Fierce Pharma
NOVEMBER 10, 2023
Valneva has won the race in the U.S. | The FDA has approved the world’s first chikungunya vaccine, giving a thumbs-up to Valneva’s Ixchiq. The French company receives a priority review voucher from the FDA, which it said it will sell. It is an accelerated approval and subject to a confirmatory, real-world study.
David Bagga
NOVEMBER 10, 2023
Medical device sales is a burgeoning market, with jobs that have an extremely high earning potential. In 2018, the average base salary of a medical sales representative was $92,698 Medical Device Sales Career Home Blog How to Break into Medical Device Sales… How to Get into Medical Device Sales Medical device sales is a burgeoning […] The post How to Get into Medical Device Sales appeared first on.
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Fierce Pharma
NOVEMBER 10, 2023
Mirati Therapeutics’ KRAS inhibitor Krazati’s EU prospects weren’t looking good after an initial rejection from Europe's drugs regulator. | European Medicines Agency’s (EMA's) Committee for Medicinal Products for Human Use (CHMP) snubbed the KRAS inhibitor in July, but changed its tune after a formal re-examination initiated by Mirati.
MedCity News
NOVEMBER 10, 2023
Blue Shield of California is now offering Mahmee, a maternal health company, to eight employer groups. It comes after a successful pilot in which Mahmee served 80 members.
European Pharmaceutical Review
NOVEMBER 10, 2023
US researchers have developed the Geometric Viability Assay (GVA), which has been shown to be a fast, cheap and sustainable method for counting microorganisms. Since it is 36 times faster than conventional methods, uses 15 times less plastic, and is low cost, Geometric Viability Assay could “replace existing viability assays and enable viability measurements at previously impractical scales”, the paper noted.
MedCity News
NOVEMBER 10, 2023
Cargo Therapeutics will use most of the IPO proceeds for clinical testing of a cell therapy engineered to overcome a common way cancers develop resistance. This program is based on research from the National Cancer Institute.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
NOVEMBER 10, 2023
As the industry moves towards more personalized medicine, pharmacogenomics could play a key role in keeping patients healthier longer and in getting them viable treatments for their unique genetic profile.
European Pharmaceutical Review
NOVEMBER 10, 2023
Bioburden and sterility testing: how to conserve gene therapy product Kathy Zagaroli, Senior Director of Quality Control at Kiniksa Pharmaceuticals, and Tom Bujold, Senior Director of Quality Control at REGENXBIO, discuss the challenges of bioburden and sterility testing for gene therapies and why industry must come together to drive increased harmonisation.
MedCity News
NOVEMBER 10, 2023
Real-time insights enable laboratories to be more proactive, strategic, and responsive in managing their staffing needs and mitigating the impact of market forces affecting labor shortages.
Pharmaceutical Technology
NOVEMBER 10, 2023
The US FDA has granted approval for Takeda’s Adzynma for congenital thrombotic thrombocytopenic purpura, a rare blood clotting disorder.
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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.
MedCity News
NOVEMBER 10, 2023
One of the major lessons learned during the pandemic is that hospitals and medical facilities are not always the safest places to recover, especially for seniors and those living with chronic conditions. Compounding this issue is that 85% of seniors in the U.S. live with one or more chronic conditions. With the United States being home to 55.8 million seniors, this is a very real, local issue.
Pharmaceutical Technology
NOVEMBER 10, 2023
AstraZeneca has posted a profit after tax of $1.37bn for Q3 2023 versus $1.64bn in the same quarter of the previous year, a decline of 16%.
MedCity News
NOVEMBER 10, 2023
Utilizing innovative technologies to prevent workplace violence and enhance security in healthcare has the potential to increase staffing retention, ultimately improving hospital operations, administration, and the healthcare industry as a whole.
European Pharmaceutical Review
NOVEMBER 10, 2023
Exploring the complex pathway of paediatric drug development The formulation development of paediatric medications poses unique challenges compared to that of adult medications. Tom Hegarty, Head of Technical Operations for Almac Pharma Services, delves into some of the key considerations when looking to develop child-friendly formulations. Definitive screening design to accelerate process characterisation Mourad Mellal, Director of Statistics, Product Development at Catalent, elucidates the rol
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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
NOVEMBER 10, 2023
Sustainability efforts in healthcare have a high return on investment and are worth leaders’ time, budget and resources. But one question remains – how?
PharmaTimes
NOVEMBER 10, 2023
The trial is testing whether Mavenclad could benefit upper limb movement in MS patients - News - PharmaTimes
Impetus Digital
NOVEMBER 10, 2023
A version of this article was previously published on PharmaPhorum. Although orphan drugs represent a sizeable portion of new drug approvals , most rare diseases still lack effective treatment. Even more so than for other conditions, rare disease management contains large care gaps that can only be filled by increased access to new and affordable treatment options.
PharmaTimes
NOVEMBER 10, 2023
A rare disease is defined as a condition that affects fewer than one in 2,000 people - News - PharmaTimes
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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.
Copyright Clearance Center
NOVEMBER 10, 2023
Authors and agents ask whether streaming audiobooks will devalue reading and harm book buying.
pharmaphorum
NOVEMBER 10, 2023
Novo Nordisk sets aside $6bn to boost production capacity Phil.
PharmExec
NOVEMBER 10, 2023
Supplemental Biologics License Application for lisocabtagene maraleucel (Breyanzi) seeks to expand the current indication include the treatment of adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who were previously treated with a BTKi and BCL2i.
pharmaphorum
NOVEMBER 10, 2023
Bayer pledges up to $1.5bn for Recursion oncology alliance Phil.
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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.
Pharmaceutical Commerce
NOVEMBER 10, 2023
New E2E workflow orchestration service is expected to simplify the processes of health systems and retail pharmacies while also reducing the risk of recalled items reaching patients.
pharmaphorum
NOVEMBER 10, 2023
Takeda gets okay in US for rare blood disorder drug Phil.
PharmExec
NOVEMBER 10, 2023
When considering factors like disease biology and patient needs in drug discovery and development, the goal is to deliver effective and scalable treatments globally by balancing established approaches like small molecules or protein therapeutics with more complex modalities such as RNA, cell, and gene therapies.
Pharmaceutical Technology
NOVEMBER 10, 2023
Following the three-month FDA review delay, Valneva’s live-attenuated chikungunya vaccine, Ixchiq received accelerated approval.
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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
PharmExec
NOVEMBER 10, 2023
Adalimumab-bwwd (Hadlima; Samsung Bioepis Co., Ltd. and Organon & Co.) is seeking to become the third Humira biosimilar deemed interchangeable with the reference product.
Pharmaceutical Commerce
NOVEMBER 10, 2023
The Flowflex COVID-19 Antigen Home Test is the first over-the-counter rapid antigen test for SARS-CoV-2 to gain FDA 510(k) marketing clearance by the FDA.
PharmExec
NOVEMBER 10, 2023
Eight rapid-, short-, and long-acting insulin products will move to tier one preferred status, which limits out-of-pocket spending to $35 or less for patients with diabetes.
Pharmaceutical Commerce
NOVEMBER 10, 2023
Financial commitment further strengthens IntegriChain’s platform as a source for pharma manufacturers' commercialization and market access goals.
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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.
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