Fri.May 03, 2024

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Texas dairy farm worker’s case may be first where bird flu virus spread from mammal to human, scientists say

STAT

A new report on the first human bird flu case tied to the outbreak in cows in the United States suggests that the Texas man may be the first detected case of the H5N1 virus transmitting from a mammal to a person. Nearly 900 people in 23 countries have been infected with the H5N1 bird flu virus since it started spreading from Southeast Asia in late 2003.

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OTC Product Roundup: In a Galaxy Far, Far Away…

Drug Topics

Are you a Wookie with a mane to maintain or a scoundrel prone to nausea? You don’t have to traverse distant planets to find OTC recommendations that meet your needs—this guide has you covered.

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CDC’s top flu scientist says the risk to the public from H5N1 is low, but she isn’t sleeping well. Here’s why

STAT

Vivien Dugan isn’t getting much sleep these days. The director of the influenza division at the Centers for Disease Control and Prevention, Dugan is leading the team of CDC scientists that is working with partners — in the U.S. Department of Agriculture, the Food and Drug Administration, and state and local health departments — to respond to the H5N1 bird flu outbreak in dairy cattle.

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In Addition to Workload and Staffing, Automation Can Help Pharmacies Tackle Pricing Pressures

Pharmacy Times

Automation has long been viewed as a tool to help improving staffing and workload, but Swanson said it can help a multitude of other challenges, as well.

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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 Medicaid rule expected to lower wait times for home-based care, raise caregiver wages

STAT

Caregivers for older adults and people with disabilities could see a bump in their wages in the coming years, thanks to a forthcoming rule by the Centers for Medicare and Medicaid Services. The new rule brings sweeping changes to a bevy of Medicaid programs throughout the country, including fee-for-service and managed care delivery systems. One of the most notable changes applies to the home and community-based services (HCBS) industry.

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Integrating Technicians in Reimbursement Requires Understanding CPT Codes

Pharmacy Times

By empowering pharmacy technicians to actively participate in billing and reimbursement processes, health care practices can streamline operations, mitigate billing errors, and optimize revenue generation.

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More Trending

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Brexpiprazole Plus Sertraline for PTSD Submitted to FDA for sNDA Review

Drug Topics

Two trials studying brexpiprazole in combination with sertraline "constitute one of the largest clinical development programs ever conducted in posttraumatic stress disorder (PTSD).

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STAT+: 4 burning questions about Amgen’s obesity drug, a potential Wegovy and Zepbound competitor

STAT

Amgen’s comments Thursday that it’s “very encouraged” by interim Phase 2 data for its obesity drug have quickly sparked immense investor interest in what could be a potential contender with Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. The injectable drug MariTide, designed to be given monthly, could be a more attractive option than Wegovy and Zepbound, which are both dosed weekly.

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Bridging the Gap: How Pharmacists Can Expand and Transform Mental Health Services

Pharmacy Times

This expansion of their role goes beyond traditional dispensing duties, positioning pharmacists as an essential bridge between patients and the broader health care system.

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Boehringer will use Walgreens trials unit for obesity trial

pharmaphorum

Walgreens’ plans to disrupt the clinical trials sector have taken a step forward with a high-profile partnership with Boehringer Ingelheim

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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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Another day, another delay for Novo's Catalent acquisition as FTC imposes 'Second Request'

Fierce Pharma

Shortly after Novo Holdings’ parent company elected to resubmit paperwork around the investment firm’s proposed $16.5 billion buyout of CDMO giant Catalent, the U.S. | Shortly after Novo Holdings’ parent company elected to resubmit paperwork around the investment firm’s proposed $16.5 billion buyout of CDMO giant Catalent, the U.S. Federal Trade Commission has teed up a further extension on the deal’s review period.

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Statehouses are a hotbed of tobacco lobbying and legislation

STAT

WASHINGTON — Around the country, s tatehouses from Harrisburg, Penn. to Tallahassee, Fla., are being flooded with tobacco industry lobbyists, according to a new report from the anti-smoking advocacy group Action on Smoking and Health.  There are now at least 950 lobbyists representing cigarette, vape, and snus companies in statehouses around the country, according to the latest edition of the group’s Tobacco Industry Lobbyist and Lobbying Firm Registration Tracker, which was r

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Apple gets FDA okay to use AFib tool in clinical trials

pharmaphorum

Apple gets FDA okay to use the atrial fibrillation history tool incorporated in some of its Apple Watch devices in clinical trials

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Opinion: Virtual first is flaming out. A virtual-second model can refresh telehealth

STAT

Telehealth needs a major refresh. Just this week, retail juggernaut Walmart announced it is shuttering its virtual care business. Not long before that, Optum announced the closing of Optum Virtual Care , Teladoc Health announced a change in leadership following a further drop in stock price , and the Peterson Health Technology Institute published a report critical of outcomes generated by most digital diabetes management providers.

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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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Video: The Inflation Reduction Act in 2024 and Beyond

Drug Topics

A lack of clarity around certain provisions of the Inflation Reduction Act has presented challenges to payers.

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Opinion: People like me with bipolar disorder must help shape research and clinical care

STAT

Doctors have observed and treated bipolar disorder for thousands of years. Known throughout history by many names, like depression, mania, manic-depressive illness, or psychosis, the disorder is common and closely tied to that which makes us human: our thinking, our behavior, our hopes, and our ambitions. A solid foundation of science grounds the understanding of bipolar disorder; what’s lacking are strong data about the experience of people with the condition.

