Fri.Jun 07, 2024

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Smoke exposure from California’s wildfires linked to 52,000 early deaths, study says

STAT

When large swaths of the East Coast were shrouded in wildfire smoke last summer, scientists in California grimly joked that maybe, finally, power brokers in New York and Washington, D.C. would be spurred to act on the burning issue that has long plagued the West Coast. Despite wildfire seasons that regularly burn hundreds of thousands of acres in California alone each year, researchers know relatively little about the long-term effects of chronic wildfire smoke on the body , and funding to reduc

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After 33 years, Geron finally crosses FDA finish line with blood cancer med Rytelo

Fierce Pharma

Once hailed as an anti-aging magic bullet, telomerase has failed to live up to the hype as it was profiled in a | The FDA has approved Geron Corporation's Rytelo (imetelstat) to treat a group of bone marrow disorders called myelodysplastic syndrome (MDS). The approval is the first for the 33-year-old California biotech.

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FDA expands approval for GSK’s RSV vaccine to cover younger at-risk adults

STAT

The Food and Drug Administration on Friday expanded the approval for GSK’s vaccine to protect against respiratory syncytial virus, or RSV, authorizing its use for at-risk adults as young as 50. Arexvy, which was the first RSV vaccine approved , now becomes the first to be available to adults under the age of 60 who are not pregnant. Prior to this FDA decision, Arexvy was licensed for use in people 60 and older.

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Industry Voices—Walmart's exit from health centers reflects broader challenges in primary care

Fierce Healthcare

Walmart announced that it is closing all 51 of its health centers and virtual care ope | The hope that retailers were poised to offer a scaled-up solution has yielded to a more realistic view that, at best, it will be a long journey.

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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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CGM, Wearable Device Data to Improve Mortality, Establish Lifestyle Changes

Drug Topics

In a session presented at the 2024 Heart in Diabetes Conference, researchers discussed the abilities of continuous glucose monitoring (CGM) to capture lifestyle data and improve mortality rates.

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In-person, virtual support groups now available to Navajo veterans

Fierce Healthcare

Navajo veterans can now access in-person and virtual peer support groups thanks to a partnership between Televeda and the Navajo Nation Veterans Administration. | The support groups take the form of talking circles, deeply rooted in the traditional practices of Indigenous people. Televeda is also offering other virtual talking circles for women and LGBTQ+ individuals.

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Oscar Health growth ambitions: Doubled footprint, planned ICHRA products launch and more

Fierce Healthcare

Sensing an opportunity in the individual market, Oscar Health believes it is poised to expand and increase its market share, the company revealed ahead of its annual investor day June 7. | Oscar Health execs outlined the company's three-year vision during June 7's investor day. The insurer plans to make more headway in the ACA market and ICHRA through robust expansion and strong financial performance.

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NIH will bring clinical research into primary care offices with $30 million pilot

STAT

For many Americans, health care means going to a local primary care office. But the vast majority of clinical research is conducted inside the walls of large, specialized academic health centers. Millions of patients are left out of those studies, which often fail to capture the population in all its diversity. Now, for the first time, the National Institutes of Health is investing in the creation of a national primary care research network to try to address this issue.

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GLP-1 treatment displays best-in-class potential for MASH

European Pharmaceutical Review

New sub-analysis data from a Phase II clinical trial show that after 48 weeks of survodutide treatment, 83.0 percent of adults with liver fibrosis achieved a statistically significant improvement of metabolic dysfunction-associated steatohepatitis (MASH). This is compared to 18.2 percent with placebo. With its novel mechanism of action, the glucagon/GLP-1 receptor dual agonist is the first to show this level of fibrosis benefit in a Phase II MASH trial following 48 weeks of treatment, according

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How much L-tyrosine do you need to take to lose weight?

