Tue.Dec 19, 2023

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How Patient Characteristics, SDOH, Impact CLL, SLL Treatment Backdrop

Drug Topics

Social determinants of health (SDOH), such as financial disparities or lack of insurance, create barriers to accessing breakthrough therapies like BTK inhibitors among patients with CLL and SLL.

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Doxycycline for Treatment of Pneumococcal Infection Could Reduce Clostridioides difficile Infection

Pharmacy Times

Less than 1% of individuals developed Clostridioides difficile infection (CDI), but for those who previously had a CDI the year before, 12% developed a new infection.

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Trending Sources

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U.S. government spent more on health care in 2022 than six countries with universal health care combined

STAT

American taxpayers footed the bill for at least $1.8 trillion in federal and state health care expenditures in 2022 — about 41% of the nearly $4.5 trillion in both public and private health care spending the U.S. recorded last year, according to the annual report released last week by the Centers for Medicare and Medicaid Services. On top of that $1.8 trillion, third-party programs, which are often government-funded, and public health programs accounted for another $600 billion in spendin

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FDA Grants Priority Review to New Biologics License Application for V116 Against Pneumococcal Disease

Pharmacy Times

If approved, V116 would offer significant improvements in safety and effectiveness for the prevention of pneumococcal disease.

FDA 145
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Here are the worst biopharma CEOs of 2023

STAT

Pfizer is this year’s anti-Eli Lilly. If David Ricks is the best biopharma CEO of 2023 , then Pfizer CEO Albert Bourla is, unfortunately, the worst. My annual Worst Biopharma CEO list is typically populated with blockheads and scoundrels. That’s not why Bourla is here. The reason is accountability. Strategic missteps , financial miscalculations, and scientific setbacks have plunged Pfizer into a deep crisis.

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FDA Accepts BLA for Garadacimab as a Once-Monthly Treatment for Hereditary Angioedema

Pharmacy Times

Previously, garadacimab was granted an orphan drug designation as a therapy for hereditary angioedema by both the FDA and EMA.

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More Trending

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Few health plans have dedicated Alzheimer’s and dementia care management strategy: survey

Fierce Healthcare

Health plans and value-based care organizations are ill-prepared to help patients with Alzheimer’s Disease or related dementia. | Only a small fraction of health plans and value-based care organizations have a fully developed care management model for its enrollees with dementia or Alzheimer's, a new survey shows.

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FDA Approves Birch Triterpenes Topical Gel for Treatment for Adult, Pediatric Patients With JEB, DEB

Pharmacy Times

This approval makes birch triterpenes the first treatment for wounds associated with junctional epidermolysis bullosa to be approved by the FDA.

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Most doctors have not yet tried AI but are 'cautiously optimistic' about the benefits

Fierce Healthcare

The hype around healthcare artificial intelligence has reached a fever pitch but most doctors are holding back from trying it out in their medical practice, for now. | Among those who are holding off, doctors report lack of confidence in accuracy and a lack of integration or access through existing tools — as key obstacles to adoption.

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STAT+: Amy Abernethy to step down as Verily’s chief medical officer in latest departure from company

STAT

Amy Abernethy, the president of product development and chief medical officer at Verily, a health care spinout of search giant Alphabet, will leave the company at the end of the first quarter to start a nonprofit aimed at changing the way the health care system collects data. The company announced Abernethy’s move to employees on Tuesday. Both Verily and Abernethy insist the company is well-positioned to move toward her vision — that changing clinical research can speed the develop

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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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2024 Outlook: How tech, incentives could push measurement-based care in behavioral health

Fierce Healthcare

Imagine if a patient came to see a doctor for high blood pressure. | Imagine if a doctor measured a patient's blood pressure once on intake, and then never again, while continuing their treatment. While the idea of not having quantifiable data to measure outcomes in medical care seems absurd, that is most often the case in behavioral health. Could that soon change?

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Expert Reflects on Trends, US Market of Biosimilars in 2023

Pharmacy Times

Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, discusses the dynamic landscape of the biosimilars market, providing key insights into its current status and future projections.

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Amid BioNTech legal fight, CureVac takes a loss as German court invalidates patent

Fierce Pharma

A German court has dealt the first blow against CureVac amid the company's heated COVID-19 vaccine patent fight with fellow German mRNA specialist BioNTech. | A German court has dealt the first blow against CureVac amid the company's heated COVID-19 vaccine patent fight with fellow German mRNA specialist BioNTech.

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2023 Federal Legislation Is Having an Impact on Oncology Practices and Patients

Pharmacy Times

The CMS FAQ ruling is resulting in barriers to care for patients.

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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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2024 Outlook: Can GLP-1 patients stop taking the drug and keep weight off?

Fierce Healthcare

GLP-1 medications were one of the hottest topics in healthcare in 2023, and interest in the weight-loss medications is only expected to increase, which will likely result in different approaches fr | If 2023 was the year of shedding pounds with anti-obesity medications, weight loss companies wonder if 2024 is the year of tapering down drug usage while still keeping the weight off.

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Interrupting Immune-Suppresser Treatment Could Boost Effects of COVID-19 Booster

Pharmacy Times

The antibody response among those that interrupted treatment was doubled at 4 weeks and 1.5 times greater at 26 weeks.

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Roche, Novartis move Xolair closer to FDA finish line for food allergies

Fierce Pharma

On the market for two decades for asthma, Novartis and Roche’s Xolair is closing in on a new indication as a way for those with food allergies to avoid severe outcomes. | On the market for two decades for asthma, Novartis and Roche’s Xolair is closing in on a new indication as a way for those with food allergies to avoid severe outcomes. The agency granted a priority review to Roche's filing and plans to make a decision during the first quarter of next year.

