Drug Topics

MAY 10, 2024

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

Hospitals 218

Hospitals 218

Pharmacy Times

MAY 10, 2024

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

FDA 152

FDA 152

STAT

MAY 10, 2024

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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Pharmacy Times

MAY 10, 2024

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.

Vaccines 153

Vaccines FDA 153

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.

STAT

MAY 10, 2024

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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Documentation 144

Pharmacy Times

MAY 10, 2024

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.

Medication Labelling 139

Medication Labelling Labelling 139

Pharmacy Times

MAY 10, 2024

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

Vaccines 151

Vaccines FDA 151

STAT

MAY 10, 2024

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.

Vaccines 144

Vaccines 144

Pharmacy Times

MAY 10, 2024

As pharmacists continue to step into additional roles, culturally competent care becomes an even more essential part of their practices.

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STAT

MAY 10, 2024

BALTIMORE — An ambitious effort to cure HIV with CRISPR genome editing fell short in an early clinical trial, investigators announced Friday morning. In the study, run by Excision BioTherapeutics, researchers tried to use the gene editing tool to address a chief reason HIV has been so hard to cure. While antiviral drugs can clear patients of replicating virus, HIV is able to worm its way into a patients’ own DNA in certain cells.

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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.

FDA

Pharmacy Times

MAY 10, 2024

On this episode, Amie Stephens, Emilee Kennelly, and Max Baire, discuss social determinants of health and how they can impact patient outcomes and medication adherence.

Community Pharmacies 132

Community Pharmacies 132

STAT

MAY 10, 2024

Pizza. Coloring books. Goody bags. They could be activities at a 5-year-old’s birthday party. But they’re not: These are many employers’ attempts to lift the morale of nurses on the frontlines of chronically understaffed organizations. What nurses really want are better working conditions so they can deliver the best care possible to their patients.

Patient Care 135

Patient Care 135

Fierce Pharma

MAY 10, 2024

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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Pharmacy Times

MAY 10, 2024

The Rika system uses an individualized nomogram to help determine the plasma collection volume that is needed for each individual donor.

FDA 137

FDA 137

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Pharmacy Management Software

Drug Topics

MAY 10, 2024

The federal agency said the delay was due to administrative constraints and did not cite any vaccine safety, efficacy or quality issues.

Vaccines 112

Vaccines FDA 112

STAT

MAY 10, 2024

A 30-year-old farm worker in North Carolina died last September on a day that was fairly typical for the state. Temperatures were in the mid-90s and the heat index , which includes humidity, was 96 degrees F. This index is often referred to as the “feels like” temperature, and is commonly used to gauge heat stress on the body. But use of the heat index to gauge whether José Arturo González Mendoza and his fellow sweet potato harvesters could work safety grossly underestim

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Fierce Healthcare

MAY 10, 2024

Below is a roundup of payer-centric news headlines you may have missed during the month of May 2024. | This month, Iowa signed into a law a postpartum Medicaid expansion, L.A. Care Health commited $3 million to providers, Aetna settled a lawsuit alleging fertility discrimination, a former NBA champion was sentenced to prison and more.

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STAT

MAY 10, 2024

After seeing its last deal go bust in the face of regulatory scrutiny, Maze Therapeutics has found another suitor for its experimental Pompe disease treatment.   Bay Area-based Maze and Shionogi said Friday that the Japanese pharma company had licensed the drug, called MZE001, with an upfront payment of $150 million. The global deal includes additional, undisclosed payments if the oral medication, which is in clinical testing, meets certain regulatory and commercial goals.

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pharmaphorum

MAY 10, 2024

The pharma industry is facing major immigration policy changes that will impact hiring of skilled talent. This blog examines new visa and salary requirements for life sciences roles and their effect on the industry.

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STAT

MAY 10, 2024

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hi all. Today we’re talking about improving the global reach of gene therapies, and about why offering access to ancestral populations could be so powerful. We see in a KFF survey that a majority of Americans want obesity drugs to be covered by Medicare, offer up a cool new podcast, and more.

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FDA 111

Fierce Pharma

MAY 10, 2024

After years of missteps in developing and commercializing its coronavirus shot, Novavax is turning to one of the biopharma industry’s most experienced vaccine companies to help salvage its COVID ef | After years of missteps in developing and commercializing its coronavirus shot, Novavax is turning to one of the biopharma industry’s most experienced vaccine companies to help salvage its COVID efforts.

