Wed.Nov 01, 2023

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Study Data Show That Time-Restricted Eating May Be Effective for Weight Loss in Patients With Type 2 Diabetes

Pharmacy Times

This “refreshing alternative” to calorie restriction does not include calorie counting, yet it is naturally associated with greater energy restriction compared to the latter.

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CVS Health beats the Street with $2.3B in Q3 profit

Fierce Healthcare

CVS Health beat the Street on both earnings and revenue in the third quarter, reporting $2.3 billion in profit. | By comparison, the company reported a $3.4 billion loss in the third quarter of 2022 as it paid out its part in a global settlement over the opioid crisis.

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Infant mortality in the U.S. rose last year for the first time in two decades, says CDC

STAT

The U.S. infant mortality rate rose 3% last year — the largest increase in two decades, according to the Centers for Disease Control and Prevention. White and Native American infants, infant boys and babies born at 37 weeks or earlier had significant death rate increases. The CDC’s report, published Wednesday, also noted larger increases for two of the leading causes of infant deaths — maternal complications and bacterial meningitis.

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What Pharmacists Need to Know to be Successful with Medical Billing

Drug Topics

Mary Stoner, president of Electronic Billing Services Inc., sat down with Drug Topics at NCPA 2023 to discuss the billing process for non-dispensing services in pharmacies.

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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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New antibiotic targets gonorrhea as well as last existing treatment, study shows

STAT

An important Phase 3 trial has shown that a new drug that targets gonorrhea works as well as the last existing antibiotic to treat the sexually transmitted infection, results that could lead to licensure of the first new treatment for gonorrhea in decades. The co-developers of the drug, the nonprofit Global Antibiotic Research & Development Partnership, or GARDP, and Innoviva Specialty Therapeutics, a subsidiary of Innoviva Inc., released topline results of the clinical trial on Wednesday.

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How behavioral health tech can help overcome adoption hurdles among neurodiverse populations

Fierce Healthcare

Technologies like wearables and virtual reality could become key tools in engaging neurodiverse patient populations, streamlining provider workflows and tracking outcomes, payers, therapists and te | Speakers at a virtual roundtable commended technologies like wearables and virtual reality (VR) for their potential to engage neurodiverse patients, streamline provider workflows, and measure and improve outcomes.

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More Trending

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After patent settlement, Amgen scores FDA nod for its biosimilar version of J&J's Stelara

Fierce Pharma

The FDA has signed off on Amgen’s biosimilar version of Johnson & Johnson’s autoimmune standout Stelara. | The FDA has approved Amgen’s biosimilar version of Johnson & Johnson’s autoimmune standout Stelara. But the new product will not launch until 2025 because of a settlement the companies made earlier this year, which delayed the launch in exchange for J&J dropping a patent infringement lawsuit.

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STAT+: Life science investors close nearly $6 billion in new funds

STAT

Biotech and life sciences investors continue to draw in new funds even as the biotech stock indexes reach new lows. On Wednesday, VC firm Bioluminescence Ventures launched with $477 million to invest in biotech startups. The firm was founded by Kouki Harasaki, who was previously a partner at M12, Microsoft’s corporate venture group, and Andreessen Horowitz.

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Subcutaneous Lecanemab Demonstrates Greater Amyloid Plaque Removal Than Intravenous Lecanemab

Pharmacy Times

Study also showed that 76% of individuals treated with lecanemab-irmb had no deterioration in the tau positron emission tomography (PET) subset.

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STAT+: Venture capitalists want to own hospitals. Can they do better than private equity?

STAT

General Catalyst’s plan to take over a hospital in the coming months could be the first of many such deals, driven by financially strained hospitals looking for saviors, and venture capitalists convinced that they have the technology solutions for fixing the health care sector’s vexing problems. The venture firm announced plans in October to acquire a health system and then use it as a proving ground for technology that its portfolio companies sell, including generative artificial

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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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Novartis' Cosentyx beats UCB drug to finish line as first new biologic for lesser-known skin condition in years

Fierce Pharma

Cosentyx may soon share the hidradenitis suppurativa (HS) field with another inflammatory biologic—but, for now, the Novartis drug has a head start. | The FDA approved Cosentyx for the treatment of moderate to severe hidradenitis suppurativa in adults, Novartis said Tuesday. The green light makes Cosentyx the first new biologic to treat the lesser-known skin affliction in nearly a decade.

