Tue.Jul 19, 2022

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The medtech industry’s responsibility in addressing the socioeconomic barriers to accessing and succeeding on renal replacement therapy

MedCity News

Aside from rallying for more patient-oriented reimbursement and removing the red tape involved so that providers can provide home-based dialysis care, medical device manufacturers must also offer a turnkey solution for home-based therapy that includes servicing the device in a door-to-door model.

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US FDA grants approval to Incyte’s Opzelura cream for vitiligo treatment

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Incyte’s Opzelura (ruxolitinib) cream 1.5% as a topical treatment of nonsegmental vitiligo in adults and paediatric patients aged 12 years and above. Opzelura is a topical formulation of a Janus kinase (JAK) inhibitor. With the latest development, Opzelura has became the first treatment for repigmentation in patients with vitiligo to receive FDA approval.

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The “only AI-powered 24/7 mental health solution” raises $20M

MedCity News

Wysa, a company that provides AI-driven mental health support through an app, received $20 million in series B funding. The company differentiates itself from competitors by providing support 24/7, its CEO claims.

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Smart Textiles Recognize Body Movements

Medgadget

Engineers at MIT have developed smart textiles that can detect and recognize body movements. The garments fit snugly, and contain a network of pressure sensors that can detect movement, and in conjunction with machine learning approaches, the technology can learn to recognize specific movements in wearers. The fabric contains conductive yarns and piezoresistive components that change their resistance when pressure is applied.

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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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Persephone rakes in $15M to support country’s biggest cancer microbiome study

MedCity News

Persephone Biosciences, a preclinical biotech focused on microbiome-based medicines, raised $15 million in seed funding on Tuesday. The company will use the money to advance its trial for oncology therapeutics, as well as to continue developing its preventive medicine for infants.

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Engaging change: Connecting patients and regulators can move the dial on drug development

pharmaphorum

Face-to-face discussion educates regulators on what matters most to patients, and guides future decision-making. Regulators are increasingly asking drug developers to include the patient voice in submissions, but the best way to go about this is less clear-cut. In the United States, learning how to navigate forums such as the FDA’s listening sessions and patient-focused drug development (PFDD) meetings could be the key to “truly moving the dial”.

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Scott Burrows, Motivational Workplace Safety Speaker 

Scott Burrows

The 7 Safety Myths As a motivational workplace safety speaker, let me pitch a serious question: Who are You Keeping Safe? It’s a proven fact that when we look out for one another, everyone in the workplace is safer.

Safety 98
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What does human behavior teach us about frictionless healthcare?

MedCity News

Incorporating behavior science enables you to better understand your consumers’ unique needs — and the personalized consumer engagements best suited to solve them. With a little less friction and a bit more fuel, you empower your end-users to make positive behavior changes and take control of their own health.

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Filings buzz in pharmaceuticals: 65% increase in cloud computing mentions in Q1 of 2022

Pharmaceutical Technology

Mentions of cloud computing within the filings of companies in the pharmaceutical industry rose 65% between the final quarter of 2021 and the first quarter of 2022. In total, the frequency of sentences related to cloud computing between April 2021 and March 2022 was 133% higher than in 2016 when GlobalData, from whom our data for this article is taken, first began to track the key issues referred to in company filings.

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FDA clears Incyte’s Opzelura as first vitiligo therapy

pharmaphorum

Incyte’s Opzelura cream has become the first medical treatment approved to re-pigment the skin of people with vitiligo in the US, adding to its current use in atopic dermatitis. The FDA’s decision to clear the new indication for the topical JAK1/JAK2 inhibitor came after a priority review that was delayed by a request for additional data by the regulator, holding back a decision by three months.

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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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Surgical Dressing Helps Kill Melanoma, Regenerate Healthy Cells

Medgadget

Scientists at the University of Nottingham in the UK have created a surgical dressing that is specifically designed to facilitate and enhance photothermal therapy following melanoma resection. The dressing allows for near-infrared photothermal therapy that lasts just 15 seconds every 48 hours. The concept involves killing any remaining melanoma cells, while encouraging healthy cells to regenerate within the resection site.

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The Salary Counter-Offer: How To Use It To Your Advantage

MedReps

So you’ve applied, prepared, endured multiple interviews and finally made it to the offer stage of a medical sales job. And all you need to do now is to ask, “Where do I sign?” Right? Wrong. If you do, you could leave precious money on the table. Remember, what you’re about to negotiate may be the most considerable salary increase you’ll ever receive at this or any other employer.

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Biotech R&D spending has skyrocketed, and so have opportunities for savings

PharmaVoice

With R&D costs on the rise, biotechs are embracing new strategies and technologies to make spending more efficient.

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Monkeypox cases prompt governments to order vaccine supply

PharmaTimes

Imvanex is a non-replicating smallpox vaccine developed in collaboration with the US government

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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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ESG Top Trends: Healthcare ESG Impact

Pharmaceutical Technology

All aspects of environmental, social, and governance (ESG) are important, and in the healthcare industry, companies must excel across all three. Listed below are the impact of ESG on healthcare, as identified by GlobalData. ESG needs to be at the core of any healthcare company or institution that wants to continue to provide quality care and services.

