Wed.Nov 22, 2023

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Expert Discusses Biosimiliars Influencing Pricing of Biologic Drugs

Pharmacy Times

Denise Giambalvo, director of Member Engagement & Business Strategy at the Washington Health Alliance and recently led a biosimilars initiative for the coalition, discusses biosimilar influence of pricing for biologic drugs, trends to expect in 2024, and why education on biosimilars are important for patients, pharmacists, prescribers, and more

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Opinion: Physician and Rep. Raul Ruiz: The infectious disease doctor shortage threatens future pandemic preparedness

STAT

In 2009, I was practicing in the emergency department when the H1N1 pandemic emerged. Then, I saw firsthand the vital role infectious disease physicians played in not only facilitating a coordinated public health response, but also helping patients, providers, and the public navigate the uncertainty that comes with confronting a novel virus. While on the frontlines of that pandemic, I depended on our community’s infectious disease specialists as I worked in real-time to provide patients w

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FDA Issues Fast Track Designation to ADP101 for Mono-, Multi-Food Allergies

Pharmacy Times

The designation allows expedited development of ADP101 as a treatment for food allergy in children ages 4 to 17 with confirmed allergy to 1 or more of the 15 foods in the drug product.

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Overdose deaths during pregnancy spiked over the past few years, study says

STAT

Overdose deaths among pregnant or postpartum people skyrocketed between 2018 and 2021, according to new research published Wednesday in JAMA Psychiatry. The study, conducted by the National Institute on Drug Abuse (NIDA) and the National Institutes of Health, compared the incidence of maternal deaths for overdose of commonly misused psychotropic drugs (such as heroin and other opioids, including synthetic ones, or cocaine) among girls and women aged 10 to 44.

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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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Pneumococcal Conjugate Vaccines Reduce Invasive Disease, Though Coverage Not Optimal

Pharmacy Times

Serotype 19A is still the most prevalent serotype for pneumococcal disease, with study authors calling for additional studies to determine the full burden of invasive pneumococcal disease.

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STAT+: U.S. Anesthesia Partners, Welsh Carson face class action over monopoly allegations

STAT

Union health plans that represent electricians and plumbers in Texas have filed a class-action lawsuit against physician group U.S. Anesthesia Partners and private equity firm Welsh, Carson, Anderson & Stowe. The lawsuit builds on the Federal Trade Commission’s complaint filed in September, which argued USAP and Welsh Carson illegally bought up anesthesia practices across Texas as a way to concentrate market power, gain negotiating leverage over health insurance companies, and raise p

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CGM Technology Bridges the Gap in Type 2 Diabetes Care for Underserved Patients

Drug Topics

Increased health care access to devices like the continuous glucose monitor (CGM) could improve health outcomes for underserved patients who may otherwise be hindered from their use.

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To address shortage, Novo Nordisk will cut production of Victoza to boost supply of Ozempic

Fierce Pharma

Unable to scale up its manufacturing fast enough to meet the spiraling demand for its GLP-1 weight loss products, Novo Nordisk is employing a new strategy—reducing production of diabetes drug Victo | Unable to scale up its manufacturing fast enough to meet the spiraling demand for its GLP-1 weight loss products, Novo Nordisk is employing a new strategy—reducing production of diabetes drug Victoza to make more Ozempic.

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FDA to Review sBLA For Idecabtagene Vicleucel in the Early Treatment of Adult Patients with RRMM

Pharmacy Times

The review comes after phase 3 trial results that indicate an improvement in overall survival and progression-free survival, reducing the risk of disease progression and death.

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Pfizer's cost-savings mission continues with office shuffle, job cuts in Ireland

Fierce Pharma

Pfizer, working through a $3.5 billion cost-cutting drive, is not done yet making changes to its workforce in Ireland. | Pfizer's commercial office in Citywest, Dublin, will move to its Ringsend office building, the Irish Independent reports. The moves could end in more job cuts in the company's commercial division.

