Wed.Oct 02, 2024

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5 Questions With a Pharmacist: Lea Wolsoncroft from Remedies Pharmacy

Drug Topics

In an installment of Drug Topics’ 5 Questions With a Pharmacist, Lea Wolsoncroft of Remedies Pharmacy in Hoover, Alabama, discussed what is going on in her pharmacy practice.

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Was Missouri’s bird flu case a one-off or something more? Quest for answers faces testing delay

STAT

U.S. health officials have run into obstacles in their efforts to determine whether a Missouri person infected with H5N1 bird flu passed the virus on to others, causing a delay that will likely fuel concerns about the possibility that there has been human-to-human transmission. The Centers for Disease Control and Prevention has blood samples from several health workers and a household contact of the Missouri case that it plans to test for antibodies that would indicate whether they too had been

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FDA Grants Priority Review to Trastuzumab Deruxtecan for HER2-low, HER2 Ultralow Breast Cancer

Pharmacy Times

The designation was based on results from the DESTINY-Breast06 trial, evaluating fam-trastuzumab deruxtecan-nxki (Enhertu; AstraZeneca, Daiichi Sankyo) compared with chemotherapy.

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Why a map of a fruit fly’s brain has neuroscientists ‘blown away’

STAT

Mapping the brain is a daunting task because it contains a huge number of cells and cell connections. It took almost 50 labs around the world to create a new neural map, or connectome, of an adult fruit fly — the largest map of its kind, and an effort that will allow researchers to better understand the brain’s inner workings. Access to the full connectome, as published Wednesday in a series of papers in Nature , could represent a new era for neuroscience, according to some re

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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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Cocaine, Cannabis Use Significantly Increased Cardiovascular Events

Drug Topics

In posters presented at the Heart Failure Society of America 2024 Annual Meeting, researchers assessed how substance use disorders impact cardiovascular outcomes.

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STAT+: After Cassava Alzheimer’s drug fiasco, the FDA must intervene to protect patients

STAT

For nearly a year, my stance on Cassava Sciences and its Alzheimer’s disease drug candidate simufilam has been clear: Emerging evidence shows the drug is inert, and patients with Alzheimer’s were misled into participating in ongoing Phase 3 clinical trials, so therefore, the Food and Drug Administration must take immediate steps to protect these vulnerable people from further harm.

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FDA Grants IND for RespiRx Inhalable Nicotine Replacement Therapy

Pharmacy Times

In a phase 1 trial, the nicotine replacement therapy (NRT) demonstrated a higher mean maximum plasma concentration was achieved faster than with an existing inhaled NRT.

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Examining Guideline-Directed Medical Therapy in Patients with HFrEF

Drug Topics

Several posters presented at the Heart Failure Society of America 2024 Annual Meeting looked into the landscape of guideline-directed medical therapy.

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Op-Ed: Lower Prescription Drug Costs, Pass PBM Reform Legislation

Pharmacy Times

Lowering prescription drug costs for patients, saving taxpayers money, helping small businesses level an anti-competitive playing field: all of this is at stake.

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GLP-1 Therapies Reduce Risk of Cirrhosis, Complications of MASLD

Drug Topics

Investigators compared semaglutide and other glucagon-like peptide-1 receptor agonists with dipeptidyl peptidase-4 inhibitors.

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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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STAT+: Key lawmakers pressure Biden to preserve telehealth prescribing of effective addiction treatment

STAT

Key federal lawmakers are pressuring the Drug Enforcement Administration to preserve health providers’ ability to prescribe a highly effective opioid addiction treatment via telehealth.  In a letter delivered to the Biden administration on Wednesday, a bipartisan group led by Rep. Annie Kuster (D-N.H.) urged the DEA to continue allowing health providers to prescribe buprenorphine, a controlled substance used to treat opioid addiction, without requiring an in-person visit.

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Physical Frailty Prominent in Women, Retired or Unemployed Patients with Heart Failure

Drug Topics

Among patients with heart failure, researchers aimed to understand the association between social detriments of health and physical frailty.

