MedCity News
JULY 14, 2022
RxBenefits, a pharmacy benefits optimizer, and Tria Health, a chronic condition and medication management company, have launched a new partnership to improve diabetes care and lower healthcare costs for the condition through a proactive approach. .
European Pharmaceutical Review
JULY 14, 2022
A new pilot project by the European Medicines Agency (EMA) will assess whether the analysis of ‘raw data’ from clinical trials improves the evaluation of marketing authorisation applications (MAAs) for new medicines as well as post-authorisation applications. The project will also evaluate the practicality of such submissions and analyses. Raw data constitutes individual patient data from clinical studies in electronic structured format that is directly accessible for analysis and visualisation.
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MedCity News
JULY 14, 2022
Employee health benefits is the theme of the MedCity INVEST Digital Health conference in Dallas, scheduled for September 28, in collaboration with Health Wildcatters. Register today.
PharmaVoice
JULY 14, 2022
The pharma giant’s ‘Depression looks like me’ campaign assembles a ‘one stop shop’ of resources to help combat high rates of severe depression in the LGBTQ community.
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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
JULY 14, 2022
Ambient scribing solutions are technical marvels, but in the end, don’t address the root problem of physician documentation. The fundamental goal is to provide an easier way for physicians to take the mental model in their head and put it into the patient’s digital file.
PharmaVoice
JULY 14, 2022
The company’s chief medical officer discusses its lead candidate and how it fits into wider oncology trends.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
pharmaphorum
JULY 14, 2022
Cost-effectiveness watchdog NICE has recommended routine NHS use of two new therapies for women with advanced breast cancer – Gilead’s Trodelvy and Novartis’ Piqray – in England. . In a statement , the health technology assessment (HTA) organisation said that the two drugs were backed after an agreement with the two developers on pricing that will make them an option for around 3,450 NHS patients.
MedCity News
JULY 14, 2022
EMR startup Canvas Medical recently raised $24 million in a Series B funding round and became the first EMR company founded in the past two decades to be federally certified by the ONC. The startup’s customers are now eligible for value-based payment models in Medicare and Medicaid programs.
pharmaphorum
JULY 14, 2022
Bayer’s venerable testosterone replacement product for men with hypogonadism – Nebido – is being sold to Grünenthal as the group continues a revamp of its healthcare business. Grünenthal is paying up to €500 million ($501 million) for rights to Nebido (testosterone undecanoate), which is sold in around 80 countries worldwide for testosterone deficiency and made sales of €117 million last year.
Pharmaceutical Technology
JULY 14, 2022
Novavax has obtained the US Food and Drug Administration (FDA) emergency use authorization (EUA) for its Covid-19 vaccine. The EUA for the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has been granted for providing a two-dose primary series for active immunisation aimed at preventing the disease in individuals aged 18 years and above. Novavax president and CEO Stanley Erck said: “Today's FDA emergency use authorization of our Covid-19 vaccine provides the US with access to the first protei
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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.
Clarify Health
JULY 14, 2022
New product expands Clarify’s Growth Solution for life sciences companies, delivering comprehensive real-world insights software for the acceleration of therapy commercialization. Clarify Health, a leading cloud analytics and value-based payments platform company, announced the launch of Clarify Access , real-world insights software that helps life sciences companies strengthen market access strategies and improve reporting efficiency through the delivery of on-demand reporting and payer insight
Pharmaceutical Technology
JULY 14, 2022
It is estimated that there are currently more than 7,000 orphan diseases, many of which are considered life-threatening and most of which have a genetic basis. Despite this high number, orphan diseases are rare by definition, affecting around one in 2,000 people as defined by the European Union. Historically, the pharmaceutical industry has failed to meet the needs of this patient population.
PharmaTimes
JULY 14, 2022
Trial focusing on children with eosinophilic oesophagitis has met its primary endpoint
Pharmaceutical Technology
JULY 14, 2022
Innoviva has signed an agreement for the sale of its 15% economic stake in Theravance Respiratory Company (TRC) to Royalty Pharma for nearly $282m in upfront cash payments and a potential contingent sales-based milestone payment of $50m. TRC receives royalties generating from sales of TRELEGY ELLIPTA (the combination FF/UMEC/VI). According to the agreement, TRC also transferred all of its ownership stakes and investments in InCarda Therapeutics, ImaginAb, Gate Neurosciences, and Nanolive to Inno
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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.
PharmaTimes
JULY 14, 2022
Piqray is a targeted treatment for thousands of advanced breast cancer patients
Pharmacy Times
JULY 14, 2022
The objective of this study is to evaluate the use of low-dose pioglitazone, without relying on high doses of insulin, by enhancing sensitivity as a suitable, cost-effective strategy compared to larger insulin doses in patients with limited access to care.
