STAT

JUNE 24, 2024

Since Texas’ ban on abortion went into effect, infant deaths in the state increased by nearly 13%, according to a new analysis published on Monday in JAMA Pediatrics. In the rest of the country, infant mortality increased less than 2% over the same period. “We had read the literature that was showing an association [of infant death increases] with prior abortion restrictions or states that are hostile to abortion,” said lead author Alison Gemmill, a demographer and perinatal

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Pharmacy Times

JUNE 24, 2024

Teplizumab (Tzield; Sanofi) has the potential to delay type 1 diabetes and the onset of stage 3 diabetes, but must be started in stage 1 of the disease.

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STAT

JUNE 24, 2024

Bird flu snapshot: This is the second installment in a series of regular updates on H5N1 avian flu that STAT is publishing on Monday mornings. To read future updates you can also subscribe to STAT’s Morning Rounds newsletter. As the H5N1 outbreak in dairy herds approaches the three-month mark, America’s top animal health official is calling on farmers to step up the use of personal protective equipment, limit traffic onto their farms, and increase cleaning and disinfection practice

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Fierce Healthcare

JUNE 24, 2024

The Department of Health and Human Services (HHS) is locking in its enforcement strategy to keep healthcare providers from blocking access to electronic health information. | Providers found to have committed information blocking will face financial repercussions tied to Medicare program participation as well as the public disclosure of the enforcement.

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Hospitals 131

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

JUNE 24, 2024

Alnylam Pharmaceuticals said Monday that its treatment for an increasingly common heart condition cut the risk of death and recurrent cardiovascular complications in a key Phase 3 study, paving the way for the likely approval of the drug. Specifically, on that composite primary endpoint, the drug, called vutrisiran, reduced the risk by 28% compared with placebo in the overall trial population, which included some people who were already taking a treatment for the disease considered the standard

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Labelling 144

Fierce Pharma

JUNE 24, 2024

In one of the most closely watched biotech trial readouts of the year, Alnylam Pharmaceuticals said its RNA interference drug reduced the risk of death or recurrent cardiovascular events in patient | In one of the most closely watched biotech trial readouts of the year, Alnylam Pharmaceuticals said its RNA interference drug reduced the risk of death or recurrent cardiovascular events.

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pharmaphorum

JUNE 24, 2024

Explore how digital twins are transforming healthcare and drug discovery, with success stories showcasing their impact in the biopharma industry. Learn about their journey from concept to real-world applications.

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STAT

JUNE 24, 2024

WASHINGTON — He hardly seems the part of the telehealth industry’s public enemy No. 1. He’s unassuming, self-effacing, soft-spoken, with the bearing of a professor. But as telehealth lobbyists seize on this moment years after pandemic lockdowns to win new protections and incentives from Capitol Hill, Ateev Mehrotra is the industry’s chief critic — determined to warn congressional committees that the booming virtual care business comes with tradeoffs.

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Drug Topics

JUNE 24, 2024

Discover how regulatory advancements are shaping the future of pharmacy automation. Our white paper explores the collaborative efforts between industry leaders and regulatory bodies, highlighting the pivotal role of regulations in advancing pharmacy practices. Learn how automation, including robotics and intelligent software, can enhance pharmacist efficiency and patient care.

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Patient Care 98

STAT

JUNE 24, 2024

When a new medical device hits the market, there’s typically still some uncertainty about whether it works. Device makers generally do not have to submit as much, or as rigorous, clinical data to the Food and Drug Administration as their biotech counterparts. Once FDA regulators decide a device is safe and effective, companies and researchers then attempt to track how the device performs in the real world.

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Insurance Hospitals FDA 126

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 24, 2024

After losing round one of its respiratory syncytial virus (RSV) vaccine bout with GSK, Pfizer is rallying. | After losing round one of its respiratory syncytial virus (RSV) vaccine bout with GSK, Pfizer is rallying. And what better way to do it than to win a major contract in your rival’s home country? The U.K. government has selected Pfizer to supply 5 million doses of its RSV shot Abrysvo over the next two years.

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Vaccines 121

STAT

JUNE 24, 2024

It’s been two years since America’s highest court removed a constitutional right — for the first time in history — that Americans have relied on for almost 50 years. Its Dobbs decision opened a Pandora’s box of attacks on reproductive care. On June 24, 2022, six Supreme Court justices decided to legislate from the bench, overturning Roe v.

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Fierce Pharma

JUNE 24, 2024

Following Novo Nordisk’s recent Wegovy approval to cut heart risks in adults with obesity, Eli Lilly appears to be homing in on the next potential label expansion for its rival GIP/GLP-1 weigh | Late last week, Lilly shared detailed results from its phase 3 SURMOUNT-OSA study, which found that Zepbound at the 10 mg and 15 mg doses aced its primary and secondary endpoints in obese patients with obstructive sleep apnea (OSA).

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Labelling FDA 112

STAT

JUNE 24, 2024

The results of a randomized controlled trial published Monday showed oral ketamine tablets were safe and effective for patients with treatment-resistant depression — the latest attempt by researchers to rigorously evaluate psychedelic drugs’ role in treating conditions like depression, anxiety and post-traumatic stress disorder. In the Phase 2 trial, the results of which were detailed in Nature Medicine , patients who took extended release ketamine tablets at an 180mg dosage twice

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Dosage 114

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Fierce Healthcare

JUNE 24, 2024

Higher care costs directly following a hospital merger have a downstream effect of local employers laying off a portion of their workers, according to a new National Bureau of Economic Researc | A new analysis ties merger-driven hospital price increases to higher employer insurance premiums and subsequent headcount reductions.