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J&J's Erleada prevails over Astellas, Pfizer’s Xtandi in real-world prostate cancer study

Fierce Pharma

While they were both approved several years back to treat the same two types of prostate cancer, Astellas and Pfizer’s Xtandi has held a larger slice of the market than Johnson & Johnson’s riva | A real-world, head-to-head study of two androgen receptor pathway inhibiting (ARPI) prostate cancer drugs indicates that Johnson & Johnson’s Erleada provides an edge in overall survival versus Astellas and Pfizer’s Xtandi.

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Data Supports Approval of Biosimilar Aflibercept for Diabetic Macular Edema

Pharmacy Times

In May 2024, the first biosimilars for aflibercept were approved, which included aflibercept-jbvf (Yesafili; Biocon Biologics), known as MYL-1701P.

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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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Humana's stock stumbles after it reveals 2025 star ratings drop

Fierce Healthcare

Humana's stock took a tumble early on Wednesday after it revealed in a filing with the Securities and Exchange Commission that its Medicare Advantage star ratings had declined significantly. | Humana's stock took a tumble early on Wednesday after it revealed in a filing with the Securities and Exchange Commission that its Medicare Advantage star ratings had declined significantly.

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Opinion: When should marijuana use deny a patient an organ transplant?

STAT

In 2023, Kentucky became the most recent state to pass a law prohibiting the denial of organ transplantation to patients solely because of their marijuana use. The legislation is scheduled to go into effect Jan. 1, 2025. Over the past 11 years, similar measures have been enacted in 21 other states. Though these laws overstep into medical decision-making, they are part of a rising trend.

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DOJ urges district court not to toss antitrust case against UPMC

Fierce Healthcare

A proposed class action lawsuit brought by healthcare workers accusing UPMC of wielding its market power to suppress the labor market has picked up support from the U.S. Department of Justice. | The federal government filed a statement of interest in support of a proposed class action alleging the large nonprofit used its market power to suppress wages and worker mobility.

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Daratumumab-Based Regimen Shows Efficacy in All Patients With Multiple Myeloma, Regardless of Cytogenic Risk

Pharmacy Times

The benefits of the daratumumab-based regimen were seen in all patients, including those with high and standard cytogenic risk levels.

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PE Firm TPG buys majority stake in health information network Surescripts

Fierce Healthcare

TPG bought a majority stake in health information network Surescripts to fuel more investment in its technology solutions and possible M&A deals, the companies announced Tuesday. | PE firm TPG Capital bought a majority stake in Surescripts to fuel more investment in its technology solutions and possible M&A deals, the companies announced Tuesday.

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STAT+: Gilead strikes voluntary licensing deals in poor countries for its pricey HIV drug

STAT

In response to increased criticism of its pricing, Gilead Sciences has reached voluntary licensing deals with companies to make generic versions of its twice-yearly HIV medicine, lenacapavir, in 120 mostly low- and lower-middle-income countries. The move comes after a pair of late-stage clinical trials found the injectable medicine was highly effective in preventing HIV, paving the way for the company to seek regulatory approval for pre-exposure prophylaxis, or PrEP.

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Amgen to face investor lawsuit over $10.7bn tax liability disclosure

pharmaphorum

A federal judge in New York has ruled that Amgen must answer to claims of misleading investors about billions owed to US tax authorities, allowing a securities-fraud class action to proceed against the pharmaceutical giant.

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STAT+: CVS could break itself up. Why, and what does that mean for you?

STAT

Blame the pickleball paddles. Over the past year, CVS has made a concerted push to court seniors to enroll in its Aetna Medicare programs by offering free sports equipment, fishing rods, and other enticements. It worked maybe a little too well for CVS, as the surge in new customers backfired when the medical costs for those sporty seniors spiraled well beyond the company’s expectations.

