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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Clarivate
JUNE 28, 2023
In the 2023 release of our Journal Citation Reports, we have taken significant additional steps to foster research integrity in the Web of Science. This is part of our ongoing efforts to proactively contribute to the maintenance of public trust in scientific and scholarly research. Learn about what’s new and some future changes. Today marks the 2023 release of the annual Journal Citation Reports (JCR ).
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.
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What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.
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.
European Pharmaceutical Review
JUNE 27, 2023
Riding on the momentum of the first faecal microbiota product approved for C. difficile in December 2022, the microbiome therapies space in 2023 has continued to see revolutionary developments and continued research advancement. Recent developments in microbiome therapeutics In May this year, first-in-human study interim results revealed that a CRISPR-based microbial gene therapy can “eliminate antibiotic-resistant E. coli strains in the gut”.
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 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.
Pharmaceutical Technology
JUNE 26, 2023
After Intercept’s Ocaliva rejection, multiple companies are taking aim at becoming the first US-approved NASH therapy.
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
European Pharmaceutical Review
JUNE 27, 2023
AC Immune SA has received Fast Track designation from the US Food and Drug Administration (FDA) for its anti-amyloid beta (Abeta) active immunotherapy vaccine candidate for Alzheimer’s disease. This follows FDA clearance of the Investigational New Drug (IND) application, enabling expansion to the US of the ongoing Phase Ib/II ABATE study of ACI-24.060 in Alzheimer’s patients and individuals with Down’s syndrome.
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 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.
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.
European Pharmaceutical Review
JUNE 30, 2023
Demand for process analytical technology ( PAT ) is being driven by the growing adoption of automation and digitalisation in sectors such as pharmaceutical industry, a report by Market.us has found. With PAT being widely used in pharma, rising R&D expenses are anticipated to boost demand for these technologies. Growth and limitations in the global PAT market The PAT market is expected to grow $10.6 billion in 2032, the report suggested.
MedCity News
JUNE 25, 2023
Apogee Therapeutics is planning an IPO to fund clinical development of biologic drugs that could offer dosing advantages over currently available immunology and inflammation drugs. Its lead program is being prepared for Phase 1 testing in atopic dermatitis, or eczema.
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
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.
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
Pfizer’s Litfulo is the first treatment approved for treating adolescents with severe alopecia areata. The drug’s approval also covers adults, were it will compete against Eli Lilly’s Olumiant.
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
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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Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten
European Pharmaceutical Review
JUNE 29, 2023
The world’s first AI-generated anti-fibrotic small molecule inhibitor drug has been administered to the first human patients. Phase II clinical trials in the US and China are now underway for INS018_055, Insilico Medicine’s potentially first-in-class oral drug candidate. Achievement of the first dose in human patients is a “milestone” for AI-driven drug discovery and drug development , stated Feng Ren, PhD, co-CEO and Chief Scientific Officer of Insilico Medicine.
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
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
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
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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
European Pharmaceutical Review
JUNE 30, 2023
The limulus amebocyte lysate (LAL) assay for bacterial endotoxin testing (BET) is currently facing some of its greatest challenges as a reagent in the pharmaceutical industry, according a paper published in the Journal of Applied Bioanalysis. The author highlighted key obstacles and offered potential opportunities for the future. Challenges The first current challenge the author discussed was the supply of materials and conservation of resources for endotoxin testing.
MedCity News
JUNE 29, 2023
UNC Health recently launched a pilot for its in-house generative AI app called Ava, which stands for “AI virtual assistant.” The app allows staff members to ask questions about the different digital health tools available to them across the health system, and it gives them concise answers about how to use the tools effectively. The goal is to prevent staff from searching through vast training libraries.
Fierce Pharma
JUNE 30, 2023
The Securities and Exchange Commission (SEC) has revealed insider trading charges against five—including former Alexion Vice President | The SEC has revealed insider trading charges against five—including former Alexion vice president Joseph Dupont and a Massachusetts police chief—who allegedly took advantage of prior knowledge of Alexion’s 2020 acquisition of Portola Pharmaceuticals.
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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