FDA Roundup: Agency Highlights from August 2024
Drug Topics
AUGUST 30, 2024
Checkout these important FDA updates from the month of August 2024.
Fri.Aug 30, 2024
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The Importance of Reaching Out: Why Talking to Someone Matters
Pharmacy Is Right For Me
AUGUST 30, 2024
As the school year begins, students often find themselves juggling a variety of responsibilities—homework, extracurricular activities, social commitments, and more. For those with aspirations in the demanding field of pharmacy, the pressure to excel can sometimes feel overwhelming. During these moments, it’s essential to remember that you don’t have to navigate challenges alone.
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Q&A: How Health Care Providers Can Help Increase COVID-19 Vaccine Uptake
Drug Topics
AUGUST 30, 2024
Chijioke Bennett, executive director of clinical development at Novavax, discusses how health care providers can increase awareness around the importance of COVID-19 vaccines.
Congress Requests Corrections to Testimony From Three Largest Pharmacy Benefit Manager Executives Following FTC Report
Pharmacy Times
AUGUST 30, 2024
The request comes as increased scrutiny is levied toward pharmacy benefit managers for alleged unfair business practices.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
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
Diabetes Roundup: FDA Clears Omnipod 5, Tirzepatide Demonstrates Trial Success, and More
Drug Topics
AUGUST 30, 2024
Catch up on important diabetes news from the month of August.
The Future of the 340B Drug Pricing Program in Modern Health Care
Pharmacy Times
AUGUST 30, 2024
An examination of the 340B Drug Pricing Program's original intent, current challenges, and potential resolutions in today's complex health care landscape.
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Pharmacy Technician Pulse brings together the best content for pharmacy technicians from the widest variety of industry thought leaders.
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Study: Higher Risk of Mental Health Conditions Present in Patients With an Aneurysm Diagnosis
Pharmacy Times
AUGUST 30, 2024
Those with an aneurysm diagnosis who were younger than 40 years of age were observed to have an even higher risk.
Los Angeles County: the epicenter of urban maternity ward closings
STAT
AUGUST 30, 2024
LOS ANGELES — Simone DeRoche, expecting her fourth child in December, had her birth plan set: delivering at USC Verdugo Hills Hospital, where her three other kids were born. But when she received the text from her OB-GYN last week that the hospital will be closing its maternity ward and NICU in November, DeRoche felt a wave of disappointment and sadness.
New Treatments Are Changing the Future of Alzheimer Disease
Pharmacy Times
AUGUST 30, 2024
Despite questions and controversy around some clinical research, new understandings of the pathophysiology of the disease are pushing treatments forward.
FDA clears updated Covid shots from Novavax, adding a 3rd fall vaccine option
STAT
AUGUST 30, 2024
U.S. regulators have cleared a third updated Covid-19 vaccine for this fall, shots made by Novavax. Already, Pfizer and Moderna are shipping shots modified to better match more recent strains of the ever-evolving coronavirus. Those doses can be used in adults and children as young as 6 months.
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.
Distinguishing Between Small Intestinal Bacterial Overgrowth and Irritable Bowel Syndrome
Pharmacy Times
AUGUST 30, 2024
Although small intestinal bacterial overgrowth (SIBO) and irritable bowel syndrome (IBS) share many of the same symptoms, SIBO affects the small intestine and IBS affects the large intestine.
Emergent Bio gets FDA green light for mpox vaccine
pharmaphorum
AUGUST 30, 2024
Emergent BioSolutions has been given FDA approval to extend the indications for its smallpox vaccine ACAM2000 to include the prevention of mpox, currently deemed a public health emergency by the WHO.
Nipocalimab Data Submitted for FDA Approval in Generalized Myasthenia Gravis
Pharmacy Times
AUGUST 30, 2024
The application includes data from the Vivacity-MG3 study, demonstrating that individuals who received the drug had superior outcomes compared with the standard of care alone.
UK biotech ReNeuron quits AIM as financing push fails
pharmaphorum
AUGUST 30, 2024
Troubled UK biotech ReNeuron will cancel its AIM listing, saying it has been unable to raise the funds it needs to bring it out of administration
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.
CMS commits $100M to support ACA navigators
Fierce Healthcare
AUGUST 30, 2024
With open enrollment on the Affordable Care Act exchanges just a few months away, the feds are investing $100 million in navigators to assist people in securing coverage. | With open enrollment on the Affordable Care Act exchanges just a few months away, the feds are investing $100 million in navigators to assist people in securing coverage.
Pharma Pulse 8/30/24: Medication Mistakes Pharmacists Want You to Stop Making, Express Scripts to Remove Humira & more
Pharmaceutical Commerce
AUGUST 30, 2024
The latest news for pharma industry insiders.
BioMarin's change in direction claims more jobs
pharmaphorum
AUGUST 30, 2024
BioMarin wields axe again, slashing 225 positions from its global workforce as it continues a major restructuring drive
Happy Labor Day Weekend 2024!
OctariusRx
AUGUST 30, 2024
Happy Labor Day Weekend 2024 from all of us at OctariusRx! OctariusRx: Where we labor to make things easier for you. May this weekend be filled with celebration, relaxation, and a shared sense of gratitude for those who hustle hard every day. Thank you to our team members, our clients, and vendors for your hard work. We appreciate all your efforts throughout the year; enjoy this extra day of rest.
