack. To repair them, researchers have tried using grafts from other blood vessels or giving growth factors to stimulate new tissue, but those solutions often fall short. Scientists from Boston Children’s Hospital report Wednesday in Nature that they managed to boost blood vessel growth by enlisting mitochondria, organelles that power the cell, to

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Pfizer’s strong Vyndaqel sales draw attention to rare disease drug’s patent life

BioPharma Dive

Sales of the transthyretin amyloidosis treatment widely beat Wall Street forecasts in the first quarter. The company aims to extend its patent exclusivity.

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U.S. maternal mortality rate dips, but will the trend continue?

STAT

After years on the rise, the U.S. maternal mortality rate decreased in 2022, new government data show. But maternal health experts warn there’s no reason to celebrate: The dip is a course correction following the Covid-19 pandemic, and mothers in the United States continue to die at dramatically higher rates than mothers in other high-income countries.

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Best Practices to Streamline Compensation Management: A Foundation for Growth

Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

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Prevention revolution: How digital tools can help us get ahead of health problems

pharmaphorum

Discover how digital tools can provide insights to help us. Digital technology could be a game-changer that offers the elusive promise of tackling the root cause, not just the conditions themselves, when it comes to human health.

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STAT+: DEA reverses a policy to avert morphine shortages

STAT

WASHINGTON  — The Drug Enforcement Administration is reversing a regulation that had been expected to create shortages of morphine and other opioid injectables, according to a DEA letter to drugmakers obtained by STAT. The DEA dictates the quantity of controlled substances that drug companies are allowed to make. Until this year, those quotas were set annually for Schedule II drugs, such as morphine and other injectable opioids that hospitals regularly use.

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Enhancing medicine manufacturing through digitalisation

European Pharmaceutical Review

By providing pharma companies with a real-life replicable model of a cloud-first manufacturing facility, we will drive forward the digital capability of pharma manufacturers” A new digital collaboration is set to take advantage of a manufacturing facility model featuring innovative technologies, accelerating how fast new medicines are made. The Centre for Process Innovation (CPI), academia, and the pharma industry will work together to develop the model which will harness artificial intell

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STAT+: Moderna ends collaboration with CRISPR company Metagenomi, parts ways with gene editing chief

STAT

Three years ago, Moderna, flush with cash from Covid vaccine sales, announced it would start investing in the burgeoning field of gene editing. It created a new division called Moderna Genomics and struck a collaboration with Metagenomi, a University of California-Berkeley spinout that specializes in developing new gene-editing enzymes. “This will be a completely new approach for Moderna and a dramatic expansion of our modality strategy,” Moderna president Stephen Hogue told invest

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

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SSRIs In Pregnancy

Med Ed 101

Depression is one of the top three health disorders in adults ages 18-34 with approximately 21.3% of these adults having depression. This means that many women suffer from depression during their peak childbearing years and will begin medication to treat it. Uncontrolled depression or anxiety may lead to issues in pregnancy. Thus, there is always […] The post SSRIs In Pregnancy appeared first on Med Ed 101.

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STAT+: CVS went hard after Medicare Advantage patients, now it’s retreating

STAT

CVS Health got walloped at the outset of 2024 as older adults in its Medicare plans continue to get a lot more medical care than the company expected. CVS’ operating income fell by 34% — roughly $1.2 billion — in the first quarter compared with the prior-year period, according to results released Tuesday. The company, which absorbed the health insurer Aetna in 2018, marketed its Medicare Advantage plans aggressively last year and expanded its geographic reach more than any i

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FTC steps up campaign on junk patents with warning letters

pharmaphorum

FTC sends more warnings to pharma companies over 'junk' patents to protect drugs from generic competition, including Novo Nordisk's Ozempic.

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STAT+: Experimental gene therapy seems to alleviate skeletal defects tied to rare inherited disease, study shows

STAT

LONDON — In 2021, a team of Italian researchers reported that an experimental gene therapy they had developed seemed to be correcting the metabolic issues at the core of a rare genetic disease that left children unable to break down sugar molecules. There remained an open question, however, about whether the therapy could address a particularly debilitating manifestation of the disease, the severe skeletal deformities it caused.

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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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AbbVie breaks ground on new R&D centre

European Pharmaceutical Review

A new state-of-the-art research and laboratory building is being built on AbbVie’s main campus at its Rhineland-Palatinate site, the company ’s second largest research and development ( R&D ) location globally. The central research building LUdwighafens neue Arbeitswelt (LUnA) will benefit from an investment of approximately €150 million. Currently, the Rhineland-Palatinate site has over 2,000 employees, and LUnA will house over 300 researchers and scientists, according to AbbVie.

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Opinion: Listen: How a new death penalty method undermines physician authority

STAT

Joel Zivot is a practicing clinician and associate professor of anesthesiology and surgery. He is also an advocate against the use of medicine in capital punishment. Back in February, Zivot wrote a First Opinion essay shortly after Kenneth Smith was executed using nitrogen gas in Alabama. In “ A new Louisiana capital-punishment bill would fundamentally alter physician licensing ,” Zivot argues against proposed bills in both Kansas and Louisiana that would allow “death by hyp

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Episode 918: What Happens If You Give a Cephalosporin to a Patient With Moderate, Severe, or Unknown Beta-Lactam Allergy?

Pharmacy Joe

In this episode, I’ll discuss the impact of giving a full-dose cephalosporin challenge to patients with a moderate, severe, or unknown beta-lactam allergy. Episode 918: What Happens If You Give a Cephalosporin to a Patient With Moderate, Severe, or Unknown Beta-Lactam Allergy? Subscribe on iTunes , Android , or Stitcher The label of “penicillin allergic” usually sticks to a patient’s medical record forever.

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Opinion: Unnecessary insurance claim denials compromise patient care and provider bottom lines

STAT

Health care providers are in an acute financial situation. Record-high wages required to attract and retain talent coupled with price inflation not seen since the early 1980s are driving higher costs, while reimbursement and federal policies limit providers’ ability to cover expenses. Adding to this budgetary stranglehold are payment delays and insurance claim denials by payers, which compromise patients’ access to health care and providers’ financial viability.

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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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MHRA ‘sandbox’ to pilot AI regulation will go live soon

pharmaphorum

The MHRA's regulatory sandbox for artificial intelligence as medical device technologies, AI-Airlock, will go live this spring, according to a new strategy document

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The latest government crackdowns on biotech you need to know

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, I highly recommend reading  this investigation  STAT published today on a research project at Mount Sinai in which doctors have been taking biopsies of living patients’ brains, sparking alarm at the FDA.

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Jacobio plans bid for China’s KRAS market with safety edge

pharmaphorum

China's Jacobio Pharma is preparing to file its KRAS inhibitor glecirasib for approval, saying it could offer a safety advantage over current drugs in the class

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STAT+: Mount Sinai’s responses to STAT’s questions about the Living Brain Project

STAT

As part of its reporting on Mount Sinai and the Living Brain Project, STAT sent a list of written questions to Mount Sinai. Below is a copy of the questions and responses. Can you describe for us what the Living Brain Project has accomplished, to date, and what promise the investigators feel it holds for future brain research? The Living Brian Project (LBP) is a unique study of the human brain that is characterizing each individual in a large cohort using all the tools that are currently availab

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Biotts claims a first with insulin delivery across skin

pharmaphorum

Polish drug delivery company Biotts says it has demonstrated delivery of insulin across the skin for the first time without the use of an injection system.

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