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AstraZeneca and Daiichi Sankyo’s Enhertu receives EU approval

PharmaTimes

Specifically engineered antibody treats HER2-positive metastatic breast cancer

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I Saw the Future of Global Pharmaceutical Production in India

PharmaTech

Guest contributor Frederic Kahn discusses the state of the Indian pharmaceutical manufacturing industry.

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Caption Health Receives CE Mark for Caption AI™ Technology Platform

Legacy MEDSearch

Caption Health , the leader in using AI and services to improve heart ultrasound access, announced that it has received a CE Mark for its Caption AI technology platform. This certification represents the first step in making Caption Health’s industry-leading technology platform available outside the US, and highlights the company’s strong clinical and regulatory track record as it uses AI and ultrasound to deliver better cardiac care. “Our technology harnesses the power of ultr

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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3 Ways to Maximize Medicare Benefits

Referral MD

Medicare Benefits: 3 Ways to Maximize Them. Image Source: Pexels. Statistics from 2020 show that 62.6 million people are a part of the Medicare program. But, not everyone knows how to maximize these benefits. Most people tend to misunderstand the benefits they’ll receive from Medicare. But, eligibility isn’t the only factor to consider to help you enjoy the benefits of Medicare.

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Asia-Pacific is seeing a hiring boom for robotics roles in pharma

Pharmaceutical Technology

Asia-Pacific was the fastest growing region for robotics hiring among pharmaceutical industry companies in the three months ending May. The number of roles in Asia-Pacific made up 2.6% of total robotics jobs - up from 0.7% in the same quarter last year. That was followed by Europe, which saw a 0.1 year-on-year percentage point change in robotics roles.

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Role Of Medical Device Reps In The OR

Medical Sales Authority

Many medical device sales reps work in the operating room to support surgical cases. Case coverage has been described as sales maintenance work. It is done to support surgeons who are already using a given product. It is how a rep demonstrates support and maintains a strong relationship. Also, it keeps the competition out. In this article we look at the role of medical device reps in the OR.

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Disappointment as Lynparza fails colorectal cancer test

pharmaphorum

AstraZeneca and Merck’s PARP inhibitor Lynparza has carved out blockbuster revenues across uses in breast, ovarian, prostate and pancreatic cancer, but colorectal cancer won’t be added to the list. Merck said the LYNK-003 rial of Lynparza (olaparib) given as either a monotherapy or in combination with Roche’s CD20-targeting antibody Avastin (bevacizumab) in advanced colorectal cancer has been halted, as a look at the unblinded data showed little chance of a positive result.

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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.

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Behind the Creative…Inspiring Award Winning Creative Carolyn O’Neill

PharmExec

Carolyn O’Neill, Chief Creative Officer of Centron discusses their APEX-award winning global disease awareness campaign for both HCPs and patients, “Dimensionalizing the Patient Experience in PNH.” PNH or paroxysmal nocturnal hemoglobinuria is a rare immune disorder that attacks a person’s red blood cells. The campaign was meant to build on it is not an inherited disease and people’s symptoms don’t exhibit externally, usually appearing in mid-life and portray the feelings of a PNH sufferer.

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AbbVie seeks EMA marketing authorisation for preventive migraine therapy

Pharmaceutical Technology

AbbVie has filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for its atogepant for prophylaxis of migraine in adults who experience a minimum of four migraine days each month. An oral CGRP receptor antagonist (gepant), atogepant is developed as a preventive migraine treatment. The application is based on the Phase III ADVANCE and PROGRESS clinical trial analysing the safety, efficacy and tolerability of atogepant in adult patients with episodic migraine a

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Drug Solutions Podcast: The Current State of Compliance and Validation

PharmaTech

In this episode, Grant Playter, assistant editor, sits down with Rosalind Beasley, Vice President, Digital Innovation, Dot Compliance, to discuss the current state of the compliance and validation industry.

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AZ, Daiichi challenge Roche with EU okay for earlier use of Enhertu

pharmaphorum

AstraZeneca and Daiichi Sankyo have claimed approval in the EU for Enhertu as a second-line therapy for HER2-positive metastatic breast cancer, moving the drug up the treatment pathway. The green light from the European Commission means that Enhertu (trastuzumab) deruxtecan) can now be used for patients whose disease has progressed after first-line therapies such as Roche’s Herceptin (trastuzumab) plus chemotherapy, a standard regimen for this type of cancer.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Pfizer's former R&D head takes on drug pricing misconceptions in new book

PharmaVoice

John LaMattina has something to say about the industry — and he hopes patients are listening.

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Lumeon Engages Amendola for Strategic PR and Marketing Services

PharmExec

Award-winning healthcare, digital health and life sciences PR agency and care orchestration leader partner to raise awareness of automating manual tasks and empowering care teams.

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Guide to Marketing and Outreach for Medical Device Companies

Penrod

The post Guide to Marketing and Outreach for Medical Device Companies appeared first on Penrod.

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Consumer Confidence in Health Information from Non-Health Care Provider Sources on the Rise in The Harris Poll's 2022 Health Information Trends Study

PharmExec

Trust in information from secondary sources like Internet searches, pharma companies, patient advocacy groups, and more has grown since 2019 Survey; Consumers need help making sense of online health information.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.