FDA Roundup: Biosimilar Approval, Hereditary Angioedema Treatment Receives Orphan Drug Designation
Drug Topics
OCTOBER 4, 2024
Check out important updates from the FDA for the week of September 30.
Drug Topics
OCTOBER 4, 2024
Check out important updates from the FDA for the week of September 30.
PharmaVoice
OCTOBER 4, 2024
Cassava Sciences’ beleaguered investigational Alzheimer’s therapy is in two phase 3 studies.
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Drug Topics
OCTOBER 4, 2024
Social pressures, physiological changes, mental health challenges, and burnout all complicate diabetes management among adolescents.
Pharmacy Times
OCTOBER 4, 2024
The new screening test provides an easier, convenient option for patients seeking to screen themselves for colorectal cancer.
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
OCTOBER 4, 2024
Cologuard Plus is approved for adults aged 45 years and older who are at average risk for the disease.
STAT
OCTOBER 4, 2024
Sam Altman, co-founder of OpenAI and co-creator of ChatGPT, keeps saying artificial intelligence will help cure cancer. Altman’s going further these days, envisioning a future where an AI essentially replaces the principal investigator. In a discussion last month that was widely circulated this week on social media, Altman recounted chatting with a cancer researcher about a time when an AI would issue experimental plans and tasks to human scientists to complete.
Pharmacy Technician Pulse brings together the best content for pharmacy technicians from the widest variety of industry thought leaders.
Pharmacy Times
OCTOBER 4, 2024
The treatment aims to reduce prolonged QTc interval in patients with long QT syndrome.
STAT
OCTOBER 4, 2024
Next year’s Medicare Advantage market will be two things at once: remarkably stable broadly, but rife with changes under the surface. Health insurance companies will still offer older adults a lot of plan choices with low, or completely free, premiums. That’s why the federal government expects enrollment in the $500 billion Medicare Advantage program to grow once again in 2025 — a stark contrast from insurers’ cries that modest payment reforms would damage them and se
Pharmacy Times
OCTOBER 4, 2024
Research showed that children born via assisted reproductive technology were 36% more likely to develop heart defects.
STAT
OCTOBER 4, 2024
Exact Sciences won Food and Drug Administration approval on Friday for an improved version of a stool-based screening test for colon cancer that should result in fewer cancer-free patients receiving unnecessary follow-up colonoscopies. The FDA approved the test, Cologuard Plus, for adults 45 and up with an average risk of cancer based on results from a large clinical trial, dubbed Blue-C, which recruited more than 20,000 participants.
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
OCTOBER 4, 2024
Nivolumab is the only PD-1 inhibitor to show statistically significant and clinically meaningful benefits in non-small cell lung cancer compared with chemotherapy.
Fierce Pharma
OCTOBER 4, 2024
After announcing the closure of its biggest manufacturing site Sunday due to flooding caused by Hurricane Helene, Baxter International—the U.S.’ top supplier of hospital IV fluids—is laying out det | While progress is already being made after Hurricane Helene, which resulted in water “permeating” Baxter’s large IV fluid production plant in North Carolina, the company cautioned that it does not yet have a timeline for when operations will be back online.
Pharmacy Times
OCTOBER 4, 2024
Significant polarization surrounding COVID-19 vaccinations in late 2020 and early 2021 looked to have had an impact in increasing vaccine hesitancy.
STAT
OCTOBER 4, 2024
Georgina Peacock vividly remembers a night when she admitted 20 babies, all struggling to breathe, into the hospital where she was doing her pediatric medical training. The illness that was robbing them of breath? Respiratory syncytial virus, or RSV. Peacock and many others who are responsible for the care of the country’s youngest children have been moving heaven and earth for the past year and a bit, to make experiences like that a thing of the past.
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
OCTOBER 4, 2024
High cholesterol levels are known risk factors for atherosclerotic cardiovascular disease.
pharmaphorum
OCTOBER 4, 2024
Bristol Myers Squibb (BMS) has been granted approval by the US Food and Drug Administration (FDA) for Opdivo to treat adults with resectable non-small cell lung cancer (NSCLC).
Pharmacy Times
OCTOBER 4, 2024
Major biomarkers for cognitive impairment were observed in hospitalized patients with neurological symptoms.
pharmaphorum
OCTOBER 4, 2024
FDA declares an end to tirzepatide shortage, the active ingredient in Eli Lilly’s popular weight loss medication Zepbound and diabetes drug Mounjaro.
