October, 2022

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How to evolve artificial intelligence models alongside societal needs

MedCity News

As society becomes more open to and reliant on these tools, it is the responsibility of technology companies, especially those tasked with assisting people’s mental health, to build and maintain artificial intelligence and machine learning models that adapt alongside societal needs.

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Meet Florence, WHO’s AI-powered digital health worker

pharmaphorum

An artificial intelligence-powered digital health worker has been unveiled by the World Health Organisation (WHO) as its latest tool for disseminating reliable health information to the public. Originally developed by New Zealand tech company Soul Machines with support of the Qatar Ministry of Health, the first version of the virtual health worker was used to combat misinformation about the pandemic.

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Trending Sources

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Robotic capsule could replace injected biologics

European Pharmaceutical Review

Scientists at MIT have demonstrated that a novel robotic capsule could potentially replace conventional biologic injection methods by tunnelling through the intestinal mucus barrier to deliver insulin. The research, published in the journal Science Robotics described how the new drug delivery system can transport large protein and small-molecule drugs, like vancomycin, an antibiotic peptide.

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GSK speeds up the race to bring first RSV vaccine for older adults to market

Pharmaceutical Technology

After decades of setbacks, the respiratory syncytial virus (RSV) vaccine field has bounced back with positive Phase III trial results in older adults. There are currently five players in the race, with vaccines in Phase III of development from GlaxoSmithKline (GSK) , Pfizer , Johnson & Johnson , Moderna and Bavarian Nordic. However, recent data from GSK’s sub-unit vaccine, GSK-3844766A, have pushed the candidate to the top, with the highest efficacy demonstrated in a pivotal trial to date.

Marketing 135
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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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3D Bioprinted Breast Tumors for Immunotherapy Testing

Medgadget

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
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The Imperative for KAM in Pharma

PM360

Over the past decade, macro trends in healthcare have pushed life sciences companies to pursue increasingly sophisticated key account management (KAM) strategies and capabilities to provide unique offerings and value. This capability requires an orchestrated, cross-functional go-to-market model designed to address the needs and engagement preferences of a defined segment of large, complex, and strategically important healthcare systems and groups.

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Verge Genomics takes AI-sourced drug for ALS into clinic

pharmaphorum

Verge Genomics has joined a select group of biotechs who have taken a drug discovered and developed using artificial intelligence into human testing. The small-molecule PIKfyve inhibitor – called VRG50635 – has been administered to the first subject in the phase 1 trial involving healthy volunteers, according to the San Francisco-based biotech, which was founded in 2015 by Alice Zhang and Jason Chen.

Pharma 131
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Novel cancer therapeutic synthesised by Stanford researchers

European Pharmaceutical Review

Research published in the journal Nature Chemistry , shows how researchers from Stanford University in the US uncovered a promising new method to synthetically manufacture the compound tigilanol tiglate, named EBC-46, which could offer targeted medicine for cancer and other diseases. Natural sources of the compound can only be found in a small section of the Northeastern Australia rainforest, in fruit seeds from the blushwood tree ( Fontainea picrosperma ).

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Cloud robotics labs are accelerating drug discovery and development

Pharmaceutical Technology

Drug discovery and development is an incredibly expensive and time-consuming process, taking between 12 and 18 years, and costing on average between $2 billion and $3 billion. Considering the low chances of success, with only 10% of drug candidates making it into clinical development, pharma companies must prevent the increased erosion of profit margins.

Pharma 124
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Video Games to Improve Cognition in Older Adults

Medgadget

Researchers at the University of California San Francisco have developed a suite of video games that have been designed to improve cognition in older adults who are otherwise healthy. The games aim to recreate common activities, such as banging a drum or driving a car. They also include a sophisticated algorithm that automatically adjusts the game difficulty depending on how well someone is playing, helping to stop less skilled players from becoming overwhelmed and more skilled players from beco

Training 116
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How Machine Learning Drives Clinical Trial Efficiency

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.

