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This poses a significant challenge for pharmaceuticalmanufacturers, not least because of the technical challenges related to operations, supply chain and the environment. This article explores the potential impact of the proposal and considers how manufacturers can ensure the safety and reliability of their products.
Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceuticalmanufacturing, the addition of AI technologies introduce a paradigm shift. Integrative Analysis of Multi-Omics Data with Deep Learning: Challenges and Opportunities in Bioinformatics.
According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), more than 600 essential medicines are at risk if a proposed restriction on the use of fluorinated substances, per- and polyfluoroalkyl substances (PFAS) across pharmaceuticalmanufacturing in the EEA, is implemented.
To address these issues, companies should adopt more advanced production strategies such as continuous flow chemistry, as they can shorten manufacturing processes, increase productivity and throughput. Simultaneously, there is increasing need for stringent quality control and traceability throughout the supply chain to ensure patient safety.
When we think of adherence in the medical world, it’s often simplified to something along the lines of the degree to which a patient correctly follows medical advice. It’s a simple statement with many, many moving parts, especially when we’re talking about patients with multiple chronic conditions. So how is this achieved?
And just as a family business thrives on its connection to the community, Chiesi is committed to connecting to the global patient community. We try to have a very long-term orientation because we believe that aligns our objectives very well with the objectives of society and the patients we serve, and it makes us a stable business.”.
In the past 12 months, PhRMA and closely allied groups spent at least $57 million — $19 million of it since July — on TV , cable , radio , and social media ads opposing price negotiations, according to monitoring by the advocacy group Patients for Affordable Drugs. First, let’s clarify how the bill saves taxpayers billions.
The involvement of patient voice in demonstrating the value of treatments in healthcare is gaining importance. While gaining patient insights is not a new topic for biopharmaceutical teams, the body of literature on the role of patient-centricity in health technology assessments (HTA) is growing. ACCESS THE FULL ARTICLE HERE.
Failing to adhere to prescribed medication regimens is one of the prime reasons for poor patient health outcomes. Pharmaceutical and healthcare companies are working continuously to improve patient adherence, which also impacts disease control and pharmaceutical industry revenues directly. Patient adherence.
Contract research, development and manufacturing organisation (CRDMO) WuXi STA has broken ground on its new 190-acre pharmaceuticalmanufacturing campus in Middletown, Delaware, US. The biopharmaceutical industry is part of Delaware’s DNA,” stated Delaware Governor John Carney.
Our Ludwigshafen site serves as a centre of excellence for both research and development and pharmaceuticalmanufacturing and will play a critical role in AbbVie’s future growth,” stated Azita Saleki-Gerhardt , PhD, Executive Vice President, Chief Operations Officer. The new R&D building in Germany is expected to completed in 2027.
SUMMARY: (JAMA) The median drug wholesale list price (as defined by Average Wholesale Price) increased by 129% from 2010-2016, while median patient out-of-pocket costs increased by 53% and median insurance payments after rebates and discounts increased by 64%. Say goodbye to all the supposed goodwill.
To appreciate the scope of the challenge facing the pharmaceutical market, as well as patients across the globe, we must understand that there are two distinct threats – ‘counterfeit’ and ‘falsified’ medicines. The latest figures suggest the pharmaceutical market is worth over $1.27 Defining ‘counterfeit’ and ‘falsified’.
Ensuring that these therapies reach the right patients at the right time requires a deep understanding of the patient journey and the healthcare professionals (HCPs) involved in their care. Lab data, coupled with strategic HCP engagement, plays a crucial role in helping pharmaceuticalmanufacturers navigate this complex landscape.
Improving our collective understanding of the patient’s overall healthcare experience is necessary to effectively deliver prescription support. How can we ensure that vital prescription information reaches patients when they need it? Where and how you message HCPs and patients must synchronize with when they are engaged.
“This important investment will ensure the continuous development of our late-phase pipeline into deliveries of important medicines for treatments to patients worldwide”, Wulff declared in the original annoucement.
The first industrial-scale pharmaceuticalmanufacturing facility for production of lead-212-based radioligand therapies has been inaugurated. Radioligand therapy developments in 2023 and 2024 Other companies making progress producing radioligand therapies include Novartis.
International Federation of PharmaceuticalManufacturers and Associations (IFPMA), the global trade body for the biopharmaceutical industry , has announced its new CEO leadership team for the next two years. Who is joining IFPMA’s new CEO leadership team? The C-suite lineup includes Albert Bourla, Chairman and CEO of Pfizer.
AI supports marketers in key areas such as personalized campaigns (with tailored messages to healthcare professionals (HCPs) and patients), predictive analytics, and social sentiment analysis. Respondents cite workflow automation, data analysis, and realtime content generation as areas of interest within their organizations.
Zygel is the first and only pharmaceuticallymanufactured, synthetic cannabidiol that is formulated as a patient-protected permeation-enhanced gel for transdermal delivery.
For example, due to prevalence of the disease across the globe, US approval of the biologic lecanemab was particularly anticipated by both the industry and patients. The findings were published in the NEMJ in April 2023 and demonstrated “the best solid tumour CAR-T data reported to date – and by a country mile!
