Pharmacy-Based PrEP Program Can Increase HIV Prevention Services Among MSM
Drug Topics
OCTOBER 11, 2024
Individuals living in rural areas can benefit from pharmacy-based pre-exposure prophylaxis programs.
Fri.Oct 11, 2024
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FDA Approves Marstacimab-hncq for Adults, Adolescents With Hemophilia A or B Without Inhibitors
Pharmacy Times
OCTOBER 11, 2024
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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Men won all the science Nobels this year. There’s an even bigger problem.
STAT
OCTOBER 11, 2024
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.
‘I’m another statistic. I feel let down’: How HIV prevention stays out of reach for many
Fierce Healthcare
OCTOBER 11, 2024
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.
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.
Opinion: Encampment sweeps threaten homeless people’s health
STAT
OCTOBER 11, 2024
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.
COVID-19 Associated with Increased Risk of Cardiovascular Events
Drug Topics
OCTOBER 11, 2024
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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The Celebrity Pharmacist Bridging Gaps in Community Care
Drug Topics
OCTOBER 11, 2024
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.
STAT+: Nobel-winning AI was built on open science. Will the quest for profits quash collaboration?
STAT
OCTOBER 11, 2024
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.
Facing Industry Disruptions, FDA Grants Temporary Exemption From DSCSA Requirements For Trading Partners
Pharmacy Times
OCTOBER 11, 2024
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.
STAT+: In stark reversal, FDA to reconsider removal of Eli Lilly weight loss drug from shortage list
STAT
OCTOBER 11, 2024
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.
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.
Abridge, Wolters Kluwer Health ink partnership to integrate UpToDate with AI medical scribe
Fierce Healthcare
OCTOBER 11, 2024
Wolters Kluwer Health, a big player in clinical decision support solutions, is teaming up with Abridge to integrate UpToDate into its AI-based medical note-taking tool. | Wolters Kluwer Health, a big player in clinical decision support solutions, is teaming up with Abridge to integrate UpToDate into its AI-based medical note-taking tool.
STAT+: John Maraganore on his new biotech venture, R&D vivacity and Nobel award-winning AI
STAT
OCTOBER 11, 2024
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.
Study: Risk Factors Associated With Developing Ocular Complications Following Shingles Diagnosis
Pharmacy Times
OCTOBER 11, 2024
Female and older patients had a greater incidence of herpes zoster ophthalmicus and were more likely to develop ocular complications.
Opinion: I swore I wouldn’t become a psychiatrist
STAT
OCTOBER 11, 2024
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?
5 Reasons to Upgrade Your Pharmacy Management Software
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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.
Early Parkinson Disease and the Potential Therapeutic Role of Lixisenatide
Pharmacy Times
OCTOBER 11, 2024
Results are promising, particularly because they represent the second clinical trial of a GLP-1 receptor agonist showing potential benefits for PD motor symptoms
FDA Approves Imuldosa, Biosimilar to Stelara
Drug Topics
OCTOBER 11, 2024
The approval is supported by results from phase 3 multi-regional clinical trials conducted in patients with plaque psoriasis.
AI Algorithm Shows Potential Identifying Women at Risk for Future Breast Cancer
Pharmacy Times
OCTOBER 11, 2024
A breast-level artificial intelligence score may be able to estimate the risk of future breast cancer, allowing for patients to take preventative measures.
STAT+: Pharmalittle: We’re reading about alleged Pfizer threats, industry payments to peer reviewers, and more
STAT
OCTOBER 11, 2024
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.
Pfizer doubles down with its 2nd FDA hemophilia approval in 6 months
Fierce Pharma
OCTOBER 11, 2024
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.
STAT+: Up and down the ladder: The latest comings and goings
STAT
OCTOBER 11, 2024
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.
FDA Approves First Weekly Subcutaneous Therapy for Hemophilia B
Drug Topics
OCTOBER 11, 2024
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.
A setback for the Denali-Sanofi partnership
STAT
OCTOBER 11, 2024
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.
The Evolving Role and Importance of Pharmacists in the Health Care System
Pharmacy Times
OCTOBER 11, 2024
Amelia Arnold, PharmD, reflects on the growing recognition of pharmacists as valuable clinical providers.
Medicare Advantage star ratings 2025—Who are the winners and losers?
Fierce Healthcare
OCTOBER 11, 2024
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.
Sanofi in talks to sell stake in consumer health spinout
pharmaphorum
OCTOBER 11, 2024
Rumours that Sanofi was in discussion with private equity groups over the sale of its consumer health business Opella have been confirmed – at least partially.The French pharma group confirmed this morning that it has entered into talks with US-based Clayton Dubilier & Rice to sell a controlling 50% stake in the unit for what has been estimated by Reuters to be in the region of €15 billion ($16.4 billion).
Streamlining Biosimilar Access: How EHR Automation Reduces Delays in Cancer Treatment
Pharmacy Times
OCTOBER 11, 2024
Sarah Hudson-Disalle, PharmD, highlights the significant impact of EHR automation on biosimilar access and costs.
Supplement Snapshot: Vitamin D and Respiratory Tract Infections
Drug Topics
OCTOBER 11, 2024
Recent research on vitamin D supplementation and respiratory tract infections can help guide pharmacists in counseling patients.
Lawmaker asks FTC to probe Novo/Catalent deal
pharmaphorum
OCTOBER 11, 2024
US Senator Elizabeth Warren asks FTC to scrutinise $16.5bn Novo Holdings/Catalent merger and sale of manufacturing plants to Novo Nordisk.
Jane Koo on leading regulatory affairs at CTMC: A journey from mAbs to cellular therapies
Outsourcing Pharma
OCTOBER 11, 2024
Jane Koo, head of regulatory affairs at CTMC, plays an important role in accelerating the development and commercialization of innovative cellular therapies.
Roche gets FDA green light for breast cancer drug Itovebi
pharmaphorum
OCTOBER 11, 2024
FDA gives Roche the first approval for PI3K inhibitor Itovebi, clearing the drug for certain types of advanced breast cancer
Facing Potential Drug Shortages, FDA Delays Enforcement of DSCSA Compliance Deadline, with Stipulations
Pharmaceutical Commerce
OCTOBER 11, 2024
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.
Teva hands over $450M to resolve kickback lawsuits involving MS drug Copaxone and generics
Fierce Pharma
OCTOBER 11, 2024
A little over four years after being sued by the United States, Teva is putting longstanding allegations that it paid kickbacks on a popular multiple sclerosis drug to bed. | Teva Pharmaceuticals USA and Teva Neuroscience have agreed to pay a combined $450 million to resolve claims that the company violated the United States' Anti-Kickback Statute and the False Claims Act, the U.S.
FDA Roundup: Hemophilia B Therapy, Stelara Biosimilar Approval
Drug Topics
OCTOBER 11, 2024
Check out important updates from the FDA for the week of October 7.
Evonik telegraphs another 260 layoffs amid multiyear reorganization
Fierce Pharma
OCTOBER 11, 2024
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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