Trending Articles

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Large amount of bird flu virus in milk suggests asymptomatic cows are infected with H5N1

STAT

Since March, when the first reported cases of H5N1 bird flu began showing up in dairy cattle in Texas, the Food and Drug Administration has been asking farmers to discard any milk from infected animals. Initially, spotting tainted milk was believed to be fairly easy because cows that get sick with H5N1 begin producing milk that is thick and yellowish.

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Exploring the Expanded Potential of GLP-1s

Drug Topics

As demand for GLP-1 receptor agonist medications increases, researchers are hopeful these drugs can be used for more indications than those that currently exist.

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CGM Use Linked to Improved Diabetic Retinopathy Outcomes in T1D

Drug Topics

The current study highlights the potential benefit of incorporating continuous glucose monitor (CGM) data into eye care assessments for patients with type 1 diabetes (T1D).

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Environmental and Social Conditions May Help Predict Severity of Asthma in Children

Pharmacy Times

With these findings contributing to the understanding of neighborhood-level asthma risks, the authors note next steps can involve identifying and addressing disparities.

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Position Your Pharmacy for Expansion

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.

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At request of AstraZeneca, Europe suspends marketing authorization of COVID vaccine Vaxzevria

Fierce Pharma

Once hailed as a landmark accomplishment for the speed with which it was developed and a shining example of British innovation, the AstraZeneca coronavirus vaccine has been grounded by the European | Once hailed as a landmark accomplishment and a shining example of British innovation, the AstraZeneca coronavirus vaccine has been grounded by the European Medicines Agency (EMA).

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Revealed: key files shredded as UK government panic grew over infected blood deaths lawsuit

The Guardian - Pharmaceutical Industry

Lost documents prevented victims from finding out the truth, official inquiry told Disastrous failures that caused the contaminated blood scandal were denied by ministers for decades after officials destroyed, lost and blocked access to key documents, memos submitted to the official inquiry reveal. Several batches of files involving the work of a blood safety advisory committee were shredded as the government faced the threat of legal action, documents show.

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Opinion: Measles is coming back. My sister Marcie isn’t

STAT

At the end of February 1960, my healthy, precocious sister Marcie was halfway through the fourth grade when she contracted measles from a classmate who lived down the street. Their cases were among the nearly 500,000 that year , before the measles vaccination program began in the U.S. in 1963. For every 1,000 people who get measles, one develops measles encephalitis , which can cause permanent brain damage.

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A 340B Compromise at Last? Draft Federal Legislation May Provide a Clear Path Forward

Pharmacy Times

In an ambitious effort to address the ongoing uncertainty within the 340B Program space, 6 senators released a draft discussion bill earlier this year titled the SUSTAIN Act.

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BioNTech plots first wave of cancer launches in 2026 as COVID vaccine sales continue to disappoint

Fierce Pharma

As BioNTech continues to endure a sharp decline in COVID-19 vaccine sales, the German mRNA specialist is looking ahead to the next leg of its commercial journey. | With plans to have at least 10 potentially registrational trials underway by the end of 2024, BioNTech is plotting the first wave of its market debut in oncology from 2026 onward.

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The race for healthcare AI models heats up as Google boasts Med-Gemini surpasses GPT-4

Fierce Healthcare

Google and DeepMind released an open access paper on their newest artificial intelligence tools intended for use in hea | Results released by Google on Med-Gemini's performance show that it outperforms existing AI/ML including GPT-4 on over a dozen industry benchmarks.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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Pharmacogenetic Testing Recommendations Needed in Clinical Guidelines to Increase Consistency

Drug Topics

A review found that many guidelines that recommended pharmacogenetic testing were inconsistent between clinical associations.

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WHO’s top scientist learned a hard lesson about H5N1 two decades ago: Stopping it takes more than biology

STAT

Jeremy Farrar, now the World Health Organization’s chief scientist, was working in Vietnam 20 years ago when the H5N1 virus started to spread across Asia — at that point in poultry. He recalls there was a reluctance among farmers to cull their chickens because they weren’t being compensated for them. Movement of infected birds to evade culling only served to disseminate the virus, which in the years since has spread to all continents except Australia.