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STAT+: After Sarepta trial failure, families and doctors brace for another debate on Duchenne therapy

STAT

To hear Sarepta CEO Doug Ingram tell it, the results Monday afternoon from a large trial of its gene therapy for Duchenne muscular dystrophy marked a clear medical breakthrough. “A massive win,” he told investors, that could lead to its approval for all patients with the fatal muscle-wasting disease regardless of age. And yet the rest of the Duchenne community was more cautious in its enthusiasm.

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CMS finalizes $140M increase to home health payments

Fierce Healthcare

Centers for Medicare & Medicaid Services (CMS) released a rule Wednesday that increases the 2024 home health payments by 0.8%, or $140 million. | CMS' new proposed rule will increase home health payments by 0.8%, or $140M, among other changes.

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STAT+: Nostrum Laboratories and its CEO — who once defended Shkreli price hikes — to pay up to $50 million over Medicaid rebates

STAT

A pharmaceutical company and its chief executive — who once defended Martin Shkreli for raising drug prices to controversial heights — agreed to pay up to $50 million to settle allegations of purposely underpaying Medicaid rebates. Nostrum Laboratories and its founder, Nirmal Mulye, violated the False Claims Act by underpaying rebates that were due for an antibiotic used to treat bladder infections, according a document released by the U.S.

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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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Already nearing blockbuster status, GSK's RSV vaccine Arexvy outdueled Pfizer rival in first round of clash

Fierce Pharma

Besides Pfizer’s fast-declining COVID-19 sales, vaccine rival GSK is giving the New York drugmaker another reason to worry. | Aside from Pfizer's declining COVID-19 sales, GSK is giving the New York drugmaker another reason to worry. In the first round of their RSV vaccine showdown, GSK's Arexvy pulled down $860 million, more than doubling the haul from Pfizer's Abrysvo.

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The scientist studying how fugitive fetal cells may affect maternal health

STAT

Chimeras — fantastical creatures composed of different animal parts —  have appeared across cultures representing the wondrous, the grotesque, and the inherent complexity of identity. In ancient Greece, the chimera was part lion, part goat, part serpent. In classical Japanese history, it was made up of a monkey, tiger, and dog. Now, modern biology holds that humans can also be chimeras , housing cells from different genetic origins.

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Argenx's Vyvgart gains commercial momentum in gMG as company plots expansion into new uses

Fierce Pharma

As Argenx works to grow the reach of its up-and-coming rare disease med Vyvgart, the company is seeing significant early gains for its lone commercial product. | Sales of Argenx’s Vyvgart increased by 151% to $329 million in the third quarter as the momentum for the treatment continues with its recent approval to be administered subcutaneously. The company also announced that it will use a priority review voucher to speed an FDA decision on an application for Vyvgart to treat a second immunoglob

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STAT+: New insights into how tumor cells hijack brain plasticity to drive cancer

STAT

The idea that cancer can hijack brain plasticity — subverting supple connections in the healthy brain that ordinarily lead to learning and memory formation — is gaining traction. First reported in Cell in 2015, research led by Stanford neuro-oncologist Michelle Monje showed that active nerve cells could promote the growth of high-grade gliomas, a form of brain cancer with a poor prognosis.

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AstraZeneca and Cellectis to collaborate for cell therapy and genomic medicine development

Pharmafile

AstraZeneca has announced a collaboration and investment agreement with Cellectis for the development of next generation cell and gene therapeutics (CGTs) in areas such as oncology, immunology and rare diseases. Under terms of this agreement, AstraZeneca will utilise Cellectis’ proprietary gene editing technologies and manufacturing capabilities with the intention of designing novel CGT products. 25 […] The post AstraZeneca and Cellectis to collaborate for cell therapy and genomic medicine

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Opinion: How the government can help lower the price — not just the cost — of cutting-edge gene therapies

STAT

At the bustling Chicago O’Hare airport, my luggage and I collided with an elderly couple. My heart sank when I realized my vision had failed me again. Because of a connective tissue disorder, my peripheral vision and balance were impaired, making such unintentional mishaps part of my journey. Moments like these are stark reminders of the day-to-day issues that patients with rare diseases often face.

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BioMarin’s longtime CEO Jean-Jacques Bienaimé hands the reins to Genentech’s Alexander Hardy

Fierce Pharma

After 18 years at the helm, BioMarin’s CEO Jean-Jacques Bienaimé is hanging up the gloves. | BioMarin lured Genentech's CEO Alexander Hardy to take over upon Jean-Jacques Bienaimé's upcoming retirement after 18 years at the helm.

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What’s the best antihistamine?