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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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4.5M have signed up for coverage on the ACA exchanges so far in open enrollment: CMS

Fierce Healthcare

Open enrollment on the insurance marketplaces began on Nov. | Open enrollment on the insurance marketplaces began on Nov. 1, and more than 4.5 million people have selected plans in the early weeks of the process, according to new federal data.

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What’s behind the urge to scratch that itch? Harvard researchers have a theory

STAT

That itchy feeling isn’t just in your head, in some cases it might actually be all over you. And it may literally get on your nerves. New research published Wednesday in Cell indicates that a common skin bacterium — Staphylococcus aureus — can make you feel itchy by directly acting on nerve cells. Even though itchiness is an everyday sensation, its causes remain mysterious.

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Ayble Health, Mayo Clinic collaborate to treat high-acuity patients in person

Fierce Healthcare

Ayble Health, a digital health platform for patients with chronic gastrointestinal conditions, has announced a new collaboration with the Mayo Clinic. | Ayble is working with the Mayo Clinic Complex Care Program to offer a hybrid care model to match patients with the appropriate virtual and in-person care based on acuity and need.

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AbbVie flexes litigation muscle with Rinvoq patent lawsuit against Sandoz, other generic players

Fierce Pharma

Looking to protect its lucrative immunology drug Rinvoq, AbbVie is suing a clutch of generic drug makers that are attempting to market copycat versions of the blockbuster. | In a lawsuit filed in Delaware federal court Monday, AbbVie accused Sandoz, Hetero Labs, Aurobindo Pharma, Intas Pharmaceuticals and Sun Pharmaceutical of trying to sidestep dozens of patents protecting Rinvoq through the next decade.

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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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Memorial Hermann implementing Laudio's AI platform to reduce admin burden on frontline workers

Fierce Healthcare

Memorial Hermann Health System is implementing Laudio’s platform to enhance employee efficiency and engagement. | Memorial Hermann Health System is tapping Laudio’s AI platform to promote efficiency and engagement among its employees.

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STAT+: Health tech startups warn that overregulating AI could hamper innovation

STAT

Entrepreneurs across the country desperate to bring the power of AI into health care are urging Washington to consider the risk of blocking innovation, bringing into focus a chasm between the startup world’s race toward deployment and regulators’ attempts to protect patients from harmful, biased algorithms. Over the next two months as the Department of Health and Human Services stands up its own AI task force — a mandate under the White House’s recent 111-page order o

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Pharmacy Technician Roles Are Growing and Expanding

Pharmacy Times

The rapidly changing environment is creating new responsibilities for all staff, including technicians

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Former Paige CEO betting big on AI in microbiome medicine with new startup Jona

Fierce Healthcare

Health tech veteran Leo Grady believes the microbiome is going to revolutionize healthcare. | Leo Grady, the former CEO of Paige, saw an opportunity to leverage his work in healthcare AI to unlock the microbiome for health. He launched Jona, a company that provides an at-home microbiome profiling kit and then uses AI to analyze an individual's gut microbiome to deliver actionable, personalized insights.

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What you need to know about treating skin tags

The Checkup by Singlecare

Skin tags are one of those things you probably don’t think about until you spot one. These small skin growths known as acrochordons are like tiny flaps of skin that don’t belong. At first glance, you may fear it’s a symptom of psoriasis , eczema , HPV warts, or skin cancer —but skin tags are common, noncancerous, and essentially harmless. In fact, according to the American Academy of Dermatology, 60% of American adults will experience skin tags at some point in their lives.

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STAT+: Evelo Biosciences, a microbiome company launched by Flagship, shuts down

STAT

Evelo Biosciences, a startup hoping to use the trillions of microbes in and on the human body to fight disease, is shutting down after running low on cash and seeing multiple drug trial failures. The biotech, which was based in Cambridge, Mass., launched in 2015 and was one of the first companies in the microbiome field, which seeks to treat disease by leveraging bacteria naturally found in and around the body.

