FDA Roundup: Agency Highlights from July 2024
Drug Topics
JULY 26, 2024
Check out these important FDA updates from the month of July 2024.
Drug Topics
JULY 26, 2024
Check out these important FDA updates from the month of July 2024.
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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Drug Topics
JULY 26, 2024
Researchers aimed to address the associations between prenatal cannabis use and maternal health outcomes over a 9-year period.
Pharmacy Times
JULY 26, 2024
The investigational drug achieved non-inferiority compared to routine Factor VIII.
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
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.
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.
Pharmacy Technician Pulse brings together the best content for pharmacy technicians from the widest variety of industry thought leaders.
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.
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.
Pharmacy Times
JULY 26, 2024
The new approach could optimize precision medicine and lead to better outcomes across a variety of disease states.
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.
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.
Pharmacy Times
JULY 26, 2024
Study finds traces of “epigenetic scars” on the immune cells of patients who recovered from chronic hepatitis C infection.
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
Pharmacy Times
JULY 26, 2024
Understanding preventive care reduces the risk of illnesses and decreases future costs.
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.
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.
Pharmacy Times
JULY 26, 2024
Increased levels of absolute lymphocyte count are associated with improved response to BCMA-targeted CAR T-cell therapy.
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.
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.
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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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.
pharmaphorum
JULY 26, 2024
Discover 5 effective strategies for biopharma companies to optimize patient recruitment in clinical trials. Learn how to enhance recruitment processes and increase patient participation.
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.
pharmaphorum
JULY 26, 2024
Discover the innovative work of Steven Damon, the CEO of Micron Biomedical, a company specialising in microneedle technology for improved healthcare delivery. Learn about his cutting-edge innovations in the field.
Pharmaceutical Commerce
JULY 26, 2024
The latest news for pharma industry insiders.
pharmaphorum
JULY 26, 2024
Discover the top 7 trends from the Cannes Lions Festival that pharma professionals should be aware of. Stay ahead of the game with these creative insights.
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.
Pharmacy Times
JULY 26, 2024
Pharmacologic approaches can increase the use of injectables.
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.
Pharmacy Times
JULY 26, 2024
Expanding horizons can take many forms for pharmacy techs
Outsourcing Pharma
JULY 26, 2024
The approval of donanemab marks a significant breakthrough in Alzheimer's treatment, promising transformative changes in patient care and research.
Fierce Pharma
JULY 26, 2024
Despite winning approvals in a range of countries like the U.S., China, Japan and Israel, Eisai and Biogen’s anti-amyloid Alzheimer’s disease med Leqembi has come up short in the eyes of European r | Despite winning approvals in a range of countries like the U.S., China and Japan, Eisai and Biogen’s anti-amyloid Alzheimer’s disease med Leqembi has come up short in the eyes of European regulators.
The Checkup by Singlecare
JULY 26, 2024
Betaine is an amino acid that your body naturally produces. It’s found in some common foods, like beets, spinach, shellfish, and whole grains, such as wheat bran and wheat germ. Betaine helps to stabilize proteins, enzymes, and cells, protecting them from stress associated with fluid shifts. Another of the main benefits of betaine is helping your body eliminate a toxic amino acid called homocysteine.
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.
pharmaphorum
JULY 26, 2024
Pfizer's haemophilia B gene therapy is approved in EU as Durveqtix, becoming the first alternative to CSL Behring's Hemgenix
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