Mon.Jul 15, 2024

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COVID-19 Cases Rise as Omicron-Derived FLiRT, LB.1 Variants Take Hold

Drug Topics

Updated vaccines are expected to be available in the coming months.

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Bird flu snapshot: As the number of infected dairy herds mount, so too does pessimism about driving H5N1 out of cows

STAT

Bird flu snapshot: This is the latest installment in a series of regular updates on the H5N1 flu outbreak in dairy cows that STAT is publishing on Monday mornings. To read future updates, you can also subscribe to STAT’s Morning Rounds newsletter. There are more human cases of H5N1 bird flu infection, and another state has joined the list of those with infected dairy cow herds.

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Trending Sources

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G900 Region In Th2 Differentiation May Have Significant Implications in Asthma, Other Conditions

Pharmacy Times

The findings demonstrate that the mG900 region plays a significant role in Type-2 helper T (Th2) cell differentiation and enhances allergic airway inflammation.

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STAT+: Top FDA officials weighing regulation of ultra-processed foods, internal documents show

STAT

WASHINGTON – Top Food and Drug Administration officials met multiple times earlier this year to discuss the regulation of ultra-processed foods, according to internal agency calendars obtained by STAT. Two FDA officials, Haider Warraich and Robin McKinnon, met multiple times in February to discuss regulating these edible industrial creations, such as sodas, prepackaged cookies, and most breakfast cereals.

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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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Atropos compares how well leading LLMs generate clinical evidence

Fierce Healthcare

A new study released by healthcare AI company Atropos found that general purpose LLMs like ChatGPT, Claude and Gemini are not fit for use in clinical decisionmaking. | Healthcare AI company Atropos conducted a study to test how reliably ChatGPT, Claude, Gemini, OpenEvidence and its own model, ChatRWD, answer clinicians' questions. General use LLMs did not fare well.

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Amgen, BMS and Merck have the most exposure as Big Pharma eyes $183B patent cliff: analyst

Fierce Pharma

While patent cliffs are looming for many of biopharma’s top-selling products, the industry has enormous capacity to respond as “conditions for M&A are favorable,” according to a research note f | While patent cliffs loom for many of biopharma’s top-selling products, the industry has enormous capacity to respond as “conditions for M&A are favorable,” according to a July 11 research note from Morgan Stanley.

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STAT+: The effort to reform physician pay is set to pit primary care docs against highly paid specialists

STAT

WASHINGTON — There’s been a long lull in fighting between primary care and specialty doctors over how much they get paid by Medicare, but that truce might not last if Congress overhauls the system that determines physician payment. This year, Congress began considering changes to the Medicare physician pay system for the first time since creating the current version in 2015.

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FDA proposes cell and gene therapy site tours to help regulators learn from industry

Fierce Pharma

It's no secret that cell and gene therapies have faced manufacturing hurdles as the advanced medicines have become increasingly popular in recent years. | It's no secret that cell and gene therapies have faced manufacturing hurdles as the advanced medicines have become increasingly popular in recent years. Now, the FDA is proposing to work directly with industry through a series of facility tours that could enable both sides to learn something from each other.

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Chicago safety-net hospital's former CFO charged in $15M embezzlement scheme

Fierce Healthcare

A Chicago safety-net hospital’s former chief financial officer and chief transformation officer have been charged for their alleged roles in a scheme to embezzle over $15 million from the nonprofit | Loretto Hospital's chief financial officer as well as its chief transformation officer allegedly authorized payments for bogus vendor goods and services.

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Medication, Health Care Affordability Improved During COVID-19 Pandemic

Drug Topics

Researchers compared health care and prescription medication affordability during the COVID-19 pandemic to pre-pandemic numbers.

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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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FTC probing DaVita, Fresenius Medical Care's noncompetes for dialysis clinic medical directors

Fierce Healthcare

The Federal Trade Commission (FTC) has opened a probe into the country’s two largest dialysis care providers and the terms of their contracts with physicians, according to a weekend report that has | A DaVita representative described a weekend report of the probe as "old news" and "not something that we feel like there’s an enormous amount of stress over.

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J&J’s CAR-T partner Legend Biotech reportedly receives buyout offer

Fierce Pharma

CAR-T specialist Legend Biotech has reportedly received a takeover bid and has tapped Centerview Partners as a financial adviser to evaluate its options, StreetInsider

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No Surprises Act audit finds inaccurate calculations by Aetna of Texas

Fierce Healthcare

The Centers for Medicare & Medicaid Services (CMS) released an audit showing Aetna Health of Texas miscalculated a key metric and was not following federal guidelines as set out by the No Surpr | The first No Surprises Act audit of health plans found significant errors in how Aetna Health of Texas calculated the qualifying payment amount for air ambulance services.

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Q&A: Why more info can lead some women to prefer delaying first mammogram

STAT

The messaging around mammography often doesn’t go beyond this simple three-word refrain: screening saves lives. Medical groups have also moved toward earlier breast cancer screening: The United States Preventive Services Task Force, for example, earlier this year recommended that all women begin screening mammography at age 40. And yet, more women prefer to wait until age 50 to begin screening after learning about breast cancer screening’s benefits and drawbacks, according to a stu

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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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GSK moves back to its roots with new central London headquarters

Fierce Pharma

After two decades headquartered in the West London suburb of Brentford, GSK is officially coming home to central London. | After two decades headquartered in the West London suburb of Brentford, GSK's new digs are officially open and will house 3,000 workers in London's Knowledge Quarter.

