Sat.Sep 14, 2024 - Fri.Sep 20, 2024

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GSK Announces Positive Topline Data for Co-Administration of RSV, Shingles Vaccines

Drug Topics

A co-administration option for both vaccinations can increase the likelihood of older adults completing the vaccination series and improve health outcomes for the patient population.

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FTC formally sues PBMs over insulin prices and warns manufacturers

Fierce Healthcare

The Federal Trade Commission is suing the titans of the pharmacy benefit manager industry for anticompetitive practices and artificially raising the price of insulin drug prices, the agency announc | As expected for weeks, the Federal Trade Commission is taking legal action against the biggest three PBMs and its related group purchasing organizations.

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Second health care worker tied to Missouri bird flu case had respiratory symptoms

STAT

A second health worker who cared for a person hospitalized in Missouri with H5N1 bird flu developed mild respiratory symptoms but was not tested for influenza, the Centers for Disease Control and Prevention reported on Friday. The CDC said Missouri health officials didn’t learn that the health worker had symptoms until after the individual had recovered, too late to run a diagnostic test.

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RFID Technology and the DSCSA: Paving the Way for a New Standard in Patient Care

Pharmacy Times

The Drug Supply Chain Security Act (DSCSA) will soon mandate end-to-end tracking of pharmaceuticals throughout the supply chain, with numerous benefits for health systems.

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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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FTC Files Lawsuit Against ‘Big 3’ PBMs for Drug Price Inflation

Drug Topics

In its first move since the July interim report detailing pharmacy benefit manager practices, the FTC is now suing CVS Caremark, Express Scripts, and Optum Rx.

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Nvidia's venture arm backs $17M investment in Hippocratic AI to build out generative AI healthcare agents

Fierce Healthcare

Three months ago, startup Hippocratic AI released its first commercial product, a generative AI-based, task-specific healthcare agent. | Nvidia's venture capital arm, NVentures, along with Greycroft and Lee Shapiro of 7Wire Ventures, backed a $17 million investment in Hippocratic AI to fuel its product development of generative AI "agents.

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The DETECT V Trial: Exploring Chemotherapy-Free Treatment for HER2+/HR+ Metastatic Breast Cancer

Pharmacy Times

Data from the second interim analysis of the DETECT V trial, presented at ESMO Congress 2024, suggest that a chemotherapy-free regimen combining dual HER2-targeted therapy with endocrine therapy, particularly with the addition of ribociclib, may be an effective treatment for patients.

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Cigna’s PBM Express Scripts Files Lawsuit in Response to July FTC Report

Drug Topics

The health care giant’s pharmacy benefit manager subsidiary filed a lawsuit claiming that the FTC’s recent 6(b) report was false and misleading.

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Indiana insurers, hospitals accused of Medicaid fraud in giant whistleblower lawsuit

Fierce Healthcare

Major Indiana managed care organizations and health systems are blamed for defrauding the state Medicaid system by tens, if not hundreds, of millions of dollars, says a newly unsealed whistleblower | A newly unsealed lawsuit alleges major health insurers and health systems defrauded Indiana Medicaid by hundreds of millions of dollars, with the government office likely influenced by corporate lobbying.

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Long-overlooked scientist shares Lasker Award with other GLP-1 researchers

STAT

GLP-1 based drugs are transforming the treatment of obesity and opening up new avenues for addressing heart disease , addiction , and even Alzheimer’s. Now, three scientists who played key roles in their invention have won a prestigious Lasker Award for biomedical research.  Announced on Thursday in New York, the Lasker-DeBakey Clinical Medical Research Award will be shared by Svetlana Mojsov and Joel Habener , who identified and characterized the GLP-1 hormone in the 1980s whil

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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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Organon pays up to $1.2B to acquire Dermavant and its steroid-free skin cream Vtama

Fierce Pharma

With its latest acquisition, women’s health outfit Organon is bringing its dermatology business to the U.S. with a potential blockbuster in tow. | Organon is set to acquire Roivant’s immuno-dermatology subsidiary Dermavant for up to $1.2 billion, the companies announced Wednesday. The crown jewel of the deal is undoubtedly Vtama, Dermavant’s steroid-free cream for plaque psoriasis, which is looking at a major expansion opportunity in eczema.

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Q&A: PCMA on the Role of PBMs and Drug Pricing Transparency

Drug Topics

Johnny Garcia, Senior Director of Policy at the Pharmaceutical Care Management Association, discussed the common misconceptions surrounding PBMs and their role within the supply chain.

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Standardizing Infusion Pumps in Large Health Systems Enhances Safety

Pharmacy Times

Analyzing consolidation of 8 drug pump libraries into 1 IV infusion library in a 9-hospital system: from standardization to implementation.

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FDA approves first at-home flu vaccine in U.S., a nasal spray

STAT

The Food and Drug Administration on Friday approved AstraZeneca’s bid to allow its nasal spray influenza vaccine, FluMist, to be sold for home administration.  Starting next flu season, people who want to order the vaccine to give it to themselves or their children at home will be able to do so.

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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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Express Scripts files suit against FTC, demands retraction of report on PBM industry

Fierce Healthcare

Express Scripts has filed suit against the Federal Trade Commission, demanding that the agency retract a damning report on the pharmacy benefit management industry. | Express Scripts is suing the Federal Trade Commission, demanding that the agency retract a damning report on the pharmacy benefit management industry.

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Q&A: PCMA on Drug Pricing and the Pharmaceutical Supply Chain

Drug Topics

Johnny Garcia, Senior Director of Policy at the Pharmaceutical Care Management Association, discussed ongoing issues within the pharmaceutical supply chain and his organization’s role within it.

