Tue.Jun 04, 2024

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GLP-1s May Lower Risk of Acute Pancreatitis in Patients with T2D, Obesity

Drug Topics

Research presented at ENDO 2024 found that glucagon-like peptide-1 receptor agonists had a lower acute pancreatitis recurrence risk than SGLT2i, DPP4i, and no medication.

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A new discovery about carbon dioxide is challenging decades-old ventilation doctrine

STAT

Carbon dioxide monitors have been around for decades. But in 2020, they became, almost overnight, a hot commodity. All of a sudden, people wanted them to help assess the safety of indoor spaces — to gauge the likelihood of breathing in coronavirus-laced particles that until very recently had been in someone else’s lungs. No sensor can monitor how many infectious aerosols are swirling around us in real time.

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Pharmacy Technician Immunizers Can Provide The Much Needed Shot In The Arm For Community Pharmacies

Pharmacy Times

The immunizing technicians stated they had greater job satisfaction and had a greater sense of being valuable pharmacy members

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STAT+: Tracking the FDA advisory panel on MDMA therapy for PTSD

STAT

Good morning, and welcome to STAT’s live blog of the Food and Drug Administration’s scientific advisory committee meeting to review safety and efficacy data for MDMA-assisted psychotherapy to treat post-traumatic stress disorder. The discussion will start at 8:30 a.m. ET and run until about 5:30 p.m. ( here’s an agenda ). We published an in-depth story on Friday about what to expect today , but here are the basics: MDMA is the first Schedule I psychedelic to be considered by

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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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GLP-1 Access Limited for Teens with T2D, Obesity

Drug Topics

In an abstract presented at the Endocrine Society’s ENDO 2024 annual meeting in Boston, Massachusetts, researchers explored access to GLP-1s for teenagers with and without type 2 diabetes.

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STAT+: How a device maker inundated pain patients with unwanted batteries and surprise bills

STAT

Michelle Bean is drowning in batteries she doesn’t need. For two years, the batteries and electrode pads arrived each month at her home in West Boylston, Mass. In theory, they’re supposed to power a basic pain management device she ordered from a company called Zynex Medical in 2020. In reality, they sit in her closet, taking up an annoying amount of space.

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Opinion: Outdated Medicare rules prevent some dementia patients from getting the medications they need

STAT

Memory loss is the most obvious symptom of Alzheimer’s disease. But for the more than 6.5 million Americans who suffer from Alzheimer’s disease — and the people who support them — memory lapses are often the least of their problems. Many people with Alzheimer’s or other forms of dementia also experience mood and behavior symptoms ranging from anxiety and depression to violent outbursts and psychosis.

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Lilly wins NICE endorsement for tirzepatide in obesity—with a catch

Fierce Pharma

A little less than a year after Eli Lilly won the blessing of England's drug value watchdog for tirzepatide in Type 2 diabetes, the National Institute for Health and Care Excellence (NICE) has retu | A little less than a year after Eli Lilly won the blessing of England's drug value watchdog for tirzepatide in Type 2 diabetes, the National Institute for Health and Care Excellence (NICE) has returned with an endorsement in obesity.

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STAT+: Medicare Advantage plan’s quality ratings were incorrectly calculated by government, judge rules

STAT

The federal government inappropriately lowered the 2024 Medicare Advantage star ratings of SCAN Health Plan, which led to the health insurance company in California losing hundreds of millions of dollars in bonuses from the government, a judge ruled Monday. The decision will lead to more than $250 million funneling back into SCAN, which covers 270,000 Medicare Advantage enrollees.

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FDA Advisory Panel Rejects MDMA-Assisted Therapy for PTSD

Pharmacy Times

The panelists expressed concerns about clinical trial data and concluded that the benefits do not outweigh the risks, but the FDA does not have to follow their recommendation.

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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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STAT+: U.S. drug shortages have reached a decade high and are lasting longer, too

STAT

Amid rising concern over prescription drug shortages, a new report finds that the number of shortages has increased over the past decade, most are lasting longer than ever before, and the problem is affecting medicines used to treat a wide range of maladies. Specifically, the average shortage lasted for more than three years in 2023 compared to about two years in 2020, and 27 of the 125 drugs in short supply were not available for more than five years.

