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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. Tuijin Jishu/Journal of Propulsion Technology, 44(3), 1384-1392.
In recent years, the biopharmaceutical industry has found itself at a crossroads – being able to offer advanced and truly innovative treatments, such as gene therapies, but facing the complex challenge of creating manufacturing standards for the biotechnology sector from the ground up.
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. The result is efficient, cost-effective and high-quality (bio)pharmaceuticalproduction. principles.
market until next year, with the pharmaceutical company announcing Tuesday a settlement with the Iceland-based Alvotech. billion last year, the highest total for any pharmaceuticalproduct and they will do anything to keep that money. AbbVie significantly inflated prices over the past two decades for patients in the U.S.
2,3 Clinical implementation of CAR T-cell technology requires a reproducible T-cell manufacturing platform, which necessitates effective gene-transfer tools and T-cell culture conditions. Due to shipping and manufacturing requirements, the time from a patient being included in the CAR T programme to receiving therapy can be several weeks.
Central Drugs Standard Control Organisation (earlier known as Drugs Controller General of India) are essential to the pharmaceuticalproduction process. They play a crucial role in assuring the efficacy and safety of products given to patients.
These formulations can improve patient adherence, the paper stated. treatment adherence can be an issue for certain patients. Use of disposable and pre-filled syringes means this equipment can be prepared and filled as per good manufacturing practice (GMP) requirements in pharmaceuticalproduction facilities, the authors wrote.
Adoption of Newly-Approved 1L mNSCLC Regimens Driven by Promotional Activities Promotion plays a major role in the successful launch of a new pharmaceuticalproduct. Seventy percent of LIBTAYO + chemo patient share came from the 18% of oncologists who received both rep and digital promotions in the past month.
Whether it’s soaring temperatures, extreme cold snaps, or devastating floods, pharmaceutical logistics providers must ensure that shipments reach their destination in their intended condition without defect or delay. Pharma manufacturing can also be affected by extreme weather events, such as storms.
One of the reasons for this is the growing importance of offering an alternative vegan capsule for patients who, for dietary reasons, do not want to consume animal products. First, we are seeing growing demand for new materials to replace the traditional gelatine capsule shell.
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. These may be mislabelled or produced in fake packaging and, most dangerously, there is no regulation around their manufacture.
Healthcare professionals are also catching up to the patient group, which has long been engaged on social media. It can be applied to comprehend patient difficulties and spot chances for clinical intervention. Patient and healthcare professionals anticipate personalized, communication based on value.
Prospects of the ampoules packaging market On the other hand, advancements in ampoule packaging, as well as sustainability measures and manufacturing innovations such as automation and robotics, were highlighted as promising contributing factors for growth of the market.
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.
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.
Packaging plays a critical part in the pharmaceuticals and medical devices industries and is developed with its own set of security standards for the safety of consumers. The document contains detailed information on the providers and their product offerings, alongside contact details to aid your purchasing or hiring decision.
While manufacturers and packaging providers worldwide continue to put sustainability at the forefront of their projects, the pharmaceutical industry faces greater challenges than most. However, when it comes to pharmaceuticalproducts, health and safety remains the primary consideration. But how will this play out?
This media becomes especially important in healthcare since it enables the clear, concise, and efficient communication of difficult medical ideas, techniques, and patient education resources. Medical video production is producing excellent videos, especially for the demands of the pharmaceutical, medical device, and healthcare sectors.
Various uses soon became apparent including those for supply chain management, anti-counterfeiting, and to improve patient safety. First has been the cost”, says Franck Germain, VP marketing at Linxens, a global technology company that manufactures electronic components for security and identification, including RFID antennas and inlays.
The specialist garments thus represent a risk during sterile productmanufacture, the authors emphasised. The post Identifying bacterial isolates to help prevent cleanroom contamination appeared first on European Pharmaceutical Review. concluded. .
PharmaceuticalProduct Development (PPD). PPD, also known as PharmaceuticalProduct Development, is an extensive research organization headquartered in the United States but has a widespread global presence. Founded: 1985 Headquarters: Wilmington, North Carolina Annual Revenue: $65.0M Employee Size: 24,000.
On concluding the NDA transfer period, Harrow will take over the complete US market operations and commence works to manufacture the products through third parties. Outside of the US region, Novartis will have sole rights to the products.
A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceuticalproducts. The evolution of CCIT. Free Webinar.
