Sat.Apr 29, 2023 - Fri.May 05, 2023

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Endogena finalises enrolment for retinitis pigmentosa trial

PharmaTimes

The treatment is a small molecule that activates endogenous retinal stem and progenitor cells

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ChatGPT Outperforms Doctors In Answering Patient Messages, Study Shows

MedCity News

A new study found that ChatGPT might actually be quite successful in providing high-quality answers to patient questions during an era in which doctors and nurses are too busy to do so. The research evaluated two sets of answers to patient inquiries — one written by physicians, the other by ChatGPT. A panel of healthcare professionals determined that ChatGPT’s answers were significantly more detailed and empathetic.

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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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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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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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Pharma’s social media problem

Dominic Tyer

Pharma has an opportunity to make more effective - and wider - use of social media, but companies are not currently meeting HCP expectations

Media 130
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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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Pfizer pulls off Q1 surprise with strong sales even as COVID vaccine demand plummets

Fierce Pharma

Pfizer pulls off Q1 surprise with strong sales even as COVID vaccine demand plummets kdunleavy Tue, 05/02/2023 - 09:27

Sales 313
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Astellas Pharma agrees to buy Iveric bio for about $5.9bn

Pharmaceutical Technology

Astellas Pharma has entered into a definitive agreement to buy US-based biopharmaceutical company Iveric bio, in a deal valued at nearly $5.9bn. Under the deal terms, the company, through Astellas US Holding’s wholly owned subsidiary Berry Merger Sub, will acquire all the outstanding Iveric Bio shares for $40.00 in cash for each share. Both the companies’ Boards of Directors have unanimously approved the deal.

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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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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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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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GSK staffers kick off series of strikes in UK for the first time in drugmaker's history

Fierce Pharma

GSK staffers kick off series of strikes in UK for the first time in drugmaker's history aliu Tue, 05/02/2023 - 14:22

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Forge Biologics and Labcorp partner for gene therapies development

Pharmaceutical Technology

Forge Biologics and global life sciences company Labcorp have announced a strategic adeno-associated virus (AAV) gene therapy development and manufacturing collaboration. Gene therapy clients will gain access to coordinated scientific expertise, drug development services and AAV manufacturing capabilities, advancing the development of new gene therapies.

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VC Identifies 3 Startups That Will Shake Up the Future of Cancer Care

MedCity News

Oncology Ventures recently announced investments in three cancer startups — VivorCare, Gabbi and Health Universe. The fund’s founding partner said each company demonstrated an ability to tackle a specific problem within the cancer care space, such as enabling earlier breast cancer diagnoses and providing personalized care plans for cancer survivors.

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Wound Dressing Detects Infection, Changes Color

Medgadget

Researchers at Linköping University in Sweden created a wound dressing that can provide a visual indication if the underlying wound is infected. Chronic wounds are difficult to manage, and presently healthcare staff must remove the dressing regularly to check if an infection is developing. However, this can disrupt the wound by damaging the scab, impairing healing, and may even introduce pathogens in the process.

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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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Moderna warns of severe sales slowdown in Q2, takes $378M charge amid lull in vaccinations

Fierce Pharma

Moderna warns of severe sales slowdown in Q2, takes $378M charge amid lull in vaccinations aliu Thu, 05/04/2023 - 10:02

Sales 275
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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 104
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Formus Labs’ Hip Surgery Planning Software Expands into the US with FDA Clearance

MedCity News

Formus Labs, a New Zealand-based medical technology startup, has received 510(k) clearance from the FDA for Formus Hip, its fully automated 3D software for hip replacement preoperative planning. The company hopes to start piloting the product at healthcare sites across the U.S. in the next few months.

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Why R&D innovation holds the key to greater patient impact

European Pharmaceutical Review

Cancer remains a global threat with around 10 million people dying from the disease each year worldwide, making it the second leading cause of death. 1,2 In the EU, an estimated 2.7 million people are diagnosed with cancer annually and the number is growing. 3 With greater scientific understanding of cancer, the industry has made significant progress in developing innovative medicines to help patients.

