Medgadget

OCTOBER 27, 2022

A team of scientists at Penn State has bioprinted breast tumor mimics with significant complexity, including a form of vascularization and the ability to precisely place cells in certain locations within the construct. The scientists used a technique called aspiration-assisted bioprinting to achieve this. With many anti-cancer therapies failing at the clinical trial stage and the ethical considerations of animal studies, there is a need for better in vitro cancer models that allow for advanced t

Ethics 126

Ethics Engineering Safety Patients 126

MedCity News

OCTOBER 27, 2022

Two decentralized clinical trial methodologies that are “low-hanging fruit” include automating data integration for patient trial selection and establishing standardized, electronic clinical trial templates and procedures.

Electronics 118

Electronics Patients Biopharma 118

PM360

OCTOBER 27, 2022

Krystal Biotech, Inc. , a clinical-stage biopharmaceutical company focused on gene therapies for dermatological diseases, recently announced positive results from a Phase 3 clinical trial on its investigational compound Beremagene Geperpavec (B-VEC), a topical gene therapy designed to treat the debilitating skin condition dystrophic epidermolysis bullosa (DEB).

Safety 104

Safety Patients FDA Medical 104

MedCity News

OCTOBER 27, 2022

Motto is the latest startup built by Redesign Health. The startup is virtual care platform that is now available for Californians and Texans with autoimmune and chronic inflammatory conditions. It seeks to increase access to care by offering virtual appointments with rheumatologists, condition management services and lifestyle coaching on its telehealth platform.

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Management 113

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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

Distribution

pharmaphorum

OCTOBER 27, 2022

The concept of patient centricity has been a key talking point across the healthcare ecosystem for years. Having recognised the tangible benefits that their unique insights and experiences can bring to the table, decision-makers are increasingly seeking new opportunities to partner with patients across a product’s lifecycle. However, fostering lasting and meaningful partnerships is not a simple task for life science companies.

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Patients Healthcare Healthcare Pharma 103

MedCity News

OCTOBER 27, 2022

The SCOTUS vote to overturn Roe v Wade has drawn greater attention to women’s health and health equity. Here’s a look at some of the health tech companies addressing this shifting landscape.

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MedCity News

OCTOBER 27, 2022

Only by bringing together medical and dental care can genuine change come to healthcare, thereby meeting the oral health needs and associated chronic diseases of our most vulnerable populations.

Medical 98

Medical Patients Healthcare Healthcare 98

pharmaphorum

OCTOBER 27, 2022

Santhera has completed a rolling application for its Duchenne muscular dystrophy (DMD) therapy vamorolone in the US, setting up a possible approval and launch in the latter half of 2023. The Swiss biotech is seeking a priority review for vamorolone, which was licensed from US biotech ReveraGen BioPharma in 2020 after Santhera its former DMD therapy candidate idebenone failed clinical testing and was abandoned.

FDA 95

FDA Side effects Biopharma Marketing 95

MedCity News

OCTOBER 27, 2022

GSK drug otilimab failed a Phase 3 test in rheumatoid arthritis. Though the antibody drug met the main goal in two other pivotal studies, GSK said the limited efficacy in the third study means the company will not seek regulatory approval.

Prospecting 104

Prospecting Biopharma Pharma 104

Medgadget

OCTOBER 27, 2022

Researchers at Pohang University of Science & Technology in South Korea developed an auditory sensor that lets people wearing face masks, such as clinicians, to communicate more easily. The device is essentially a wearable microphone that picks up the vibrations of the skin in the neck that occur when someone talks. The researchers hope that it could be useful for clinicians who must wear face masks as protection against pathogens such as COVID-19, but who also need to communicate with each

Healthcare 90

Healthcare Healthcare Patients Medical 90

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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.

Safety

MedCity News

OCTOBER 27, 2022

Agios Pharmaceuticals sold royalties to an approved cancer drug to get immediate cash to support its new focus on rare diseases. Earlier this year, the FDA approved the biotech’s first rare disease drug, a treatment for a type of anemia.

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FDA Pharmaceutical Biopharma Healthcare 103

pharmaphorum

OCTOBER 27, 2022

On 28 September 2022, the international and European self-regulatory bodies for the research-based pharmaceutical industry ( IFPMA , the International Federation of Pharmaceutical Manufacturers and Associations, and EFPIA , the European Federation of Pharmaceutical Industries and Associations) published a Note for Guidance to assist member companies with their use of social media and digital channels and to help ensure they stay within the regulations on promotion of medicines to the public.

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Media Pharmaceutical Medicine Electronics 94

MedCity News

OCTOBER 27, 2022

GE Healthcare is preparing for its spinoff from GE, which is planned for the first week of January. The company’s split will allow it to operate under a new board, as well as manage its own capital. That capital will be primarily invested in acquisitions and research and development efforts, according to GE Healthcare’s CEO for the U.S. and Canada.

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Healthcare Healthcare Management Medicine 103

European Pharmaceutical Review

OCTOBER 27, 2022

The Biotechnology Innovation Organization (BIO) and the Council of State Bioscience Associations (CSBA) has released new data on the US bioscience industry, indicating it was valued at $2.9 trillion dollars in 2021. The report also found that in 2021, the US industry employed 2.1 million people in over 127,000 businesses. The report , developed in partnership by TEConomy Partners and BIO, is the tenth in a biennial series that assesses the state of the US bioscience industry and its innovation s

Pharmaceutical manufacturing 92

Pharmaceutical manufacturing Pharmaceutical Manufacturing Medical 92

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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.

