MedCity News
SEPTEMBER 29, 2022
While some areas in the mental health tech space have been effective, some areas need improvement, experts said at MedCity’s Invest Digital Health conference. Providing digital mental health care can be difficult do in a cost-effective way, and many clinicians are wary of adopting technology in their practices.
European Pharmaceutical Review
SEPTEMBER 29, 2022
According to a new report , implementing a Transferable Exclusivity Extension (TEE) system could solve the “broken economic model” for researching and developing new antibiotics in Europe. As the threat of antimicrobial resistance (AMR), sometimes called the hidden or silent pandemic , grows, new and novel antibiotics are needed to combat infections becoming more resistant to current treatments.
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MedCity News
SEPTEMBER 29, 2022
The patient financial experience in the U.S. is poor — patients have a hard time understanding pricing data and they often face exorbitant prices for care and medications. This problem will only get better if the healthcare industry rids itself of price-gouging middlemen and closed-door price negotiations held by businesspeople, according to a recent healthcare innovation panel.
pharmaphorum
SEPTEMBER 29, 2022
Biogen and Eisai have resurrected hopes that amyloid-targeting drugs could have a benefit in Alzheimer’s disease with a claim that their new drug lecanemab showed a “highly statistically significant” reduction in clinical decline in a phase 3 trial. The highly-anticipated readout from the Clarity AD has shown that lecanemab met primary and secondary endpoints in patients with early-stage Alzheimer’s, said the two companies in a joint statement – although for now only the
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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
SEPTEMBER 29, 2022
Eisai Alzheimer’s disease drug candidate lecanemab now has data from a pivotal study showing a statistically significant reduction in cognitive decline. Lecanemab is already under FDA review for potential accelerated approval but the agency has said that results from this larger study could support full approval of the antibody drug.
European Pharmaceutical Review
SEPTEMBER 29, 2022
Brii Biosciences , a multi-national drug development company, has published top-line results from a Phase I study evaluating its long-acting, single-dose, intramuscularly injected drug BRII-296 in postpartum depression (PPD). “We are encouraged by the possibility of providing a novel treatment option to the 900,000 people in the US affected by postpartum depression each year in which the current standard of care is suboptimal, often requiring hospitalisation, repeat therapy and daily doses of tr
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
pharmaphorum
SEPTEMBER 29, 2022
Regulators and health technology assessment (HTA) bodies are increasingly demanding the patient voice play a central role in drug development – making it riskier for developers to ignore the need for engagement than to embrace it. Shifting operations to meet this new way of working may seem challenging, but it doesn’t have to be, as very often there is an existing ground in pharmaceutical and biotech companies to align advocacy and engagement in medicines development and access, says Red Thred S
Copyright Clearance Center
SEPTEMBER 29, 2022
The post Missing Revenue in the Global Flip: Getting the Open Access Math Right appeared first on Copyright Clearance Center.
pharmaphorum
SEPTEMBER 29, 2022
In Part 1 of this series, general wellness devices and mobile medical applications (MMAs) will be considered. Part 2 of this series will be devoted to clinical decision support (CDS) software. The FDA’s General Approach to Regulating mHealth Products. Although mHealth has been gaining in popularity for at least the past decade, before commercializing their mHealth products, developers must determine whether the product is subject to U.S.
Pharmaceutical Commerce
SEPTEMBER 29, 2022
Former head of data management and knowledge management at Germany’s National Center for Diabetes Research, Dr. Alexander Jarasch outlines his ideas around the future of AI and data management in the pharma and healthcare space.
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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
SEPTEMBER 29, 2022
The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme. 1 One of the recommendations in a report by the FDA’s Drug Shortage Task Force called for the implementation of such a ratings system that would provide pharmaceutical buyers greater
Storyvine
SEPTEMBER 29, 2022
No more dull, outdated presentations. Do you have a big sales meeting coming up? If so, then you already know how important it is to motivate your salespeople. You don’t want to show them the same thing you did last year, and the year before. So, what can you do? One way to get your sales people motivated is by , Sharing Patient Success Stories with them.
Copyright Clearance Center
SEPTEMBER 29, 2022
The post Realizing Tomorrow’s Future Today with Standards appeared first on Copyright Clearance Center.
PharmaTimes
SEPTEMBER 29, 2022
Results show reduction of clinical decline in global study of people with Alzheimer's Disease
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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.
Medgadget
SEPTEMBER 29, 2022
Researchers at the University of California San Diego have developed a microrobot system to treat bacterial pneumonia. The microrobots consist of living algal cells that can swim very effectively in biological fluids, allowing them to navigate throughout the lungs and deliver drugs to difficult-to-reach areas. The algal cells are studded with antibiotic-loaded polymer spheres that are coated with cell membranes from neutrophils, which help them to neutralize inflammatory molecules that are relea
pharmaphorum
SEPTEMBER 29, 2022
Sanofi and Regeneron have claimed the first approval in the US for a drug for prurigo nodularis, after the FDA gave a green light to Dupixent as a treatment for adults with the rare skin disease following a priority review. There are about 75,000 adults in the US living with prurigo nodularis who are in desperate need of new treatment options, according to the two drugmakers.