Clarify Health
JULY 14, 2022
New product expands Clarify’s Growth Solution for life sciences companies, delivering comprehensive real-world insights software for the acceleration of therapy commercialization Clarify Health, a leading cloud analytics and value-based payments platform company, announced the launch of Clarify Access , real-world insights software that helps life sciences companies strengthen market access strategies and improve reporting efficiency through the delivery of on-demand reporting and payer insights
InCrowd
JULY 14, 2022
As much as I and my fellow colleagues try to separate work and home life, being a female provider is unique in that we face the same challenges as other professional women when it comes to having children. We are more likely to lose time from work both during maternity leave, and when children are sick, and are more likely to be the ones responsible with managing coordination of family tasks, schedules, and chores (Gold, 2020).
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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.
Pharmaceutical Technology
JULY 14, 2022
Processing powder blends can present a number of challenges: component powders may be poorly flowing in the process, the blends may be susceptible to segregation, or the formation of agglomerates may affect homogeneity. Granulation is used in a range of industries and applications to combine multiple components of a blend into a more free-flowing, homogeneous intermediate product for downstream processing.
Penrod
JULY 14, 2022
This recognition is based solely on ratings from female employees in the previous 12 months. With over 15 million ratings across 70,000 companies, Comparably is one of the most trusted reputation platforms for assessing the quality of workplace culture and employee happiness. Comparably’s recognition follows three quarters of record-high employee satisfaction, as measured by Penrod’s engagement surveys.
Pharmaceutical Technology
JULY 14, 2022
Avrobio has received orphan drug designation for its gene therapy, AVR-RD-05, from the US Food and Drug Administration (FDA) to treat mucopolysaccharidosis type II (MPSII) or Hunter syndrome. The rare and seriously debilitating lysosomal disorder, Hunter syndrome primarily affects young boys and is caused by a deficiency in the lysosomal enzyme iduronate-2-sulfatase (IDS).
pharmaphorum
JULY 14, 2022
The immediate threat to patient care from COVID-19 has diminished with the passing of the acute phase of the pandemic, but its impact continues to be stubbornly significant. After placing unprecedented pressure on health systems for two years and more, patient backlogs in Europe could take six years to clear and there’s still much unknown about ‘ long COVID ’ or even the virus’ links with other conditions like diabetes.
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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.
Pharmaceutical Technology
JULY 14, 2022
Regulatory decisions have a ripple effect, first affecting the pharma sponsors, and then the companies tasked to manufacture the drug. Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes. In this ongoing series , we put a spotlight on contracts between pharma companies and contract manufacturing organizations (CMOs).
pharmaphorum
JULY 14, 2022
A pilot study has been launched by the EMA to see whether it is helpful for regulators to look at the ‘raw data’ from clinical trials submitted in support of new marketing application along with the usual structured analyses from sponsors. The pilot will focus on individual patient data from clinical studies in electronic structured formats that are “accessible for analysis and visualisation,” said the EU regulator.
PharmExec
JULY 14, 2022
Over two dozen pharma brands and agencies have embraced the industry’s first and only healthcare-specific data marketplace with hundreds of ready-to-activate custom segments.
pharmaphorum
JULY 14, 2022
The European Commission’s failure to reveal text messages between president Ursula von der Leyen and Pfizer chief executive Albert Bourla on COVID-19 vaccine procurement has earned it a formal rebuke from the EU Ombudsman. Emily O’Reilly today upheld her earlier preliminary verdict of “maladministration” by the Commission, saying the judgment is a “wake up call for all EU institutions about ensuring accountability in an era of instant messaging” The messages w
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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
Pharmacy Times
JULY 14, 2022
Donald Klepser, PhD, MBA, professor and dean of academic affairs at the College of Pharmacy in the University of Nebraska Medical Center, discusses how the COVID-19 pandemic has changed the role of pharmacy technicians and what is expected as we move forward.
PharmExec
JULY 14, 2022
Application for OTC contraceptive highlights efforts to broaden access to medicines.
Pharmacy Times
JULY 14, 2022
Dutch biopharmaceutical company Byondis submitted the BLA for [vic-]trastuzumab duocarmazine (SYD985) in the treatment of patients with HER2-positive metastatic breast cancer with the goal of improving patient outcomes.
PharmExec
JULY 14, 2022
The specialty offering will leverage Pharmacultural®, a proprietary approach to multicultural marketing in the pharmaceutical space.
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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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