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Still Thriving After 160 Years: Hieber’s Pharmacy in Pennsylvania

Pharmacy Times

Rosemary Sassic-Mihalko, PharmD, is the fourth owner and first female owner of pittsburgh’s oldest pharmacy

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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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Jefferson Health, Lehigh Valley Health Network targeting $14B, 30-hospital merger

Fierce Healthcare

Philadelphia-based Jefferson Health and Allentown, Pennsylvania-based Lehigh Valley Health Network (LVHN) have taken the initial steps toward a $14 billion merger, the systems announced Tuesday.

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Study Investigates Amiodarone As a Potential Toxin Inhibitor for Clostridioides difficile Infections

Pharmacy Times

Amiodarone also provides pan-variant protection against toxins, a potentially growing area of research in C. difficile infection treatment.

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STAT+: Health care industry fights back against crackdowns on health data tracking

STAT

Wherever you go on the internet, trackers follow. These ubiquitous bits of code , invisibly embedded in most websites, are powerful tools that can reveal the pages you visit, the buttons you click, and the forms you fill to help advertisers tail and target you across the web. But put those trackers on a health care website, and they have the potential to leak sensitive medical information — a risk that, in the last year, has driven the Department of Health and Human Services and the Feder

Hospitals 116
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Biogen notches another Tecfidera patent win in Europe as officials revoke generic approvals

Fierce Pharma

Following a significant loss at the U.S. Supreme Court last October, Biogen’s Tecfidera patent odyssey continues to spin in the company’s favor overseas. | The European Commission has revoked marketing authorizations for generic versions of Biogen's multiple sclerosis med Tecfidera, also known as dimethyl fumarate, that are owned by Accord, Mylan, Neuraxpharm, Polpharma and Teva.

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Why digital therapeutics (DTx) are effective and safe, but not being prescribed

pharmaphorum

In a new episode of the pharmaphorum podcast, host Nicole Raleigh welcomes Joel Morse, CEO and co-founder of Curavit Clinical Research, and Andy Molnar, CEO of the Digital Therapeutics Alliance (DTA), for a discussion on why it is that digital therapeutics (DTx) are effective and safe, but not being prescribed.

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The imperative of fridge-free vaccines

European Pharmaceutical Review

Many of today’s vaccines are produced in ready-to-inject liquid formulations that must be kept cold to maintain stability. A requisite cold chain has been designed and implemented to be uninterrupted from factory to patient. However, this greatly complicates both the worldwide distribution and stockpiling of vaccines and other drugs. Since only about 20 percent of the world’s population is lucky enough to live in areas where reliable refrigeration is available, 1 the remaining majority live with

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Big pharma places big bets on antibody-drug conjugates

pharmaphorum

Big pharma companies like Pfizer are making significant investments in antibody-drug conjugates, a promising class of therapies. This article explores the growing interest and recent developments, including FDA approvals and the potential impact on the pharmaceutical industry.

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After missing out on FDA voucher, bluebird quickly raises funds to support gene therapy launches

Fierce Pharma

Despite bluebird bio winning a recent FDA nod for its muc | Bluebird's FDA approval for sickle cell disease gene therapy Lyfgenia left something to be desired because the agency rejected a request for a priority review voucher. Without that voucher, bluebird is moving fast to try to fund its launches.

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FDA says no to Checkpoint’s skin cancer drug cosibelimab

pharmaphorum

Checkpoint Therapeutics’ PD-L1 inhibitor cosibelimab has been turned down by the FDA as a treatment for skin cancer cSCC

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STAT+: Pharmalittle: Weight loss drugs are being paired with bariatric surgery; Carl Icahn plans to oust Illumina directors

STAT

Top of the morning to you. And a fine one it is. Lots of sunshine and clear blue skies are enveloping the Pharmalot campus, where the official mascots are bounding about the grounds and the short person has departed for a challenging apprenticeship. As for us, we are as busy as ever hunting and gathering items of interest. We trust you have your own busy agendas.

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Owkin and MSD join forces on AI-powered digital pathology

pharmaphorum

Owkin and MSD join forces on AI-powered digital pathology Phil.

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Deloitte: Improving health equity in 2024 is a top-10 goal for most execs

Fierce Healthcare

More than 80% of C-suite executives from healthcare and life sciences organizations see improved health equity as a top-10 goal for 2024, a recent report by Deloitte found. | The report also found that nearly 50% of respondents expect to increase equity investments next year.

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Bioanalytical labs need to reimagine data to streamline their operations

pharmaphorum

In the ever-evolving field of bioanalytical labs, reimagining data processes can greatly streamline operations during various trial phases of drug development.

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Opinion: There’s a public health crisis lurking in our data: the Census option ‘some other race’

STAT

According to the 2020 Census, the second most common race in America , after white, is “Some other race,” an option chosen by an astonishing one out of seven people. The nationwide failure to accurately measure the variety of races and ethnicities that make up the U.S. population makes underrepresented groups invisible in public health data, resulting in policies informed by inadequate or misleading information.

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Otsuka to commercialise hereditary angioedema drug in Europe

European Pharmaceutical Review

Otsuka Pharmaceutical has agreed to acquire exclusive marketing rights to Ionis’ hereditary angioedema (HAE) drug candidate, donidalorsen, in Europe. Under the terms of the agreement, Otsuka will pay California-based Ionis $65 million upfront, along with additional milestone-related payments. Ionis is also eligible to earn tiered royalties ranging from 20 to 30 percent based on aggregate annual net sales.

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