Fri.May 26, 2023

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First Oral Antiviral Treatment For COVID-19 Gets FDA Approval

Drug Topics

More than 11.6 million treatment courses of the medication have been prescribed in the U.S. to date.

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The ‘superpowers’ pharma leaders should cultivate

PharmaVoice

Executives honored by the Healthcare Businesswomen’s Association share the key traits that help them drive results.

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Five Trends Transforming Pharmacies into Wellness Centers of the Future

Pharmacy Times

With so many radical developments in medicine and technology unfolding at once, the role and potential of the pharmacy as we know it is evolving at breakneck speed.

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Johnson & Johnson cites rebates and discounts for drug price increases

Fierce Pharma

Johnson & Johnson cites rebates and discounts for drug price increases kdunleavy Fri, 05/26/2023 - 07:36

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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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3 FDA decisions that could be delayed if the U.S. defaults on its debt

PharmaVoice

If federal lawmakers don’t vote to raise the debt limit by early June, these FDA actions could be impacted.

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Counsel Patients On the Range of Treatments for Depression

Pharmacy Times

Patients with depression require long-term treatment and supportive care, either with medications or non-pharmaceutical options.

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Oncology Pharmacists Connect Meeting Promises Focus on Changing Treatment Paradigms, Implementation Challenges for Pharmacists

Pharmacy Times

Program Chair Ryan Haumschild, PharmD, MS, MBA, discussed what attendees can look forward to at the inaugural Oncology Pharmacists Connect meeting.

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Some hoped a new oral vaccine would solve all the polio campaign’s problems. Reality is settling in

STAT

When a new and hoped-to-be safer oral polio vaccine started to make its way into use in March 2021, there was huge optimism that this long-needed tool would help the polio eradication campaign quell a growing problem that was — and is still — complicating efforts to stamp out polio forever. Two years later, expectations surrounding the new vaccine, known as novel oral polio vaccine type 2, or nOPV2 for short, are moderating a bit.

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How the Decentralization of Clinical Trials Can Transform Health Care

Pharmacy Times

Decentralization has already been shown to streamline clinical trials, but it also has the potential to improve the broader health care ecosystem.

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Elon Musk’s Neuralink says FDA has cleared human trial

pharmaphorum

Elon Musk’s Neuralink says FDA has cleared human trial Phil.

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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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Incidence of C. diff Infection Increased Significantly in Some Countries During the Pandemic

Pharmacy Times

In Greece, the stark increase in Clostridioides difficile (C. diff) incidence cannot be explained by a rise of antimicrobial use during the pandemic.

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Report: Retailers are vying for 'a piece of the medical pie.' How should traditional providers respond?

Fierce Healthcare

Report: Retailers are vying for 'a piece of the medical pie.' How should traditional providers respond?

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Incorporating FMT Treatment Into Clinical Practice

Pharmacy Times

Candace Cotto, RN, reviews the process of incorporating fecal microbiota, live-jslm treatment into clinical practice, what patients can expect, and the room sanitation process after the procedure.

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Walgreens reportedly to slash 10% of corporate workforce

Drug Store News

The 504 employees affected are in Deerfield and Chicago, according to a Sun-Times/NBC Chicago report.

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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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Migraine: Much Progress Made, Significantly More Needed

Pharmacy Times

Although an established standard of care for migraine prophylaxis exists, the current protocol is not without significant shortcomings.

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FDA grants priority review for Takeda and HUTCHMED’s fruquintinib NDA

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted priority review for Takeda and HUTCHMED’s new drug application (NDA) for fruquintinib. Fruquintinib is a selective and potent oral VEGFR -1, -2 and -3 receptors inhibitor and is used for the treatment of adults with previously treated metastatic colorectal cancer. Fruquintinib will be the first and only highly selective inhibitor of these receptors approved in the US.

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Overweight, Obese BMI Associated With Increased Risk of Gastrointestinal Cancer

Pharmacy Times

Overweight or obesity between middle and later adulthood had a statistically significant risk for noncolorectal gastrointestinal cancer.

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Krystal Biotech receives FDA approval for DEB topical gene therapy

Pharmaceutical Technology

Krystal Biotech has received approval from the US Food and Drug Administration for topical gene therapy VYJUVEK to treat dystrophic epidermolysis bullosa (DEB) in adults and in children aged six months and above. VYJUVEK is designed to address the underlying genetic cause of the disease. An excipient gel applied topically is a key component of the therapy, which is supplied by Krystal’s client, Berkshire Sterile Manufacturing (BSM).

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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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Pharmacoscopy Platform Creates Automated, Personalized Selection of Treatment Options for Patients With Multiple Myeloma

Pharmacy Times

Multiple myeloma treatment selection is critical due to the potential for developing treatment resistance over time to the currently prescribed drugs.

