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.
STAT
OCTOBER 4, 2024
Experimental vaccines and therapeutics to combat the deadly Marburg virus will begin arriving this weekend in Rwanda, where they will be used in clinical trials expected to begin soon, a U.S. government official confirmed on Friday. There are currently no licensed vaccines or drugs to prevent or treat Marburg, a cousin of the Ebola family of viruses that transmits and causes illness in the same way as Ebola.
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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
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 Times
OCTOBER 4, 2024
The treatment aims to reduce prolonged QTc interval in patients with long QT syndrome.
Pharmacy Technician Pulse brings together the best content for pharmacy technicians from the widest variety of industry thought leaders.
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
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
Nivolumab is the only PD-1 inhibitor to show statistically significant and clinically meaningful benefits in non-small cell lung cancer compared with chemotherapy.
STAT
OCTOBER 4, 2024
As primary care physicians, we see a scene play out almost daily. A patient is sitting in front of us, explaining her symptoms: She could have difficulty breathing, stress at home, fatigue. We know there is nothing more important than being fully present. However, our minds and eyes keep darting to the computer screen and the growing inbox of messages from other patients: “I forgot my Lipitor for a week, should I double up tomorrow?
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
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
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.
Pharmacy Times
OCTOBER 4, 2024
High cholesterol levels are known risk factors for atherosclerotic cardiovascular disease.
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.
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.
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.
PharmaVoice
OCTOBER 4, 2024
Cassava Sciences’ beleaguered investigational Alzheimer’s therapy is in two phase 3 studies.
Pharmacy Times
OCTOBER 4, 2024
Major biomarkers for cognitive impairment were observed in hospitalized patients with neurological symptoms.
Drug Topics
OCTOBER 4, 2024
Cologuard Plus is approved for adults aged 45 years and older who are at average risk for the disease.
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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.
Drug Topics
OCTOBER 4, 2024
Researchers aimed to determine whether or not opioids were appropriate for treating adolescents experiencing chronic pain.
NF2 BioSolutions
OCTOBER 4, 2024
Hello everyone, For the last 3 years, I have been a NF2 BioSolutions-funded PhD student working within Manchester alongside Grace Gregory, and it has been such a rewarding and positive experience, not only for my personal development, but for driving forward our understanding of NF2 -related Schwannomatosis ( NF2 SWN) and potential new treatments. Alas, my PhD has finally come to an end, but I’m please to share with you some of the key findings from my work that will hopefully change the ways in
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).
Fierce Pharma
OCTOBER 4, 2024
As Sanofi continues to clean out its medicine chest, Italy’s Recordati is getting in on the action. | Recordati is floating $825 million upfront—plus another $250 million in potential commercial milestones—to get its hands on the global rights to Sanofi’s rare disease biologic Enjaymo. In 2022, Enjaymo became the first and only therapy specifically approved by the FDA for treating patients with the uncommon blood disorder cold agglutinin disease.
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.
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
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
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.
NF2 BioSolutions
OCTOBER 4, 2024
Hi everyone! What a journey it has been over the last 3 years, being one of the first two NF2 BioSolutions UK and Europe PhD students alongside Adam! I have enjoyed every moment, and I have made the most of all the opportunities to pass my way through the University of Manchester, NF2 research community and the Charity, all of whom have driven this research forward.
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.
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.
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.
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