MedCity News
JUNE 26, 2023
Public health is heavily dependent on collecting and sharing accurate patient data. Standards for data collection and interoperability can move the needle toward better health data, but it is up to healthcare organizations to take ownership of their data quality by following best practices and adopting technologies that can detect and eliminate bad patient data before it is disseminated.
Fierce Pharma
JUNE 29, 2023
After an initial rejection in 2020 and a review delay earlier this year, BioMarin’s Roctavian has finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder. | After an initial rejection in 2020 and a review delay earlier this year, BioMarin’s Roctavian has finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder.
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European Pharmaceutical Review
JUNE 30, 2023
A collaborative approach to advancing adoption of RMMs EPR ’s Caroline Peachey explores collaborative efforts to accelerate validation and adoption of rapid microbial methods across the pharmaceutical industry. The power of rapid methods for fungal ID By leveraging rapid identification techniques, pharmaceutical facilities can enhance their ability to detect and mitigate fungal contamination, safeguarding product quality and patient safety.
Pharmaceutical Technology
JUNE 30, 2023
Health Canada has approved Endo International’s Xcopri as adjunctive therapy in the management of partial-onset seizures in adults with epilepsy.
MedCity News
JUNE 28, 2023
Through LifeMD’s new weight management program, consumers can gain access to GLP-1 prescriptions like Ozempic and Wegovy, clinical support, lab testing, education and more.
Fierce Pharma
JUNE 30, 2023
A former statistician at Pfizer and his associate have been charged (PDF) with insider trading, using advance inform | A former statistician at Pfizer and his associate have been charged with insider trading, using advance information to make more than $350,000 from stock purchases that they executed one day before the company made trial results public for COVID-19 blockbuster Paxlovid.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
Pharmaceutical Technology
JUNE 26, 2023
After Intercept’s Ocaliva rejection, multiple companies are taking aim at becoming the first US-approved NASH therapy.
MedCity News
JUNE 26, 2023
New York Governor Kathy Hochul signed new legislation that will protect the state’s doctors, medical providers and facilitators who prescribe abortion care telehealth services to patients outside of New York from litigation in states where abortion services are banned or restricted.
Fierce Pharma
JUNE 27, 2023
AbbVie recently filed a patent infring | AbbVie recently filed a patent infringement lawsuit against BeiGene over their blockbuster BTK franchises. Although the litigation was launched right after a patent’s issuance, AbbVie may actually have a case here, according to one expert.
Clarivate
JUNE 29, 2023
OpenAI’s launch of ChatGPT on March 14 heralds a new era of artificial intelligence that will have profound implications for society, including the life science and healthcare industries. As when any new technology appears on the horizon, a tremendous amount of overheated hyperbole has dominated coverage of the topic in the months since. There are, however, some truly alluring potential use cases for generative AI applications such as ChatGPT for the life sciences and healthcare industries – as
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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.
Copyright Clearance Center
JUNE 29, 2023
This is the first in a series of blog posts in which CCC shares this analysis with the scholarly community to spark dialogue and drive action with respect to metadata management during each stage of the research lifecycle.
MedCity News
JUNE 26, 2023
Lawsuits filed in opposition to the White House’s drug pricing negotiation program are beginning to mount, but legal experts agree that the plaintiffs’ arguments probably won’t hold up during a court battle. However, these lawsuits still could delay when the government’s ability to negotiate price goes into effect.
Fierce Pharma
JUNE 29, 2023
Much attention has been paid to Vertex’s efforts to develop a stem cell therapy for Type 1 diabetes. | Much attention has been paid to Vertex’s efforts to develop a stem-cell therapy for Type 1 diabetes. But flying under the radar with an allogenic (donor) gene therapy for the disorder has been Chicago startup CellTrans. Thursday, the FDA signed off on CellTrans’ Lantidra (donislecel), the first cell therapy for type 1 diabetes.
PM360
JUNE 26, 2023
Access to medicines have persisting and systemic differences across the globe and within countries. It is estimated that nearly two billion people globally do not have access to essential medicines. 1 The issue of access to medicines is addressed as part of the United Nations Sustainable Development Goals, with the objective to “provide access to medicines for all.
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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
Copyright Clearance Center
JUNE 29, 2023
The post CCC Named a Stevie® Award Winner for Customer Service Department of the Year in the 2023 American Business Awards® appeared first on Copyright Clearance Center.
MedCity News
JUNE 26, 2023
Eyenuk recently received FDA clearance to use the Topcon NW400 retinal camera with its EyeArt AI system, which automatically detects diabetic retinopathy. The company said this FDA clearance makes its system the only AI system that is FDA-cleared for use with multiple retinal cameras produced by different manufacturers.