Moreover, pharmaceuticalmanufacturing poses a huge detriment to the state of the planet’s ecosystem. Active pharmaceutical ingredients (APIs) are particularly impact intensive, soaking up a large quantity of resources in terms of heat, energy and water when being produced.
How can we help ensure patients continue to take their medications as prescribed? The reasons why a patient may not take their medication are plentiful, and as a result so are the solutions now available to attempt to solve this issue. But it is not a simple answer. Furthermore, it is estimated to reach $6.5
Pharmacy's position at the intersection of the care team gives it a unique ability to connect providers, payers, and pharmaceuticalmanufacturers, and support patients to maximize their health outcomes.
“Today marks a significant achievement for our company and reflects our continued commitment to expansion and innovation in the region,” declared Hideki Shima, Chief Manufacturing Officer, Astellas Pharma. Last year, Astellas announced plans to build the new pharmaceuticalmanufacturing facility in Tralee, where it has operated since 1990.
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 pharmaceuticalmanufacturing site quality rating system, the Quality management maturity (QMM) programme.
The pharmaceutical industry has numerous use cases for AI. From the drug discovery phase to patient care, AI has the potential to enhance almost every stage of the product life cycle. It’s remarkable to see the progress made in the technology compared to only a few months ago and there are no signs of the progress slowing down.
And as these stakeholders are presented with more and more RWE from pharmaceuticalmanufacturers, they are asking tough questions to better understand whether to use this evidence when making critical decisions that impact the health of patients.
And as these stakeholders are presented with more and more RWE from pharmaceuticalmanufacturers, they are asking tough questions to better understand whether to use this evidence when making critical decisions that impact the health of patients.
The investment at the LEAP site marks the company’s biggest manufacturing investment at a single location to date. The investment will support up to 1,000 scholarships for those interested in pursuing careers in pharmaceuticalmanufacturing. Last year, the company committed to providing $42.5m
Call to Action Pharmaceuticalmanufacturers continue to push forward with active combination therapy pipelines, seeking to offer improvements over SoC in oncology. It is their prerogative to support and commercialize new innovation, providing new therapeutic options to patients. Certain markets (e.g.,
Despite physicians conducting an average of six professional searches every working day, only 17% of them searched with the words “pharmaceuticalmanufacturers.” Helpfully, Google conducted research to work out how healthcare professionals were sourcing products online.
Central Drugs Standard Control Organisation (earlier known as Drugs Controller General of India) are essential to the pharmaceutical production process. They play a crucial role in assuring the efficacy and safety of products given to patients.
The Voluntary Scheme for Branded Medicine Pricing, Access and Growth (VPAG) Investment Programme is a joint initiative between the Department of Health and Social Care (DHSC), NHS England and the Association of the British Pharmaceutical Industry (ABPI). Importantly, NHS patients will be able to access new treatments earlier.
Manufacturer assistance programs are designed to make treatments more affordable, yet only about 10% of these dollars are used by patients. The cost of filling a prescription can keep 21% of patients from getting an Rx, and one in ten patients will modify their treatment plan because of cost, according to recent polling data from KFF.
One involves helping patients, while the other requires you to meet sales quotas. You’ll find areas that are biotech hotbeds, those that have numerous pharmaceuticalmanufacturers and so on. However, is it really that easy to go from one job to another? After all, medical sales seem like a very different animal from nursing.
Additionally, it aids clients in introducing products to international markets and varied patient populations by delivering tech-driven services spanning from clinical development consultation to marketing authorisation. The company provides strategic assistance and regulatory support to biopharma firms across the lifecycle of the product.
With increasing global competition, including incentives from countries such as Singapore and the US, AstraZenecas move signals potential challenges for the UKs ability to retain large-scale pharmaceutical investments. The post AstraZeneca cancels 450m Liverpool vaccine facility expansion appeared first on European Pharmaceutical Review.
Key study findings Study results demonstrated that precise control of tablet surface geometry “effectively tailored drug release profiles, enhancing patient compliance and treatment efficacy”. their approach in the study addresses “diverse pharmaceuticalmanufacturing demands”. Therefore, according to Wang et al.
Indeed, a key aspect of EU GMP Annex 1 is the requirement for pharmaceuticalmanufacturers to develop a comprehensive Contamination Control Strategy (CCS) that documents their approach to assuring the sterile drug product’s high quality and, therefore, enhancing patient safety.
Addition of our facility at the Princeton West Innovation Campus adds manufacturing and clinical development capabilities…to advance quality medicines faster for patients,” commented John Oyler , Co-Founder, Chairman and CEO of BeiGene. The company highlighted that its oncology pipeline addresses “80 percent of the world’s cancers”.
The Guidance will act as a non-binding and evolving resource for companies and provide additional clarification about communications with healthcare professionals (HCPs), healthcare organisations (HCOs), patient organisations (POs), and other stakeholders, including the general public.
Pharmaceuticalmanufacturers have submitted Citizen Petitions raising safety or efficacy concerns about proposed competing generic and biosimilar products, and such submissions often delay FDA approval of the proposed products while the FDA resolves the pending petitions. Conclusion.
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