June, 2023

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Cybersecurity in pharma: Securing the future

Pharmaceutical Technology

Earlier this year, Sun Pharmaceutical Industries , one of India’s largest generic drug producers, reported a major cybersecurity breach , impacting its business operations. A ransomware group later claimed responsibility for the incident, which was one of several high-profile cybersecurity breaches in India over the past three years. Pharma companies around the world have also faced similar threats , some of which have impacted national security and public health.

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A pharma summer — how leaders unwind and recharge their teams in the warmer months

PharmaVoice

Vacation is calling, but so are patients. Here's how the industry adjusts in the summer.

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Trending Sources

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10 clinical trials to watch in the second half of 2023

BioPharma Dive

A Duchenne gene therapy faces a crucial test, while highly anticipated study results are expected in lung cancer, obesity and heart disease.

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STAT+: Grail faces uphill battle to get Medicare to cover its cancer screening test

STAT

WASHINGTON — Grail is aggressively lobbying to get Medicare to pay for its cancer-screening test Galleri — but experts tell STAT that the company has a far more complicated path to that end than the makers of most medicines or medical devices. Grail’s controversial blood test Galleri screens for multiple cancers. The Food and Drug Administration has not yet approved it, so Medicare hasn’t had to make a decision on whether to cover it or not.

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Navigating Payroll Compliance: Future-Proofing Payroll in an Evolving Regulatory Landscape

Speaker: Jennifer Hill

Payroll compliance is a cornerstone of business success, yet for small and midsize businesses, it’s becoming increasingly challenging to navigate the ever-evolving landscape of federal, state, and local regulations. Mistakes can lead to costly penalties and operational disruptions, making it essential to adopt advanced solutions that ensure accuracy and efficiency.

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Pursuing a Career in Pharmacy: Empowering LGBTQIA+ Students through Advocacy and Diversity

Pharmacy Is Right For Me

Join us as we explore the inspiring journey of Cayden Miller, a passionate pharmacy graduate from Southern Illinois University at Edwardsville School of Pharmacy. Cayden’s experience as a member of the LGBTQIA+ community has shaped his path in pharmacy, driving him to become an advocate for diversity, equity, and inclusion (DEI) within the profession.

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STAT+: Two type 1 diabetes patients now freed from insulin shots with cell therapy, Vertex reports

STAT

Vertex Pharmaceuticals said Friday that, over a year after receiving the company’s stem-cell therapy, two type 1 diabetes patients no longer need to take insulin injections and saw stark reductions in a biological marker of disease.  The results, presented at the American Diabetes Association conference in San Diego, bolstered experts’ hopes that the treatment could provide a functional cure for some patients.

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Opinion: Peter Hotez is not alone: Online harassment of doctors is a public health issue

STAT

Father’s Day weekend was anything but calm on Twitter, which erupted as vaccine expert Peter Hotez was challenged online to a debate by podcaster and former reality TV host Joe Rogan. Rogan’s challenge began when Hotez, a professor of pediatrics and molecular virology and microbiology at Baylor College of Medicine and vaccine expert, tweeted his  concern about Rogan’s three-hour interview with longtime anti-vaccine activist  and presidential candidate Robert F.

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‘The drug bust paradox’: Study shows opioid deaths double after police action

STAT

Police drug busts are strongly associated with a large and sudden spike in overdose deaths, according to a new study. In the week following a major opioid bust, fatal overdoses in the same neighborhood in Indianapolis doubled, the analysis showed. Calls to 911 and the use of naloxone , the overdose-reversal medication, also spiked.

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STAT+: Coherus works with Mark Cuban to sell biosimilar Humira at steep discounts

STAT

In a bold move, Coherus BioSciences plans to sell a biosimilar version of Humira — one of the world’s best-selling medicines — at a steep discount, and will work with Mark Cuban’s generic drug company to make the medicine available directly to consumers for even less. Specifically, the Coherus medicine will carry a $995 list price for a carton of two autoinjectors, an 85% discount from the $6,922 that AbbVie charges for Humira, which is used to treat rheumatoid arthri

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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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STAT+: ‘We don’t agree’ on drug pricing policy, FDA chief tells biotech leaders

STAT

BOSTON — The drug industry has spent the past year speaking against new mechanisms that could limit how much governments or insurers pay for certain new medicines. Robert Califf, the Food and Drug Administration chief, walked on stage Wednesday and told a crowd of biotech leaders that drug costs needed fixing. “We don’t agree,” said Califf, referring to a conversation he had backstage with Ted Love , the new chair of the Biotechnology Innovation Organization.