Fierce Pharma
JUNE 27, 2023
This has been a second straight year of regulatory struggles in the United States for UCB with one of the those issues revolving around the FDA needing additional time to
PM360
JUNE 26, 2023
The healthcare industry is coming to terms with the longstanding practice of clinical trials that underrepresented clinically relevant communities—a practice with potentially serious implications. In explaining the issue, the National Institutes of Health (NIH) notes that for years most trials were based on white male participants. Meanwhile the life sciences market research trade association, Intellus, noted that market insights participants are often white, female, and upper middle income, eve
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.
Pharmaceutical Commerce
JUNE 27, 2023
In an interview at the DIA Global Annual Meeting with Pharma Commerce Editor, Nicholas Saraceno, Cal Collins, CEO of OpenClinica discusses impacting the broader supply chain.
MedCity News
JUNE 28, 2023
Clop, a Russian ransomware gang known for going after healthcare providers, has been recently exploiting a software vulnerability called MOVEit. Johns Hopkins University and its health system were recently victims of a data breach caused by hackers targeting this vulnerability, as was Texas-based Harris Health System.
Fierce Pharma
JUNE 26, 2023
The FDA's review teams were moving against an approval of Sarepta's Duchenne muscular dystrophy gene therapy. | The FDA's review teams were moving against an approval of Sarepta's Duchenne muscular dystrophy gene therapy. But Peter Marks, director of the agency's Center for Biologics Evaluation and Research, disagreed with the staffers' interpretations, coming to a "different conclusion" that led to an eventual approval, a memo shows.
PM360
JUNE 26, 2023
The world is abuzz about how generative artificial intelligence (AI), such as OpenAI’s ChatGPT, might revolutionize how we work. In one year, over 140 generative-AI startups launched, securing massive amounts of funding. Microsoft made a reported $10 billion investment in OpenAI, and other big tech firms, including Google and Meta, have launched their own generative AI tools.
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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
European Pharmaceutical Review
JUNE 29, 2023
The US Food and Drug Administration (FDA) has approved Lantidra, the first cell therapy for certain adults with Type 1 diabetes. The allogeneic pancreatic islet therapy is made from deceased donor pancreatic cells and is indicated for Type 1 diabetes patients who are unable to approach target glycated haemoglobin due to current repeated severe hypoglycaemia episodes even with intensive diabetes management and education.
MedCity News
JUNE 26, 2023
A Northeast Business Group on Health survey, published Monday, found that 26% of employers never identify the needs of employees, nor the “awareness and effectiveness” of their mental health programs. About three in ten respondents don’t have messaging campaigns through social media and internal platforms on mental health.
Fierce Pharma
JUNE 29, 2023
A new treatment for Alzheimer’s disease agitation episodes might be on the horizon, but a principal trial investigator skirting protocol could muddy the waters. | After a December FDA inspection revealed a principal trial investigator skirted several study protocols, BioXCel found forged emails making it out that the site had properly adhered to reporting requirements for adverse events.
PM360
JUNE 26, 2023
Nothing is more humbling for a marketer than walking through the convention floor of ASCO 2023. You are surrounded by some of the world’s most brilliant minds fighting cancer, one of humanity’s greatest scourges. It is incredibly inspiring to see so many advances being made on so many fronts in this war. You see treatments and diagnostics evolving from one size fits all to being ever more personalized and precise.
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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.
European Pharmaceutical Review
JUNE 27, 2023
Lonza and Vertex Pharmaceuticals Incorporated have agreed to collaborate to support the manufacture of Vertex’s Type 1 diabetes cell therapy portfolio. The companies will partner in the process development and manufacturing scale-up at a new, large-scale facility in Portsmouth, New Hampshire, US. Operated by Lonza, the 130,000 square foot facility is anticipated to create up to 300 new jobs at peak capacity.
MedCity News
JUNE 30, 2023
With few workers entering a field dominated by older Gen X-ers and Baby Boomers, there’s a growing gap in skilled medical coders — people who read notes from doctors and apply appropriate codes for billing and reimbursement purposes. So many are turning to AI.
Fierce Pharma
JUNE 29, 2023
After growing the Institute for Clinical and Economic Review (ICER) into an influential drug pricing watchdog, Steve Pearson, M.D., is stepping down. | After growing the Institute for Clinical and Economic Review into an influential drug pricing watchdog, Steve Pearson is stepping down.
PM360
JUNE 26, 2023
Over 300 drugs in the U.S. are in limited supply or unavailable, marking the worst national drug shortage in years. Patients struggle to get the necessary treatments, in some cases resulting in increased hospitalization and death. Although the driving factors of the shortage are complex, the bottom line is that drug manufacturers, particularly those that produce generic drugs, can’t afford to stockpile raw materials and products to prepare for shortages due to financial, storage capability, and
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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.
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