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Pharmacy Times
OCTOBER 4, 2024
Carrie Koenigsfeld, PharmD, FAPhA, discusses an overview of RSV, including its transmission, incidence, seasonality, and clinical presentation.
Fierce Healthcare
OCTOBER 4, 2024
Though their margins have largely remained level, hospitals are starting to get a handle on length of stay and per-patient expense growth as demand for inpatient care remains strong, according to A | Kaufman Hall's monthly index report showed continued demand and more efficient inpatient care, but muted revenue gains. A concurrent report on third quarter M&A also outlined a spike in dealmaking.
STAT
OCTOBER 4, 2024
A pleasant Friday morning to you! Adam Feuerstein, here, reporting from the Pharmalittle campus, temporarily relocated to Cambridge, Mass., as your regular New Jersey host Ed takes the day off. Like the one-and-only Mr. Pharmalot, I enjoy my daily headlines with a hot cup of joe. Have a great weekend. Italian pharma company Recordati said it will buy from Sanofi the global rights to an approved drug to treat cold agglutinin disease , a rare autoimmune disorder, for $825 million, Reuters re
The Checkup by Singlecare
OCTOBER 4, 2024
You open the medicine cabinet to take a dose of fluconazole prescribed to tackle a stubborn yeast infection. Later, as you meet friends for dinner, you wonder whether it’s safe to enjoy a glass of wine. Fluconazole , also sold under the brand name Diflucan , is a commonly used antifungal medication, but generally, it’s not recommended to drink while taking it.
Fierce Healthcare
OCTOBER 4, 2024
A proposed rule from the Centers for Medicare & Medicaid Services (CMS) released Oct. | CMS is looking to shake up the risk adjustment model and wants the ability to suspend shady brokers from the insurance marketplace, the agency wrote among other updates in a new proposed rule.
STAT
OCTOBER 4, 2024
This story first appeared in The Readout newsletter. Sign up for The Readout and receive STAT’s award-winning biotech news delivered straight to your inbox. Hello, hello. Today we talk about whether the AI overlords will commandeer cancer research (on top of everything else in this world), WuXi is looking to sell some of its operations, ostensibly because of the BIOSECURE Act, and more.
Pharmacy Times
OCTOBER 4, 2024
When considering the 3-stage framework, perhaps a greater emphasis on pre-treatment phase research could help identify some of the more individual traits used to better predict patient outcomes.
STAT
OCTOBER 4, 2024
Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here. Today’s item on bacterial outbreaks linked to hospital ice machines reminded me of The National’s song “Ice Machines,” so pardon me for slipping into music recommendation mode for a second.
The Checkup by Singlecare
OCTOBER 4, 2024
Many people struggle with managing blood sugar levels and dealing with excess weight. If you’re in this situation, you might feel frustrated and worried about developing Type 2 diabetes. This double burden isn’t just exhausting; it may also be harmful to your health. A healthcare provider might suggest a medication like Wegovy (semaglutide) to manage these problems.
STAT
OCTOBER 4, 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.
European Pharmaceutical Review
OCTOBER 4, 2024
A study has reported an approach for optimising metronidazole colonic delivery systems, to increase their potential efficacy when treating diverticulitis. Researchers developed intestinal colon-coated sustained-release matrix metronidazole tablets, using a Quality by Design (QbD) approach. Arévalo-Pérez et al. noted that metronidazole is a synthetic nitroimidazole and has activity against anaerobic bacteria.
Outsourcing Pharma
OCTOBER 4, 2024
Rebekah's father passed on his passion for science and problem solving to her and much her of childhood was spent doing fun hands-on activities from taking apart household mechanics to building rockets.
Pharmaceutical Technology
OCTOBER 4, 2024
Amidst the long-running Cas9 patent battle, Editas Medicine has struck a deal to sell a portion of its future revenue…
The Honest Apothecary
OCTOBER 4, 2024
Founded in 1947 with a mission to provide compassionate care while pursuing cutting-edge research to combat cancer, Dana-Farber Cancer Institute, is a world leader in cancer treatment and research. One of its most notable fundraising events is the Jimmy Fund Walk, which began in 1989.
Fierce Healthcare
OCTOBER 4, 2024
As a community pediatrician with firsthand experience, I've observed an enduring curiosity among parents and caretakers about food, nutrition and health. | The potential for implementing Food as Medicine for pediatric settings is promising, with growing support from stakeholders, lawmakers and health agencies.
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