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STAT+: FDA panel unanimously endorses Eisai’s Alzheimer’s drug

STAT

Expert advisers to the Food and Drug Administration on Friday voted unanimously in favor of expanding the approval of Leqembi, an Alzheimer’s disease treatment from Eisai and Biogen, further clearing the way for what could be the first widely available medicine that delays the disease’s progress. The group voted 6-0 that an 1,800-patient study of Leqembi confirmed its benefits for patients in the early stages of Alzheimer’s, recommending the FDA widen the drug’s

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STAT+: Illumina to lay off 10% of research and development team in bid to cut costs by $100 million

STAT

SAN DIEGO — Months after announcing plans to cut costs by $100 million, DNA sequencing giant Illumina has begun to lay off 10% of its research and development team, according to internal emails obtained and reviewed by STAT. The layoffs, which began last Wednesday, impact research teams across the company’s California sites in San Diego and Foster City, as well as locations in Madison, Wisconsin; Singapore; and the United Kingdom.

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ADA says all diabetes patients should be screened for nonalcoholic fatty liver disease

STAT

SAN DIEGO — The American Diabetes Association said Sunday that all adults with type 2 diabetes or prediabetes should be screened for nonalcoholic fatty liver disease, an increasingly prevalent condition that can lead to serious liver damage. There are no approved medications for the disease, but among available diabetes drugs, the ADA singled out GLP-1 treatments as an option doctors could consider, according to recommendations published during the annual ADA conference.

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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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AMA asks doctors to de-emphasize use of BMI in gauging health and obesity

STAT

CHICAGO — The American Medical Association on Tuesday strongly criticized the body mass index , urging doctors to de-emphasize its use in assessing health and obesity and acknowledging that the measurement has been used for “racist exclusion” and has caused “historical harm.” The AMA, one of the largest medical groups in the U.S., voted to adopt this policy during its annual meeting here.

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Teens seeking addiction care unlikely to be offered standard medication

STAT

Adolescents who seek treatment for opioid addiction at an inpatient facility are more likely to be offered horseback riding than given full access to a common, highly effective addiction medication. According to a new research paper, just one out of every eight residential treatment facilities open to patients ages 16 or 17 offers full access to buprenorphine.

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Xylazine, or ‘tranq,’ is making opioid overdoses harder to reverse

STAT

For years, public health guidance about opioid overdoses has been relatively simple: Administer naloxone , then call 911. But the days of simply spraying naloxone into an overdose victim’s nose, then watching that person resume breathing and wake up within minutes, are over.

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STAT+: After promising early data, gene therapy trial for Huntington’s takes puzzling turn

STAT

Last year, after a string of high-profile trial failures , the Huntington’s disease community got positive news in the form of very early data from an experimental gene therapy for the rare neurodegenerative condition. On Wednesday, however, the company behind the drug released updated figures that were more mixed — even befuddling. The study from Uniqure, a Dutch biotech, randomized early stage Huntington’s patients to receive low-dose treatment, a high-dose treatment, or a

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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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FDA’s letter to medical device maker iRhythm is a warning for the industry

STAT

Heart monitoring company iRhythm is in hot water with the Food and Drug Administration, which issued a stern warning letter to the device maker this week for marketing its product for “high risk” patients and changing its algorithm without seeking the FDA’s permission. The letter highlights FDA’s growing scrutiny of digital health and patient monitoring tools — as well as the grave impacts even small device glitches can have on patients.

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Opinion: The FDA’s approval of a new gene therapy for Duchenne muscular dystrophy won’t help me — but it gives me hope

STAT

When I was diagnosed with Duchenne muscular dystrophy 20 years ago, there was no hope. The guidance the diagnosing doctor gave my parents was simple: Love your child as much as you can now because he won’t be here very long. That was the inspiration that my mom needed to start CureDuchenne. Her intention — our whole family’s intention — was to cure this disease so no other parents would have to go through the same traumatic prognosis.