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Vaccines 109

pharmaphorum

MAY 10, 2024

Sanofi has licensed joint commercial rights to Novavax’s COVID-19 vaccine and will work with the biotech on the development of combined flu/COVID shots in a deal worth up to $1.2 billion.

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Vaccines 105

The Checkup by Singlecare

MAY 10, 2024

Vraylar (cariprazine) is a brand-name prescription drug used to treat schizophrenia and bipolar disorder. It is also sometimes used with antidepressants for major depressive disorder. Vraylar is not intended to treat dementia-related psychosis in older adult patients as it may cause an increased risk of death. This drug is part of a class of medications called second-generation, or atypical, antipsychotics.

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Adverse Reactions Documentation Dosage 105

European Pharmaceutical Review

MAY 10, 2024

the success of CGT depends on a robust and reliable supply chain” Cell and gene therapies (CGT) offer a revolutionary approach to the treatment, prevention and potential cure of diseases. These advanced medical treatments provide hope for patients suffering from conditions that have historically been poorly understood and widely considered incurable, including genetic diseases and cancers.

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Communication Hospitals 105

The Checkup by Singlecare

MAY 10, 2024

Trazodone is a prescription serotonin antagonist and reuptake inhibitor (SARI) that is FDA-approved to treat major depressive disorder. Also sold under brand names like Desyrel and Oleptro, this medication affects certain chemicals (or neurotransmitters) in your brain to help alleviate symptoms of depression. Like most antidepressants, trazodone is meant to be taken daily on a long-term basis.

Labelling 105

Labelling Dosage FDA 105

pharmaphorum

MAY 10, 2024

London's burgeoning life sciences scene is kicking off 2024 with optimism as the city prepares to host major conferences like Anglonordic. Discover how antibody discovery biotechs like Alchemab are driving growth and innovation in the sector.

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The Checkup by Singlecare

MAY 10, 2024

Latuda is a brand of lurasidone, a prescription drug used in the treatment of bipolar disorder (specifically, bipolar depression) and schizophrenia. Latuda is part of a class of medications called atypical, or second-generation, antipsychotics. Abruptly stopping a drug like Latuda may result in a rebound of symptoms. Quitting antipsychotics may also cause withdrawal-like symptoms such as nausea , diarrhea , restlessness, and uncontrolled muscle movements.

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Dosage Adverse Reactions 103

Fierce Pharma

MAY 10, 2024

While some biopharma contract manufacturers have been able to weather a tough business environment in recent months, many others continue to struggle against financing headwinds affecting the great | AGC Biologics, which employs more than 2,500 workers worldwide, has “had to reduce positions at our Seattle and Colorado sites and global functional areas,” a spokesperson confirmed Friday in an emailed statement.

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pharmaphorum

MAY 10, 2024

An insightful interview with Peter Stenico, global head of biosimilars and country president, Sandoz Austria at Reuters Pharma Europe, Barcelona 2024

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Outsourcing Pharma

MAY 10, 2024

In an interesting development in the field of rare disease therapeutics, Shionogi & Co., Ltd., and Maze Therapeutics, Inc. have sealed an exclusive worldwide license agreement for MZE001, a novel therapeutic candidate aimed at tackling Pompe disease.

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BioPharm

MAY 10, 2024

Studies conducted by a team at Oxford Biomedica demonstrated that HIC can be used to effectively separate non-deamidated capsids from deamidated capsids.

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Drug Topics

MAY 10, 2024

Dive in and learn more about the answers to yesterday’s quiz.

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The Checkup by Singlecare

MAY 10, 2024

Synthroid ( levothyroxine sodium ) is a prescription drug that works as a synthetic thyroid hormone replacement. It is typically prescribed to people with hypothyroidism (underactive thyroid), a condition where the thyroid does not produce enough hormones naturally. This medication helps replenish and balance thyroid hormone levels in the body, which are necessary for metabolism, energy levels, and overall health.

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Dosage Labelling FDA 88

Pharmaceutical Technology

MAY 10, 2024

The FDA approved WestGene’s mRNA therapeutic cancer vaccine as mRNA cancer vaccine development rises in popularity.

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Vaccines FDA 111