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Navigating the Shadows: Understanding the Psychology and Pharmacology of Treating Postpartum Depression

Pharmacy Times

A new treatment for postpartum depression has been developed with rapid onset, cutting down the time it has taken previous treatments to take effect by weeks or months.

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House lawmaker brings FDA into biosecurity crackdown on China

Fierce Pharma

Amid a U.S. | In a letter to FDA Commissioner Robert Califf, M.D., the House Committee on Oversight and Accountability chairman argued that China’s influence over global pharmaceutical supply chains constitutes an act of economic warfare against the United States.

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5 Reasons to Upgrade Your Pharmacy Management Software

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.

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Medicare hospital trust fund extended by five years to 2036

Fierce Healthcare

The Hospital Insurance Trust Fund will be fully solvent for longer than previously projected, according to an annual Medicare Trustee report. | The Medicare Hospital Insurance Trust Fund won't run out of money as quickly as expected. Here's how federal officials are reacting.

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STAT+: NYU professors who defended vaping didn’t disclose ties to Juul, documents show

STAT

WASHINGTON – Two New York University professors collaborated directly with executives of the vaping company Juul without disclosing those relationships to academic journals or Congress, a STAT investigation reveals. At the height of the youth vaping crisis, when many public health experts were calling for sweeping action that could upend the entire industry, David Abrams and Ray Niaura emerged as two authoritative voices willing to defend vaping — despite its growing popularity amo

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FDA Grants Fast Track Designation to Eneboparatide for Treatment of Patients With Hypoparathyroidism

Pharmacy Times

Currently, the treatment is being evaluated in the phase 3 CALYPSO study to further prove the safety and efficacy in patients with hypoparathyroidism.

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Emergent BioSolutions to cut 300 employees, shutter 2 facilities in restructuring launched under new CEO

Fierce Pharma

Just about two months into his CEO job at Emergent BioSolutions, Joseph Papa has laid out his turnaround plan for the CDMO-turned-biopharma company. | Merely about two months into his CEO job at Emergent BioSolutions, Joseph Papa has laid out his turnaround plan for the CDMO-turned-biopharma company. And it involves a major organizational restructuring.

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'Too big to fail': Consolidation concerns loom over hearing on Change Healthcare cyberattack

Fierce Healthcare

The scale of UnitedHealth Group's sprawling empire was under the microscope on Wednesday as CEO Andrew Witty testified before a key Senate panel about the cyberattack on Change Healthcare that's ha | The scale of UnitedHealth Group's sprawling empire was under the microscope on Wednesday as CEO Andrew Witty testified before a key Senate panel about the cyberattack on Change Healthcare that's had ripple effects across healthcare.

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Fentanyl Education, Prevention Key to Ending Crisis in US

Drug Topics

For National Fentanyl Awareness Day, Drug Topics talked with Scott H. Silverman about how public health leaders can address the fentanyl crisis and the best ways to educate the public on the dangers of fentanyl use.

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STAT+: Alzheimer’s risk gene APOE4 may cause a distinct form of the disease, study suggests

STAT

For more than 30 years, Alzheimer’s researchers have thought of APOE4 as a major genetic risk factor for most cases of the devastating neurologic disease. But a new study published on Monday argues that this gene variant plays an even more important role than scientists had realized and causes a distinct form of Alzheimer’s. Researchers analyzed data from more than 13,000 people, including nearly 800 APOE4 homozygotes, people who carry two copies of the gene variant.

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CDC Report Finds US Residents in Rural Areas Face Higher Percentages of Preventable Premature Deaths

Pharmacy Times

The authors emphasize that additional research addressing disparities and including race, age, and ethnicity should be conducted.