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Malaria cases in Florida and Texas: Here’s what you need to know

STAT

The five cases of malaria diagnosed in Florida and Texas in recent weeks — the first cases of local transmission in the United States in 20 years — have worried some residents and led state and federal officials to issue public alerts about the cluster of infections. But scientists and public health officials, while advising people in the affected areas to take precautions, say there is little cause for alarm, for several reasons: The number of cases is very low; there are easy, lo

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STAT+: GSK settles first lawsuit set for a U.S. trial over cancer links to Zantac

STAT

GSK reached a settlement with a man who claimed its Zantac heartburn medication caused his cancer, avoiding the first such case that was about to go to trial in the U.S. In a brief statement , the company disclosed that it reached a settlement with James Goetz, who filed a lawsuit in a California state court. The deal reflected its desire “to avoid distraction related to protracted litigation in this case.

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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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Medical leaders decry Supreme Court decision on affirmative action

STAT

Medical leaders on Thursday reacted swiftly to the Supreme Court’s decision to severely restrict the use of race in college admissions, saying the ruling could reverse decades of progress toward diversifying the nation’s physician workforce — something seen as key to helping end the country’s widespread and deeply entrenched health disparities.

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Gates Foundation to fund trial of long-awaited new tuberculosis vaccine candidate

STAT

The Gates Foundation unveiled plans Wednesday to fund a long-awaited trial for what, if proven effective, would be the first new tuberculosis vaccine in over a century. The 26,000-person, Phase 3 study, set to begin next year, will test a vaccine known as M72/AS01 that showed promising results from a smaller trial in 2019. The findings stoked excitement at the time.

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Obesity impairs brain responses to nutrients, even after weight loss, study finds

STAT

Brain responses to nutrients in the gut are impaired in people with obesity, and that doesn’t change even after they lose weight through changes in diet, a new study finds, adding to mounting research showing the complexity and persistence of the biological effects of obesity. Using brain imaging, researchers saw that when people without obesity received nutrients, they experienced reduced activity in areas of the brain involved in food intake, suggesting the brain is signaling to them th

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STAT+: Immunogen drug prolongs survival of women with advanced ovarian cancer

STAT

CHICAGO — An antibody that delivers chemotherapy directly to tumor cells extended the lives of women with a form of advanced ovarian cancer in a large study, researchers reported Sunday. The drug, called Elahere, is made by the biotech company Immunogen. It was granted conditional approval in the U.S. last November based on preliminary evidence showing it shrank tumors.

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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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Opinion: The FDA needs a risk evaluation and mitigation strategy for Alzheimer’s drug lecanemab

STAT

Over the past several months, my conversations with colleagues in the Alzheimer’s field have featured an unusual sentiment: optimism inflected with worry. Optimism because, after years of failed studies and the disastrous accelerated approval of aducanumab, we’re enjoying a less than one-year-old streak of good news. The latest bright flash is the June 9 Food and Drug Administration hearing on the anti-amyloid antibody lecanemab (to be sold by Eisai as Leqembi).

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Suicide hotlines promise anonymity. Dozens of their websites send sensitive data to Facebook

STAT

This article was co-published with The Markup , a nonprofit newsroom that investigates how powerful institutions are using technology to change our society. Sign up for its newsletters here. Websites for mental health crisis resources across the country — which promise anonymity for visitors, many of whom are at a desperate moment in their lives — have been quietly sending sensitive visitor data to Facebook, The Markup has found.

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Academia’s postdoc system is teetering, imperiling efforts to diversify life sciences

STAT

For young life scientists hoping to land a prestigious faculty job in academia, postdoctoral research is practically a requirement. But it’s not a path equally open to everyone. Freshly minted life science Ph.D. graduates who have started families or have big loans, or are Black or female, say they plan to pursue postdoc positions at lower rates than their peers, according to a STAT analysis that includes previously unreported data from the National Center for Science and Engineering Stat

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