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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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J&J's consumer group Kenvue set for $41B IPO, the largest US market debut in more than a year

Fierce Pharma

J&J's consumer group Kenvue set for $41B IPO, the largest US market debut in more than a year esagonowsky Thu, 05/04/2023 - 09:58

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Five Years of Forbes | Legacy MEDSearch Ranks on the Forbes Best Executive Recruitment Firms for a Fifth Consecutive Year

Legacy MEDSearch

ORLANDO, Fla., May 3, 2023 – Legacy MEDSearch has been named to the Forbes Best Executive Recruitment Firms and Forbes Best Professional Recruiting Firms out of over 25,000 recruitment and staffing firms in the United States, its fifth consecutive mention since 2019. Forbes Best Recruiting Firms lists are based on votes by industry professionals, who have directly worked with recruiting firms and rankings are earned based on merit.

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As Workforce Shortages Intensify, CMS’ Value-based Care Ambitions Hang in the Balance

MedCity News

Absent the ability to bolster their ranks with more clinicians, what rural health centers need first and foremost to shift to value are technologies that amplify their clinical capacity without further burdening and burning out their core staff.

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Vertex secures FDA clearance for infants’ cystic fibrosis therapy

Pharmaceutical Technology

Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for KALYDECO (ivacaftor) to treat children with cystic fibrosis (CF) aged between one and four months. The approval allows KALYDECO to be used in infants who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to the therapy, on the basis of clinical and/or in vitro assay results.

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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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Poland takes its COVID-19 vaccine fight to Pfizer's shareholders, urging the company to be a good corporate citizen

Fierce Pharma

Poland takes its COVID-19 vaccine fight to Pfizer's shareholders, urging the company to be a good corporate citizen zbecker Tue, 05/02/2023 - 16:34

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Ultrasound Patch Delivers Drugs Through the Skin

Medgadget

Engineers at MIT have developed a patch that uses ultrasound to deliver drugs through the skin. Ultrasound can create temporary openings in skin, allowing drugs to pass through. The skin is typically a difficult area for drug delivery, as it forms a tough barrier. However, the patch, which contains piezoelectric transducers, can push drugs through the skin highly efficiently.

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Report: Noncitizens Will Account for One-third of Uninsured Population in 2024

MedCity News

A recent Urban Institute report found that the uninsurance rate for nonelderly people who aren’t citizens will be 39.2% in 2024, about four times higher than it is for the entire U.S. population at 9.8%.

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FDA accepts Bristol Myers Squibb’s Reblozyl sBLA for anaemia  

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted the supplemental biologics licence application submitted by Bristol Myers Squibb for Reblozyl (luspatercept-aamt) as a first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes (MDS). The regulatory body has also granted priority review to the application and set 28 August 2023 as a target date for the prescription drug user fee act (PDUFA).

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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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Teva, MedinCell win FDA approval for slow-release schizophrenia drug Uzedy

Fierce Pharma

Teva, MedinCell win FDA approval for slow-release schizophrenia drug Uzedy kdunleavy Mon, 05/01/2023 - 07:35

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FDA Accelerates Approval for Qalsody, the First Treatment Targeting Genetic Cause of ALS

PharmExec

Biogen Inc. announced the approval, a groundbreaking treatment for adults with ALS, offering hope to patients suffering from SOD1-ALS, a rare and fatal genetic form of the disease.

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Mount Sinai Doctors Vote to Strike Over Pay, Benefits Disparities

MedCity News

Resident physicians at Mount Sinai’s Elmhurst Hospital in Queens have voted to authorize a strike. The union that represents these residents has noticed significant disparities in Mount Sinai’s compensation and benefits when compared to the resident physicians employed at the health system’s flagship hospital in Manhattan.

Doctors 111
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Sanofi Canada’s Dupixent receives approval to treat EoE

Pharmaceutical Technology

Sanofi Canada has received approval from Health Canada for its Dupixent (dupilumab injection) to treat eosinophilic esophagitis (EoE) in adults and in adolescent patients aged 12 years and above. It is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. In Canada, it is commercialised by Sanofi Canada and Regeneron Canada.

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.