Pharmacy Times

JULY 26, 2024

Unbridled drugflation, or a point-in-time measure of the rising cost of pharmacy benefits, is taking its toll on corporate bottom lines and household budgets.

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STAT

JULY 26, 2024

Want to stay on top of health news? Sign up to get our Morning Rounds newsletter in your inbox. I’m Brittany Trang, STAT health tech reporter and your new Friday morning host.

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Drug Topics

JULY 26, 2024

Researchers aimed to address the associations between prenatal cannabis use and maternal health outcomes over a 9-year period.

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STAT

JULY 26, 2024

A decade ago, Pfizer began investing heavily in gene therapy, bringing in experimental treatments for a range of genetic diseases, pumping $800 million into “state-of-the-art” manufacturing facilities and announcing its intention to become an “industry leader” that would deliver “one-time, transformative therapies” for rare diseases.

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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.

Drug Topics

JULY 26, 2024

Check out these important FDA updates from the month of July 2024.

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Fierce Pharma

JULY 26, 2024

Johnson & Johnson’s latest attempt to get a handle on its talc litigation using the controversial Texas two-step bankruptcy strategy has once again fallen flat after a federal appeals court rul | The ruling from the Third Circuit Court of Appeals came the night before claimants in the talc litigation were set to vote on a sweeping $6.48 billion settlement proposal from J&J.

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Fierce Pharma

JULY 26, 2024

Amid the sturm und drang over Inflation Reduction Act (IRA) drug price negotiations, Bristol Myers Squibb has been among the biopharma companies casting the most woe over the oncoming measures. | Bristol Myers Squibb CEO Chris Boerner said after seeing the final negotiated price for Eliquis that he is "increasingly confident" the company can navigate the impact of the IRA.

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STAT

JULY 26, 2024

LONDON — European regulators on Friday said that an Alzheimer’s therapy from Eisai and Biogen should be rejected, again diverging from their U.S. counterparts on a medicine for a condition where treatments are desperately needed. In a statement, the regulators said that the benefits of Leqembi did not outweigh the risks of potentially dangerous side effects.

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Pharmacy Times

JULY 26, 2024

The investigational drug achieved non-inferiority compared to routine Factor VIII.

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STAT

JULY 26, 2024

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. We’ve made it to the end of the week! I don’t know about you, but it’s felt like an especially long week for me. It’s probably cause of all the news that we will get into right now.

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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.

FDA

Pharmacy Times

JULY 26, 2024

The molecule can be a potential treatment that counters effects of early-life antibiotics, which can impact the gut microbiota and increase the risk of childhood atopy and asthma.

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STAT

JULY 26, 2024

On July 6, 2024, Sonya Massey, 36, called 911 to report a potential home intruder at her home in Springfield, Ill. “Don’t hurt me,” were her first words to the two officers who responded. Deputy Sean Grayson reassured her, “Why would I hurt you? You called us.” When Massey was questioned about her mental well-being, she confirmed taking her medicine.

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Labelling 68

Pharmacy Times

JULY 26, 2024

Medical professionals describe how pneumococcal disease manifests in adults, detailing its potentially lethal consequences such as sepsis or severe pneumonia, and explain how vaccination can effectively mitigate these serious health risks.

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STAT

JULY 26, 2024

About 5% of Americans require skilled care at some point as they age. The horrific reports of more than 200,000 deaths of nursing home residents and staff during the Covid-19 pandemic put the nursing home industry under intense national scrutiny. But not all nursing homes experienced this level of tragedy and loss. One major reason why some fared better than others was adequate nurse staffing.

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pharmaphorum

JULY 26, 2024

Vaccination with GSK's recombinant shingles vaccine Shingrix could delay the onset of dementia, according to researchers in the UK.A study published in Nature Medicine suggests that people administered Shingrix have a lower risk of dementia compared to those given Zostavax - an older shingles shot based on a different technology – and builds on earlier research suggesting a benefit from this type of vaccination.

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Vaccines 64

STAT

JULY 26, 2024

“Regulation is stifling innovation” seems to be a prevailing opinion among medtech leaders who believe the Food and Drug Administration’s rules are slowing medical device advancements — especially when it comes to software. I couldn’t disagree more. As someone who has led artificial intelligence (AI) and machine learning (ML) efforts at Amgen, I’ve seen firsthand how vital these regulations are for keeping patients safe.

