Drug Topics

JUNE 17, 2024

The world’s information is at our fingertips, but understanding that information and applying it to patient care still requires a rigorous education.

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Patient Care 211

Pharmacy Times

JUNE 21, 2024

The quadruplet regimen added bortezomib to the current standard of care, which is a triplet regimen of isatuximab, lenalidomide, and dexamethasone for patients with transplant-ineligible, newly diagnosed multiple myeloma (NDMM TI).

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STAT

JUNE 20, 2024

For a third time, Sarepta Therapeutics has convinced a top Food and Drug Administration official to overrule the prevailing view of their staff and approve a drug for Duchenne muscular dystrophy. On Thursday evening, the FDA announced it expanded the approval of Elevidys, Sarepta’s Duchenne gene therapy, to cover nearly all patients, regardless of age or wheelchair status, despite the fact that the drug failed a large, Phase 3 trial last year.

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FDA Documentation 145

Fierce Pharma

JUNE 20, 2024

For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. | For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. For Gilead, it serves as one of two pieces for a potential FDA filing. For GSK, it means a major competitor could be looming around the corner.

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FDA 144

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.

Drug Topics

JUNE 21, 2024

In a webinar conducted by the National Foundation for Infectious Diseases (NFID), experts gathered to publicly address the ongoing bird flu outbreak across many US states.

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Pharmacy Times

JUNE 21, 2024

With improved technology and innovations for diabetes, it is essential for health care providers and health agencies to collaborate to combat rising rates of diabetes.

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FDA 138

Fierce Healthcare

JUNE 21, 2024

The Fifth Circuit Court of Appeals has issued a decision in a major legal case that observers have said could fundamentally alter the preventive services provision in the Affordable Care Act. | The Fifth Circuit Court of Appeals has issued its ruling on Braidwood Management v. Becerra, a case that has wide-ranging implications on millions of Americans.

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Drug Topics

JUNE 17, 2024

Clinical recommendations for the management of type 1 diabetes (T1D) in older adults are urgently needed as the global population ages and as improved diabetes care and management of complications have extended the life expectancy of the patient population.

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Pharmacy Times

JUNE 19, 2024

Being able to communicate in a different language can improve treatment adherence and medication efficacy outcomes

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Communication 170

STAT

JUNE 20, 2024

Gilead said Thursday that twice-a-year injections of a new antiviral drug, called lenacapavir, completely protected cisgender women from contracting HIV in a large Phase 3 trial. In the study, none of the 2,134 women who received lenacapavir contracted HIV. By comparison, 16 of the 1,068 women who received the long-running daily pill Truvada contracted HIV.

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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

Fierce Pharma

JUNE 17, 2024

The FDA has approved the world’s first pneumococcal disease vaccine designed for adults, signing off on Merck’s Capvaxive (formerly V116) and positioning it to become the primary shot used by senio | The FDA has approved the world’s first pneumococcal disease vaccine designed for adults, signing off on Merck’s Capvaxive (formerly V116) and positioning it to become the primary shot used by seniors to protect against the bacterial infection.

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Vaccines FDA 137

Drug Topics

JUNE 18, 2024

Sandra C. Canally, RN, founder and CEO of The Compliance Team, discussed the goals, benefits, and opportunities of value-based care in pharmacy.

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Pharmacy Times

JUNE 18, 2024

The findings also show that skin testing positivity for perennial allergens was higher in patients with childhood-onset asthma compared with those with adult-onset asthma.

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STAT

JUNE 20, 2024

In a surprise move, Doctors Without Borders is closing down its access-to-medicines campaign, which has been credited with ensuring needed drugs and vaccines have been made available to countless patients in low-income countries around the world. The organization plans to close its campaign by the end of this year and create a new effort devoted to access to products for health care.

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Vaccines 145

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Fierce Healthcare

JUNE 17, 2024

Color Health is working with OpenAI to test out computer-generated personalized care plans for cancer patients. | Color developed a new copilot app that leverages GPT-4o to identify missing diagnostics and create tailored workup plans for patients.

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Drug Topics

JUNE 19, 2024

Medication nonadherence can account for up to 50% of treatment failures and over $500 billion in annual health care costs.

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Pharmacy Times

JUNE 20, 2024

Ambient-UVB radiation could improve 25(OH)D prediction in the future, improving widespread vitamin D deficiencies among non-White individuals.

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STAT

JUNE 21, 2024

As a toddler, Veronica Ayala loved Fridays. At 5 o’clock sharp, her mom whisked her away from the grim Moody State School for Cerebral Palsied Children for a 48-hour reprieve. Ayala’s house was mere minutes away, but the doctors insisted that she had to live at the Galveston, Texas institution during the week so she could learn how to walk.

