Fri.Oct 11, 2024

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Pharmacy-Based PrEP Program Can Increase HIV Prevention Services Among MSM

Drug Topics

Individuals living in rural areas can benefit from pharmacy-based pre-exposure prophylaxis programs.

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Men won all the science Nobels this year. There’s an even bigger problem.

STAT

Since the Nobel Prizes were created in 1901, just 24 women have received awards in the sciences. This year, that number stayed the same: All seven laureates in physics , chemistry , and physiology or medicine were men.  Some scientists have expressed frustration about the lack of women in this year’s awardees, particularly the omission of two women who contributed to the work honored for the prize in physiology or medicine.

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‘I’m another statistic. I feel let down’: How HIV prevention stays out of reach for many

Fierce Healthcare

This story was reported in partnership with Uncloseted Media, a nonpartisan, investigative, LGBTQ | Ending the HIV epidemic hinges on both treatment and prevention, particularly through access to PrEP. For at-risk individuals living in the U.S. South—where HIV is a daunting reality—PrEP use is very low compared to the number of new HIV cases.

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Opinion: Encampment sweeps threaten homeless people’s health

STAT

Recently, California Gov. Gavin Newsom granted $130.7 million for local governments addressing homelessness, including clearing encampments. It comes in the wake of  a June Supreme Court ruling that gave cities full authority to implement and enforce policies that would allow them to clear encampments as they see fit. In early August, Newsom was even filmed removing homeless people’s belongings from public view in Mission Hills in Los Angeles County.

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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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FDA Approves Marstacimab-hncq for Adults, Adolescents With Hemophilia A or B Without Inhibitors

Pharmacy Times

This approval marks the first and only anti-tissue factor pathway inhibitor approved in the US for the treatment hemophilia A or B, and the first approved hemophilia treatment to be administered via a pre-filled, auto-injector pen.

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As Eli Lilly, compounders battle over weight loss drugs, patients are caught in the middle

STAT

There’s a war brewing over blockbuster weight loss medications — and patients are now getting caught in the crossfire. Last week, the Food and Drug Administration declared an end to the shortage of Eli Lilly’s tirzepatide, sold under the brand name Mounjaro for diabetes and Zepbound for obesity. The move was a clear warning to compounders that they can no longer make copycat versions of the drugs — a process that is only permitted when the medications are on

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STAT+: Nobel-winning AI was built on open science. Will the quest for profits quash collaboration?

STAT

The 2024 Nobel Prizes will be remembered as the year that artificial intelligence took the awards by storm. The physics prize this week was awarded to two scientists, John Hopfield and Geoffrey Hinton, who laid the groundwork for the field of machine learning. The next day, the chemistry prize went to a trio of researchers whose work built on Hopfield and Hinton’s principles, developing AI models that predict the structure of proteins and design entirely new ones.

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Study: Risk Factors Associated With Developing Ocular Complications Following Shingles Diagnosis

Pharmacy Times

Female and older patients had a greater incidence of herpes zoster ophthalmicus and were more likely to develop ocular complications.

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STAT+: In stark reversal, FDA to reconsider removal of Eli Lilly weight loss drug from shortage list

STAT

The Food and Drug Administration on Friday said it would reconsider its decision to remove Eli Lilly’s tirzepatide, sold as Mounjaro for diabetes and Zepbound for obesity, from its shortage list, and, for the time being, would not pursue regulatory action against certain compounding pharmacies making copies of the drugs.  The decision, disclosed in a court filing, marked a stark reversal.

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Facing Industry Disruptions, FDA Grants Temporary Exemption From DSCSA Requirements For Trading Partners

Pharmacy Times

The exemption allows more time for partners to adhere to enhanced distribution security requirements in the Food, Drug, & Cosmetics Act and prevents possible supply chain disruptions.

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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 Celebrity Pharmacist Bridging Gaps in Community Care

Drug Topics

In an interview with Drug Topics, TaQuina Warren, PharmD, discussed what it means to serve her community and how she has garnered a reputation within her profession.

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The Evolving Role and Importance of Pharmacists in the Health Care System

Pharmacy Times

Amelia Arnold, PharmD, reflects on the growing recognition of pharmacists as valuable clinical providers.

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STAT+: John Maraganore on his new biotech venture, R&D vivacity and Nobel award-winning AI

STAT

It’s been two years since Alnylam’s founding CEO John Maraganore announced he was stepping back from the company. And in that time, he’s built up a bit of a persona for himself as biotech’s elder statesman. Multiple venture capital firms have enlisted his help in starting new companies and many founders aspire for him to join their boards.

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Medicare Advantage star ratings 2025—Who are the winners and losers?

Fierce Healthcare

Analyses of 2025 Medicare Advantage star ratings continue to pour in and not all of it bodes well for the conventional juggernauts. | UnitedHealth and Humana saw star ratings decrease, whereas insurtechs celebrated their scores. We break down how all major insurers—and their investors—are reacting.