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Angle signs AstraZeneca deal to develop prostate cancer assay

Pharmaceutical Technology

UK liquid biopsy company, Angle, has agreed a supplier agreement with AstraZeneca to develop a Parsotix-based Androgen Receptor (AR) assay for use in prostate cancer studies.

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STAT+: Senate drug shortage bill would pay hospitals bonuses for good contracting practices

STAT

WASHINGTON — The Senate Finance Committee has drafted a bipartisan bill to mitigate drug shortages by rewarding hospitals for business practices that ensure an adequate supply of drugs. Drug shortages have been a persistent problem for years, and they’re worse than ever, according to a recent report by the American Society of Health-System Pharmacists.

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Amgen's new Horizon products bolster top line despite continued Tepezza struggles

Fierce Pharma

During the Q&A portion of Amgen’s quarterly conference call Thursday, eight of the first nine questions were about the company’s investigational efforts in obesity. | The buzz about Amgen’s obesity prospects overshadowed the company’s solid work on the top line as revenue came in at $7.4 billion for a 22% increase. Much of the boost can be attributed to sales of products acquired in Amgen’s $27.8 billion buyout of Horizon Therapeutics, which was completed early in the fourth quarter of last

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Price cut unlocks NHS use of sickle cell drug Oxbryta

pharmaphorum

Some NHS patients in the UK will finally be able to access Pfizer’s sickle cell disease therapy Oxbryta after agreement was reached on a price cut

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Leo Pharma prepares to come for the topical JAK market as Incyte's Opzelura cream launch cools off

Fierce Pharma

Watch out, Incyte. Leo Pharma and its JAK inhibitor cream delgocitinib are coming to disrupt the topical atopic dermatitis market, currently inhibited by Incyte’s approved Opzelura. | Leo Pharma's delgocitinib, which the company calls a potential growth driver, could shake up the topical JAK market and put pressure on Incyte's approved Opzelura.

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FDA Drafts Guidance Document for Materials Used in the Manufacture of CGTs and Tissue-Engineered Therapeutics

BioPharm

A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.

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STAT+: Pharmalittle: We’re reading about an Amgen obesity drug, a Senate bill on shortages, and more

STAT

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still on the drawing board, but we do plan to catch some outdoor sounds, promenade with the official mascots, manicure the grounds, and hold another listening party, where the rotation will likely include this , this , this , this and this.

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GSK defends itself—again—after senator argues it withdrew popular asthma med to dodge price caps and Medicaid rebates

Fierce Pharma

GSK defends itself—again—after senator argues it withdrew popular asthma med to dodge price caps and Medicaid rebates fkansteiner Fri, 05/03/2024 - 09:54

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ICER casts doubt on Sarepta’s DMD gene therapy

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning! A crowdsourced Readout today, to be sure, with contributions from STAT’s Jason Mast, Elaine Chen, and Jonathan Wosen. We get into earnings from Novo Nordisk, Amgen, and Illumina, and see that ICER is not so enthused about a gene therapy from Sarepta.

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FDA grants RMAT designation to Taysha’s Rett syndrome gene therapy 

Pharmaceutical Technology

The FDA has awarded the designation following a review of initial safety and efficacy data from two Phase I/II clinical trials.

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STAT+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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NICE recommends new haemolytic anaemia treatment

European Pharmaceutical Review

In final draft guidance , the National Institute For Health and Care Excellence (NICE) has recommended voxelotor (Oxbryta) with or without hydroxycarbamide as a treatment for haemolytic anaemia, which is caused by sickle cell disease. According to NICE, around 4,000 people aged 12 years and older with sickle cell disease in England will be able to benefit from the treatment.

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FDA Roundup: Humira Biosimilar, WHIM Syndrome Treatment

Drug Topics

Check out important updates from the FDA for the week of April 29.

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Moderna reports $1.2bn net loss in Q1 2024

Pharmaceutical Technology

Moderna reported a net loss of $1.2bn in the first quarter (Q1) of 2024, a stark contrast to its net income of $79m in Q1 2023.

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Combination treatment could provide new standard-of-care for aggressive lymphoma

European Pharmaceutical Review

An interim analysis of a Phase III trial of Calquence (acalabrutinib) plus chemoimmunotherapy has revealed positive progression-free survival outcomes for adults with untreated mantle cell lymphoma. AstraZeneca ’s ECHO Phase III trial evaluated acalabrutinib in combination with standard-of-care chemoimmunotherapy , bendamustine and rituximab. Calquence (acalabrutinib) is a next-generation, Bruton’s tyrosine kinase (BTK) inhibitor.

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NHS to provide Pfizer’s Voxelotor to treat sickle cell disease

Pharmaceutical Technology

The NHS in the UK has announced plans to offer Pfizer's Voxelotor (Oxbryta), a new treatment option for sickle cell disease.

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‘Our culture is dying’: vulture shortage threatens Zoroastrian burial rites

The Guardian - Pharmaceutical Industry

Inadvertent poisoning of scavengers across Indian subcontinent is forcing some communities to give up ancient custom Traditional Zoroastrian burial rites are becoming increasingly impossible to perform because of the precipitous decline of vultures in India, Iran and Pakistan. For millennia, Parsi communities have traditionally disposed of their dead in structures called dakhma, or “towers of silence”.

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Healthcare AI from Cera ‘could save NHS and UK £1bn a year’

pharmaphorum

AI-powered home healthcare model from Cera could save NHS and UK £1bn in 2026 if adopted nationwide, says new study

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