Fierce Pharma
JANUARY 17, 2023
CDC probes possible safety risk for Pfizer's new COVID shot, sees no need to change vaccine practices. zbecker. Tue, 01/17/2023 - 11:49.
MedCity News
JANUARY 17, 2023
The 41st annual J.P. Morgan Healthcare Conference concluded last week. After the pandemic prompted it to go virtual, it was back in person, smaller in size and more effective. Here are my takeaways.
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Fierce Pharma
JANUARY 17, 2023
Protesting 'punitive' clawbacks, AbbVie and Eli Lilly bow out of British drug pricing scheme. fkansteiner. Tue, 01/17/2023 - 09:32.
MedCity News
JANUARY 17, 2023
Elicio Therapeutics dipped its toe in the IPO waters but decided to go public by merging with publicly traded Angion Biomedica. Clinical-stage Elicio is developing immunotherapies, including cancer vaccines, that work by targeting immune cells located in the lymph nodes.
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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
Fierce Pharma
JANUARY 17, 2023
JPM23: Novartis takes sweeping approach to 'US-first' mindset, exec says. aliu. Tue, 01/17/2023 - 10:54.
MedCity News
JANUARY 17, 2023
Sunnyside is promoting “Dry(ish)” January that promotes drinking in moderation versus complete sobriety. The company offers a direct-to-consumer app that helps users make a plan for their drinking and provides peer coaching.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
JANUARY 17, 2023
Transcarent recently announced a partnership with The Clinic by Cleveland Clinic, which provides second opinions from medical specialists via video visits. Now Transcarent members can access The Clinic’s services as a benefit, which means they won’t face any out-of-pocket costs in most cases.
Fierce Pharma
JANUARY 17, 2023
Bayer feeling more heat from activist investors, this time from Bluebell. kdunleavy. Tue, 01/17/2023 - 07:09.
Pharmaceutical Technology
JANUARY 17, 2023
Spain’s Hospital Universitario 12 de Octubre researchers, along with the Josep Carreras Leukaemia Research Institute, have developed a new cell therapy based on STAb cells to treat a type of leukaemia. The Spanish Association Against Cancer (AECC) provided funding for the new STAb therapy development. It could be used for T-Cell Acute Lymphoblastic Leukaemia (T-ALL) treatment in patients for whom bone marrow transplantation and chemotherapy failed to work.
Fierce Pharma
JANUARY 17, 2023
Loading mRNA into extracellular vesicles reduces wrinkles in mice. ntaylor. Tue, 01/17/2023 - 10:04.
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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
JANUARY 17, 2023
The uninsured rate declined to 10.5% in 2021 from 11.1% in 2019, according to a recent report from HHS. Some of the largest gains in coverage were among demographic groups that historically have had higher uninsured rates, such as younger adults, Latino individuals, American Indian/Alaska Natives and non-English speaking adults.
Fierce Pharma
JANUARY 17, 2023
Entering J&J's fiefdom, Luye wins FDA approval of long-acting schizophrenia drug. ntaylor. Tue, 01/17/2023 - 07:03.
European Pharmaceutical Review
JANUARY 17, 2023
The Cell and Gene Therapy (CGT) Catapult has published its ‘ UK Advanced Therapy Medicinal Products (ATMP) Clinical Trials Report 2022 ’. In the data, T cells were revealed as the most commonly investigated cell type continuing to increase. The research observed this cell type took up 58 percent of UK ATMP clinical trials in 2022. . Matthew Durdy, Chief Executive of CGT Catapult commented: “It is encouraging to see continued growth of UK clinical trial activity, demonstrating the UK as a favoura
pharmaphorum
JANUARY 17, 2023
Late last year, pharmaphorum spoke with AstraZeneca’s Ben Challis, VP and head of translational science and experimental medicine, cardiovascular, renal, and metabolism (CVRM), together with Magnus Jörnten-Karlsson, executive director of Unify. Unify, launched in December 2020, is AstraZeneca’s patient app and clinical trial support tool. Already, it is operating at scale across the company, used in more than 28 countries and available in 62 languages.
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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.
European Pharmaceutical Review
JANUARY 17, 2023
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorisation for Ximluci ® (ranibizumab), a biosimilar referencing Lucentis®, to help treat a leading cause of blindness globally. Ximluci ® has been approved in the UK for treating wet age-related macular degeneration (wet AMD), diabetic macular oedema (DME), diabetic retinopathy (PDR), retinal vein occlusion (RVO) and visual impairment due to choroidal neovascularization (CNV) in adults.
pharmaphorum
JANUARY 17, 2023
UK digital brain health company Cambridge Cognition has bolstered its speech analysis capabilities with the acquisition of Winterlight Labs of Toronto, Canada, in a cash and stock deal worth £7 million ($8.6 million). The deal extends Cambridge Cognition’s technology in the area of the use of voice-based assessments that can be used to detect and monitor health conditions, and according to the company gives it a platform “that can deliver most of the voice tasks used today by psychol
PharmaTimes
JANUARY 17, 2023
Biosimilar gains MHRA marketing authorisation for use throughout Britain
pharmaphorum
JANUARY 17, 2023
Drugmaker AstraZeneca has teamed up with Indian digital health specialist Qure.ai and a clinical group in the UK to test an artificial intelligence-powered technology to help radiologists detecting lung cancer in chest X-rays. The aim of the pilot is to scan and review more than 250,000 images generated at clinics in the Greater Manchester Cancer Alliance, to see if Qure.ai’s qXR software can make faster and more accurate diagnoses of lung cancer.