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.
National Academies Progress Report Shows Consequences of Underrepresentation in Clinical Research
Pharmacy Times
AUGUST 30, 2024
The author suggest how to improve the representation of women, older adults, and minorities in clinical research that will require effort from a broad range of stakeholders.
Are PBMs to blame for high drug prices in the US?
Pharmaceutical Technology
AUGUST 30, 2024
US Congress labelled pharmacy benefit managers (PBMs) as ‘anticompetitive’; PBMs blame manufacturers for increasing pharmaceutical prices.
Eli Lilly partner Hutchmed scraps China stomach cancer filing as approval seems unlikely
Fierce Pharma
AUGUST 30, 2024
Hutchmed, the original developer of Takeda’s Fruzaqla, has decided not to pursue an approval for the VEGFR inhibitor in stomach cancer for now in its home country. | Hutchmed, the original developer of Takeda’s Fruzaqla, has decided not to pursue an approval for the VEGFR inhibitor in stomach cancer in its home country for now thanks to doubts around patients’ overall survival.
How the Life Sciences Innovative Manufacturing Fund can boost funding for pharma
pharmaphorum
AUGUST 30, 2024
Discover how the Life Sciences Innovative Manufacturing Fund can help boost funding for pharmaceutical companies. Learn how this fund can support innovation and growth in the life sciences sector.
ESC 2024: UK's George Medicines posts positive results for triple-combo blood pressure drug on heels of FDA submission
Fierce Pharma
AUGUST 30, 2024
ESC 2024: UK's George Medicines posts positive results for triple-combo blood pressure drug on heels of FDA submission fkansteiner Fri, 08/30/2024 - 15:54
Monica from ‘Friends’, RFK Jr., and how many ‘r’s are in ‘strawberry’
STAT
AUGUST 30, 2024
Want to stay on top of health news? Sign up to get our Morning Rounds newsletter in your inbox. I just returned from a lovely two-week remote work/vacation trip to Oregon and this meme is my mood today.
Can you take MiraLAX every day?
The Checkup by Singlecare
AUGUST 30, 2024
If you feel like you need to go but just…can’t, you might be dealing with constipation. It’s a common problem—about 4 million people in the U.S. experience it regularly. While lifestyle modifications are the first line of treatment , several over-the-counter (OTC) remedies can help, too. MiraLAX (polyethylene glycol 3350) is a popular osmotic laxative that works by bringing water into the bowel to make stools easier to pass.
J&J launches gMG market bid with nipocalimab filing
pharmaphorum
AUGUST 30, 2024
J&J files FcRn blocker nipocalimab for generalised myasthenia gravis (gMG) in US, setting up a challenge to rival drugs from Argenx and UCB
Twice Yearly Inclisiran Demonstrates Meaningful LDL-C Lowering in Patients With ASCVD Risk
Pharmacy Times
AUGUST 30, 2024
Pharmacists play an essential role in ensuring the medication is dispensed to patients with high atherosclerotic cardiovascular disease risk.
Chutes & Ladders—NAHC-NHPCO Alliance's inaugural CEO; New president of IU Health Physicians
Fierce Healthcare
AUGUST 30, 2024
Welcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry. | Welcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry. Please submit the good news—or the bad—from your shop, and we will feature it here at the end of each week.
Alnylam's Amvuttra turns in 'grand slam' showing in ATTR-CM, but leaves a window open for rivals
Fierce Pharma
AUGUST 30, 2024
Alnylam is circling the bases after walloping—in the words of chief medical officer Pushkal Garg M.D.—a “grand slam” with data that position its RNA silencer Amvuttra (vutrisiran) to potentially be | At the European Society of Cardiology conference in London, Alnylam presented positive data from the phase 3 HELIOS-B trial which assessed RNA silencer Amvuttra (vutrisiran) as a treatment for transthyretin amyloid cardiomyopathy (ATTR-CM).
The Impact of Cyber Breaches in Healthcare: Implications for Technology Companies and Startups
Fierce Healthcare
AUGUST 30, 2024
By Amith Nair | Discover how healthcare leaders navigate rising cyber threats, balancing innovation with robust security to protect sensitive patient data.
J&J targets generalised myasthenia gravis landscape with nipocalimab
Pharmaceutical Technology
AUGUST 30, 2024
J&J’s BLA was supported by data from the Phase III VIVACITY study, demonstrating the safety and efficacy of biweekly nipocalimab.
Johnson & Johnson Submits Biologics License Application for Nipocalimab in Patients with Antibody-Positive Generalized Myasthenia Gravis
PharmExec
AUGUST 30, 2024
Submission is supported by results from the Phase III Vivacity-MG3 study, which demonstrated that nipocalimab, combined with standard care, significantly improved outcomes for patients with antibody-positive generalized myasthenia gravis.
ESC 2024: Latest FLOW trial analysis highlights how Ozempic can benefit CKD patients
Pharmaceutical Technology
AUGUST 30, 2024
If approved, Novo Nordisk's Ozempic will become the first GLP-1 therapy option for patients with type 2 diabetes and chronic kidney disease.
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