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Living with Obesity for 10 or More Years Increases Heart Attack, Stroke Risk

Drug Topics

While elevated BMI at baseline was not associated with increased cardiovascular risk, cumulative excess BMI was associated with an increased risk in people under 50.

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Judge sides with SCAN Health Plan in dispute with CMS over Medicare Advantage star ratings

Fierce Healthcare

SCAN Health Plan secured a court victory Monday when a federal judge agreed that the Centers for Medicare & Medicaid Services (CMS) inappropriately calculated its star ratings for the 2024 plan | SCAN Health Plan secured a court victory Monday when a federal judge agreed that the Centers for Medicare & Medicaid Services inappropriately calculated its star ratings for the 2024 plan year.

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Abbott’s OTC glucose monitor ‘will grow the market’

pharmaphorum

Just a few weeks after Dexcom’s Stelo became the first over-the-counter continuous glucose monitor (CGM) to be approved by the FDA, Abbott has got the green light for its Lingo device - and analysts think uptake by patients is now poised to take off.

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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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Lawmakers request intelligence briefing on CDMO GenScript, Legend Biotech's ties to China

Fierce Pharma

For several months, a U.S. security crackdown on biopharma firms suspected to be linked to the Chinese Communist Party (CCP) has continued to gain steam. | For several months, a U.S. security crackdown on biopharma firms suspected to be linked to the Chinese Communist Party has continued to gain steam. Now, several new names could be feeling the heat.

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Bayer taps Samsung wearables for menopause sleep study

pharmaphorum

Sleep disturbances are one of the most common and disruptive symptoms in menopausal women, but not enough is known about the causes, and current sleep aids are often ineffective. To plug that gap, Germany’s Bayer has joined forces with electronics group Samsung to carry out an observational study on sleep disturbances during menopause (SDM), tapping into the South Korean company’s position as one of the world's largest producers of consumer electronics.

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mRNA-4157 (V940) Plus Pembrolizumab Shows Sustained Improvements in RFS and DMFS in Patients With High-Risk Melanoma

Pharmacy Times

Compared with pembrolizumab alone, the combination treatment showed stronger recurrence-free survival and distant metastasis-free survival in patients with resected high-risk stage III or IV melanoma.

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ASCO: Moderna may file melanoma vaccine on phase 2b data

pharmaphorum

New data from a phase 2b trial of Moderna and MSD’s neoantigen melanoma vaccine may be strong enough to consider filing for accelerated approval before a phase 3 programme.

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Can you take Adderall while breastfeeding?

The Checkup by Singlecare

Adderall ( dextroamphetamine-amphetamine ) is a central nervous system stimulant that’s primarily used to treat attention deficit hyperactivity disorder (ADHD) in children and adults. It’s also sometimes used to treat narcolepsy in adults and children ages 12 and older. Many expectant moms take medications for their mental health and physical well-being during pregnancy.

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ASCO 2024 - Mohit Manrao

pharmaphorum

Get insights into the exclusive interview with Mohit Manrao, AstraZeneca SVP and Head of Oncology. Explore the highlights of the conversation and ASCO 2024 here.

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5 takeaways from STAT’s look at unwanted supplies and surprise bills from device maker Zynex Medical

STAT

Sending patients heaps of medical supplies to score more money from insurers is common in the device industry. If insurers decline to cover the supplies, patients are stuck paying for materials they didn’t need. STAT examined one of the companies perpetuating this practice, a pain management device company called Zynex Medical, and the frustration among both its patients and former employees.

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Advancing innovation in life sciences R&D and Quality: Towards a single source of truth

pharmaphorum

Discover the latest advancements in life sciences R&D and quality at the Veeva R&D Quality Summit at the Marriott Auditorium Hotel in Madrid. Join industry leaders as they discuss the importance of a single source of truth.

