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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In-House Health nabs $4M to build out AI-enabled scheduling platform for nursing teams

Fierce Healthcare

Almost every hospital and health system currently struggles with a growing workforce shortage and rising costs to deliver care. Agencies have stepped in to fill the gap, often resulting in unp | In-House Health developed an artificial intelligence-driven scheduling and management platform for modern nursing teams. The startup picked up $4 million in seed funding from NEA and TMV to build out its platform.

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STAT+: Gene therapy trial targeting rare form of deafness shows ‘jaw-droppingly good’ results

STAT

Two congenitally deaf children can hear for the first time after being treated with gene therapy, according to data presented at a conference Wednesday. The results are “jaw-droppingly good, just shocking how good. It exceeded the wildest expectations of anybody who started this work,” said Larry Lustig, an otolaryngologist at Columbia University and an investigator on the study.

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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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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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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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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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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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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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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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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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Opinion: It shouldn’t be easy to buy synthetic DNA fragments to recreate the 1918 flu virus

STAT

It should be hard — exceedingly hard — to obtain the synthetic DNA needed to recreate the virus that caused the deadly 1918 influenza pandemic without authorization. But my lab found that it’s surprisingly easy, even when ordering gene fragments from companies that check customers’ orders to detect hazardous sequences. Our experiment demonstrates that the immense potential benefits of biotechnology are profoundly vulnerable to misuse.

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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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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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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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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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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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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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Potential best-in-class antibody shows “remarkable efficacy” in atopic dermatitis

European Pharmaceutical Review

New data from a Phase IIa trial in moderate-to-severe atopic dermatitis has demonstrated that a novel monoclonal antibody (mAb) could facilitate dosing every 12 weeks for induction therapy. This is due to a 31-day half-life at anticipated therapeutic dose levels, Inmagene Biopharmaceuticals confirmed. Humanised anti-OX40 IgG1 mAb IMG-007 works via a silenced antibody -dependent cellular cytotoxicity (ADCC) function, Inmagene explained.

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Is it safe to take trazodone while pregnant?

The Checkup by Singlecare

Trazodone is a serotonin antagonist and reuptake inhibitor (SARI), a type of antidepressant medication that is FDA approved to treat major depressive disorder. It is also often prescribed off-label to treat other conditions such as sleep disorders , anxiety, substance abuse, eating disorders, Alzheimer’s disease, and fibromyalgia. In other words, there are a lot of different reasons you may be taking this medication when you decide to become pregnant.

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OTC Product Roundup: Skin Care

Drug Topics

Spring and summer not only bring sunshine, but also stronger UV rays. Whether you are barbecuing, swimming, or taking a hike, skin protection is paramount while soaking up the sunshine.

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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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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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Slideshow: The Gut-Skin Connection

Drug Topics

Recent research exploring the gut-skin connection shows that dietary modifications and probiotic supplements may help skin conditions like acne, atopic dermatitis, and rosacea.

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Brain worms are more common than you think. Here’s what doctors who’ve treated them say.

STAT

Yes, it’s possible to have a worm living in your brain — in fact, it’s far more common than you might think, said Dr. David Hamer, a professor of global health and medicine at the Boston University School of Public Health, who also directs a travel clinic at Boston Medical Center. Brain worms became a topic of public fascination Wednesday after the  The New York Times  reported that presidential candidate Robert F.

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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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