FDA Roundup: Advisers Reject MDMA, Recommend New COVID-19 Vaccines
Drug Topics
JUNE 7, 2024
Check out important updates from the FDA for the week of June 3.
Drug Topics
JUNE 7, 2024
Check out important updates from the FDA for the week of June 3.
STAT
JUNE 7, 2024
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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Drug Topics
JUNE 7, 2024
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.
STAT
JUNE 7, 2024
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
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
Drug Topics
JUNE 7, 2024
Vaccinated men and women are at a reduced risk for HPV-related cancers, according to research presented at ASCO 2024.
STAT
JUNE 7, 2024
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.
Pharmacy Technician Pulse brings together the best content for pharmacy technicians from the widest variety of industry thought leaders.
Fierce Pharma
JUNE 7, 2024
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.
Drug Topics
JUNE 7, 2024
Dive in and learn more about the answers to yesterday’s quiz.
Pharmacy Times
JUNE 7, 2024
A single dose of the vaccine showed long-lasting protection against RSV-associated lower respiratory tract disease in older adults.
Drug Topics
JUNE 7, 2024
In an abstract presented at ENDO 2024, researchers addressed practitioners’ current knowledge of CGM and their experience prescribing in low-income communities.
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.
Fierce Healthcare
JUNE 7, 2024
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.
pharmaphorum
JUNE 7, 2024
Explore how commercialisation is the new frontier for digital innovation in the pharmaceutical industry, with a focus on GLP-1 drugs, digital strategies, and reducing patient acquisition costs.
Fierce Healthcare
JUNE 7, 2024
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.
pharmaphorum
JUNE 7, 2024
Nestle Health Science bids to take control of Seres Therapeutics’ oral microbiome product Vowst for preventing C. diff infections.
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.
Fierce Healthcare
JUNE 7, 2024
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.
pharmaphorum
JUNE 7, 2024
UK group Cycle Pharma has made an unsolicited takeover bid to buy Vanda Pharma, which is already fending off an overture from Future Pak.
European Pharmaceutical Review
JUNE 7, 2024
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
pharmaphorum
JUNE 7, 2024
Learn how building resilience can positively impact cancer trials in the field of oncology. Learn more about CancerEngage.
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STAT
JUNE 7, 2024
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.
European Pharmaceutical Review
JUNE 7, 2024
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).
STAT
JUNE 7, 2024
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.
The Checkup by Singlecare
JUNE 7, 2024
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.
STAT
JUNE 7, 2024
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.
Pharmacy Times
JUNE 7, 2024
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.
STAT
JUNE 7, 2024
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
PharmaVoice
JUNE 7, 2024
How leaders from biotech, Big Pharma and the investment world know when they've found the right candidate or company to back.
STAT
JUNE 7, 2024
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.
The Checkup by Singlecare
JUNE 7, 2024
Shingles isn’t necessarily a household name, but statistically speaking, it’s more common in the United States than heart disease, diabetes, and asthma. According to the CDC, 1 in 3 Americans will get Shingles in their lifetime. This rash-causing virus is certainly prevalent, but it’s also avoidable thanks to immunizations like Shingrix. Millions of people have already received at least one dose of this shingles vaccine—but does it actually work?
STAT
JUNE 7, 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.
Pharmacy Times
JUNE 7, 2024
Currently, the drug is being evaluated in a phase 1 clinical trial to determine the safety and efficacy in patients.
pharmaphorum
JUNE 7, 2024
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).
Fierce Pharma
JUNE 7, 2024
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.
pharmaphorum
JUNE 7, 2024
Join us for an exclusive interview with Dr Suzanne Trudel at ASCO 2024, where she will share insights on the latest advancements in cancer research and treatment. Stay tuned for this exciting conversation!
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