Wed.May 08, 2024

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Mental Health Awareness Month: Resources Roundup

Drug Topics

Check out this list of resources to share with patients who are experiencing mental health conditions.

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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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Trending Sources

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Pfizer moves to settle more than 10,000 Zantac cases in state courts: Bloomberg

Fierce Pharma

Following the lead of French pharmaceutical giant Sanofi, Pfizer has agreed to settle more than 10,000 personal-injury claims from users of heartburn drug Zantac, resolving litigation in several U. | Following the lead of French pharmaceutical giant Sanofi, Pfizer has agreed to settle more than 10,000 personal-injury claims from users of heartburn drug Zantac, resolving litigation in several U.S. state courts, according to Bloomberg.

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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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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

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Ascension reports systems, clinical operations disrupted amid apparent 'cybersecurity event'

Fierce Healthcare

Ascension disclosed Wednesday that it has detected “unusual activity” on some of its technology networks that it believes “is due to a cybersecurity event.” | The Catholic health giant said it detected "unusual activity" Wednesday and "immediately" activated remediation processes, including hiring a third-party cybersecurity firm.

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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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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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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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STAT+: A nonprofit does deals in Brazil and India to make low-cost CAR-T cell therapies widely available

STAT

In the latest bid to widen access to medicines, a nonprofit is sending technology and materials for making expensive CAR-T cell therapies to the Brazilian government and an Indian manufacturer that will, in turn, look to provide the treatments available at a fraction of current prices in the U.S. The deals will initially involve manufacturing cell therapies for combating lymphoma and leukemia, which carry price tags in the hundreds of thousands of dollars in wealthy nations.

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The Sleepy-Girl Mocktail Trend for Sleep Aid: A Pharmacist’s Perspective

Pharmacy Times

With the current social media trend of the “Sleepy-Girl Mocktail” claiming to provide quality sleep, is this trend fact or faux as a quality sleep aid?

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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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STAT+: In fundamental advance, Google says AlphaFold 3 can map a vast universe of biomolecules

STAT

Google on Wednesday unveiled an artificial intelligence tool capable of predicting the structure and interaction of a vast universe of biomolecules, a fundamental advance that may help scientists unravel poorly-understood aspects of biology and disease. The new AI, dubbed AlphaFold 3, improves upon earlier versions of the model by predicting not just the structure of proteins, but all the molecules that interact with them in cells, including RNA, DNA, ions, and other small molecules.

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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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STAT+: Software glitch caused Tandem insulin pumps to prematurely shut down, FDA warns

STAT

At least 224 diabetes patients have been harmed by a software error causing their insulin pumps to spontaneously shut down, the Food and Drug Administration announced in a recall notice on Wednesday. The product is made by Tandem Diabetes Care, which sells touchscreen insulin pumps and an accompanying app to help dose the medicine. Around 300,000 people use the technology.

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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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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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STAT+: Apple pushes into clinical trials with new FDA nod for Apple Watch

STAT

The Apple Watch has secured a new qualification from the Food and Drug Administration that could make the smartwatch an appealing tool for medical device companies hoping to illustrate the benefits of a common heart procedure. Last week, the Apple Watch’s Atrial Fibrillation History feature became the first digital tool qualified under the Medical Device Development Tools (MDDT) program.

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Officials Release Draft Legislation Aimed at Prescription Drug Shortage Issues

Pharmacy Times

Ongoing and active shortages are currently at the highest number since January 2001.

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Cell therapy fails to slow early type 1 diabetes, but safety is established

STAT

Tolerance is the holy grail in calming autoimmune disease, a truce in the immune system’s faulty battle against the body’s own fabric. In type 1 diabetes, immune fighters attack beta cells in the pancreas that produce insulin, the hormone that controls glucose levels in the blood. Scientists have tried to enlist defenders in the form of regulatory T-cells, or Tregs, extra white blood cells whose job is to tamp down the misguided immune response.

