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The designation addresses the unmet need for prevention of H5N1, which remains a global health risk, and a phase 1 trial of the vaccine was initiated in November 2024.
After Hurricane Ian, as Floridians returned home to sodden furniture and moldy piles of debris, many with asthma could feel their chests tightening. To figure out what was safe, some sent their concerns directly to the U.S. Centers for Disease Control and Prevention. But on Tuesday — days before floods ravaged Nashville, potentially prompting similar queries — the people who would normally answer such asthma questions stopped working.
By Kurt R. Karst The FDA Reduction-in-Force (Termination)or RIF(T)announced last week has resulted in countless stories in the press and on personal LinkedIn accounts from those RIFd. As the dust begins to settle and we all assess what this means for the future of FDA and the public health, generally, this blogger wanted to call out one particular division in the Office of Generic Drugs (OGD), funded by user fees under the Generic Drug User Fee Amendments (GDUFA), that was eradicated and what t
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
For more than four decades since the passage of the Hatch-Waxman Act, the U.S. generic drug market has provided patients with low-cost alternatives to brand-name medicines, saving the health care system billions while preserving incentives for biopharmaceutical innovation. Today, low-cost generics account for nine out of every 10 prescriptions dispensed in the United States and come with an average copay of about six dollars.
The National Institute For Health and Care Excellence ( NICE )s has recommended a new combination treatment for advanced breast cancer patients. AstraZenecas Truqap (capivasertib) in combination with fulvestrant is indicated as a treatment option for around 1,100 UK adults with hormone receptor (HR)-positive HER2-negative breast cancer with certain genetic mutations.
Hotlines that have fielded millions of calls from people — including new mothers — looking for mental health support or to quit smoking are in limbo after federal officials fired the workers who oversaw them. Employees were cut from offices that fund prevention work on the local, state, and tribal level. Those include hotlines like the Maternal Mental Health Hotline run by the Health Resources and Services Administration, and another to help smokers quit using tobacco.
Many people are interested in generic drug availability since brand-name drugs are often costly. Mounjaro (tirzepatide) is a brand-name prescription medication that is approved by the Food and Drug Administration (FDA) to improve blood sugar levels in people with Type 2 diabetes. It is also commonly used off-label for weight loss because, as a dual glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist, tirzepatide helps control appetite
Dosium Touchdose has gone live at West Middlesex University Hospital, UK, a clinical decision support technology proven to significantly reduce prescribing errors. This follows go-live at both Chelsea and Westminster Hospital last month, and St Marys Hospital last summer, marking the final stage of rollout across the entire West London Childrens Healthcare (WLCH) partnership.
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.
New findings from The Pistoia Alliance report major challenges to adoption of data-driven innovation and AI in life sciences. The research is based on a poll conducted at the organisations annual European conference. Resistance to change emerged as the biggest obstacle to innovation (51 percent). To overcome this, the Alliance urged the pharmaceutical industry to prioritise cultural and behavioural change in digital transformation efforts.
A study found that patients who acquired a SARS-CoV-2 infection during pregnancy had a lower risk of developing long COVID compared to those who were not pregnant.
A new federal report suggests that U.S. autism rates are rising modestly, an increase that health researchers said reflected expanded diagnostic tools and access to care, among other factors. But health secretary Robert F. Kennedy Jr. instead has pointed to the data as evidence of a growing crisis. The Centers for Disease Control and Prevention report says that 3.2% of kids surveyed in 2022 have autism spectrum disorder, a slight uptick from the 2.8% of kids surveyed in 2020 for the previous rep
Introduction If the past few years have taught pharma marketers anything, it’s that agility, data, and digital-first thinking aren’t just buzzwordsthey’re survival tactics. Marketing in pharma has undergone a radical shift, propelled by digital transformation, patient-centric demands, and evolving regulatory landscapes. In 2025, the strategies that succeed are rooted in personalization, innovation, and real-time adaptability.
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.
People with Type 2 Diabetes have many treatment options these days, though not all are covered by insurance. Ozempic is a prescription weekly injection manufactured by Novo Nordisk. It is often covered by insurance when prescribed for diabetes (not weight loss ). However, not all insurance plans cover Ozempic and when it is covered, the coverage amount may vary by provider and plan.
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.
Layoff notices began arriving early Tuesday for thousands of employees of the sprawling Department of Health and Human Services and its subsidiary agencies, with as many 10,000 workers potentially expected to be hit by the cuts. “I regret to inform you that you have been affected by a reduction in force (RIF) action,” an email to affected employees said.
Analytical testing is an essential part of guaranteeing the quality, safety and effectiveness of pharmaceutical products. However, the process is not without its challenges and it requires a proactive approach if both compliance and efficiency are to be maintained. This is why it is essential to develop and validate analytical methods to support activities and functions such as process validation controls, stability tests and dissolution profiles.
By Dr. Naomi Lowy, Principal Drug Regulatory Expert Trade and national press have reported that recent changes in FDA staffing levels have already led to slower responses to calls and emails. According to reports, which were published before the most recent reports of HHS staff level reductions and tumultuous changes in leadership, FDA staff were missing minor deadlines.
Imagine launching a brand campaign without guessworkwhere your message reaches the right healthcare professional at the right time on the right channel. Thats the promise of data-driven marketing , a strategy thats rapidly transforming how pharmaceutical companies approach promotion, education, and engagement in 2025. As privacy regulations evolve, customer expectations change, and AI-driven technologies emerge, pharma marketers must adapt or risk becoming irrelevant.
In an unusual move, an audit of commercial health plans by Tennessee officials found that Express Scripts, one of the largest pharmacy benefit managers in the United States, violated state laws in its dealings with pharmacies, according to newly released documents. Specifically, the company failed to properly reimburse pharmacies, favored its own specialty pharmacy operations by paying higher dispensing fees than to other pharmacies, and did not properly handle appeals filed by pharmacies, accor
Strattera (atomoxetine) is a brand name, non-stimulant drug approved by the U.S. Food and Drug Administration (FDA) to treat attention deficit hyperactivity disorder (ADHD). Its also prescribed off-label for other medical conditions, such as treating a specific type of low blood pressure called neurogenic orthostatic hypotension and reducing symptoms of major depressive disorder in people who also have ADHD.
Over the past decade, we have witnessed the arrival of a new era in biopharmaceutical R&D. Traditional methods and processes, such as wet labs, are being augmented by a rapidly expanding digital ecosystem in pharma. Across the industry, this shift is offering extraordinary opportunities to increase the speed, accuracy, and reproducibility of research.
TauRx Pharmaceutics reports that hydromethylthionine mesylate (HMTM) could be an oral treatment for slowing the progression of Alzheimer’s disease over a period of at least 18 months. If approved by regulators, HMTM could be the first oral treatment for the disease that targets the tau protein. Conventionally, targeted therapies for Alzheimers focused on amyloid protein […] The post Research finds tablet effective in slowing progression of Alzheimers disease over 18 months appeared f
In a rare move, the Food and Drug Administration told an unspecified number of drug companies that studies used to support therapeutic equivalence of some of their medicines have been rejected due to false data generated by a contract research organization. The agency identified “significant” problems with data integrity and the way studies were conducted by Raptim Research, which had been hired by the drugmakers to test their medicines.
Atorvastatin , a medication in the statin drug class , is prescribed to treat high cholesterol. Available in both tablet and liquid form, atorvastatin blocks the enzyme needed to make low-density lipoprotein (LDL) cholesterol (aka bad cholesterol) in the liver. Since high cholesterol can cause heart attacks and strokes, and this risk increases as people age, older adults may be more likely to need lipid-lowering agents like atorvastatin.
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