PharmaTimes
SEPTEMBER 29, 2022
Positive results in COVID-19 therapy phase 3 trials show effectiveness against five symptoms
Pharmaceutical Technology
SEPTEMBER 29, 2022
The European Medicines Agency (EMA) has accepted Moderna ’s submission seeking a variation to the Conditional Marketing Authorization (CMA) for assessing a 50µg dose of the Omicron-based bivalent Covid-19 booster candidate, mRNA-1273.222, for adults aged 12 years and above. The mRNA-1273.222 vaccine comprises 25µg doses of mRNA-1273 (Spikevax) and a vaccine candidate against the BA.4/BA.5 subvariants of Omicron.
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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.
pharmaphorum
SEPTEMBER 29, 2022
Outdated or offensive terminology can reinforce barriers to clinical trial participation and accessible healthcare. Language matters in every walk of life, and research – where access barriers contribute to systemic health inequalities – is no exception. Yet, new research published by campaign group Demand Diversity, with the support of COUCH Health, found a number of terms in common usage were outdated or even offensive.
Pharmaceutical Technology
SEPTEMBER 29, 2022
Indian company Torrent Pharmaceuticals has signed a definitive agreement for the complete acquisition of Curatio Healthcare for $245.16m (Rs20bn). The deal comprises cash and cash equivalents worth $14m (Rs1.15bn) in the acquired business representing an enterprise value of $231m (Rs18.85bn). The latest takeover is anticipated to boost the presence of Torrent in the dermatology segment.
Pharma Marketing Network
SEPTEMBER 29, 2022
Programmatic advertising is the automated buying, selling, placement, and optimization of digital ad space. When a user visits a website, a request is sent to an ad exchange with information that is then matched against available advertisers in a real-time auction. The winning bid gets to display its ad on the webpage. This all used to happen manually, but real-time bidding allows for improved and faster targeting.
PharmExec
SEPTEMBER 29, 2022
Thursday, September 29,2022 at 11am BST | 12pm CEST | 6am EDT Learn how to utilize Advance Analytics and Machine Learning on integrated Real-World Data (RWD) to enhance your current understanding of the market to rapidly identify patients who can benefit from treatment. Hear experts explore several use cases including an interactive demo: from early opportunity patient finding and patient activation to brand positioning and contextualized HCP messaging of disease characterization.
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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.
pharmaphorum
SEPTEMBER 29, 2022
A digital patient monitoring tool developed by UK company CyberLiver has been given a breakthrough designation by the FDA for out-of-hospital management of patients with cirrhosis at risk of complications. The digital therapeutic (DTx) – called CirrhoCare – has been shown in pilot testing to allow early diagnosis of new complications (decompensation events), with fewer and shorter hospital readmissions compared to a control group with standard follow-up over a three-month period.
European Pharmaceutical Review
SEPTEMBER 29, 2022
Eisai , a Japanese pharmaceutical company based in Tokyo, has published positive top-line data for their large global Phase III CLARITY AD study assessing the drug lecanemab, an anti-amyloid beta (Aβ) protofibril antibody for the treatment of early Alzheimer’s disease (AD), revealing that participants experienced a considerable reduction in clinical cognitive deterioration.
Quantified
SEPTEMBER 29, 2022
Being a successful sales manager certainly means leading a team that converts many prospects into customers. But that isn’t all it entails. What qualities and skills do you need to build the foundation that facilitates this kind of success? . High-growth organizations understand that sales managers do far more than oversee sales operations. The position itself consists of a series of micro-roles, each just as important as the last.
Pharmaceutical Technology
SEPTEMBER 29, 2022
Scribe Therapeutics and Sanofi have signed a strategic partnership to expedite the development of breakthrough clustered regularly interspaced short palindromic repeats (CRISPR)-based cell therapies for cancer. The alliance will leverage the CRISPR genome editing technologies of Scribe to facilitate in genetic modification of new natural killer (NK) cell therapeutics for cancer.
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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
PharmaTech
SEPTEMBER 29, 2022
Thursday, September 28, 2022 at 11am ET | 10am CT | 8am PT Learn the key benefits of continuous OSD production as well as the importance of authenticating OSD products at the dose-level with experts from Syntegon and Colorcon in this episode of the PharmTech Drug Digest Video Series.
CLD, Inc.
SEPTEMBER 29, 2022
The most impactful and dynamic training deliverables in life sciences focus on the patient. These pieces can help learners have and convey empathy for the burden of disease, discuss the limits and possibilities of treatment, perceive more of the hidden consequences of a disease, and learn about patient and caregiver "wish lists" for managing their disease -- ultimately helping learners better position treatments to HCPs.
PharmaTech
SEPTEMBER 29, 2022
Thu, Sep 29, 2022 11:00 AM EDT Are your biological samples held up in customs? Understand how to import and export biological samples with efficiency in this webcast.
PharmaVoice
SEPTEMBER 29, 2022
The co-founder of Pepper Bio entered the biotech world three years ago with the goal of transforming drug discovery through the emerging discipline of transomics.
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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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