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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FDA Approves Expanded Use of ACAM2000 Vaccine for Mpox Amid Public Health Emergency
Drug Topics
AUGUST 30, 2024
Emergent BioSolutions has announced that it will donate 50,000 doses of ACAM2000 for potential deployment across affected areas in Central Africa.
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
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.
STAT+: Wegovy cut patients’ chances of dying from Covid-19, new analysis shows
STAT
AUGUST 30, 2024
LONDON — Novo Nordisk made worldwide headlines last year when a study demonstrated that Wegovy, its powerful and exceedingly popular weight loss medicine, helped reduce the risk of cardiovascular emergencies like heart attacks. Researchers on Friday unveiled results demonstrating another benefit that the drug offered to patients in that study: Compared to placebo, it cut the chances of dying from Covid-19 by roughly a third.
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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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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.
STAT+: Detailed data on Alnylam’s heart drug show substantial benefit, while competition likely awaits
STAT
AUGUST 30, 2024
LONDON — An experimental drug from Alnylam Pharmaceuticals substantially cut the risk of death and serious cardiovascular complications among patients with an increasingly diagnosed heart disease, likely teeing up the medicine to be a new option for patients, but one that will face competition from another treatment also nearing potential approval.
New ACIP Recommendations for RSV Vaccines Aim to Solve Challenges With Shared Clinical Decision-Making
Pharmacy Times
AUGUST 30, 2024
Shared clinical decision-making presented drawbacks, resulting in age-based recommendations for adults aged 75 years and older and risk-based recommendations for individuals aged 60-74 years.
Is anyone taking the world’s priciest drugs?
PharmaVoice
AUGUST 30, 2024
A slew of breakthrough gene therapies won FDA approval in recent years — but high price tags haven’t always yielded big returns.
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.
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.
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.
STAT+: New Wegovy analysis could boost Novo Nordisk’s bid to expand drug’s label in heart failure
STAT
AUGUST 30, 2024
Novo Nordisk’s obesity drug Wegovy cut the risk of severe complications in patients with a common form of heart failure, according to a new analysis that could boost the company’s efforts to expand the label for the blockbuster treatment. Researchers combined data on nearly 4,000 patients across four trials who had heart failure with reduced ejection fraction (or HFpEF) and found that 5.4% of those treated with Wegovy experienced cardiovascular-related death or heart failure events
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.
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.
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.
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.
Novo rekindles heart failure hopes for semaglutide with new pooled analysis
Fierce Pharma
AUGUST 30, 2024
After a regulatory hiccup earlier this month, Novo Nordisk’s heart failure ambitions for its obesity star Wegovy (semaglutide) are starting to get back on track. | Novo’s semaglutide cut the risk of combined cardiovascular death or worsening heart failure events by 31%, based on an incident rate of 5.4% in semaglutide patients versus 7.5% in those on placebo, the company said Friday.
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.
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.
STAT+: Pharmalittle: We’re reading about Wegovy study results, an Alnylam heart drug, and more
STAT
AUGUST 30, 2024
And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda, so far, is rather modest. We plan to promenade with the official mascots, spend time with our Pharmalot ancestor, and catch up on our reading. With any luck, we will also find time for another listening party, where the rotation is likely to include this , this , this , this and this.
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.
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.
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
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.
Emergent's smallpox vaccine picks up FDA nod for mpox as Africa outbreak spreads
Fierce Pharma
AUGUST 30, 2024
As a new deadly strain of mpox continues its global spread, Emergent BioSoultion's smallpox vaccine ACAM2000 has officially joined the ranks of FDA-approved defense measures against the virus. | With the nod, Emergent's vaccine joins Bavarian Nordic's Jynneos as approved protection options to address the continued outbreak in Africa, which was recently deemed a public health emergency.
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.
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
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.
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.
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
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.
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