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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.
For the first time in over ten years, the US Food and Drug Administration (FDA) has approved a new targeted treatment for chronic spontaneous urticaria. Sanofi and Regeneron Pharmaceuticals collaborated to develop Dupixent (dupilumab). Under the FDA’s new authorisation, the therapy is indicated for individuals aged 12 years and over with the chronic inflammatory skin disease, who still experience symptoms despite taking histamine-1 (H1) antihistamine medication.
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.
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.
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
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.
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.
Antonio Ciaccia, President of 3 Axis Advisors, CEO of 46brooklyn Research, and pharmacy benefits expert, discusses litigious, market-based, and legislative reform for pharmacy benefit managers.
Health and Human Services Secretary Robert F. Kennedy Jr. has railed against what he sees as a “revolving door” between workers at drug companies and the Food and Drug Administration. But his department’s actions now seem to be causing that door to spin ever faster. Scores of FDA employees are searching for an exit from an agency in turmoil, particularly staff members tasked with reviewing drug applications, according to interviews with former employees and industry re
Research reveals that children face significant long-term health risks, including kidney, gastrointestinal, and cardiovascular issues, after COVID-19 infection.
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.
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.
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.
Some key public health figures are taking an extraordinary step to try to shore up U.S. vaccination policy, feared to be under threat from Health and Human Services Secretary Robert F. Kennedy Jr., a longtime vaccine critic. The “Vaccine Integrity Project,” which was publicly launched Thursday by the University of Minnesota’s Center for Infectious Disease Research and Policy, will be aimed at assessing the best ways for vaccine proponents to safeguard vaccination policy and
America’s biopharmaceutical companies are committed to revitalizing American manufacturing, and they continue expanding their U.S. footprint. Supporting nearly five million jobs and more than 1,500 facilities across the U.S., we’re making investments that help develop new treatments and cures and contribute to America’s economy.
Vect-Horus has announced the appointment of Philippe Masset to the companys board of directors. This contributes to a series of senior leadership appointments which are strategic for Vect-Horus growth. Masset is a senior banking executive with a wealth of experience in investment banking, environmental, social and governance (ESG) topics, sustainable finance, and AI.
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.
Glucagon-like peptide-1 medications are the fastest-growing class of medication and will continue to be prevalent as more indications, such as sleep apnea, are added.
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.
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.
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.
On behalf of 39 state and territory attorneys general, the National Association of Attorneys General issued a letter to Congress regarding major PBMs conflicts of interest.
Even before the Department of Health and Human Services announced its recent major reorganization, the media had been reporting on anticipated changes to the Centers for Disease Control and Prevention, the Food and Drug Administration, and the National Institutes of Health. But the very last bullet on the HHS fact sheet was a complete surprise to most people: the elimination of the Administration for Community Living (ACL).
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.
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