Tue.Feb 20, 2024

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STAT+: FDA warns medical device makers about rise in fabricated data

STAT

An increasing number of medical device companies are submitting fabricated and unreliable data, the Food and Drug Administration noted Tuesday morning. The data comes from third-party labs hired by device firms to test the quality of their products. Triple-check your data or we’ll reject your device, the FDA warned. The goal of third-party testing is to ensure a device meets the FDA’s standards in a range of areas, including biocompatibility, sterility, and mechanical performance.

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Value and potential of IoT and AI for chronic diseases treatment

PharmaVoice

A significant growth is predicted for both AI and IoT in healthcare. By 2030, the AI market is expected to reach $187.95 billion USD, while the IoT market is projected to climb even higher to $312.7 billion USD.

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Phage therapy: Researchers sharpen another arrow in the quiver against antibiotic resistance

STAT

Lynn Cole was in a never-ending cycle of getting recurrent blood infections. And no antibiotic drugs managed to kill off her zombie-like bacteria. “It just got so frustrating over the years because we couldn’t find the source, so we couldn’t figure out how to treat it and prevent it from happening,” said Mya Cole, Lynn’s daughter.

Hospitals 362
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ACMT Toxicology Visual Pearl: Salt, not Shock

ALiEM - Pharm Pearls

What agent would most likely be responsible for these ECG findings? Cyclobenzaprine Digoxin Flecainide Sotalol Reveal the Answer 3. Flecainide Background [1-3] Flecainide is a class IC antiarrhythmic that binds to the voltage-gated sodium channel of the myocardium, slowing depolarization and prolonging phase 0 of the action potential. In toxicity, bradydysrhythmias, AV nodal blockade, ventricular tachycardia, and rate-dependent QRS widening occur.

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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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Opinion: New CMS rules will throttle access researchers need to Medicare, Medicaid data

STAT

Groundbreaking research more than a decade ago showed that almost one-fifth of people enrolled in Medicare were being readmitted within 30 days after being discharged from the hospital, harming patients and increasing costs. That study led to a sea change in health care. The government started closely monitoring readmission rates and imposing fines on hospitals with high rates.

Hospitals 361
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Kite’s next-gen CAR-T aims include quicker production and more disease targets

PharmaVoice

While buzz builds around “off the shelf” CAR-T cell therapies, Kite is staying competitive with a shorter manufacturing turnaround and a focus on broadening applications.

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More Trending

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Iovance, with approval of ‘TIL’ cell therapy, readies for complex launch

BioPharma Dive

The biotech set a price of roughly $515,000 per patient for its therapy Amtagvi, the first to be approved based on a decades-old technique of using tumor-infiltrating lymphocytes.

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STAT+: Obamacare plans don’t have to cover weight loss drugs. The government is considering changing that

STAT

WASHINGTON — Drugmakers are doing everything to tap the bottomless well of demand for new obesity drugs , and they might get some government help. The agency that regulates Obamacare insurance is considering a technical change that would require insurers to cover obesity drugs in a market of more than 20 million Americans. Weight loss drugs are a blessing for patients , a boon for drugmakers , and a potentially huge expense for insurers and taxpayers.

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FDA starts review of Argenx drug in rare disease CIDP

pharmaphorum

The FDA has said it plans to deliver a decision in June on the use of Argenx’ Vyvgart Hytrulo in rare autoimmune disease chronic inflammatory demyelinating polyneuropathy (CIDP).

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STAT+: As regulators play catch up with AI, tech startups say uncertainty is slowing them down

STAT

The federal government’s plan to boost its oversight of the use of artificial intelligence tools in health care drew censure from startups arguing that overregulation stifles new ideas. But as Washington forges ahead, founders say they’re in the dark about who will be regulated and how — and they’re urging policymakers to offer clarity.

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Why Every Small Business Needs an HCM Solution: A Comprehensive Guide

Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.

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UKHSA investigating rise in tuberculosis cases

The Pharmacist

The UK Health Security Agency (UKHSA) is investigating what is behind an 11% rise in tuberculosis cases in England last year. There were 4,850 tuberculosis cases in 2023 compared to 4,380 in 2022, representing a jump of 10.7%, according to provisional data. Even before the Covid-19 pandemic, TB incidence was lower than this, with 4,615 […] The post UKHSA investigating rise in tuberculosis cases appeared first on The Pharmacist.

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STAT+: Ring Therapeutics, a gene therapy startup, lays off 20% of staff

STAT

Ring Therapeutics, a gene therapy startup launched by Flagship Pioneering, has laid off just under 20% of its staff, or 19 employees, Flagship confirmed to STAT. The move comes as Sonata Therapeutics, another Flagship startup, has let go of a third of its staff , part of a broader hunkering down by platform companies. As funding for private biotechs remains scarce, startups hoping to develop new technologies — always an expensive, setback-ridden process — have had to make tough cho

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Pfizer’s ulcerative colitis drug Velsipity gets EU okay

pharmaphorum

The European Commission has approved Pfizer’s S1P receptor modulator Velsipity as a treatment for ulcerative colitis (UC), raising the pressure on Bristol-Myers Squibb’s first-to-market Zeposia.

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Bayer, short on cash, reaches into shareholders’ pockets

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. The need-to-know this morning Rapt Therapeutics  said the  FDA placed a clinical hold  on its anti-inflammation drug, called zelnecirnon, following a case of liver failure in one patient enrolled in a mid-stage atopic dermatitis study.

