Blueprint's Ayvakit picks up long-awaited FDA approval in indolent systemic mastocytosis
Fierce Pharma
MAY 22, 2023
Blueprint's Ayvakit picks up long-awaited FDA approval in indolent systemic mastocytosis zbecker Mon, 05/22/2023 - 14:43
Fierce Pharma
MAY 22, 2023
Blueprint's Ayvakit picks up long-awaited FDA approval in indolent systemic mastocytosis zbecker Mon, 05/22/2023 - 14:43
Clarivate
MAY 22, 2023
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.
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Fierce Pharma
MAY 22, 2023
Pfizer, Moderna among many biopharma giants to post Q1 sales declines, as Novo Nordisk led growth charge kdunleavy Mon, 05/22/2023 - 13:04
PharmExec
MAY 22, 2023
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.
Fierce Pharma
MAY 22, 2023
Bayer's blockbuster hopeful Nubeqa, AstraZeneca's Forxiga pick up nods from England's NICE zbecker Mon, 05/22/2023 - 10:44
MedCity News
MAY 22, 2023
NeuroFlow — a startup that provides behavioral health integration software — struck a new partnership with Atlantic Health System, which will be using the company’s technology across 16 ACO sites. The health system’s goals for the partnership are to expand access to behavioral health professionals, alleviate administrative burden among primary care practices and improve performance in its ACO’s value-based contracts.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
Pharmaceutical Technology
MAY 22, 2023
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted an investigational new drug application (IND) for SinoMab BioScience’s SM17 to treat asthma. SM17 is a humanised IgG4-k monoclonal antibody that targets IL-17RB to treat asthma, idiopathic pulmonary fibrosis (IPF), atopic dermatitis (AD) and other immunological disorders.
Fierce Pharma
MAY 22, 2023
ASCO: Merck gives final look at Keytruda study in first-line cervical cancer. Will FDA change its mind?
MedCity News
MAY 22, 2023
We cannot foresee how generative AI will play out, but much like a smartphone with Tiktok, it is only limited by our imaginations and ingenuity.
European Pharmaceutical Review
MAY 22, 2023
A review by Swedish researchers has identified the benefits of smart contracts on blockchain platforms in the pharmaceutical supply chain and its role in combating counterfeit drugs. While the counterfeit market is estimated to be a market of over $200 billion and despite its benefits, blockchain technology has not been fully implemented in the pharmaceutical supply chain, according to the paper.
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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.
MedCity News
MAY 22, 2023
Ironwood Pharmaceuticals is paying $1 billion to acquire VectivBio, a biotech whose lead program could become a blockbuster treatment for a gastrointestinal disorder. Preliminary Phase 3 data are expected by the end of 2023.
Medgadget
MAY 22, 2023
Scientists at the University of Minnesota have developed a method to detect misfolded proteins more rapidly and sensitively. The technique could eventually allow clinicians to diagnose diseases that involve misfolded proteins more easily, including Alzheimer’s, Parkinson’s, and Creutzfeldt-Jakob disease. The approach involves an enhancement to an existing assay called Real-Time Quaking-Induced Conversion (RT-QuIC) assay.
MedCity News
MAY 22, 2023
Experts argued that value-based care is here to stay and will play a major role in the future of healthcare during MedCity’s Invest conference in Chicago. A panel of four agreed that the success of value-based care depends on organizational commitment — it’s a quixotic mistake to think these alternative payment models can gain traction overnight.
Pharmaceutical Technology
MAY 22, 2023
The European Medicines Agency (EMA) has accepted and verified Sobi’s marketing authorisation application for a new factor VIII (FVIII), efanesoctocog alfa, to treat haemophilia A patients of all ages. The application is supported by results from the Phase III XTEND-1 trial in adults and adolescents and backed by the XTEND-Kids paediatric trial in patients aged under 12 years.
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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
MedCity News
MAY 22, 2023
There are too many flaws in AI for it to replace physicians, execs said during a Monday panel at the MedCity INVEST conference in Chicago. Instead, it should be used to make physicians’ work easier.
European Pharmaceutical Review
MAY 22, 2023
Sixty eight percent of people in the UK would consider taking part in a clinical trial, a survey has found. With over 9 in 10 of people living in the UK having never taken part in a clinical trial , there is huge untapped potential for trial recruitment, suggested the survey. The data released by Lindus Health offers pharmaceutical policymakers an understanding of how to help get the UK back on track to fulfil its ambitions to be a life sciences superpower.
