Sat.May 04, 2024 - Fri.May 10, 2024

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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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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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Farmers resist push for workers to wear protective gear against bird flu virus

STAT

WASHINGTON — The Centers for Disease Control and Prevention recommended this week that dairy and poultry farms with infected animals supply protective gear to workers in a bid to stave off human transmission of the H5N1 virus. The challenge now is making it happen. The CDC has no legal authority to order those protective measures, and health officials in some of the nine states with reported outbreaks in cattle have had little luck getting farmers to take them up on offers of free persona

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Justice Department 'upping its game' on healthcare antitrust enforcement with new task force

Fierce Healthcare

The U.S. Department of Justice announced Thursday it has established a new task force to take on healthcare monopolies and collusion. | The U.S. Department of Justice announced Thursday it has established a new task force to take on healthcare monopolies and collusion.

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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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FDA Approves sBLA for Adalimumab-adaz as Interchangeable Biosimilar for Humira

Pharmacy Times

A provisional determination is also provided for the 40 mg/0.4 mL strength due to remaining interchangeability designation for another biosimilar to Humira.

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Insulin App Recall Prompts FDA Warning After More Than 200 Reported Injuries

Drug Topics

Tandem Diabetes Care, Inc has reported 224 injuries associated with a software malfunction in a companion insulin app, leading the company to issue a recall of the technology.

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More Trending

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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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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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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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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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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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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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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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Ascension Hospitals Face Disruptions from Suspected Cyberattack

Drug Topics

The company, which operates 140 care sites across the country, was forced to shut down health systems earlier this week because of the disruption.

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Federal officials will fund farms’ protective measures to contain H5N1 bird flu

STAT

WASHINGTON — The federal government will provide livestock farms as much as $28,000 apiece to bolster protective measures and testing for the avian flu virus spreading among dairy cows, officials said Friday. The Agriculture Department also allotted $98 million to aid states restricting the interstate movement of affected cattle, and health officials announced they would put an additional $101 million toward expanded surveillance, tests, treatments, and vaccines for the virus, which has n

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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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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 WGc-043, EB Virus-Related mRNA Therapeutic Cancer Vaccine for Use in Clinical Trials

Pharmacy Times

This is the first approval of an EB virus-related mRNA therapeutic cancer vaccine and is a landmark achievement in future research on cancer treatment.

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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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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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Crafting a Recipe for Research Success in Pharmacy Residency Programs

Pharmacy Times

Multiple preparatory steps are involved in creating a delicious meal. Planning, preparation, and revision are similarly important in building a successful residency research program.

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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+: 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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House's updated biosecurity bill sets 2032 decoupling deadline for industry's work with WuXi AppTec

Fierce Pharma

Right after an industry survey suggested that switching away from Chinese CDMOs could take biopharma companies up to eight years, lawmakers have adjusted the BIOSECURE Act. | Right after an industry survey suggested that switching away from Chinese CDMOs could take biopharma companies up to eight years, lawmakers have adjusted the BIOSECURE Act. The new draft lays out a 2032 deadline for the separation mandate.

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Develop Strategies for Managing Medications During Sick Days

Pharmacy Times

Strategies for intervention design focused on opportunities for both patients and providers by way of medication labeling, specific prescription instructions, prescribing prompts, and educational services.

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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+: No, alcohol isn’t good for you. Will new dietary guidelines be shaped more by health or industry interests?

STAT

In 1995, when Marion Nestle was on the committee drafting the Dietary Guidelines for Americans, things were run differently. She and other experts handled it all: deciding on nutrition-related research questions, collecting the evidence, issuing a scientific report, and then writing guidance for how Americans should eat. When it came time for that last part — the writing — Nestle and two co-authors got together at a bar, ordered glasses of wine, and got to work.

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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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FDA Approves WGc-043, EB Virus-Related mRNA Therapeutic Cancer Vaccine

Pharmacy Times

This is the first approval of an EB virus-related mRNA therapeutic cancer vaccine and is a landmark achievement in the treatment of cancers.

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A CPT code for prior authorization? Here’s how it could happen

Fierce Healthcare

One physician is making the case that prior authorization for procedures should be reported to insurance plans as a CPT code—and the proposal could pass this week at an American Medical Association | A New York urologist believes prior auth CPT codes will realign incentives and better support patients and physicians.

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STAT+: Sanofi enters vaccine licensing deal with Novavax, giving beleaguered biotech a lifeline

STAT

LONDON — Novavax, the beleaguered maker of a Covid-19 vaccine, just got a boost of its own.   The French pharma company Sanofi on Friday said it had reached a licensing deal to sell Novavax’s Covid shot going forward as well as to try to combine the vaccine with Sanofi’s own flu shot. The pact includes a $500 million upfront payment, with up to $700 million more on the table if certain regulatory and launch milestones are reached.

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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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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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Clover Health authorizes $20 million share buyback program

Fierce Healthcare

Clover Health is raising its full-year adjusted EBITDA guidance and announced a share repurchase program of up to $20 million over the next two years, the insurtech said ahead of its first quarter | Clover Health announced an improved year-over-year adjusted EBITDA, insurance revenue and MCR during its first quarter earnings call.

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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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