Articles
The U.S. Food and Drug Administration approved a new application of a current pleural mesothelioma treatment, according to a press release Monday from Eagle Pharmaceuticals. The FDA approved pemetrexed injection for patients who are not surgical candidates. Pemetrexed is the generic name for the chemotherapy drug Alimta, which is administered intravenously. The injection version of pemetrexed is branded Pemfexy. The new treatment method will not be available until February 1, 2022. Pemetrexed is one of two FDA-approved chemotherapy drugs for mesothelioma. The other is cisplatin. The press release from Eagle Pharmaceutic…
How to Organise Your Day When Working from Home If you are new to telecommuting, it may feel like someone dropped you in the deep forest without a compass. Many of the routines that tell you what to do when in the office go out the window. While it’s natural to feel unsettled, you need structure to work at your productive best. Once you master the art of working from home, you’ll likely find that you accomplish more than ever. Follow the tips below to develop a routine that lets you produce your best…
The question of which expertise to trust has always been a tricky, sometimes even touchy subject. Nowhere is this better evidenced than the COVID-19 crisis. Every nation in the world – from Sweden to Saudi Arabia has had its own scientific community put under the microscope. Misinformation continues to circulate through global health networks, to the detriment of individual countries’ ability to respond effectively to the pandemic. Even the World Health Organization’s expertise has come under unprecedented scrutiny in…
“Supply chain planning in life sciences has always been complex. It is a highly regulated sector; pharmaceuticals products typically have limited life spans, and supply chains are often based on functional silos. Planning cycles can sometimes extend over 5-10 years. Excess inventory can also be a problem but the overriding concern is getting products quickly out to end users to keep them well. …
Regulatory teams have much to learn from the standardised approach that quality assurance colleagues take to managing information. The legacy, document-based view of information management is fast being replaced by a data-first approach. Up-to-date, high quality data is key to success, argues Romuald Braun, VP of Strategy for Life Sciences, AMPLEXOR. Across pharma businesses, teams work together to meet Regulatory commitments, perhaps sharing u…
January National Blood Donor Month National Glaucoma Awareness Month National Volunteer Blood Donor Month Cervical Cancer Awareness Month National Birth Defects Prevention Month Dry January 19-25th: National Activities Professional Week 25th: National Intravenous Nurse Day February American Heart Month AMD/Low Vision Awareness Month National Cancer Prevention Month National Senior Independence Month Feb. 1-7: Patient Recognition Week Feb. 3-7: Pride in Food Service Week Feb. 9-15: National Cardiac Rehabilitation Week Feb. 14-21: Alzheimer's and Dementia Staff Education Week February 4th: World Cancer Day …
Today, there are numerous external and internal drivers for life sciences organisations to be collecting, preparing, publishing/submitting and managing more and more data, and to be doing this more and more using a structured format. Regulatory agencies are demanding increased safety and traceability detail; requirements about what goes on packaging and labelling are becoming more stringent; and the public is calling for greater transparency about the products they use. Meanwhile, companies need to be smarter, faster and more cost-efficient in…
Providing electronic product information, something international health authorities are steadily moving towards as a requirement, promises to be a much more efficient and user-friendly way of conveying the latest manufacturing details and safety recommendations to patients and healthcare professionals. But how ready are life sciences companies, asks Amplexor’s Agnes Cwienczek. Continued reliance on paper-based ins…
PharmiWeb is pleased to announce the launch of our IOS Job Search App for the pharma and life science sector. Even in these times, PharmiWeb’s niche job board (PharmiWeb.Jobs) maintains a vast selection of active job vacancies from countries right across Europe and into Australia. The new app is designed to help job seekers quickly search over 2500 current vacancies from more than 80 actively recruiting employers and agencies. Once installed, job seekers can save their searches, shortlist the roles or apply online using their hand held devices. Developed by our platform partner Madgex, our IOS app complements our existing Android app already available on the Google App…
Compared with other functions across the pharmaceutical product lifecycle, Safety and Pharmacovigilance (PV) teams are the least likely to employ smart technology to help lighten the load. This is surprising given that life sciences companies today spend a disproportionate amount of their PV budget simply amassing reports of suspected drug reactions - which are often of poor quality. So what’s stopping them exploiting proven technology to lighten the load? Building the business case In pr…