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For every million-dollar gene therapy, Peter Marks gets an email from FDA chief Robert Califf

Fierce Pharma

After Orchard Therapeutics’ gene therapy for a rare genetic disease was approved in March, Peter Marks, M.D., Ph.D., received a simple email from Commissioner Robert Califf, M.D. | After Orchard Therapeutics’ gene therapy for a rare genetic disease was approved in March, Peter Marks, M.D., Ph.D., received a simple email from Commissioner Robert Califf, M.D.

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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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Opinion: Making the promise of monoclonal antibody therapies available to all

STAT

As the U.S. grapples with the lasting effects of the Covid-19 pandemic, it is important to highlight the ongoing challenges faced by the 7 million immunocompromised Americans. For them, the battle against Covid-19 is far from over. Often overlooked or sidelined by newsmakers and policymakers, these individuals continue to confront a heightened risk of severe illness or death due to their compromised immune systems, while society largely adjusts to life with the virus.

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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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Steward Health Care tells bankruptcy court it plans to sell all 31 hospitals, but summer deadline 'not feasible'

Fierce Healthcare

All of Steward Health Care’s hospitals are up for grabs as the now-bankrupt system works to settle its debts, but as of now the company doesn’t believe there will be any closures that would interru | The for-profit, which has about $9 billion in total liabilities, on Tuesday received the go-ahead on a $75 million debtor-in-financing loan. In a virtual hearing, its legal representation bemoaned regulatory delays with its planned physician group sale to Optum that "would have been more than e

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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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Avel eCare to offer virtual behavioral health services to people in crisis in North Dakota

Fierce Healthcare

Avel eCare, provider of clinician-to-clinician telemedicine services, has rolled out its Crisis Care program in central North Dakota to support law enforcement agencies. | The program is a co-responder model that supports law enforcement with 24/7 behavioral health services via cellular-enabled tablets. Participating police departments can leverage the program to assist with de-escalation, stabilization and real-time safety assessment on individuals in crisis.

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Regeneron gene therapy restores hearing in deaf child

pharmaphorum

Regeneron’s gene therapy for otoferlin-related hearing loss restored hearing to normal levels in one profoundly deaf child within just 24 weeks

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Rad AI clinches $50M to scale generative AI tech for radiologists

Fierce Healthcare

Rad AI, a startup that developed an AI platform for radiology, pocketed $50 million in fresh capital to expand global availability of its generative AI solutions. | Rad AI, a startup that developed an AI platform for radiology, pocketed $50 million in fresh capital to expand global availability of its generative AI solutions.

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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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Spectral AI nears first sales of wound care system

pharmaphorum

The first commercial sales of Spectral AI's DeepView wound imaging system for burns are due to start in the UK, its first market, later this year

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AstraZeneca to withdraw Covid-19 vaccine globally

Pharmaceutical Technology

AstraZeneca has begun the global withdrawal of its Covid-19 vaccine Vaxzevria, citing a surplus of updated vaccines.

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12 Questions with Ariel Buda-Levin

pharmaphorum

Get to know Ariel Buda-Levin from the IPG Health Network better with these 12 insightful questions. Learn more about her background, expertise, and experiences.

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Uzedy partners Teva and MedinCell's latest long-acting schizophrenia candidate notches phase 3 win

Fierce Pharma

After bringing slow-release schizophrenia drug Uzedy to market last year, Teva and France’s MedinCell are using the same playbook for a similar candidate. | The companies second go at a long-acting schizophrenia med uses popular antipsychotic olanzapine, which Eli Lilly first marketed in the 90s but found safety issues with its own long-acting version.

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Pharma gets ruthless as job losses mount across industry

pharmaphorum

As pharma R&D jobs face deep cuts, workers struggle with an uncertain future. Can the industry recover or will more jobs disappear?

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Opinion: Listen: Why rehabilitation engineers need to listen to patients and their families

STAT

In 2020, James Sulzer’s personal and professional lives suddenly intersected after his then 4-year-old daughter sustained a devastating injury. As a researcher and associate professor in physical medicine and rehabilitation at Case Western Reserve University, Sulzer has spent his life tinkering with tools that help patients with neurological conditions.

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Clinical trials: Their design, location, and, potentially, their simulation

pharmaphorum

Clinical trials, their design and location, and these days their simulation, are the focus of today’s podcast with Dr Gen Li, founder and president of Phesi.

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