May, 2023

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How AI Will Change the Way Patients Get Medication

MedCity News

There is a huge opportunity for PBMs and health systems to use AI to help address the challenges surrounding the affordability and accessibility of medicines, from navigating formularies to resolving prior authorization. More automation in pharmacies and with ordering workflows is one piece of that puzzle.

Medical 137
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Your Guide to Virtual Reality Reimbursement in the U.S. Healthcare Market

Nixon Gwilt Law

As a law firm focused specifically on healthcare innovation, we get really excited about developing areas of the healthcare industry. One area we are particularly excited about? Virtual Reality. Providers are already integrating Virtual Reality ( VR ) into patient care in a variety of ways. For example, using VR to gamify physical therapy exercises for pediatric patients to keep them engaged in their treatment, or to provide targeted exposure therapy in a controlled environment for patients with

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In Therapeutic Innovation, Digital Must Be Held to the Same Rigor as Biotech

MedCity News

While these are key benefits of digital therapeutics and this optimism may have been laudable, this approach to market relies on promise without proof of efficacy and ignores the fact that not all digital therapeutics are created equal.

Marketing 134
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Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease

Fierce Pharma

Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease zbecker Fri, 05/19/2023 - 16:25

FDA 362
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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BioNTech’s RNA vaccine sparks potential in pancreatic cancer

Pharmaceutical Technology

Results published in Nature for a personalised pancreatic cancer vaccine that uses neoantigens from patients’ tumours have lent further support to early positive signals. The vaccine, developed by BioNTech, led to half of the patients with pancreatic cancer in the Phase I trial remaining cancer-free 18 months later. In the study, 16 patients were treated with a vaccine called autogene cevumeran that contained a maximum of 20 neoantigens, alongside Roche’s anti-PD-L1 immunotherapy Tecentriq (atez

Patients 138
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Building trust through transparency: Our pledge to provide more clarity around Web of Science journal coverage

Clarivate

As part of our on-going commitment to research integrity, we recently shared that we planned to investigate how we can provide greater transparency regarding which journals are covered in the Web of Science Core Collection. We thank our many community partners for their feedback and acknowledge the request for even more clarity around which journals are added or removed.

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European biotechs choosing Switzerland as base, research shows

European Pharmaceutical Review

New research by IQVIA and recently published in the 2023 Swiss Biotech Report shows that 20 percent of European biotech companies are now headquartered in Switzerland. Sixty three out of a total of 265 companies settling in Switzerland were biotechs. This makes it the second most important sector after ICT, the research found. 2022 statistics by the Swiss federal government confirm that the trend to base here is continuing.

Biopharma 112
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Telehealth Companies Applaud DEA for Delaying Telemedicine Restrictions of Controlled Substances

MedCity News

The Drug Enforcement Administration received 38,000 comments on its proposed rule that would roll back Covid-19 flexibilities for the prescribing of controlled substances via telemedicine. In response, the DEA chose to temporarily extend the flexibilities, a decision telehealth companies like Bicycle Health and Mindbloom are in support of.

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ASCO: Novartis pressures Lilly with Kisqali, targeting $3B opportunity in early breast cancer

Fierce Pharma

Adding Kisqali to endocrine therapy after surgery reduced the risk of invasive tumor recurrence or death by 25% in certain early-stage breast cancers.

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US FDA approves Bausch + Lomb and Novaliq’s DED treatment Miebo

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval to Bausch + Lomb and Novaliq’s Miebo (perfluorohexyloctane ophthalmic solution) to treat the signs and symptoms of dry eye disease (DED). Formerly known as NOV03, Miebo is a first-in-class eye drop designed for preventing the evaporation of excessive tears and restoring tear balance in evaporative DED patients.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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How Clarivate uses Artificial Intelligence you can trust to transform your world

Clarivate

From self-driving cars to ChatGPT and Amazon Bedrock, the world is quickly waking up to the enormous potential for artificial intelligence (AI) to change our world. Much discussion has focused on whether this will ultimately be for better or worse; but as with any seismic shift in technology, the answer will depend on how we choose to engage with and deploy the new tools.

Training 115
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2022 Prescription Trends

PharmExec

The market for prescription medicines in the United States was subject to major shifts in use across therapeutic areas in 2022, reflecting changes in patient health needs, the development, and availability of novel medicines, and complex market dynamics.

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Graphene Patch Affixes to Heart for Pacemaking

Medgadget

Researchers at Northwestern University and the University of Texas at Austin have developed a thin and flexible graphene “tattoo” that can be affixed to the outside of the heart, and which can monitor heart rhythms and apply corrective electrical impulses to treat arrhythmias. The patch is optically clear, allowing the researchers to also use light to monitor and stimulate the heart.

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Why Patients Are Demanding a More Digital Healthcare Payment Process

MedCity News

Patient demand for digital payment communication — both reminders about bills, as well as text messages that enable bill payment — is on the rise, according to a recent report. This is in line with growing consumerism trends in the U.S. — patients want their healthcare payment experience to mimic the convenience and ease they have when they pay for things like travel or retail goods.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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ImmunoGen touts 'home run' as ovarian cancer drug Elahere extends lives in landmark trial win

Fierce Pharma

ImmunoGen touts 'home run' as ovarian cancer drug Elahere extends lives in landmark trial win aliu Wed, 05/03/2023 - 14:50

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SK Bioscience gains UK authorisation for SKYCovion Covid-19 vaccine

Pharmaceutical Technology

SK Bioscience has received marketing authorisation from the UK’s medicines and healthcare products regulatory agency (MHRA) for its Covid-19 vaccine, SKYCovion. SKYCovion is intended for the prevention of Covid-19 resulting from SARS-CoV-2 infection in individuals aged 18 years and above. The authorisation allows the distribution of the vaccine in Scotland, Wales and England.