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Growth in Cell and Gene Therapy Market

PharmaTech

Biopharma focuses on streamlining biomanufacturing and supply chain issues to drive uptake of cell and gene therapies.

Biopharma 143
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From transactions to transformation: How to deliver on the patient-centric promise

MedCity News

We’ve been talking about improving patient satisfaction and creating a more patient-centric care experience for years. But we’ll never get there if we continue to be focused on transactional healthcare, which is where our efforts toward interoperability have traditionally been drawn.

Patients 139
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Janssen leads effort to cut waste in digital health devices

pharmaphorum

A consortium of industry and academic groups – led by Johnson & Johnson’s pharma division Janssen – has been set up to tackle the environmental impact of digital health products, specifically aimed at minimising waste that could end up in landfill. The Digital Health in a Circular Economy (DiCE) group was formed earlier this year with the aim of developing ways to “design, collect, directly reuse, refurbish, remanufacture, and recycle digital health devices.” The programme

Leads 123
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Tackling immune-mediated disease with CAR Tregs

European Pharmaceutical Review

In recent years there has been significant development within the cell therapy field, as chimeric antigen receptor (CAR) T-cell therapy demonstrated an ability to transform the treatment of patients with haematological malignancies. Recognising the potential of CAR T cells to act as highly targeted therapeutics, several biotechnology companies – including Sangamo Therapeutics – have established development pipelines of CAR T regulatory cells (Tregs) that aim to tackle immune?

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How to Stay Competitive in the Evolving State of Martech

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

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Lilly agrees to acquire gene therapy developer Akouos for $610m

Pharmaceutical Technology

Eli Lilly and Company has signed a definitive agreement for the acquisition of all outstanding shares of precision genetic medicine firm Akouos for a total deal value of up to nearly $610m or up to $15.50 for each share in cash. The deal comprises an acquisition value of $12.50 for each share in cash payable at closing along with one non-tradeable contingent value right per share (CVR) of up to another $3 in cash.

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Novel Devices to Help Surgeons Sculpt a New Ear

Medgadget

At Johns Hopkins, clinical researchers have developed a set of surgical tools that allow them to more easily create a replacement ear for those born with malformed or missing ears. Currently, using cartilage harvested from the ribs, surgeons can create a new ear, but the process is difficult and requires some artistic talent to sculpt the cartilage into the right shape.

Medicine 115
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Uncover Hidden Consumer Insights & SEO Opportunities with Google Trends

Healthcare Success

Google Trends is a powerful but underutilized tool that helps healthcare marketers. Conduct search engine optimization (SEO) research, Identify current trends, Find out what people are interested in, And build better, more relevant campaigns. It also allows marketers to analyze search term popularity over time, explore related keywords, and compare how search terms vary across different geographical areas.

Marketing 110
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How payers, employers can expedite healthcare’s transition to value-based care

MedCity News

Moving to value-based care models isn’t easy. But payers may be in the best position to make this change, according to the Business Group on Health. Employers, meanwhile, can encourage their employees to receive care from providers participating in value-based care.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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Merck’s Lagevrio ‘no better than placebo’ in COVID hospitalisations

pharmaphorum

A UK study has found that Merck & Co’s oral COVID-19 therapy Lagevrio was unable to reduce hospitalisations compared to placebo in patients at higher risk from the virus, adding fuel to assertions in some quarters that its authorisation was premature. The 25,000-subject PANORAMIC trial conducted by researchers at Oxford University looked at the addition of a five-day course of Lagevrio (molnupiravir) to standard care in people aged over 50, or adults aged 18 and over with conditions th

Patients 118
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CHMP recommends Pluvicto® for treating advanced prostate cancer

European Pharmaceutical Review

Novartis announced that The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Pluvicto ® radioligand therapy for treatment of patients with prostate cancer. Pluvicto combines a targeting compound (ligand, in this case directed to PSMA) with a therapeutic radioisotope (in this case lutetium-177).