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Mild Cognitive Impairment is Extremely Undiagnosed, Expert Says

Pharmacy Times

The chief product and strategy officer at Linus Health is hopeful that pharmacists can be key players in the detection of mild cognitive impairment.

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Year-long fallout over retracted trans youth paper highlights new research era

STAT

Last year, a Springer Nature journal published a study surveying 1,700 parents of adolescents and young adults with gender dysphoria. Just a few months later, the study was retracted because there had been no formal process for those parents to consent to the study. But the story didn’t end there. Ongoing fallout from the paper and its retraction has opened up an internal rift among academic editors and journal staff that led to one editor’s resignation, as first reported by Retrac

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Noom to offer compounded GLP-1 drug to rival pricey branded weight loss meds

Fierce Healthcare

Noom is the latest digital health company to jump into the off-label weight loss drug market to make medications more accessible to consumers. | Noom is the latest digital health company to jump into the off-label weight loss drug market to make medications more accessible to consumers.

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Opill Marks a New Era for Birth Control Access

Drug Topics

Stephanie Sober, MD, MSHP, shares insights into the research that led to Opill’s FDA approval and its implications for women’s access to contraception.

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Study Finds Women With Asthma Are More Likely to Need Fertility Treatments

Pharmacy Times

The authors also found that there was a higher frequency of miscarriages compared with women who did not have asthma.

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Pediatricians’ obesity guidelines rest on shaky evidence about eating disorder risks

STAT

To address soaring rates of childhood obesity, the American Academy of Pediatrics last year endorsed tactics it once considered risky.  “Watchful waiting” had been standard practice, in part from concern that a doctor’s focus on weight could inadvertently plant the seed for stigma or eating disorders like anorexia and bulimia.

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Hackensack Meridian Health inks partnership with K Health to roll out virtual primary care service

Fierce Healthcare

New Jersey-based Hackensack Meridian Health is teaming up with K Health to launch a new 24/7 virtual primary care service to provide easier access to the health system's clinicians. | New Jersey-based Hackensack Meridian Health is teaming up with K Health to launch a new 24/7 virtual service to provide easier access to the health system's clinicians for primary care.

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FDA Approves Benralizumab for Eosinophilic Granulomatosis with Polyangiitis

Drug Topics

The approval was based on data from the phase 3 MANDARA trial, where the therapy met the primary endpoint of proportion of patients in remission at weeks 36 and 48.

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FDA Approves Isatuximab With Bortezomib, Lenalidomide, and Dexamethasone for NDMM

Pharmacy Times

The decision expands treatment options for patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM).

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Opinion: Tested in Africa, used in America

STAT

At the recent annual International AIDS Conference, a startling presentation about the newest wonder drug in HIV prevention brought a raucous standing ovation. Lenacapavir, a novel drug given as an injection under the skin every six months, was 100% successful in preventing HIV in adolescent girls and young women in two countries in Africa. It felt to many like a generational moment.

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Senate HELP Committee votes for civil, criminal charges after Steward CEO dodges subpoena

Fierce Healthcare

The Senate Committee on Health, Education, Labor and Pensions voted unanimously Thursday morning to bring civil enforcement and a criminal contempt charge against Steward Health CEO Ralph de la Tor | Ralph de la Torre, M.D., invoked the Fifth Amendment in his refusal to appear before Congress. Sens. Sanders and Cassidy said that he must invoke that right in person and in response to specific questions during testimony.

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Examining the Impact of ePROMs in a Pharmacist-Led Telephone Clinic

Drug Topics

Patients who completed electronic patient-reported outcome measures said they made them feel more involved in their care and better supported.

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Granules India scolded over truckloads of torn manufacturing documents after recent FDA inspection

Fierce Pharma

From truckloads of torn documents to avian incursions in the production plant, Granules India’s recent manufacturing reprimand from the FDA is alarming no matter which way you look at it. | Earlier this month, Granules was slapped with a Form 483 following an inspection of its Telangana facility in India that ran from Aug. 26 to Sept. 6. The FDA’s report cites six observations around poor quality control procedures, subpar cleaning, cross-contamination risks and more.

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Opinion: What the doctors’ protests in India are missing

STAT

In early August, a doctor was raped and murdered in a Kolkata public hospital by a “ civic volunteer ” who was neither a patient nor a staff member. The crime has enraged and rattled the medical profession in India. For weeks now, doctors have been protesting throughout the country, demanding among other things “justice for the victim” and a safer work environment.

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Amazon inks digital health partnership with Talkspace, adds mental health provider to health conditions program

Fierce Healthcare

Amazon has added virtual behavioral health provider Talkspace to its health conditions program, a service it rolled out in January to help connect customers with virtual care benefits. | Amazon has added virtual behavioral health provider Talkspace to its health conditions program, a service it rolled out in January to help connect customers with virtual care benefits.

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Liraglutide with Lifestyle Interventions Decreased BMI for Children 6 to 11

Drug Topics

Compounded with lifestyle interventions, researchers compared liraglutide with a placebo to measure its efficacy amongst children under 12 years old.

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Bristol Myers Squibb axes 79 more in NJ as $1.5B cost-reduction program rolls on

Fierce Pharma

The hits just keep on coming for Bristol Myers Squibb staffers amid the company's cost-savings program. | Bristol Myers Squibb is laying off an additional 79 staffers in Lawrenceville, New Jersey. The cuts will be effective between Dec. 12 and May 30 of next year and are part of BMS's $1.5 billion cost reduction program.

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Opinion: End the ‘forced swim test’ on mice for antidepressant research

STAT

In 2022, more than 22 million Americans had serious thoughts of suicide or had made a plan to end their life. To treat depression, the leading cause of suicide death, there is an urgent need for novel antidepressants, as existing ones are only effective roughly 50% of the time. But there is a serious problem with the way we conduct research to improve depression treatment.

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