MedCity News
MAY 22, 2023
By incorporating elements of risk that complement a health system’s vision, healthcare leaders can drive a sustainable growth strategy that benefits patients and staff and better positions the organization for the future.
Medgadget
MAY 22, 2023
Researchers at the University of Colorado at Boulder and the National Institute of Standards and Technology (NIST) have developed a laser-based breathalyzer technology that can detect molecules in breath samples that indicate the presence of specific diseases, such as COVID-19. The device is called a frequency comb breathalyzer, and using it involves pumping a breath sample into the device where lasers irradiate it at many different frequencies, and mirrors bounce the light around to ensure that
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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.
MedCity News
MAY 22, 2023
Found for Business is an evidence-based obesity care program that prescribes 13 different medications (including GLP-1s) in 60 different combinations. It combines the medication with support from providers, coaching and an app that offers meal and activity tracking.
Medgadget
MAY 22, 2023
Researchers at MIT have developed a method that allows them to analyze the three dimensional interactions of sections of the genome in unprecedented detail. The technique could let scientists investigate the origin and progression of genetic diseases, as well as identifying new therapeutic targets for them. The new approach, called Region Capture Micro-C, involves using an enzyme to cut a section of the genome into small and uniform fragments, and then linking pieces of the genome together again
PharmaVoice
MAY 22, 2023
The company's CEO on the vital role its late-stage candidate could play in the lives of DMD patients.
PharmaTimes
MAY 22, 2023
ACD856 is the leading candidate therapy on the company’s NeuroRestore platform
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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.
PharmaVoice
MAY 22, 2023
How these consumer and service companies are tapping into major trends in the biopharma industry.
PharmaTimes
MAY 22, 2023
Treatment involves early Alzheimer’s disease and will be potentially used across Great Britain
Healthcare Success
MAY 22, 2023
Is your website easy to use? Is it intuitive? Is it pleasant to interact with while also effectively delivering the information your consumers need? A successful website employs key UI/UX principles beyond beautiful pages. UI/UX ensures your website is Accessible, Intuitive Consumer-focused, and Trustworthy In this post, I’ll cover 10 UI/UX design basics that can positively impact your healthcare business.
Pharmaceutical Technology
MAY 22, 2023
Intercept Pharmaceuticals faced a setback after a US Food and Drug Administration’s (FDA) Advisory Committee (AdCom) meeting on the prospective use of its drug Ocaliva in pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH) did not go in its favour. Twelve of the 16 AdCom members gave out a negative vote on whether the benefits of 25mg of Ocaliva outweigh the risks in NASH patients with Stage 2 or Stage 3 fibrosis based on available data.
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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
Rep-Lite
MAY 22, 2023
In today’s competitive job market, an entry-level resume serves as your key to unlocking the doors of your dream job. It is a crucial document that showcases your skills, qualifications, and potential to prospective employers. With a well-crafted entry-level resume, you can significantly boost your chances of securing an entry-level position and embark on a fulfilling career journey.
Pharmaceutical Technology
MAY 22, 2023
Thermo Fisher Scientific has expanded its sterile manufacturing and research capabilities in the Asia-Pacific region with the opening of a new sterile drug facility in Singapore. The new good manufacturing practices facility was established with support from the Singapore Economic Development Board. It comes with quick vaccine fill-finish capabilities and offers end-to-end pharmaceutical development and manufacturing services.
InCrowd
MAY 22, 2023
Marisa Meyers is the Director of Digital Marketing at Apollo Intelligence, learn more about her below! Tell us about your role. As the Director of Digital Marketing, I design, implement, and measure digital marketing strategies for Apollo and its commercial brands, InCrowd and Survey Healthcare Global. That can mean anything from managing website content and social media channels to launching email marketing campaigns and online ads targeting professionals in the healthcare and life sciences ind
Legacy MEDSearch
MAY 22, 2023
Orlucent, Inc., a company focused on clinical assessment of suspicious moles, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s Orlucent® Skin Fluorescence Imaging System. The Orlucent system is a handheld point-of-care molecular-based imaging system designed to noninvasively identify and clinically assess the presence of biological tissue remodeling activity associated with the development of atypical moles in adults.
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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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