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A CEO’s quest to solve a 400-year-old medical mystery — and he’s also a patient

PharmaVoice

The CEO of Ventoux Biosciences has the disease that his company is aiming to treat, and it's driving him to find better medications.

Medical 126
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The 2023 PM360 ELITE 100

PM360

Maya Angelou said, “If you’re going to live, leave a legacy. Make a mark on the world that can’t be erased.” For nine years, we have looked to recognize those people in healthcare and life sciences who are making a mark on our industry, on patients, on colleagues, on the world. These people represent our ELITE 100: the individuals and teams who throughout their careers are building legacies marked by helping people live better—and hopefully longer—lives.

Education 105
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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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Implanted Ultrasound Lets Chemo Access Brain

Medgadget

Researchers at Northwestern University have trailed an implanted ultrasound device in patients, which is used in combination with microbubbles to transiently open pores in the blood brain barrier, allowing chemo drugs to enter. We have reported on this technique before as a lab-based concept (see flashbacks below), but this is the first time that it has actually been trialed in human patients, in this case patients with glioblastoma, a difficult to treat brain cancer.

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Virtual Primary Care: The New Frontier of Healthcare Delivery [Sponsored]

MedCity News

In an interview, Rob Bressler, general manager for Teladoc Health’s virtual primary care solution Primary360, talked about the company’s shift from telehealth for urgent care to whole person care.

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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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XtalPi announces $250m AI drug discovery collaboration with Eli Lilly

Pharmaceutical Technology

XtalPi has made a partnership deal with US-based Eli Lilly to leverage artificial intelligence (AI) for drug discovery. XtalPi will receive $250m in upfront and milestone payments. The two companies will use XtalPi’s integrated AI capabilities and robotics platform for the de novo [without consideration of previous instances] design and delivery of drug candidates for an undisclosed target.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Can GLP-1 obesity therapy restore NK cell function?

European Pharmaceutical Review

NK cell functionality was restored in participants following gold-standard pharmacological obesity GLP-1 analogue treatment, according to a study published in Obesity. This may contribute to the benefits reported with these medications in people with obesity, the data showed. Reducing the risk of cancer in obese individuals Boosting function of NK cells Previous research has found that people with obesity are at higher risk for developing cancer.

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Finding Balance: A Decentralized Trial Strategy to Help Sponsors Address the New FDA Draft Guidance

PM360

The world is full of tradeoffs—it’s the way progress is made while proportionately managing risk. When it comes to decentralized clinical trials (DCTs), arguably the most transformative innovation clinical research has seen in decades, the same is true. The new Food and Drug Administration (FDA)’s Decentralized Clinical Trial Draft Guidance issued May 1 st has started to outline guidelines for increased oversight and planning while simultaneously supporting broader DCT adoption.

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Chest Wearable Provides Key Heart Measurements

Medgadget

Researchers at the University of Texas at Austin have developed a new chest wearable that can obtain both electrocardiogram and seismocardiogram data from the underlying heart. While basic ECG can be monitored via smart watches, no other wearable combines it with seismocardiography, which would conventionally be obtained by listening to the heart using a stethoscope.

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Is ChatGPT Healthcare’s Autopilot?

MedCity News

While human empathy will never be replaced, AI technologies and ChatGPT are providing new possibilities to help healthcare providers engage more efficiently with their patients and streamline administrative duties so physicians can focus more on their patients.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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FDA warns patients about compounded versions of Novo Nordisk's Ozempic, Wegovy

Fierce Pharma

FDA warns patients about compounded versions of Novo Nordisk's Ozempic, Wegovy kdunleavy Wed, 05/31/2023 - 13:02

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The emergence of tranq amidst the fentanyl crisis

Pharmaceutical Technology

In February, the FDA issued an alert restricting the import of the veterinary sedative xylazine or tranq and the ingredients used to make the drug. This followed in the wake of a Drug Enforcement Agency (DEA) Joint Intelligence Report in October 2022, which stated that xylazine is widely available from Chinese suppliers on the internet. According to a June 2022 study, xylazine has been detected in the illicit drug supply in 36 US States, and the DEA has reported that approximately 30% of the f

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Could FDA recommend new antibiotic for hospital-acquired pneumonia?

European Pharmaceutical Review

A Phase III trial has found that the novel combination antibiotic sulbactam-durlobactam prevents at least as many fatalities of hospital-acquired pneumonia as colistin, the best currently approved treatment. This finding alongside the other data from the trial led the US Food and Drug Administration (FDA)’s Antimicrobial Drugs Advisory Committee to recommend the FDA approve the combination antibiotic for often-fatal pneumonia strain carbapenem-resistant Acinetobacter baumannii–calcoaceticus co

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Taking your biotech global? Here’s how you can navigate cultural norms

PharmaVoice

What’s so different about doing pharma business in the U.K. versus Japan? One of Moderna’s top brass shares her tips for navigating choppy cultural waters.

Pharma 105
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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.