Drug Topics

DECEMBER 20, 2024

With pressure from the House GOP, expected PBM reform was not included in Congress end-of-year spending package.

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Packaging 180

Fierce Healthcare

DECEMBER 18, 2024

It still needs to pass, but an end-of-year package for healthcare is looking probable. The legislation includes PBM reform, telehealth extensions and more.

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Packaging 126

IDStewardship

DECEMBER 15, 2024

In this posta list of peculiar journal articles are highlighted, which may serve as conversationstarters from the medical literature. Authored by: Timothy P. Gauthier, Pharm.D., BCPS, BCIDP Social events like holiday parties or kids birthday parties can be unpredictable. Sometimes you know everyone and it is a lot of fun. Sometimes you do not know many people and you are stuck trying to make conversation with new acquaintances.

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Fierce Pharma

DECEMBER 17, 2024

Johnson & Johnson has received coal in its stocking from the FDA as manufacturing issues have tripped up the companys attempt to gain approval of its subcutaneous version of lung cancer drug R | The FDA has sent complete response letters to Johnson & Johnson and AstraZeneca, rejecting J&J's application for subcutaneous Rybrevant and AZ's bid for a full approval of Andexxa.

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FDA 121

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

Patient Care

Pharmacy Times

DECEMBER 17, 2024

The radiation emerging from these isotopes can be used in 2 different ways in cancer trials: imaging (detection of tumors) and therapy (destruction of tumors).

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Drug Topics

DECEMBER 18, 2024

The American Pharmacists Association announced the inclusion of pharmacist-backed PBM reform in Congress end of the year spending package.

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Packaging 172

Fierce Healthcare

DECEMBER 16, 2024

Pharmacy benefit manager reform is included in a larger-than-anticipated healthcare package, but the PBM lobby is fighting the legislation at the eleventh hour. | With a deal closer than ever, the PBM industry is hoping to sow doubt over provisions in an end-of-year healthcare package.

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Packaging 104

STAT

DECEMBER 20, 2024

Novo Nordisk’s next-generation obesity candidate led patients to lose a substantial amount of weight in a pivotal study but fell short of expectations, results that cast into doubt the future competitiveness of the company in the booming weight loss market. The treatment, called CagriSema, led patients to lose 20% of their weight at 68 weeks in a late-stage study when looking at all participants, including those who dropped out, Novo said Friday.

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Pharmacy Times

DECEMBER 17, 2024

The investigators also find that age of initiation and frequent use were not associated with a greater age-related cognitive decline.

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Drug Topics

DECEMBER 17, 2024

Treatment of comorbidities may help patients overcome resistance or refractoriness to migraine therapies.

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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.

The Checkup by Singlecare

DECEMBER 19, 2024

Tens of millions of people start their day with coffee without a second thoughtmany even find it difficult to have any thoughts at all before their first cup. But if youre taking prescription drugs on a regular basis, such as Linzess (the brand name for linaclotide), you may be wondering if you need to rethink your morning joe. Linzess is an oral medication that is approved by the Food and Drug Administration for the treatment of irritable bowel syndrome with constipation (IBS-C) as well as chro

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Fierce Pharma

DECEMBER 16, 2024

Another checkpoint inhibitor has entered the fray, as Checkpoint Therapeutics has passed the FDAs checkpoint with its PD-L1 inhibitor cosibelimab. | Another checkpoint inhibitor has entered the fray, as Checkpoint Therapeutics has passed the FDAs checkpoint with its PD-L1 inhibitor cosibelimab.

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FDA 100

STAT

DECEMBER 19, 2024

Most of the formularies run by some of the largest health plans in the U.S. generally provide “fair access” to 11 treatments for several serious diseases, although transparent coverage information is often lacking for some medicines, a new analysis has found. Almost uniformly, the 11 formularies made the drugs available fairly when judged on three criteria: eligibility based on clinical data, restrictions placed on prescribers, and step therapy, which requires patients to try other

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Department of Veterans Affairs Insurance 90

Pharmacy Times

DECEMBER 20, 2024

Vanzacaftor/tezacaftor/deutivacaftor (Alyftek) also received approval for the treatment of cystic fibrosis in people 6 years and older who have at least 1 F508del mutation.

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FDA 105

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

Drug Topics

DECEMBER 18, 2024

MannKind announced results from the INHALE-1 study that examined Afrezza in children and adolescents with diabetes.

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The Checkup by Singlecare

DECEMBER 19, 2024

Originally approved to help people with Type 2 diabetes, the class of medications known as GLP-1 agonists and dual GIP/GLP-1s quickly acquired a reputation for helping people shed stubborn pounds. As a result, the use of medications like Ozempic , Wegovy , Zepbound , Rybelsus , and Mounjaro has skyrocketed, as people turned to these medications to help them lose weightcausing drug shortages and creating a market for compounded versions of these brand-name drugs.