Specialization

MedCity News

OCTOBER 27, 2022

HealthJoy has raised more than $108 million total. This funding round was led by Valspring Capital, while other investors of the company include Endeavour Vision, CIBC Innovation Banking and U.S. Venture Partners.

Healthcare 100

Healthcare Healthcare 100

European Pharmaceutical Review

OCTOBER 27, 2022

Elements leading to a rational design of cyclodextrin-based formulations. Cyclodextrins are a frequently used excipient in the pharmaceutical industry, employed in multiple dosage forms and with multiple purposes simply because of their numerous positive properties, including being generally well tolerated and safe. In this short article, René Holm, Professor in pharmaceutical physical chemistry at the University of Southern Denmark, provides a few examples of how a rational formulation design f

Pharmaceutical 91

Pharmaceutical Leads 91

MedCity News

OCTOBER 27, 2022

Huma plays a vital role in leveraging its digital infrastructure to help medical device companies navigate the regulatory complexities of generating RWE.

Patients 98

Patients Medical FDA 98

PharmaVoice

OCTOBER 27, 2022

Biogen and Eisai's new Alzheimer's drug is wowing investigators, and it might help the companies get past previous failures.

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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.

Safety

pharmaphorum

OCTOBER 27, 2022

GSK has said it will not be able to move ahead with regulatory filings for otilimab as a treatment for rheumatoid arthritis (RA), after it failed to show the desired level of efficacy in two phase 3 trials. The phase 3 clinical programme, named ContRAst, was the first in RA to include head-to-head comparisons of otilimab with current treatments, hoping to build a niche for otilimab among hard-to-treat patients who have an inadequate response to or cannot tolerate available drugs.

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Side effects FDA Patients Sales 88

MedCity News

OCTOBER 27, 2022

Latino and Black communities saw the largest increase in Marketplace enrollment. HHS credited the rise partially to improved outreach and education efforts.

Education 97

Education 97

pharmaphorum

OCTOBER 27, 2022

Last month, pharmaphorum had the chance to speak with Dr Isabelle Ray-Coquard, professor of medical oncology (specialism sarcomas and GISTs) at the Centre Léon Bérard (CLB), a hospital 100% dedicated to cancer care and research. Discussion was centred around ESMO 2022, where Dr Ray-Coquard presented collated data from a landmark five-year follow-up of the AstraZeneca/MSD PAOLA-1 phase 3 trial, the results from which suggested a clinically meaningful improvement in overall survival rates of certa

Patients 80

Patients Leads Specialization Networking 80

MedCity News

OCTOBER 27, 2022

In this episode, we are conversing with Sonia Millsom, CEO of executive search firm Oxeon, to discuss trends shaping the marketplace following the Great Resignation as well as how Oxeon is spurring innovation through its venture studio.

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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.

Management

PharmaTimes

OCTOBER 27, 2022

UK only places 11th in terms of total R&D investment as a percentage of GDP

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MedCity News

OCTOBER 27, 2022

On the first day of American Society of Human Genetics meeting, PacBio rolls out new long and short-read sequencers…music group Maroon 5.

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PharmaTimes

OCTOBER 27, 2022

Study involves patients with advanced common cancers and solid tumours

Patients 113

Patients 113

Pharmaceutical Technology

OCTOBER 27, 2022

Belfast startup AMPLY has raised £900,000 to develop a range of new products that hopes to tackle multi-drug resistent pathogens using its artificial intelligence (AI) drug discovery platform. It hopes to ensure new strains of antibiotics can still tackle global threat diseases, despite antimicrobial resistance. Antimicrobial resistance is when bacteria and viruses become resistant to medication, making previous treatments ineffective.

Marketing 59

Marketing Medicine Medical Pharmaceutical 59

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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

Leads

PharmaVoice

OCTOBER 27, 2022

Shasqi founder and CEO José Mejía Oneto on how the company’s approach could provide a more effective alternative to ADCs and other emerging cancer therapies.

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European Pharmaceutical Review

OCTOBER 27, 2022

Astellas has announced it will acquire 15 percent of Taysha Gene Therapies, Inc through a $50 million investment, gain licensing to two of its adeno-associated virus (AAV) gene therapy programmes for Rett syndrome and giant axonal neuropathy (GAN). . Taysha develops and commercialises drug therapies for rare and large-market indications such as monogenic central nervous system (CNS) diseases.

Food and Drug Administration 52

Food and Drug Administration Engineering FDA Food 52

PharmExec

OCTOBER 27, 2022

In episode 120, Nico Saraceno, editor of Pharmaceutical Commerce and host of the Pharmaceutical Commerce Podcast, and Andy Studna, associate editor and cohost of the Applied Clinical Trials Podcast, discuss what their respective podcasts offer to listeners, best guests, and more.

Pharmaceutical 52

Pharmaceutical 52

Pharmaceutical Technology

OCTOBER 27, 2022

The US Food and Drug Administration (FDA) has accepted Seres Therapeutics’ Biologics License Application (BLA) for SER-109 to prevent recurrent C. difficile infection (rCDI) for priority review. A decision from the regulatory agency on approval for the therapy is anticipated on 26 April next year. Additionally, the FDA said that it is not presently planning to organise an Advisory Committee Meeting to discuss the BLA for SER-109.

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Food and Drug Administration FDA Food Safety 52

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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.

Patients