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Opinion: STAT+: An overlooked way to make participants in clinical trials look more like America

STAT

A recent report from the National Academies of Sciences, Engineering and Medicine (of which one of us, GC, is an author) shows that underrepresentation of population subgroups in clinical research is bad for the health of Americans. For instance, recent research showed that appropriate dosing for an often- prescribed blood thinner, warfarin, differs due to genetic variants.

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5-Year Follow-Up Studies Support B/F/TAF Regimen As Long-lasting, Effective Treatment for Patients With HIV-1

Pharmacy Times

Bictegravir/emtricitabine/ tenofovir alafenamide tablets (B/F/TAF) provides long-term virologic suppression for nearly 100% of patients.

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Texas wants to wean trans youth off meds in a ‘safe and medically appropriate’ way. Doctors say that’s impossible

STAT

In a wave of anti-LGBTQ legislation , 19 U.S. states thus far have banned at least some gender-affirming health care for minors — care that is evidence-based and supported by the major medical and professional organizations. The state of Texas may soon add to that count, with legislators passing a bill last week that Governor Greg Abbott has promised to sign when it comes across his desk.

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Study: Mifepristone Does Not Statistically Improve Symptoms of Chronic PTSD in Male Veterans

Pharmacy Times

The steroid could be more effective for veterans with post-traumatic stress disorder who do not have a history of traumatic brain injury.

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Science finally figured out how to make effective RSV vaccines. Will seniors care?

STAT

The world has waited decades for vaccines to protect older adults against RSV. One, made by GSK, was approved by the Food and Drug Administration earlier this month. A second, made by Pfizer, is expected to follow by the end of May. Both will likely be in use this fall, in time to protect seniors going into the next RSV season. So it’s tempting to think the fight against respiratory syncytial virus in older adults is about to kick into high gear, that as early as next winter the United St

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Priority review granted by FDA for 'landscape changing' colorectal cancer drug

Outsourcing Pharma

A drug that has the ability to âtransform the landscapeâ for people living with metastatic colorectal cancer (CRC) has been granted priority review by the US Food and Drug Administration (FDA).

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Omada tackles obesity drugs, Boston Scientific nixes deal, and Microsoft health exec on GPT

STAT

You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences.  Sign up to get this newsletter  delivered in your inbox every Tuesday and Thursday.  Omada Health  announced it will launch  a new service  to help employers respond to the soaring demand for  e xpensive GLP-1 weight loss treatments like Wegovy.

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Commercial clinical trial investment announced by Government to ease NHS pressure

Hospital Pharmacy Europe

The UK Government has announced five funding commitments totalling £121m to accelerate commercial clinical trials, making it easier for revolutionary healthcare treatments to reach patients and helping to cut NHS waiting times. The commitments include measures to make the approvals and set up of trials quicker, with the aim of approving all trials within 60 days, and improving trial recruitment through increased transparency and accessibility of clinical trial data.

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STAT+: Neuralink can now study its brain implant in humans, but it’s still catching up to its peers

STAT

Neuralink can now study its brain implant in humans after securing a go-ahead from the Food and Drug Administration. It’s a critical turning point for the Elon Musk-led company — but the startup, however closely watched, is playing catch-up compared to its peers in the neurotechnology field. “In terms of first in human, Neuralink is almost two decades behind,” said JoJo Platt, a neurotech strategist.

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Primary care a weak link in trials, says O’Shaughnessy

pharmaphorum

Primary care a weak link in trials, says O’Shaughnessy Phil.

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STAT+: Pharmalittle: EMA urges revoking authorization for Novartis sickle cell drug; U.K. tries to placate pharma execs

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 taking shape, but we hope to check in on the Pharmalot ancestors, hang with our shortest person, promenade with the official mascot, and squeeze in a listening party — the rotation will include this , this , this and this.

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Overcoming bottlenecks in the advanced therapy supply chain

European Pharmaceutical Review

In recent years, the pharmaceutical industry has had to grapple with the scalability of advanced therapies. Yet as the traditional issue of production capacity eases, what has been given far too little attention, so far, is whether the required digital and supply chain management infrastructure is in place. The personalised nature of each treatment means every application comes with an unusually high administrative burden, making the wider adoption simply unworkable in many clinical settings.

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Health Innovators – Jennifer Schranz

pharmaphorum

Health Innovators – Jennifer Schranz Mike.

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EU regulators recommend yanking authorization for Novartis' sickle cell med Adakveo after phase 3 miss

Fierce Pharma

EU regulators recommend yanking authorization for Novartis' sickle cell med Adakveo after phase 3 miss zbecker Fri, 05/26/2023 - 10:48

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