The Checkup by Singlecare

L-tyrosine (also known as tyrosine) is one of the 20 amino acids your body needs to function. It’s a nonessential amino acid , which means your body can produce it from phenylalanine, another amino acid. Tyrosine has several vital functions in your body. It helps produce the neurotransmitters dopamine, epinephrine, and norepinephrine; contributes to melanin production, the pigment that gives color to skin and hair; and supports your adrenal, pituitary, and thyroid glands in hormone production.

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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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Pharmacy Focus: The Role of Pharmacists in Promoting Mental Health Care

Pharmacy Times

Molly McGraw, PharmD, BCPS, coordinator of Pharmacy Quality UPMC Health Plan and Kim Castelnovo, RPh, Pharmacy Manager at Community Care Behavioral Health Organization, talk about the importance of mental health care for patients.

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FDA Roundup: Advisers Reject MDMA, Recommend New COVID-19 Vaccines

Drug Topics

Check out important updates from the FDA for the week of June 3.

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Cycle Pharma makes $466m takeover bid for Vanda

pharmaphorum

UK group Cycle Pharma has made an unsolicited takeover bid to buy Vanda Pharma, which is already fending off an overture from Future Pak.

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STAT+: Stephen Quake on the Chan Zuckerberg quest to cure, prevent, or manage all diseases by 2100

STAT

SAN DIEGO — Decades ago, as a young physics Ph.D. student, Stephen Quake stumbled into the messy, dazzlingly complicated world of biology — and he’s stayed there ever since. Quake, a professor of bioengineering and applied physics at Stanford, is a prolific academic whose discoveries have fueled the field of blood-based prenatal testing and the use of microfluidic chips, which allow scientists to quickly analyze DNA, RNA, proteins, and cells.

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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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Building resilience in cancer trials

pharmaphorum

Learn how building resilience can positively impact cancer trials in the field of oncology. Learn more about CancerEngage.

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Regulation and legislation in the era of automation and digitalisation

European Pharmaceutical Review

Friend or foe? Pharmaceutical companies ask themselves this question before embracing the latest technologies because every innovation comes with both opportunities and risks. Today, technological advancements in artificial intelligence (AI), machine learning (ML), digitalisation, and robotic manufacturing automation solutions stand to revolutionise R&D, clinical trials, and manufacturing in the pharmaceutical industry.

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Patient Preferences, Odds of Reading Educational Cancer Materials

Drug Topics

Researchers addressed patients’ preferences for the delivery method of educational cancer resources as well as the demographics that were influenced to read materials or not.

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Nestle bids to take control of Seres’ C diff drug Vowst

pharmaphorum

Nestle Health Science bids to take control of Seres Therapeutics’ oral microbiome product Vowst for preventing C. diff infections.

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Ex-staffer pleads guilty to scamming Takeda out of $2.3M through fake consulting firm

Fierce Pharma

After fessing up to wire fraud charges, a former Takeda employee will be preparing for a sentencing hearing rather than walking down the aisle with $2.3 million garnered through a scheme to defraud | Priya Bhambi, 40, pled guilty to wire fraud charges after running a detailed scheme to scam Takeda into paying for non-existent services from a fake consulting firm.

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STAT+: Pharmalittle: We’re reading about Lilly’s Alzheimer’s drug, the GSK-Elsie deal, and more

STAT

Good morning, Jason Mast here filling in for Ed. Today, we’re sipping a hot cup of caffeinated black, while mulling the rise and fall and, apparently (!), rise again of Luckin Coffee, a chain whose cashless kiosks and discount lattes were once seen as China’s answer to Starbucks, before allegations emerged of widespread accounting fraud.

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With 2 planned launches, Boehringer Ingelheim looks to make a name for itself in oncology

Fierce Pharma

With 25 launches planned through 2030, Boehringer Ingelheim is gearing up for a busy few years. | The company expects to introduce brigimadlin in dedifferentiated liposarcoma and zongertinib in HER2-mutated non-small cell lung cancer next year. The launches are part of the company's wider plan to bring 25 new products to the market by 2030.