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Vertex sues U.S. government over access to fertility support services for Casgevy patients

STAT

One of the makers of Casgevy — the world’s first CRISPR-based medicine —  filed a lawsuit Monday intended to clear the way for the company to pay for fertility preservation services and treatment for people receiving the therapy, which can interfere with reproduction.  In the lawsuit, Vertex Pharmaceuticals challenged an oral opinion issued by the Health and Human Services Office of the Inspector General that its fertility support program would violate federal anti

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How to increase blood oxygen levels

The Checkup by Singlecare

Oxygen is essential to life—just three to six minutes without oxygen can cause brain damage or even death. Your blood oxygen level, or the amount of oxygen circulating in the blood, can be an indicator of your overall wellness. You can even measure your blood oxygen level at home with a device called a pulse oximeter. The device is placed on a finger (a toe or earlobe may also be used) and uses a light to measure your oxygen saturation.

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STAT+: Early data from Lexeo’s gene therapy for rare heart disease shows promise

STAT

Lexeo Therapeutics said Monday that a gene therapy designed to prevent fatal cardiac complications of a genetic disorder called Friedrich’s ataxia reduced signs of heart disease in a handful of patients. The data are very early and less-than-clear-cut. But given a top Food and Drug Administration official’s recent efforts to advance gene therapies under accelerated approval — most notably, with the decision to expand approval for Sarepta’s Duchenne muscular dystrophy

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Biosimilar Disease-Modifying Antirheumatic Drugs Show Potential Cost Savings for Rheumatoid Arthritis

Pharmacy Times

After failure with methotrexate, treatment with leflunomide is typically recommended, but treatment with biosimilars could have greater quality-adjusted life years.

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Women in Science - Jasmina Jankicevic from founding organizations for prevention of HIV to CMO at Innovaderm Research

Outsourcing Pharma

When she was a teenager, Dr Jasmina Jankicevic wanted to research and promote better ways for children and adults to stay healthy, or regain health and well-being.

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Opinion: Medicare drug pricing rules will delay access to promising therapies

STAT

Medicare’s new guidelines cover how it will conduct the drug price negotiations authorized by the Inflation Reduction Act. Unfortunately, the Centers for Medicare and Medicaid Services is interpreting the law in a way that will discourage companies from finding new uses — sometimes lifesaving new uses — for existing drugs. It will also deter companies from doing research on existing medicines to create improved versions that are more effective and have fewer side effects.

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Consumer-Wearable Devices for Patients With Heart Failure, Atrial Fibrillation Have Clinical Implications

Pharmacy Times

Consumer-wearable devices can monitor treatment response and provide continuous health data for patients with heart disease and atrial fibrillation.

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Call goes out for simpler clinical trial regulation in UK

pharmaphorum

Framework governing early-stage clinical trials in the UK is stifling research and needs to be simplified, says BJCP paper

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STAT+: Medicare pay proposals are good news for health tech, bad news for docs

STAT

You’re reading the web version of Health Care Inc., STAT’s weekly newsletter following the flow of money in medicine. Sign up to get it in your inbox every Monday.  Just you, a beach chair, and Medicare regs Medicare dropped its own summer reading list last week — a tidy 3,200 pages of regulations that govern how  doctors , surgery centers, and  hospital outpatient departments will get paid next year.

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Expert: Stigma, Price Point Major Obstacles for Widespread OTC Naloxone Use

Pharmacy Times

Allison Burns, president and CEO of EMO Health, discusses the price point and stigma surrounding OTC naloxone in an interview with Pharmacy Times.

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Mediterranean Diet, Omega-3 Supplements May Reduce Acne Severity

Drug Topics

Patients with acne who adhered to a mediterranean diet and supplemented with omega-3s saw improvements in inflammatory and non-inflammatory lesions.

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Advancements in Oncology: Key Data From the 2024 ASCO Annual Meeting

Pharmacy Times

The 2024 American Society. ofClinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, highlighted significant advancements across various oncology disciplines.

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AstraZeneca’s Tagrisso gains approval in Canada for NSCLC

Pharmaceutical Technology

AstraZeneca has obtained Health Canada’s Notice of Compliance (NOC) for Tagrisso (osimertinib) to treat NSCLC.

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What are the odds we get an heir to Paxlovid?

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Morning! Today, we look at some promising, but early, gene therapy data from Lexeo Therapeutics, examine Medicare’s new price negotiation rules and their impact on innovation, and more.

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Germany inches closer to confidential pricing for drugs

pharmaphorum

Germany inches closer to confidential pricing for patented medicines, with passage of Medical Research Act

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Treating Rheumatoid Arthritis Patients With Biosimilars Versus Leflunomide: An Economic Evaluation

Pharmaceutical Commerce

A study explores the cost-effectiveness of combining methotrexate with various drugs as a way to combat failed methotrexate monotherapy.

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Investors take issue with Taisho Pharma’s buyout price

pharmaphorum

Two investment funds have decided to contest Taisho Pharma’s recently announced management buyout plan in court

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Vertex sues US for right to provide fertility assistance program to gene therapy patients

Fierce Pharma

To receive Vertex and CRISPR Therapeutics’ $2.2 million gene therapy Casgevy for sickle cell disease (SCD) and transfusion dependent beta thalassemia (TDT), patients must first undergo chemotherapy | Vertex has filed a lawsuit in federal court in Washington, D.C. against the U.S. Department of Health and Human Services (HHS) seeking to overturn the “erroneous legal positions” of the agency’s Office of the Inspector General (OIG).

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Lexeo therapy gives hope to Friedreich's ataxia patients

pharmaphorum

An experimental gene therapy developed by Lexeo Therapeutics has shown early promise in treating one of the most serious complications of rare neurodegenerative disorder Friedreich's ataxia (FA).In a phase 1/2 SUNRISE-FA trial, the LX2006 therapy showed a reduction in cardiomyopathy – the most common cause of death in FA – in an initial group of patients with enlarged hearts at the start of the trial.

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