Nitrosamines have garnered significant attention from the pharmaceutical industry due to their detection in commonly prescribed medications for conditions like type 2 diabetes, high blood pressure, and heartburn. [1] However, this regulatory ban does not impact active pharmaceutical ingredients (APIs).
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.
This means numerous key aspects of how pharmaceuticals are regulated in the EU could be affected, from costing and reimbursement to intellectual property rights, incentives and more. But what are the key potential changes and how could they impact drug developers and manufacturers? Key areas of potential legislative change.
Regulatory bodies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) place great importance on data integrity in the pharmaceutical/life science industry. What is the biggest impact of having compromised data when working with regulatory bodies in the pharmaceutical industry?
Copilots for Maintaining the Client-Provider Relationship Gen AI copilots are introduced during the conversation between the patient and the physician. PharmaceuticalProduct Development Gen AI is a special tool for manufacture of new pharmaceuticalproducts.
They can be used in pharmaceuticalproduct sales, marketing, and advertising. VR and AR can help you communicate effectively with healthcare practitioners in order to visualize the benefits of your products. Because of the greater understanding of how products work, these solutions may also persuade patients to purchase goods.
Each strain was selected to take into account: the variability of environmental and human strains in a pharmaceuticalproduction environment strains known for their particular growth conditions, such as growth temperature, invasiveness, growth difficulties, etc (eg, Cladosporium , specific moulds, corynebacteria , Bacillus , etc).
Amivantamab is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
From new legislation to functional shifts in marketing and advertising, the pharma industry works hard every day to keep up with new regulatory requirements and the constantly evolving expectations of prescribers and patients. – Increased Caution From Patients & Prescribers. – New & Updated Legislation.
Jiangsu Hengrui Medicine overview Jiangsu Hengrui Medicine (Jiangsu Hengrui) is a biopharmaceutical company that focuses on the research, development, manufacture, and distribution of novel pharmaceuticalproducts. It is formulated as solution for intravenous route.
Medical sales offer a compelling opportunity for individuals seeking involvement in healthcare innovation, with lucrative financial rewards and a chance to directly impact patient care. These typically dictate that a medical sales representative participates in manufacturer training and exams to become more proficient and credible.
Shanghai Fosun Pharmaceutical (Group) is to collaborate with the International Finance Corporation (IFC) to construct a new pharmaceuticalproduction facility and distribution hub near Abidjan, Côte d’Ivoire. The IFC will provide two loans totalling $53.49m (€50m) to Fosun Pharma’s subsidiaries.
The number of unauthorised and unregulated online outlets selling counterfeit pharmaceuticalproducts is continuously growing, with many selling counterfeit medications via the internet typically posing as legitimate vendors. Covert-hologram seals are also atracting interest within the pharmaceutical packaging sector.
TRB-1 and TRB-2 are our first offerings in development which will help improve access for potentially millions of patients. The company operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden, the UK and the US and is headquartered in Stockholm, Sweden. About Recipharm.
Due to their compatibility, many of the new molecules launched as hard capsules over the last three years have been formulated in HPMC capsules” Gren : One of the reasons for this is the growing importance of offering an alternative vegan capsule for patients who do not want to consume animal products.
A requisite cold chain has been designed and implemented to be uninterrupted from factory to patient. This requires the development of technologies to rapidly produce effective, safe, stable vaccines that can be manufactured and distributed quickly. However, so far manufacturing has only been achieved on a modest scale.
Avoiding potentially misleading practices, providing accurate information and prioritizing patient welfare are important concepts reps must follow. Ethical conduct helps maintain the company’s integrity and foster trust with HCPs and patients. Ethical Conduct: In pharma sales, ethical conduct and behavior is crucial.
Juno Pharmaceuticals Canada has purchased Omega Laboratories, a specialist injectable pharmaceuticalmanufacturer in Canada, for an undisclosed sum. The merged entity represents one of the biggest specialist generic injectable operations in Canada with local manufacturing facilities.
Quality by design (QbD) is a concept introduced into the pharmaceutical regulatory lexicon in 2005. It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Following QbD to guarantee a drug product's safety.
Edoxaban tosylate is used for the prevention of venous thromboembolism (VTE) in patients undergoing total knee arthroplasty, total hip arthroplasty and hip fracture surgery and severe pulmonary embolism. The company offers a wide range of prescription drugs, over the counter (OTC) drugs, vaccines, and others.
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