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Exclusive interview: Diane Lacroix talks innovations in clinical data management

Outsourcing Pharma

In celebration of Clinical Trials Day last month, OSP sat down with Diane Lacroix, vice president of clinical data management at eClinical Solutions, to delve into the latest advancements and future directions in clinical trials.

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Climate change may aggravate multiple sclerosis

Pharmaceutical Technology

A June 2024 literature review has revealed that climate change has the potential to intensify MS symptoms, as well as the incidence, prevalence, and severity of other major neurological disorders.

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ASCO Takeaways: Winners, snoozers, the China question, and the art of cancer care

STAT

You’re reading the web edition of ASCO in 30 Seconds, STAT’s guide to the American Society of Clinical Oncology annual meeting. We’ll resume for ASCO 2025.  Well, dear readers. Our ASCO reporting, including this newsletter, has come to the end. Read below for takeaway thoughts from Matt, Adam, and Angus.

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GSK shares fall 9% in wake of Zantac court ruling

Pharmaceutical Technology

Monday saw a 9% drop in GlaxoSmithKline’s (GSK) share price on the London Stock Exchange (LSE) following a Delaware judge’s ruling on 31 May that over 72,000 lawsuits over discontinued heartburn drug Zantac, known generically as ranitidine, could go ahead.

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STAT+: Novartis is flashing warning signs about the fate of its newly acquired myelofibrosis drug

STAT

CHICAGO — Something is off about the way Novartis is talking about pelabresib, its newly acquired and costly treatment for myelofibrosis. I suspect the Swiss pharma giant’s previously stated plan to submit a marketing application to the Food and Drug Administration this year has been blocked. I’m not just speculating wildly. It’s looking increasingly likely that the $3 billion purchase of MorphoSys to acquire pelabresib — a deal pushed hard by top Novartis exec

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Mirum’s Livmarli gets thumbs up from CHMP for treating PFIC in young patients

Outsourcing Pharma

Mirum Pharmaceuticals just got a major boost as the European Committee for Medicinal Products for Human Use (CHMP) gave a positive nod to Livmarli (maralixibat) oral solution for treating Progressive Familial Intrahepatic Cholestasis (PFIC) in patients aged three months and up.

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NIH AI tool predicts cancer patients’ immunotherapy outcomes

Pharmaceutical Technology

Scientists at the NIH have introduced an AI tool to predict the response to immune checkpoint inhibitors for cancer patients.

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FDA panel votes against Lykos’ pioneer psychedelic therapy

pharmaphorum

FDA advisors voted against the use of Lykos Therapeutics’ MDMA-based therapy for PTSD, in a first regulatory test for the emerging psychedelics sector

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ASCO 2024: Alligator shares positive data for pancreatic cancer drug

Pharmaceutical Technology

Alligator Bioscience’s CEO says that its pancreatic cancer drug may mark a meaningful improvement on current treatment standards.

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How 3 digital health companies built sustainable partnerships with employers and health plans

Fierce Healthcare

NEW YORK CITY— Health plans and employers are flooded with pitches from digital health solutions. | Health plans and employers are flooded with pitches from digital health solutions. Executives at FarmboxRx, Summer Health and Bold share how they got their foot in the door and what it takes to build a successful enterprise-startup partnership.

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Eli Lilly selects new EVP of Global Quality

European Pharmaceutical Review

Eli Lilly and Company has announced its new Executive Vice President of Global Quality. This news follows a statement by the firm at the start of this year declaring the retirement of its long-serving current EVP. A new start at Eli Lilly Melissa Seymour will begin her new role as EVP at Eli Lilly on 22 July 2024. As part of this position, she will also serve as a member of the company’s Executive Committee.

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Sword Health rolls out new AI tech, banks financing round that boosts valuation to $3B

Fierce Healthcare

Sword Health, a virtual provider of musculoskeletal care, banked a financing round of $130 million in a mix of primary and secondary sale, boosting its valuation to a reported $3 billion. | Sword Health, a virtual provider of musculoskeletal care, banked a financing round of $130 million in a mix of primary and secondary sale, boosting its valuation to a reported $3 billion.

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