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Fierce Healthcare

JUNE 17, 2024

Amazon Pharmacy is expanding its prescription drug subscription program, called RxPass, to Prime members on Medicare insurance. | The RxPass program, launched in January 2023, provides unlimited access to 60 eligible generic medications and will ship the medications to customers' homes for a flat monthly fee of $5.

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Insurance 131

Drug Topics

JUNE 21, 2024

Four abstracts presented at ASCO 2024 delved into cannabis and pain management, potential medication interactions, and symptom mitigation, in patients with cancer.

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Pharmacy Times

JUNE 17, 2024

Persistent chemotherapy drug shortages challenge oncology providers. American Oncology Network employs a drug shortage committee for organized shortage management that involves pharmacists and interdisciplinary stakeholders.

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Chemotherapy 132

STAT

JUNE 20, 2024

Change Healthcare is beginning the process of notifying a “substantial proportion” of Americans that their private information, such as Social Security numbers and medical diagnoses, was compromised in the cyberattack that brought portions of the U.S. health care system to a halt earlier this year. On Thursday, Change will begin to notify health care providers, insurance companies, and other customers that their patients’ data was stolen in the company’s February cybe

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Insurance 145

Fierce Healthcare

JUNE 17, 2024

LAS VEGAS — Last week, leaders across the health insurance industry descended on Sin City to dig deep into the biggest topics facing payers. | LAS VEGAS — Last week, leaders across the health insurance industry descended on Sin City to dig deep into the biggest issues facing payers.

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Insurance 131

Drug Topics

JUNE 19, 2024

In 2 abstracts presented at ASCO 2024, researchers addressed the use of GLP-1s for weight loss and to reduce cardiovascular outcomes in women with breast cancer.

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Pharmacy Times

JUNE 17, 2024

The FDA approved blinatumomab for treatment of patients with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia.

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FDA 139

STAT

JUNE 20, 2024

A coalition of researchers, historians, and journalists is urging that major scientific publishers, including Elsevier and Springer, retract the racist articles of an academic known — and sometimes lauded for — a long career espousing ideas of racial superiority and eugenics. The call for retraction, made Thursday in a First Opinion published in STAT, focuses on hundreds of papers published by the late Richard Lynn of the University of Ulster, who has described “the decay of

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Fierce Pharma

JUNE 20, 2024

There’s no slowing the momentum of Sarepta’s groundbreaking Duchenne muscular dystrophy (DMD) gene therapy Elevidys—not even the failure of a confirmatory trial. | The FDA has expanded the label for Sarepta's Elevidys to all Duchenne muscular dystrophy patients ages 4 and older. It’s a major boost for the first gene therapy to treat the inherited disorder, which received an accelerated approval a year ago—nearly to the date—but only for ambulatory boys ages 4 to 5.

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Labelling FDA 123

Pharmaceutical Technology

JUNE 17, 2024

Novavax has sought US FDA approval for an updated JN.1 version of its Covid-19 vaccine, NVX-CoV2705, for individuals aged 12 years and above.

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Vaccines FDA 145

Pharmacy Times

JUNE 18, 2024

The indication is for adult patients with primary advanced or recurrent endometrial carcinoma and is the third indication that pembrolizumab has received for this disease state.

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Chemotherapy FDA 121

STAT

JUNE 21, 2024

WASHINGTON — A House panel is exploring holding a vote on scaled-back versions of two major health care bills that would expand Medicare’s coverage of cancer screening tests and hugely popular weight loss drugs, five sources familiar with the planning told STAT. Full Medicare coverage for both items has broad bipartisan support, but the expansion has been hampered by the likely exorbitant price tags to the federal government.

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Fierce Pharma

JUNE 18, 2024

Kansas Attorney General is accusing Pfizer of "misrepresenting" its vaccine's safety and efficacy in a 179-page civil suit.

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Vaccines 145

Drug Topics

JUNE 18, 2024

The vaccine covers 8 serotypes not currently covered by any FDA-approved pneumococcal vaccines.

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Vaccines FDA 199

Pharmacy Times

JUNE 21, 2024

There are numerous challenges with cell and gene therapies in oncology, such as accessibility, cost, and prior authorizations, as well as the need for improved education and training within the oncology community.

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STAT

JUNE 20, 2024

The Food and Drug Administration on Thursday approved Elevidys, Sarepta’s gene therapy for Duchenne muscular dystrophy, for nearly all patients with the fatal muscle-wasting disease, dramatically expanding the initial, narrow authorization handed down last year. The decision will likely be greeted by many families and doctors as a turning point in the fight against the muscle-wasting disease, even if it’s not nearly the seismic shift some had hoped for just a couple of years ago.

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FDA 143