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Novartis drops subpoena request in trade-secret spat with Takeda

Fierce Pharma

Novartis has withdrawn its request to access Takeda’s documents as part of an investigation over potential trade secrets theft. | Novartis has withdrawn its request to access Takeda’s documents as part of an investigation over potential trade-secrets theft.

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Maternal Diet Plays Role in Shaping Childhood Wheeze Trajectories

Drug Topics

Maintaining a healthy diet before pregnancy was associated with a 10% reduced risk of children developing 'transient early' and 'persistent' wheeze patterns.

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Medtronic isn’t afraid of Wegovy’s potential to disrupt

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hello, everyone. Damian here with an update on biotech’s silly season, a looming showdown in Washington, and the latest twist in the Ozempic panic. This newsletter is taking the next couple days off in the spirit of the holiday, but we’ll be back in your inbox Monday morning.

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Study Links False-Positive Mammography Result to Increased Breast Cancer Risk

Drug Topics

Findings detailing long-term breast cancer outcomes for women who receive a false-positive result underscore the significance of false-positive results as a critical public health issue.

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Opinion: Listen: Living in cancer limbo

STAT

Fifteen years ago, Mara Buchbinder and colleagues came up with the concept of the “patient in waiting.” The concept described a new category of patients created by cutting-edge testing — say, prenatal diagnostics that alerted parents to potential problems, even though they might not appear. The patient in waiting was, quite literally, someone who was waiting to see if they would become ill.

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Eli Lilly supports Alto Neuroscience in $45m Series C round

Pharmaceutical Technology

The funding will go towards the development of the company's four CNS candidates, with Phase II study data readouts expected by early 2025.

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Researchers Create Growth Chart from AI-Based Tool to Measure Muscle Mass

Pharmacy Times

The growth chart could be a fast and accessible resource to indicate lean muscle mass in children.

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Pharmalittle: European patent agency invalidates a Moderna mRNA patent; pharma ally Eshoo plans to retire

STAT

Good morning! This is Jonathan Wosen, West Coast biotech and life sciences reporter, filling in for Ed Silverman while he’s away from the Pharmalot campus. There won’t be a newsletter this Thursday or Friday because of the Thanksgiving holiday. Speaking of which, if you wake up tomorrow and realize that your turkey hasn’t thawed, never fear, you can safely cook a fully or partially frozen turkey, according to the U.S.

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Talking techbio with NVIDIA: Accelerated computing, NLP, and GenAI in drug discovery

pharmaphorum

Talking techbio with NVIDIA: Accelerated computing, NLP, and GenAI in drug discovery Mike.

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Emicizumab Adherence in Hemophilia A: Real-World Insights

Pharmacy Times

Experts discuss adherence to emicizumab in real-world settings, comparing it to factor products and highlighting the convenience and ease of administration associated with emicizumab.

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Chutes & Ladders—New CEO atop Mount Sinai Health System summit

Fierce Healthcare

Welcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry.

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Watch DSN: The vital link between literacy and community health

Drug Store News

Denine Torr, executive director of the Dollar General Literacy Foundation and Dollar General's vice president of corporate social responsibility and philanthropy, shares how laying the groundwork for literacy can boost community health outcomes.

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Signal: Moderna mRNA patent revoked by EPO after Pfizer suit

Pharmaceutical Technology

Pfizer and BioNTech countersued Moderna following an initial August 2022 suit alleging that its patents were overly broad.

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EC approves first-line ovarian cancer treatment

European Pharmaceutical Review

The European Commission (EC) has authorised a Type II variation for the poly (ADP-ribose) polymerase (PARP) inhibitor Rubraca ® (rucaparib). The small molecule treatment is indicated as a first-line maintenance treatment for individuals with advanced ovarian cancer regardless of their BRCA mutation status, who have responded to first-line platinum-based chemotherapy.