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Pharmafile

JULY 26, 2024

Clinical-stage biopharmaceutical company AC Immune announced that the US Food and Drug Administration (FDA) has granted its Alzheimer’s disease (AD) candidate ACI-35.030 (now called JNJ-2056) Fast Track designation. ACI-35.030 is an active-immunotherapy targeting phosphorylated Tau (pTau). It has been shown to induce a strong polyclonal antibody response against Tau aggregation, thereby potentially reducing the pathological […] The post AC Immune’s pTau-targeting immunotherapy awarded Fast

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Pharmacy Times

JULY 26, 2024

The FDA’s designation builds off positive results in a phase 1b/2a clinical trial, showing that the vaccine can effectively target the Tau protein.

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pharmaphorum

JULY 26, 2024

CHMP recommends against approval of Eisai, Biogen's Alzheimer's disease therapy Leqembi, saying side effects outweigh its benefits

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Pharmacy Times

JULY 26, 2024

Understanding preventive care reduces the risk of illnesses and decreases future costs.

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STAT

JULY 26, 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.

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Fierce Pharma

JULY 26, 2024

After Eli Lilly’s Olumiant won the distinction of becoming the first med approved by the FDA to treat the follicle-attacking autoimmune disease alopecia areata, Pfizer followed up with a green ligh | The FDA signed off on Sun’s oral JAK inhibitor deuruxolitinib to treat adults with severe alopecia areata. The drug is now approved in 8 mg tablets under the brand name Leqselvi.

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pharmaphorum

JULY 26, 2024

Leading figures from industry and academia, including AstraZeneca, have urged UK PM Keir Starmer to turn the Oxford-Cambridge region into the "crown jewel" of his industrial growth plan

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Pharmafile

JULY 26, 2024

Calliditas Therapeutics AB today announced that the phase 2b TRANSFORM trial met its primary endpoint. The trial showed statistically significant improvement in alkaline phosphatase (ALP) for both doses tested versus placebo. The trial evaluated setanaxib, a NOX enzyme inhibitor, in patients with primary biliary cholangitis (PBC) and elevated liver stiffness.

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Pharmacy Times

JULY 26, 2024

Medical experts outline the key indicators, symptoms, and transmission mechanisms of pneumococcal infections in adult populations.

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PharmaVoice

JULY 26, 2024

Citius Pharmaceuticals CEO Leonard Mazur has personally invested $22.5 million into the company, which is fast approaching a potential turning point.

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Fierce Pharma

JULY 26, 2024

While it may well be the dog days of summer, European drug regulators are showing no signs of slowing down in their review of new medicines and proposed label expansions. | While it may well be the dog days of summer, European drug regulators are showing no signs of slowing down in their review of new medicines and proposed label expansions.

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Outsourcing Pharma

JULY 26, 2024

Discover the groundbreaking work of Cure51, co-founded by Nicolas Wolikow and Simon Istolainen, revolutionizing cancer treatment through advanced AI and biotechnology.

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Pharmacy Times

JULY 26, 2024

Study finds traces of “epigenetic scars” on the immune cells of patients who recovered from chronic hepatitis C infection.

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Fierce Healthcare

JULY 26, 2024

Centene beat the Street even as Medicaid redeterminations pose a significant headwind heading into the back half of 2024, according to its

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Pharmacy Times

JULY 26, 2024

The new approach could optimize precision medicine and lead to better outcomes across a variety of disease states.

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The Checkup by Singlecare

JULY 26, 2024

The World Health Organization once predicted depression would be the leading cause of disease burden by 2030. Fortunately, antidepressants like Trintellix (vortioxetine) can help carry the weight of that burden. Like many drugs that treat major depressive disorder, Trintellix influences the brain’s serotonin levels to help regulate moods—but stopping treatment can get complicated.

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Hospital Pharmacy Europe

JULY 26, 2024

The shingles vaccine that has been used in the NHS since last year is associated with a reduced risk of dementia, researchers have reported. A study of more than 200,000 adults before and after the US switched from Zostavax to the Shingrix vaccine found at least a 17% reduction in dementia diagnoses. The team from the University of Oxford also found a 23-27% lower risk of dementia in people who had been given Shingrix was compared to those who had not had Shingrix but had other vaccinations such

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Outsourcing Pharma

JULY 26, 2024

In a candid interview at the DIA conference, James Bellamy, leader of the Solutions Consulting team at Qinecsa, shared his insights into the evolving landscape of pharmacovigilance (PV) technology.

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