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Vanda Pharmaceuticals has another suitor

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Well, this wraps up one of the most eventful weeks of the biotech year — ASCO, followed by BIO. Anyone else as zonked as I am? Today, we discuss the impact that the BIOSECURE Act is already having on the industry, preview what FDA reviewers want to know about donanemab, and more.

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Increased CGM Utilization, Education Needed for Low-Income Communities

Drug Topics

In an abstract presented at ENDO 2024, researchers addressed practitioners’ current knowledge of CGM and their experience prescribing in low-income communities.

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Geron finally brings a drug to market as FDA clears Rytelo

pharmaphorum

More than 30 years after it was first founded, Geron has claimed FDA approval for its first product – myelodysplastic syndromes (MDS) treatment Rytelo. The US regulator has cleared Rytelo (imetelstat) for adults with lower-risk MDS who have transfusion-dependent anaemia and have stopped responding to or cannot be treated with erythropoiesis-stimulating agents (ESAs) like erythropoietin (EPO).

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Opinion: Obesity drugs pose a big challenge for health care equity

STAT

Weight loss treatments have the potential to revolutionize health care in rich countries. They are driving a race among drugmakers for a slice of a market that could exceed $100 billion by 2030. But little thought has apparently been given to helping people in low- and middle-income countries, where obesity rates are soaring despite poor nutrition. Without decisive action to develop fair access plans to these drugs for people living in poorer countries, there is a real danger that a significant

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First-in-class telomerase inhibitor approved for blood cancer

European Pharmaceutical Review

The first telomerase inhibitor has been approved by the US Food and Drug Administration (FDA). RYTELO ( imetelstat ) is authorised for adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent (TD) anaemia. The first-in-class oligonucleotide telomerase inhibitor is indicated for these patients who need four or more red blood cell units over eight weeks, who are unresponsive to or ineligible for erythropoiesis-stimulating agents (ESA).

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HPV Vaccine Reduces Risk of Infection-Related Cancers

Drug Topics

Vaccinated men and women are at a reduced risk for HPV-related cancers, according to research presented at ASCO 2024.

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Opinion: When medical debt relief is not enough: A study showing what doesn’t work may help point to better solutions

STAT

Philanthropists and foundations like the one I work for take a lot of calculated risks. We invest in research, advocacy, strategic communications, technical assistance, and many other activities, hoping they will help us advance our strategic priorities. We evaluate our efforts whenever we can, but many defy measurement — assessing the impact of our work is a persistent challenge.

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FDA Grants Orphan Drug Designation to AGMB-447 for Idiopathic Pulmonary Fibrosis

Pharmacy Times

Currently, the drug is being evaluated in a phase 1 clinical trial to determine the safety and efficacy in patients.

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Beyond one-size-fits-all: How compounding pharmacies address allergies with precision

pharmaphorum

Discover how compounding pharmacies use genetic information to create precision medications tailored to individual allergies. Learn how personalised treatments can benefit you.

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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.

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Healthcare payments tech company Waystar hits the public market, raising $968M

Fierce Healthcare

Healthcare payment software maker Waystar debuted on the public market Friday, raising $967.5 million, and marking the biggest health tech IPO since 2022. | Healthcare payment software maker Waystar debuted on the public market Friday, raising $967.5 million, and marking the biggest health tech IPO since 2022.

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Registration Open for NCPA 2024 Annual Convention

Pharmacy Times

Registration opens today, June 5, for the National Community Pharmacists Association’s 2024 Annual Convention, set for Oct. 26-29 in Columbus, Ohio.

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Nuclera gains £1.14m funding from Innovate UK

Pharmafile

Nuclera has announced that it has been awarded two grants from Innovate UK, totalling £1.14m. The post Nuclera gains £1.14m funding from Innovate UK appeared first on Pharmafile.

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