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Hospitals Insurance 109

STAT

JUNE 24, 2024

Good morning, everyone, to another working week. We hope the weekend respite was relaxing and inspiring, because that oh-so familiar routine of online meetings, deadlines, and what-not has predictably returned. But what can you do? The world, such as it is, continues to spin. So time to give it a nudge in a better direction with a cup or more of stimulation.

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Packaging 110

Fierce Healthcare

JUNE 24, 2024

UnitedHealthcare is betting big on its Surest unit as the insurer releases new data on where the plan has seen success in the past several years. | UnitedHealthcare is betting big on its Surest unit as the insurer releases new data on where the plan has seen success in the past several years.

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Insurance 108

STAT

JUNE 24, 2024

VALLETTA, Malta — The most sweeping corruption trial in the history of this Mediterranean country kicked off with a former prime minister and a host of top government officials parading through a phalanx of police into a courthouse. Hundreds of onlookers crammed narrow cobblestone streets, some screaming of their distrust in the government and disdain for the men who allegedly used their power to line their pockets.

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Hospitals 108

Fierce Healthcare

JUNE 24, 2024

Digital health company Sharecare has agreed to be acquired by private equity firm Altaris for $1.43 in cash per share, or about $518 million. | Digital health company Sharecare has agreed to be acquired by private equity firm Altaris for $1.43 in cash per share, or about $518 million.

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The Checkup by Singlecare

JUNE 24, 2024

If you have recurring back or neck pain or are dealing with an acute muscle spasm, over-the-counter pain medications, like ibuprofen , can offer much-needed relief. When those treatments still aren’t taking the edge off, your healthcare provider might prescribe something stronger, such as cyclobenzaprine. Also known by the brand name Flexeril, this medication is FDA approved to treat muscle spasms associated with painful musculoskeletal conditions.

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FDA 105

Pharmaceutical Technology

JUNE 24, 2024

The osteoporosis market is expected to grow at a compound annual growth rate of 5.4% from 2023 to 2032, reaching $17.9bn across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) by the end of this forecast period, according to leading data and analytics company GlobalData’s recent report: Osteoporosis: Seven-Market Drug Forecast and Market Analysis.

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Compounding 105

pharmaphorum

JUNE 24, 2024

Daiichi Sankyo has a second approval in Japan for Ezharmia, its first-in-class dual EZH1 and EZH2 inhibitor, as a treatment for relapsed or refractory peripheral T-cell lymphoma (PTCL).Ezharmia (valemetostat tosylate) remains the first and only drug in the class to be approved for marketing around the world, having been cleared in Japan in 2022 for relapsed or refractory adult T-cell leukaemia/lymphoma (ATL).

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STAT

JUNE 24, 2024

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. On top of today’s Alnylam news, we have Congress gearing up to vote on Medicare coverage for multi-cancer screenings and obesity drug coverage. Also, updates on Vertex’s type 1 diabetes cell therapy, and a push for phage therapy.

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FDA 102

pharmaphorum

JUNE 24, 2024

Fenofibrate, a decades-old drug used to lower cholesterol levels, has been shown to reduce the progression of diabetic retinopathy in a large-scale trial.

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Fierce Healthcare

JUNE 24, 2024

The Supreme Court will not hear a legal challenge to the nearly $2.7 billion Blue Cross Blue Shield settlement. | The Supreme Court will not hear a legal challenge to the nearly $2.7 billion Blue Cross Blue Shield settlement.

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Pharmacy Times

JUNE 24, 2024

Compared to placebo, nicotinamide riboside significantly improved the 6-minute walking capabilities in patients with decreased endurance and muscle function due to peripheral artery disease.

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Fierce Pharma

JUNE 24, 2024

Following a yearslong back-and-forth in the courts, a clutch of major drugmakers will get to re-challenge allegations that the companies helped fund terrorism through their business dealings in Ira | After a long legal dispute, a clutch of major drugmakers will get to re-challenge claims that they helped fund terrorism through their business dealings in Iraq.

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Pharmacy Times

JUNE 24, 2024

Shahida Choudhry, PharmD, shares her journey in pharmacy ownership.

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Fierce Pharma

JUNE 24, 2024

Despite coming to market second, Bristol Myers Squibb’s Mirati Therapeutics-inherited cancer med Krazati has gained the lead on its Amgen rival Lumakras in a heated KRAS race. | Late Friday, the U.S. FDA granted an accelerated approval for BMS’ KRAS inhibitor Krazati plus Eli Lilly’s Erbitux (cetuximab) to treat certain chemotherapy-experienced adults with KRAS-mutated locally advanced or metastatic colorectal cancer.

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FDA Chemotherapy 91

Pharmacy Times

JUNE 24, 2024

Adagrasib receives accelerated approval for patients with previously treated KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC).

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FDA 136

Pharmaceutical Commerce

JUNE 24, 2024

A study examines the economical validity of using this therapy as a treatment for unresectable stage III non–small cell lung cancer.

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pharmaphorum

JUNE 24, 2024

Alnylam shares spike after vutrisiran aces HELIOS-B trial in ATTR-cardiomyopathy, setting up regulatory filings

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Pharmacy Times

JUNE 24, 2024

This case highlights the legal principle of premises liability

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pharmaphorum

JUNE 24, 2024

Bristol-Myers Squibb’s KRAS inhibitor Krazati has been approved for a second indication, colorectal cancer

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FDA 110