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Amneal agrees to $272.5M settlement to resolve opioid lawsuits

Fierce Pharma

Amneal Pharmaceuticals has agreed to pay $272.5 million to settle approximately 900 lawsuits brought by state, local and Native American jurisdictions claiming that the New Jersey generics producer | Amneal Pharmaceuticals has agreed to pay $272.5 million to settle approximately 900 lawsuits brought by state, local and Native American jurisdictions claiming that the New Jersey generics producer fueled the opioid crisis by failing to act on suspicious opioid orders.

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AstraZeneca admits Covid-19 vaccine may cause blood clots in “very rare” cases

Pharmaceutical Technology

AstraZeneca has maintained that while the vaccine may, in “very rare” cases, cause TTS, the casual mechanism for this effect remains unknown.

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FDA Approves Myhibbin for Prophylaxis of Organ Rejection in Adult, Pediatric Transplant Recipients

Drug Topics

Mycophenolate mofetil oral suspension is the only FDA-approved ready-to-use liquid formulation.

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CDC’s top flu scientist says the risk to the public from H5N1 is low, but she isn’t sleeping well. Here’s why

STAT

Vivien Dugan isn’t getting much sleep these days. The director of the influenza division at the Centers for Disease Control and Prevention, Dugan is leading the team of CDC scientists that is working with partners — in the U.S. Department of Agriculture, the Food and Drug Administration, and state and local health departments — to respond to the H5N1 bird flu outbreak in dairy cattle.

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FDA Committee to Review Data Supporting New Drug Application for MDMA for PTSD in June

Pharmacy Times

This is the first FDA advisory committee meeting that will review a potential new posttraumatic stress disorder treatment in 25 years.

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Pfizer hires Citi analyst Andrew Baum to manage portfolio strategy, business development

Fierce Pharma

“Our next question will come from Andrew Baum with Citi.” | Citi analyst Andrew Baum, after covering Pfizer for more than a decade, will join the Big Pharma company as chief strategy and innovation officer. In the role, he'll oversee the drugmaker's portfolio management and business development activities.

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Top charities team up with $300m for climate, health equity

pharmaphorum

The Novo Nordisk Foundation, the Bill & Melinda Gates Foundation, and Wellcome have joined forces to tackle some of the most pressing threats to human health and wellbeing. The new initiative gets underway with $300 million in funding over three years earmarked for handling infectious diseases and antimicrobial resistance (AMR), addressing climate change, and raising our understanding of how nutrition can impact immunity, disease, and the development of children.

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Expert: Education of Providers, Patients Key to Biosimilar Uptake

Drug Topics

Savings associated with biosimilar uptake are projected to reach $181 billion through 2027.

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Texas dairy farm worker’s case may be first where bird flu virus spread from mammal to human, scientists say

STAT

A new report on the first human bird flu case tied to the outbreak in cows in the United States suggests that the Texas man may be the first detected case of the H5N1 virus transmitting from a mammal to a person. Nearly 900 people in 23 countries have been infected with the H5N1 bird flu virus since it started spreading from Southeast Asia in late 2003.

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Expert: Pharmacists Have Vital Role in Multiple Myeloma Treatment

Pharmacy Times

The vice president of pharmacy operations at American Oncology Network says that pharmacists can contribute by educating patients and offering resources for support and treatment adherence.

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Can a Device Be Found Not Substantially Equivalent Because of Cybersecurity Risks? A Review of FDA’s Draft Guidance on Cybersecurity in Medical Devices

The FDA Law Blog

By Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance. The draft guidance provides recommendations on what is required to meet cybersecurity obligations under section 524B of the Food, Drug and Cosmetic Act (FD&C).

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Activist investor urges changes to Novavax board

pharmaphorum

Shah Capital has stepped up its campaign for change at vaccine producer Novavax, lobbying against the re-election of three directors and executive pay packages in a letter to fellow stockholders. The hedge fund says it wants to send a “strong and clear message” to the board at Novavax, reiterating the claim – first made a few weeks ago – that the company is “being hindered by an overly conservative board and management that clings to failed strategies.

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