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Blue Shield of California bypasses PBMs to slash Humira prices by 90%

pharmaphorum

In a bold move to tackle soaring drug costs, Blue Shield of California is pioneering a strategy that bypasses traditional pharmacy benefit managers to slash the cost of Humira by 90%

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STAT+: ResMed CEO on how wearables, GLP-1s will impact sleep apnea device sales

STAT

NEW YORK — The morning after presenting an upbeat outlook to analysts in a gilded hall in the New York Stock Exchange building, Mick Farrell, the CEO of ResMed, looked refreshed, despite a post-presentation cocktail reception. If the sleep tech magnate could have used more shuteye, he didn’t show it. Farrell leaned forward enthusiastically to inspect data from a reporter’s Apple smartwatch showing that it hadn’t detected signs of sleep apnea.

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Onyda XR, First Liquid Nonstimulant for ADHD, Now Available in US

Drug Topics

The once-daily, extended release, oral suspension medication was approved by the FDA in May 2024.

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Aspen Neuroscience, underway with Parkinson's cell therapy trial, bolsters manufacturing with new San Diego facility

Fierce Pharma

Aspen Neuroscience, underway with Parkinson's cell therapy trial, bolsters manufacturing with new San Diego facility fkansteiner Wed, 10/02/2024 - 07:31

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STAT+: Humana tumbles as insurer faces $3 billion hit to revenue over lower Medicare star ratings

STAT

Humana’s Medicare business has taken a financial beating all year, and it’s only going to get worse.

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Amgen can't sidestep investor lawsuit over $10.7B tax bill

Fierce Pharma

Roughly a year and a half after the introduction of a shareholder lawsuit, Amgen has lost its bid to toss the case accusing the California biotech giant of concealing a massive tax bill with the IR | New York District Judge John Cronan has rejected Amgen’s motion to dismiss an investor lawsuit—originally filed by a Michigan-based union pension fund—accusing the company of hiding a $10.7-billion tax bill from the public.

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STAT+: The biotech scorecard for the fourth quarter: 14 stock-moving events to watch

STAT

Here is STAT’s biotech scorecard, our regular ledger of stock-moving biotech events, for the fourth quarter: Rarely before has a large-cap biotech had so much riding on the outcome of a Phase 2 study as Amgen does with its obesity treatment MariTide , also known as AMG 133. Results are coming before the end of the year. Novo Nordisk will report results of a Phase 3 study involving its obesity drug candidate CagriSema before the end of this year.

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CMS readies changes for 2nd round of drug price negotiation program

Fierce Healthcare

The Centers for Medicare & Medicaid Services (CMS) rolled out guidance Oct. 2 as stakeholders prep for the second round of the drug price negotiation program. | CMS is looking to increase feedback from drug manufacturers and foster better communication with pharmacies as stakeholders prep for the next round of drug price negotiations.

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STAT+: Lawmakers want FTC to probe big PBMs over private-label biosimilar deals

STAT

A pair of U.S. lawmakers is urging the Federal Trade Commission to investigate the parent companies of two large pharmacy benefit managers over concerns that new business units might unfairly steer patients toward higher-cost medicines. The effort comes after CVS Health and Cigna — which own CVS Caremark and Express Scripts, respectively — launched subsidiaries that are striking “co-manufacturing” deals with companies that make biologic medicines and lower-cost versio

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Lymphoplasmacytic Lymphoma Vaccine Leads to Potential Clinical Benefit as Early Intervention

Pharmacy Times

Patients exhibited improved disease-free progression with minimal adverse effects.

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Revisionist history on healthcare at the VP debate

pharmaphorum

In the VP debate, Tim Walz and JD Vance were forceful, unexpectedly convivial, and fast and loose with the facts, particularly on healthcare.

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Study Results Show Flu Vaccination Not Associated With Risk of Adverse Perinatal Outcomes

Pharmacy Times

The findings support current recommendations for pregnant individuals or those who might become pregnant during the influenza season, specifically those with successive pregnancies.