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Compounding FDA Labelling Compounding Pharmacies 81

pharmaphorum

DECEMBER 19, 2024

At its third attempt, Mesoblast has secured FDA approval for the first-ever mesenchymal stem cell (MSC) therapy, Ryoncil for acute GvHD in children.

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FDA 96

STAT

DECEMBER 14, 2024

Novo Holdings, the parent company of Novo Nordisk, can proceed with its planned $16.5 billion acquisition of Catalent, a leading contract drug manufacturer, after U.S. regulators declined to challenge the deal following months of scrutiny. The companies expect to close the transaction in the next several days, after a deadline passed for the U.S. Federal Trade Commission to raise objections and other regulatory conditions were fulfilled, according to statements issued by Novo Nordisk and Catalen

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Pharmacy Management Software

Pharmacy Times

DECEMBER 18, 2024

The researchers suggest that an imbalance between pro-inflammatory and resolving lipid mediators may drive tumor growth.

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Drug Topics

DECEMBER 20, 2024

Zepbound from Eli Lilly is the first and only prescription medicine approved by the FDA for adults with obstructive sleep apnea and obesity.

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FDA 131

Fierce Healthcare

DECEMBER 18, 2024

Health AI company Suki rolled out two new features to its Suki AI Assistant powered by Google Cloud. | Suki AI released new features Thursday that brings its technology closer to a general AI assistant for clinicians from just an ambient AI scribing tool. The company touts that it is the first to release a patient summarization and search feature.

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pharmaphorum

DECEMBER 18, 2024

The FDA has started a review of MSD's RSV antibody clesrovimab, a potential rival to Beyfortus, with a verdict due in the middle of next year

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FDA 89

STAT

DECEMBER 19, 2024

The Food and Drug Administration on Thursday confirmed that a shortage of Eli Lilly’s obesity drug tirzepatide has been resolved, a move that will soon put a stop to companies making cheaper copies of the injection. The agency said it would give these compounders a grace period of 60 to 90 days before enforcing rules that would put a halt to their work, in an effort to avoid disruption for patients.

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Compounding FDA Compounding Pharmacies 93

Pharmacy Times

DECEMBER 16, 2024

The approval builds on previous indications for tapinarof, an aryl hydrocarbon receptor agonist, for the topical treatment of atopic dermatitis.

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FDA 95

Drug Topics

DECEMBER 19, 2024

The lawsuit alleges that the company knowingly violated both the Controlled Substances Act and the False Claims Act.

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Controlled Substances 130

Fierce Healthcare

DECEMBER 16, 2024

Medicare Advantage has steadily grown over the past decade, and now encompasses more than half of all seniors eligible for Medicare. | Medicare Advantage has steadily grown over the past decade, and now encompasses more than half of all seniors eligible for Medicare. However, over the past year, the industry has faced significant headwinds that have stymied some of their expansion plans.

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Fierce Pharma

DECEMBER 17, 2024

After pulling off a surprise third-quarter beat and full-year guidance raise amid shareholder activism earlier this year, Pfizer now expects its 2025 revenues to come in the same range as in 2024.< | After pulling off a surprise third-quarter beat and full-year guidance raise amid shareholder activism earlier this year, Pfizer now expects its 2025 revenues to come in the same range as in 2024.

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STAT

DECEMBER 14, 2024

A U.S. government agency warned Sanofi that it faces sanctions over plans to change the way payments are made to most hospitals participating in a drug discount program, the third time in recent months that a major pharmaceutical company has been threatened with such a step. In a Dec. 13 letter , the Health Resources & Services Administration said that if Sanofi proceeds with its plan, the company could be terminated from the 340B Drug Discount Program.

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Hospitals Pharmaceutical Companies Pharmaceutical Companies 84

Pharmacy Times

DECEMBER 16, 2024

Based on positive results from the HERCULES trial, the new designation will allow for more thorough regulatory review and development of the multiple sclerosis treatment.

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FDA 91

Drug Topics

DECEMBER 20, 2024

Recent upticks of the bird flu virus in both dairy cattle and humans have also led to a state of emergency in California.

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Fierce Healthcare

DECEMBER 18, 2024

AppliedVR continues to build out clinical evidence to support the use of immersive therapeutics to address chronic pain. | The company's flagship virtual reality device for chronic lower back pain delivered meaningful reductions in pain intensity for patients, particularly for high-impact chronic pain patients, according to a recent clinical study.

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pharmaphorum

DECEMBER 19, 2024

Novo Holdings' $16.

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STAT

DECEMBER 18, 2024

Hello, everyone, and how are you today? We are doing just fine, thank you, especially since the middle of the week is upon us. After all, we have made it this far so we are determined to hang on for another couple of days. And why not? The alternatives — at least those we can identify — are not so appetizing. And what better way to make the time fly than to keep busy.

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FDA 98