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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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Early Parkinson Disease and the Potential Therapeutic Role of Lixisenatide

Pharmacy Times

Results are promising, particularly because they represent the second clinical trial of a GLP-1 receptor agonist showing potential benefits for PD motor symptoms

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FDA Approves Imuldosa, Biosimilar to Stelara

Drug Topics

The approval is supported by results from phase 3 multi-regional clinical trials conducted in patients with plaque psoriasis.

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Streamlining Biosimilar Access: How EHR Automation Reduces Delays in Cancer Treatment

Pharmacy Times

Sarah Hudson-Disalle, PharmD, highlights the significant impact of EHR automation on biosimilar access and costs.

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COVID-19 Associated with Increased Risk of Cardiovascular Events

Drug Topics

A study published in Arteriosclerosis, Thrombosis, and Vascular Biology found the risk of major adverse cardiac events was higher in patients hospitalized with COVID-19.

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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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AI Algorithm Shows Potential Identifying Women at Risk for Future Breast Cancer

Pharmacy Times

A breast-level artificial intelligence score may be able to estimate the risk of future breast cancer, allowing for patients to take preventative measures.

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Pfizer doubles down with its 2nd FDA hemophilia approval in 6 months

Fierce Pharma

Six months after scoring FDA approval for hemophilia B gene therapy Beqvez, Pf | For the second time in six months, the FDA approved a Pfizer treatment for hemophilia. On Friday the U.S. regulator signed off on Hympavzi, an anti-tissue factor pathway inhibitor for patients age 12 and older with hemophilia A or B.

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Opinion: I swore I wouldn’t become a psychiatrist

STAT

I entered medical school absolutely certain of one thing: I didn’t want to be a psychiatrist like my father. I’m sure someone like Freud could come up with a deep therapeutic reason for why I didn’t want to follow in my father’s footsteps. Or, maybe I could ask the surgeon who belittled me as a medical student and asked, “Are you going to go into the same field as your daddy?

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Lawmaker asks FTC to probe Novo/Catalent deal

pharmaphorum

US Senator Elizabeth Warren asks FTC to scrutinise $16.5bn Novo Holdings/Catalent merger and sale of manufacturing plants to Novo Nordisk.

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STAT+: Pharmalittle: We’re reading about alleged Pfizer threats, industry payments to peer reviewers, and more

STAT

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda, in fact, is already overflowing. Besides stopping to observe ancient rituals, we plan to celebrate with our Pharmalot ancestor who turns the 90th page on the proverbial calendar, and hang with a couple of our short people.

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Evonik telegraphs another 260 layoffs amid multiyear reorganization

Fierce Pharma

Earlier this year, Evonik unveiled a restructuring project that will result in up to 2,000 layoffs. | After Evonik in March unveiled a restructuring project that will result in up to 2,000 layoffs, the company is now announcing another round of job cuts as it retools portions of its drug ingredients and nutrition businesses.

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Roche gets FDA green light for breast cancer drug Itovebi

pharmaphorum

FDA gives Roche the first approval for PI3K inhibitor Itovebi, clearing the drug for certain types of advanced breast cancer

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What to do about Ozempic constipation

The Checkup by Singlecare

Ozempic (active ingredient semaglutide) is a prescription medication manufactured by Novo Nordisk that is FDA approved to improve glycemic control in adults with Type 2 diabetes. It’s also commonly prescribed off-label as a weight loss drug. Like Wegovy and Trulicity, Ozempic belongs to a class of drugs known as glucagon-like peptide-1 agonists, or GLP-1 receptor agonists.

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Facing Potential Drug Shortages, FDA Delays Enforcement of DSCSA Compliance Deadline, with Stipulations

Pharmaceutical Commerce

The now-11-year odyssey to track drugs by item through the supply chain will be under a regulatory exemption for up to two years.

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A setback for the Denali-Sanofi partnership

STAT

This story first appeared in The Readout newsletter.  Sign up for The Readout  and receive STAT’s award-winning biotech news delivered straight to your inbox.  This newsletter was penned in the company of some mastodon fossils in New York. They say good morning, too.

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FDA Roundup: Hemophilia B Therapy, Stelara Biosimilar Approval

Drug Topics

Check out important updates from the FDA for the week of October 7.

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STAT+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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FDA Approves First Weekly Subcutaneous Therapy for Hemophilia B

Drug Topics

Marstacimab-hncq is the first non-factor and once-weekly treatment available for patients with hemophilia B and promises to reduce the burden of care.

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Updating of England’s budget impact test threshold

pharmaphorum

Stay updated on the impact test threshold for England's budget, particularly as it relates to the NHS. Learn how changes may affect healthcare funding and services.

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Supplement Snapshot: Vitamin D and Respiratory Tract Infections

Drug Topics

Recent research on vitamin D supplementation and respiratory tract infections can help guide pharmacists in counseling patients.

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