Peter Kohut, Director of Drug safety at Arriello, explores the main hurdles preventing greater automation of PV data capture processes within life sciences firms, and suggests a way forward. With more and more safety data to capture, and a window of just 15 days to assess and report serious adverse events to health authorities, the case for automating the most labour-intensive aspects of pharmacovigilance (PV), is strong. So, what is holding companies back from investing in process transformation? 1. A lack of suitable solutions Look at most other industries, especially thos…
Clinical trial patient recruit…
Annemie Venter, R&D Director, External Product Development – Outside Innovation, Health For decades now, global consumers have relied on blanket advice when it comes to their health and wellbeing, with guidance frequently centred on eating well, exercising frequently and sleeping for a recommended period per night. Whilst these adages are still absolutely true, recent decades have witnessed significant advancements in genetics, which have paved the way for a far more personalised approach to maintaining and improving health and wellbeing. One field where these…
In the consumer world, smartphone apps are transforming people’s visibility, into their consumption habits for example, helping them to make better choices. Now the same needs to happen in life sciences, based on more unified product and regulatory status insights. In the 2020s, breaking down walls, consolidating disparate applications, and behaving more cohesively as a unified global business with end-to-end operational visibility, is a commercial imperative. Whatever the short- and longer-term fallout of Covid-19, organisations will need to come back fighting – with new tools at their disposal, ready to raise t…
Intelligent analytics and smart process automation rely 100 per cent on the trustworthiness of underlying data. Steve Gens of Gens & Associates and Remco Munnik of Iperion Life Sciences Consultancy offer five best-practice tips for achieving and maintaining integrity across company-wide product information to create a sure footing for AI-driven innovation. ‘New’ technologies including artificial intelligence/machine learning (AI/ML) o…
Substantial investment has gone into the preparations for the EU’s implementation of the ISO IDMP (identification of medicinal products) standards, which must not be compromised in 2020 - whatever the current hold-ups with European Medicines Agency’s IDMP implementation guidelines, and despite the new Veterinary Regulation vying for attention. The goal of IDMP is to create a current central data repository of medicinal products that can be readily searched, understood and relied upon internationally. SPOR (Substance, Product, Organisation and Referential) data management services are the key to enabling this, paving the way fo…
~ Exploring AI, blockchain and packaging ~ From personalised medicine and cannabis oil, to track and trace and the Falsified Medicines Directive (FMD), the pharmaceutical industry has witnessed a whole host of changes over the past decade. But what does the future hold? Here, Adrian Pittock, marketing director at pharmaceutical consumables supplier Valley Northern, looks at pharmaceutical trends for 2020. Artificial intelligence Ar…
The growing appetite and opportunity for increased personalisation of medical treatment plans, devices and medicines is clear, promising to improve the efficacy and safety of life sciences products and services for patients. Yet this in turn places a growing burden on manufacturers and supply chains to manage multiplying stock-keeping units, as the number of variants of each product increases. Batches are becoming smaller and the number of packaging and labelling variants are soaring to meet the growing demand of personalisation. Managing this logistical complexity reliably, efficiently and consistently across markets and for all target…
The COVID-19 pandemic has created an unprecedented challenge for pharmaceutical companies thrusting them into an unforeseen scenario where they must manage competing priorities for the protection of both their patients and their personnel. As companies strive to manage and maintain their supply chains to minimise patient impact, they are required to restrict travel, follow government directives limiting social contact and ensure they prevent exposure of their personnel to infection with COVID-19. In the pharmaceutical industry there is an emphasis on robu…
A new study gives weight to emerging evidence that a loss of smell and taste is a common symptom of COVID-19 – according to University of East Anglia (UEA) smell expert Prof Carl Philpott. The study, from Kinds College London, looked at responses from more than 400,000 people reporting suspected COVID-19 symptoms via an app. It found that 59 per cent of 579 people who said they had tested positive for the virus reported a loss of smell or taste. But loss of smell and taste are also signs of other infections, such as the common cold. Prof Philpott, from UEA’s Norwich Medical School, said: "Coronaviruses have been associated with what we refer to as post-vi…