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Drug Topics talked with Gregg Sylvester, MD, chief health officer and vice president of medical affairs at CSL Seqirus, about what can we learn from this unique situation to improve future vaccine development and distribution.
Since the first FDA biosimilar approval of filgrastim-sndz (Zarxio) in 2015, a total of 44 biosimilars for 15 originator products have been approved and more than 20 are marketed.
Discover how artificial intelligence (AI) is revolutionising the drug development process and transforming the way FDA-approved drugs are produced, ensuring compliance and optimising the supply chain. Learn more about the future of AI in pharmaceuticals.
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
Innovation in the vaccine area continues. In 2023, the FDA approved six vaccines, including several important firsts. But they face a difficult landscape where federal policies dictate coverage.
Nearly four decades after its first conception, the first TIL therapy, an immunotherapy that harvests cancer-fighting immune cells from the patient’s own body, received accelerated approval from the Food and Drug Administration for advanced melanoma. The therapy, called Amtagvi or lifileucel from Iovance, is the first cell therapy approved for a solid tumor.
Nearly four decades after its first conception, the first TIL therapy, an immunotherapy that harvests cancer-fighting immune cells from the patient’s own body, received accelerated approval from the Food and Drug Administration for advanced melanoma. The therapy, called Amtagvi or lifileucel from Iovance, is the first cell therapy approved for a solid tumor.
Many patients with the condition continue to experience severe hypoglycemic events even with the use of continuous glucose monitors and other disease management tools.
If approved, this would mark the first MDMA-assisted therapy and psychedelic-assisted therapy approved, calling for a reschedule of MDMA from Schedule I. A PDUFA was set for this summer.
WASHINGTON — A new trove of internal emails and other documents from the e-cigarette maker Juul reveals the company’s extensive behind-the-scenes efforts to promote its interests in Washington — a rare insight into the otherwise opaque methods corporations use to influence the government. It’s well documented that Juul spent significant sums on registered lobbyists and political donations back in 2018 and 2019, when the head of the Food and Drug Administration declare
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.
A new study found that opioid morphine milligram equivalents dose prescribed in the 60 days prior to delivery date was significantly associated with a higher likelihood of spontaneous preterm birth.
Public health messages have told us for decades that if you smoke, you should quit. And if you don’t smoke, don’t start. But a new study suggests smoking may be even worse than we thought. The study , published Wednesday in Nature, underscores the importance of never lighting up that first cigarette, based on its conclusion that smoking has much longer harmful effects on immune responses than previously understood.
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.
Commissioner Dr. Robert Califf signals how the FDA will consider AI in drug development and how the agency may use the emerging technology in the future.
As the use of artificial intelligence technology in healthcare grows, federal lawmakers are weighing how to protect patients without hindering innovation and many in Congress are pushing for strong | As the use of artificial intelligence technology in healthcare grows, federal lawmakers are weighing how to protect patients without hindering innovation and many in Congress are pushing for stronger regulation.
More than 100,000 doctors have left private practice and become employees of hospitals and other corporate entities since 2019. Today, nearly three in four physicians are employees of larger health care entities or other corporations — a record high. As an independent physician, I know exactly why so many are making that choice.
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.
Participants of a recent study who experienced more daily cognitive symptoms had a greater likelihood of reporting moderate interference with functioning, less likelihood of full-time employment, and greater severity of depressive symptoms.
A new study has shown that people vaccinated against Ebola who still developed the disease had a substantially lower risk of dying than people who were not vaccinated, even if they received the vaccine when they were already infected with the virus. It confirms just how major an advancement the Ebola vaccine remains; the study is the first to show that in addition to preventing infections, the vaccine can save some people who are already sick with the often fatal disease.
The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunothera | The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunotherapy developed by Iovance Biotherapeutics.
There was a time when an allegation of data mishandling, scientific misconduct, or just a technical error felt like a crisis to Barrett Rollins, an oncologist and research integrity officer at Dana-Farber Cancer Institute. Now, it’s a Tuesday. The renowned cancer treatment and research center is in the midst of a lengthy review of possible discrepancies involving around 60 papers co-authored by four of its top researchers over a period of over 15 years, including CEO Laurie Glimcher and C
This marks omalizumab’s fourth FDA-approved indication for allergic and inflammatory conditions, such as severe persistent allergic asthma, with its initial approval being in 2003.
Study results indicate that using salt substitutes can be a viable population-wide strategy in preventing cardiovascular disease and controlling hypertension.
As more and more rural hospitals find their operations dropping into the red, the rising enrollment of rural residents in Medicare Advantage plans could pull these providers under, healthcare advis | A new analysis found the largest-ever single-year jump in rural hospitals operating in the red and a nearly 50% rise in Medicare Advantage enrollment over the past five years.
A growing body of data show that South Asians are at greater risk of developing heart disease than white people, and they tend to get complications at younger ages, but it’s not been fully clear what explains this disparity. A new study suggests one potential reason is that South Asians have a decreased ability to repair blood vessels that get injured from cardiovascular problems.
The FDA approval marks the first and only FDA-approved oral therapy for this patient population, and the drug is expected to be available by the end of February.
Long-Term Care (LTC) pharmacies are playing a critical role in delivering care primarily for our aging population. Yet LTC pharmacies face many challenges, including rising costs, space constraints, labor availability and many others.
Providers working in hospitals and critical access hospitals may now text patient information and patient orders among care team members without landing on the wrong side of Medicare’s Conditions o | Texting patient info has been against Medicare's Conditions of Participations for over half a decade, due to concerns of insecure texting platforms.
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