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Best Practices to Streamline Compensation Management: A Foundation for Growth

Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

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Codeine linctus reclassified to prescription-only amid addiction risk

The Pharmacist

Codeine linctus has been reclassified to a prescription-only medicine (POM) following concerns it was being used recreationally for its ‘opioid effects’, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced. The cough syrup, which is indicated for dry cough and contains the opioid painkiller codeine, was previously a Pharmacy (P) status medicine.

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STAT+: Pharmalittle: We’re reading about weight loss drugs, a cell therapy for melanoma, and more

STAT

Good morning, everyone, and welcome to another working week, which is getting off to a late start on this side of the pond thanks to a holiday break. Whatever your timetable, we hope you are feeling invigorated and inspired, because another busy day is on the way. To cope, yes, we are firing up the trusty coffee kettle and brewing cups of stimulation.

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FDA Accepts Biologics License Application for Datopotamab Deruxtecan

Pharmaceutical Commerce

The agency will make its final decision surrounding the locally advanced or metastatic nonsquamous NSCLC drug —based on results from the TROPION-Lung01 Phase III trial—by Q4 2024.

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STAT+: A lawsuit over a controversial Sanofi drug shortage is unexpectedly revived

STAT

A U.S. appeals court revived a controversial lawsuit brought by nearly two dozen people who claimed they were harmed by a contaminated rare disease medicine sold by a Sanofi subsidiary and a subsequent rationing plan that only worsened their health. And if some upcoming procedural hurdles are cleared, the suit may shine a light on an unusual patient dilemma when a drug is in short supply.

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

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How transparent is the VPAG?

pharmaphorum

Learn about the transparency of the Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG) regarding medicines pricing and the Association of the British Pharmaceutical Industry (ABPI). Explore how these factors impact the pharmaceutical industry.

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Should ACA plans cover weight loss drugs?

STAT

You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine.  Sign up here  to receive it in your inbox on Tuesdays and Thursdays. Should ACA plans cover weight loss drugs? Drug makers are doing everything to tap the bottomless well of demand for new obesity drugs — and now, they might get some government help.

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Alkaloid has developed ready-to-use liquid Omeprazole

Express Pharma

Alkaloid has developed ready-to-use liquid Omeprazole. This drug is primarily designed to treat reflux esophagitis and GERD in young children unable to swallow tablets, as well as in adult patients who have difficulty swallowing and those with an inability to swallow. It is typically available in the form of gastro-resistant tablets and capsules, as well as powder for dissolution.

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Single-use technology propelling upstream bioprocessing market expansion

European Pharmaceutical Review

A report from Data Bridge Market Research has predicted that the upstream bioprocessing market will value $14,256.78 million by 2029. Additionally, the research calculated that market is anticipated to undergo a CAGR of 6.85 percent between 2022 and 2029. The rising productivity of cell lines has improved the performance of upstream processing with low cost and high process reproducibility, the report explained.

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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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Bayer takes novel deep vein thrombosis drug into phase 2

pharmaphorum

Bayer takes anti-alpha2 antiplasmin antibody BAY3018250 into phase 2 as a deep vein thrombosis treatment, hoping to improve on thrombolytics.

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Patients with treatment-resistant depression sought for trial of psychedelic drug

Outsourcing Pharma

Some forms of depression cannot be cured by current treatments including antidepressants or going to psychological counselling or psychotherapy.

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Bioptimus is born with $35m for foundation model for biology

pharmaphorum

Google DeepMind and Owkin scientists have joined forces to create Bioptimus, an AI startup that aims to develop a foundation model for biology

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Researchers develop nanogel to deliver anti-inflammatory drugs for spinal cord injury

Pharma Times

The nanogels, in combination with rolipram, contributed to the recovery of injured tissue

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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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Opening the digital front door to advanced healthcare

pharmaphorum

In a new episode of the pharmaphorum podcast, host Nicole Raleigh speaks with Dr Brigham Hyde, co-founder and CEO of Atropos Health, and Ardy Arianpour, co-founder and CEO of SEQSTER, about their latest partnership, with its goal of personalised registries and the notion of the digital front door for patient information.

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AstraZeneca CEO Pascal Soriot’s £17m pay package under fire

The Guardian - Pharmaceutical Industry

Governance thinktank asks whether he has earned a hundred times that of many of his employees AstraZeneca’s chief executive, Pascal Soriot , received a pay package of nearly £17m last year, cementing his position as one of the best-paid FTSE 100 bosses as he drew criticism from corporate governance experts. Soriot, who has made nearly £120m in the decade since he took the helm at the drugmaker in October 2012 , was paid £16.9m last year, including salary, benefits and bonuses, up from £15.3m the

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Patient feedback is creating next-gen drug delivery devices

pharmaphorum

Patient feedback is driving innovation in next-generation drug delivery devices, improving patient adherence and experience. Learn how these advancements are shaping the future of healthcare.

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Xolair amplifies reach after FDA approval for treating food allergies 

Pharmaceutical Technology

Xolair is the first FDA-approved drug to reduce allergic reactions in people with one or more food allergies, as per Roche’s announcement.

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Florence Healthcare and Slope join forces to address site technology ecosystem demand

Outsourcing Pharma

Connectivity for research site processes and research has strengthened significantly following a partnership between Florence Healthcare and Slope.

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