The Checkup by Singlecare

Antihistamines are medications that help alleviate allergy symptoms such as hives, itchy eyes, sneezing, sinus congestion, runny nose, and watery eyes. Allergies are the sixth leading cause of chronic illness, with over 100 million Americans experiencing allergies yearly. According to a 2021 survey , 50% of adults with seasonal allergies in the United States reported they used over-the-counter (OTC) antihistamines to relieve their symptoms.

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Merck's Keytruda nabs FDA nod in biliary tract cancer, catching up with AstraZeneca's Imfinzi

Fierce Pharma

After AstraZeneca’s Imfinzi last year claimed new territory the biliary tract cancer space, Merck’s Keytruda has hit the scene with an FDA nod to match its rival. | The approval was based off of Merck's phase 3 KEYNOTE-966 trial and marks Keytruda's sixth in gastrointestinal cancers. Meanwhile, AZ's Imfinzi scored its first approval in the space last year.

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Humana raises MA enrollment projections again, beats EPS market estimates

Fierce Healthcare

Humana expects to add 35,000 more members to its Medicare Advantage (MA) plans and grow by 19% in 2023 to reach approximately 860,000 members, an increase of about 85,000 more members than projecte | Utilization rates and popularity in MA offerings remain high, Humana announced during its third-quarter earnings call.

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Gene editing has had a big week in the spotlight. Here’s what’s going on

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 good news for biotech startups, a milestone in CRISPR, and an idea for making gene therapy cheaper — both to make and to take.

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Accelerating AMR vaccine development

European Pharmaceutical Review

In July 2022, the World Health Organization (WHO) released its inaugural report on the pipeline of vaccines currently in development to prevent infections caused by antimicrobial resistance (AMR) bacterial pathogens. 1 WHO’s analysis was stark. It asserted the need to accelerate trials for AMR-related vaccines in late‑stage development and maximise the use of those already on the market.

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STAT+: Pharmalittle: Panel tells FDA that CRISPR sickle cell therapy is safe enough for patients; U.K. is urged to scrap IP demands in trade talks with India

STAT

Rise and shine, everyone. The middle of the week is upon us. Have heart, though. You made it this far, so why not hang on for another couple of days, yes? And what better way to make the time fly than to keep busy. So grab that cup of stimulation — our flavor today is pistachio creme — and get started. To help you along, we have assembled another laundry list of items of interest for you to peruse.

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Adverse Effect Burdens of OCS, ICS Use in Asthma

Drug Topics

Adverse effects of oral and inhaled corticosteroid use may impact quality of life for people with asthma.

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European approval for third adapted COVID-19 vaccine

European Pharmaceutical Review

The European Commission has authorised the Nuvaxovid XBB.1.5-adapted COVID-19 vaccine, developed by Novavax for this autumn and winter season. The vaccine, known as Nuvaxovid XBB.1.5, is to be used for preventing COVID-19 in adults and children from 12 years of age. It was developed to target Omicron XBB in line with recommendations from the European Medicines Agency’s Emergency task force (ETF) as well as other international regulators and the World Health Organization.

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Digitalization: The Route to Biopharma 4.0

BioPharm

The implementation of Industry 4.0 is projected to save time and cost for designing an optimal manufacturing process.

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Aetna CVS Health co-branded ACA exchange products to be offered in 17 states

Drug Store News

Aetna will now offer its Aetna CVS Health co-branded insurance product on the individual insurance exchange marketplace in select counties in 17 states.

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Opinion: Listen: Sniffing out the power, and limits, of the placebo effect

STAT

Have you ever taken phenylephrine for a stuffed-up nose and then felt better? If so, you might have been perplexed when Food and Drug Administration experts recently said that that the drug — which is in some versions of DayQuil, Sudafed, and other medicines — is no more effective than a placebo. But to Michael H. Bernstein, an assistant professor of diagnostic imaging at the Warren Alpert Medical School of Brown University, it all makes sense.

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FDA Approves Secukinumab for Hidradenitis Suppurativa

Pharmacy Times

The approval marks the first new biologic treatment option for this patient population in nearly a decade.

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'The Top Line': Exploring the promise of earlier Alzheimer's treatment

Fierce Pharma

While the new Alzheimer’s disease medicine Leqembi has generated lots of buzz since its debut this year, one research team is investigating whether the medicine holds promise in preventing disease | While the new Alzheimer’s disease medicine Leqembi has generated lots of buzz since its debut this year, one research team is investigating whether the medicine holds promise in preventing disease progression before any Alzheimer’s symptoms are evident.

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