Medicine 119
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Provention and Sanofi enter deal to launch teplizumab for type 1 diabetes

Pharmaceutical Technology

Provention Bio and Sanofi US have signed a co-promotion agreement to launch the former’s lead investigational drug candidate, teplizumab for the delay in the onset of clinical type 1 diabetes (T1D). The agreement aids Provention in leveraging the capabilities and commercial resources of Sanofi to back teplizumab’s launch. The US Food and Drug Administration (FDA) is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk.

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mRNA Therapy Prevents COVID Virus Entering Cells

Medgadget

Scientists at Oregon State University have developed a new treatment for COVID-19. The technology is based on mRNA, which has also been put to good use in COVID-19 vaccines. However, in this instance, the delivered mRNA encodes for human angiotensin-converting enzyme 2 (hACE2), which is the binding site for SARS-CoV-2 on airway cells. The lipid nanoparticle-encapsulated mRNA therapeutic is delivered to cells in the body, and then the cells begin to produce and release a free-floating form of hAC

Patients 113
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Accelerating Clinical Supply Through Integrated Drug Development

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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A longtime believer in mRNA, Strand Therapeutics’ co-founder is now pushing the tech to the next level

PharmaVoice

The company’s co-founder and head of R&D on how it’s using synthetic mRNA to create “smarter” therapies that could provide cures for cancer and more.

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5 years after FDA approval, CAR-T treatment looks like the future of medicine

MedCity News

CAR-T has become increasingly recognized as an exciting and potentially paradigm-shifting treatment in the past five years. In fact, more than 10,000 patients have undergone this new treatment for certain types of leukemia, lymphoma. and multiple myeloma.

Medicine 132
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Innovative Medicines Fund and the opportunity for ICSs to mobilise NICE approvals

pharmaphorum

In June, NHSE and NICE published details on the Innovative Medicines Fund, which will help improve patient access to cutting-edge medicines, with a particular focus on rare diseases, and ensure global pharmaceutical and biotech organisations continue to prioritise the UK as a launch destination. Join us on Wednesday 23rd November at 12:30 GMT / 13:30 CET / 7:30 am EST as the panel discuss how the Innovative Medicines Fund works, what the implications are for industry organisations in securing fu

Medicine 116
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RemeGen receives ODD for myasthenia gravis treatment

European Pharmaceutical Review

RemeGen has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for its proprietary novel fusion protein Telitacicept (RC18) for the treatment of myasthenia gravis (MG). Telitacicept is a proprietary novel fusion protein from RemeGen to treat autoimmune diseases. It is constructed with the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor and the fragment crystallisable

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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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Merck and Moderna partner to develop and sell cancer vaccine

Pharmaceutical Technology

German pharmaceutical firm Merck has extended its partnership with Moderna to jointly develop and sell mRNA-4157/V940, an investigational personalised cancer vaccine (PCV). In 2016, the companies entered a strategic partnership to develop novel messenger RNA (mRNA) based PCVs. They subsequently expanded the collaboration to include the development of antigen mRNA cancer vaccines in 2018.

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Wearable EEG Patch Measures Brain Activity

Medgadget

Researchers at Osaka University in Japan engineered a wearable electroencephalography (EEG) device that can measure brain activity, potentially letting clinicians monitor conditions such as depression or dementia. At present, assessing brain activity requires a trip to a facility with bulky and expensive equipment, making long-term monitoring difficult.

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Woman of the Week: Ironwood Pharmaceuticals’ Diane Stroehmann

PharmaVoice

The VP of regulatory affairs and global patient safety explains why her line of work lets her do “a little of everything,” and the company’s plans to score a new approval for its blockbuster drug.

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Former Uber Health founder launches new startup with a fresh take on egg freezing

MedCity News

Cofertility is a new startup aiming to make egg freezing more accessible by tying it to egg donation. The startup offers women two programs: Keep and Split. With Keep, women can pay to freeze their eggs and store them all for their own later use. The Split program allows women to freeze their eggs for free when they give half to a family who can’t otherwise conceive.

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Clinical Supply Strategies for CROs

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client.