May, 2024

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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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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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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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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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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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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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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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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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Elevating Pharmacists, Empowering Pharmacy Technicians: A Symbiotic Journey in Health Care Excellence

Pharmacy Times

As pharmacy practice continues to evolve, it is imperative to recognize the vital contributions of all members of the pharmacy team, including pharmacy technicians.

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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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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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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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FDA Approves Second Formulation of Humira Biosimilar Cyltezo

Drug Topics

According to Michael Osso, president and chief executive officer of the Crohn’s & Colitis Foundation, “the flexibility of having multiple biosimilar formulations to choose from is important to support broader patient access to biologic medicine.

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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 Accepts Biologics License Application for Subcutaneous Formulation of Nivolumab

Pharmacy Times

The new administration method, which is co-formulated with rHuPH20, is usable in previous approved nivolumab indications for solid tumors in adult patients.

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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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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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'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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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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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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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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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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Kenvue maps out hundreds of layoffs as service pact with J&J winds down

Fierce Pharma

Even after consumer outfit Kenvue split from Johnson & Johnson one year ago, the company has been performing certain services for the pharma and medtech giant as part of a transition process. | Kenvue’s board of directors on Monday approved a plan to cut 4% of the company’s global workforce. The J&J spinoff employed about 23,000 staffers at the end of last year, so the layoff initiative could affect some 920 workers.

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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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Prevention revolution: How digital tools can help us get ahead of health problems

pharmaphorum

Discover how digital tools can provide insights to help us. Digital technology could be a game-changer that offers the elusive promise of tackling the root cause, not just the conditions themselves, when it comes to human health.

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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+: Young boy dies in trial for Pfizer Duchenne gene therapy

STAT

A young boy died in a trial for Pfizer’s experimental gene therapy for Duchenne muscular dystrophy, the company told patient advocates Tuesday. The boy was enrolled in Daylight, a trial studying the treatment in boys aged 2 or 3. The boy had received the therapy early last year, Pfizer told the advocates in a note posted online by Parent Project Muscular Dystrophy.

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Treatment Options for Hemophilia A and B

Pharmacy Times

With gene therapy, anti-tissue factor pathway inhibitors, and RNA interference therapy targeting antithrombin, there are many new options that will be available for the patients impacted by hemophilia.

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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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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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Sorcero genAI conjures plain language from scientific papers

pharmaphorum

Understanding complex scientific studies is often a challenge for patients as well as healthcare professionals, but one that may become easier thanks to artificial intelligence.

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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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Opinion: As livestock move around the country, so does H5N1. The U.S. needs real-time tracking of livestock movements

STAT

The presence of H5N1 avian influenza virus, better known as bird flu, among dairy cows in Texas — the second largest producer of dairy cattle — was first confirmed in late March. By then, H5N1 had likely been circulating among dairy cows for months. Six weeks later, the nine states responsible for more than one-quarter of U.S. dairy production, which accounts for 3.5% of the U.S.

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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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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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New collective of women's health companies aims to scale access to specialty care

Fierce Healthcare

A newly formed group of women’s health companies aims to tackle gaps in care, with a focus on improving outcomes while reducing costs. | A newly formed group of women’s health companies aims to tackle gaps in care, with a focus on improving outcomes while reducing costs.

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