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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.
Pharmaceutical Technology
JANUARY 17, 2023
Orphagen Pharmaceuticals has received a rare pediatric disease designation (RPDD) for OR-449 from the US Food and Drug Administration (FDA) to treat paediatric adrenocortical carcinoma (ACC). OR-449 is a first-in-class, orally bioavailable, potent and selective small molecule antagonist of the orphan nuclear receptor steroidogenic factor-1 (SF-1, NR5A1).
pharmaphorum
JANUARY 17, 2023
Ben Hargreaves speaks to Liberate Bio, a company that is hoping to address the delivery issues that could prevent mRNA, as well as siRNA and ASO therapeutics, from reaching their full potential. The pandemic proved that mRNA technology could provide effective protection against infectious disease, at least in the case of COVID-19. Research into mRNA dates back to the 1970s, but with the approval of both Moderna and BioNTech/Pfizer’s vaccines, this approach has finally been validated.
PharmaTimes
JANUARY 17, 2023
Industry-first cancer screening technology boosted by biomedical grant funding
pharmaphorum
JANUARY 17, 2023
Angion Biomedica ended 2022 in the midst of a strategic review after its lead drug for kidney diseases flamed out, and it has now charted a path forward – a reverse merger with clinical-stage biotech Elicio Therapeutics. Shares in the company fell sharply this morning after the announcement of the deal, which will see the two companies combine behind lead programme ELI-002, an immunotherapy targeting KRAS-driven cancers that is currently in a phase 1 trial in pancreatic ductal adenocarcinoma and
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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.
PharmaVoice
JANUARY 17, 2023
Companies with advanced molecular therapies, oncology assets and obesity treatments could be fuel for a dealmaking fire this year.
Scott’s Directories
JANUARY 17, 2023
As a business-to-business seller, you want to make sure that your products and services are seen by the right people. One way to maximize your visibility is to use a Vancouver physician directory. This type of directory allows you to list your company and products in order to target doctors in British Columbia who may be interested in what you have to offer.
Copyright Clearance Center
JANUARY 17, 2023
January 17, 2023 – Danvers, Mass. – CCC , a leading provider of Open Access (OA) workflow solutions, announces the American Society for Microbiology (ASM), has adopted RightsLink for Scientific Communications (RLSC) to manage its growing OA program. ASM is one of the largest life science societies, composed of more than 30,000 scientists and health professionals.
Scott Burrows
JANUARY 17, 2023
“Safety Affects Everyone in the 2023 Workplace – Including You” There has been an important shift in workplace safety that will involve everyone in your organization. As a motivational safety speaker, I must emphasize that “safety” is more critical than ever. Forget the posters and harnesses?
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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
Pharmaceutical Technology
JANUARY 17, 2023
On January 12, Versanis Bio announced that enrollment had begun for its Phase IIb trial, BELIEVE (NCT05616013), which aims to study bimagrumab’s (BYM-338) efficacy and safety in the US, among other locations. Bimagrumab is of interest in the obesity space as it is a first-in-class therapy for obesity. In a previous Phase II trial (NCT03005288), which studied the effect of bimagrumab in obese or overweight patients with type 2 diabetes, fat loss exceeding 20% was demonstrated by week 48 of the st
pharmaphorum
JANUARY 17, 2023
Finland’s Institute for Health and Welfare (THL) has temporarily discontinued use of its official account on Twitter, saying it has become increasingly concerned about misinformation and conspiracy theories being perpetuated on the social media platform. A spokesperson for THL – an R&D institute operating as part of Finland’s Ministry of Social Affairs and Health – told local newspaper Helsingin Sanomat that it has become alarmed by inappropriate responses to its tweets, generate
PharmaVoice
JANUARY 17, 2023
Marcus Delatte discusses how and why he focuses his expertise on counseling smaller companies and mentoring the next generation of technical experts.
pharmaphorum
JANUARY 17, 2023
Boehringer Ingelheim and Takeda are the only two pharmaceutical groups to be named among the 15 Global Top Employers for 2023, an award dedicated to companies that enrich the workplace environment. Run by the Netherlands-headquartered Top Employers Institute, the annual competition is open to around 2,000 organisations that have already been validated and certified as good employers based on a wide range of factors including employee wellbeing, diversity and inclusion, career development, sustai
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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.
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