STAT

FEBRUARY 20, 2024

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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PharmaVoice

FEBRUARY 20, 2024

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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STAT

FEBRUARY 20, 2024

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 351

Hospitals 351

ALiEM - Pharm Pearls

FEBRUARY 20, 2024

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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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.

STAT

FEBRUARY 20, 2024

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 342

Hospitals 342

PharmaVoice

FEBRUARY 20, 2024

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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The Pharmacist

FEBRUARY 20, 2024

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

FEBRUARY 20, 2024

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.

Drug Pricing 308

Drug Pricing 308

The Pharmacist

FEBRUARY 20, 2024

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

FEBRUARY 20, 2024

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.

Documentation 292

Documentation 292

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Pharmacy Management

BioPharma Dive

FEBRUARY 20, 2024

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

FEBRUARY 20, 2024

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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pharmaphorum

FEBRUARY 20, 2024

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

FEBRUARY 20, 2024

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.

Drug Pricing 253

Drug Pricing Drug Development 253

pharmaphorum

FEBRUARY 20, 2024

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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STAT

FEBRUARY 20, 2024

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.

Diabetes 206

Diabetes Pharmaceutical Companies Pharmaceutical Companies 206

PioneerRx

FEBRUARY 20, 2024

Many pharmacy trends have taken center stage over the last few years. The long-term care at-home model is rapidly gaining traction. Med sync is becoming less of.

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STAT

FEBRUARY 20, 2024

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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Pharmaceutical Commerce

FEBRUARY 20, 2024

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

FEBRUARY 20, 2024

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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pharmaphorum

FEBRUARY 20, 2024

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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Express Pharma

FEBRUARY 20, 2024

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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Packaging 99

pharmaphorum

FEBRUARY 20, 2024

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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The Pharmacist

FEBRUARY 20, 2024

The UK risks continuing shortages if it does not pay more for its medicines, Community Pharmacy England (CPE) director of pharmacy funding Mike Dent has warned. In a parliamentary inquiry into pharmacy yesterday, Mr Dent told MPs that the low cost of medicines in the UK made it a low priority for global manufacturers when […] The post Concern UK ‘will not be top of the list’ for global drug shortages appeared first on The Pharmacist.

Community Pharmacies 93

Community Pharmacies Diabetes 93

pharmaphorum

FEBRUARY 20, 2024

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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Outsourcing Pharma

FEBRUARY 20, 2024

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

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pharmaphorum

FEBRUARY 20, 2024

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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Pharma Times

FEBRUARY 20, 2024

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

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pharmaphorum

FEBRUARY 20, 2024

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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European Pharmaceutical Review

FEBRUARY 20, 2024

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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Process Improvement Biosimilars Drug Development 81

Pharmaceutical Technology

FEBRUARY 20, 2024

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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Putting Patients First Blog

FEBRUARY 20, 2024

Guest Post: Legislation Needed to Improve Access to Vital Treatment for Medicare Rare Disease Patients February 20, 2024 By Lisa Butler, Executive Director of the GBS | CIDP Foundation International As the Executive Director of the GBS | CIDP Foundation International, I have had the privilege of meeting numerous patients with chronic inflammatory demyelinating polyneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN).

Immunity 85

Immunity Immunization 85

World Pharma News

FEBRUARY 20, 2024

Any drug that is taken orally must pass through the lining of the digestive tract. Transporter proteins found on cells that line the GI tract help with this process, but for many drugs, it’s unknown which of those transporters they use to exit the digestive tract. Identifying the transporters used by specific drugs could help to improve patient treatment because if two drugs rely on the same transporter, they can interfere with each other and should not be prescribed together.

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Pharma Times

FEBRUARY 20, 2024

The new programme will engage with children and young people under the age of 18 years

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Express Pharma

FEBRUARY 20, 2024

Viatris announced that its Aurangabad, India, facility has received certification from the British Standards Institution (BSI) for meeting a new industry standard on Minimised Risk of Antimicrobial Resistance (AMR). The standard was facilitated by BSI for the AMR Industry Alliance, an organisation made up of over 100 companies and associations from across the life-sciences industry with the shared goal of providing sustainable solutions to curb AMR.

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