Fierce Pharma
OCTOBER 13, 2023
Even as Amylyx’s ALS drug gains steam in the U.S. after a long-awaited FDA approval, the company is struggling with regulatory hurdles overseas. | Europe's drug regulator wasn't swayed by Amylyx's phase 2 data. The European Commission will make the final call on the drug's approval in the bloc by the end of the year.
PharmExec
OCTOBER 13, 2023
Industry experts discuss the relationship between digital and traditional (key) opinion leaders and how companies are adjusting their strategies to harness the unique brand engagement benefits each role can provide in driving better patient outcomes.
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Fierce Pharma
OCTOBER 13, 2023
The popular diabetes med Ozempic and its sister weight-loss drug Wegovy are boosting Novo Nordisk to new highs again and again. | The popular diabetes med Ozempic and its sister weight-loss drug Wegovy are boosting Novo Nordisk to new highs again and again.
MedCity News
OCTOBER 13, 2023
Pfizer’s new FDA-approved ulcerative colitis drug Velsipity comes from its $6.7 billion Arena Pharmaceuticals acquisition. The small molecule will compete against blockbuster Bristol Myers Squibb drug Zeposia, which addresses the same target.
Fierce Pharma
OCTOBER 13, 2023
Back in February, Leo Pharma revealed that its JAK-inhibitor cream delgocitinib met its primary and secondary endpoints in a phase 3 trial in chronic hand eczema, putting pressure on Incyte’s appro | Back in February, Leo Pharma revealed that its JAK-inhibitor cream delgocitinib met its primary and secondary endpoints in a phase 3 trial in chronic hand eczema, putting pressure on Incyte’s approved topical Opzelura.
MedCity News
OCTOBER 13, 2023
A recent webinar sponsored by AVIA Health and Seamless MD examined how health systems use remote patient monitoring beyond the usual chronic condition applications, including surgical prep and recovery, women’s health, and more.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
OCTOBER 13, 2023
The last few years, both during and after the pandemic, have been turbulent times for healthcare providers and patients alike. For now, although it appears that healthcare staffing shortages will continue, providers are not without practical strategies for attracting and retaining talent.
PharmExec
OCTOBER 13, 2023
Exploring the pharma and biotech financing, M&A, and stock market pictures through the first half of 2023—and implications for the future, as market challenges continue to weigh heavily in senior management decision-making.
MedCity News
OCTOBER 13, 2023
At the HLTH conference last week, MedCity News’ editorial team interviewed 11 health leaders from a variety of organizations to get a sense of which areas within healthcare will see consolidation over the next 12 months.
European Pharmaceutical Review
OCTOBER 13, 2023
The Committee for Medicinal Products for Human Use (CHMP) has recommended approval of BRUKINSA ® (zanubrutinib), a Bruton’s tyrosine kinase inhibitor (BTKi), in combination with obinutuzumab. BeiGene’s anti-cancer treatment is indicated for adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior lines of systemic therapy.
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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
OCTOBER 13, 2023
Health tech to support care for seniors and track the progression of conditions such as Parkinson’s disease and heart failure were on display at HLTH 2023. The National Institute on Aging also added a startup boot camp leading up to HLTH.
Pharmaceutical Technology
OCTOBER 13, 2023
The dose-selection Phase I trials for evaluating PepGen’s peptide-conjugated antisense oligonucleotide have been cleared to begin in the US.
MedCity News
OCTOBER 13, 2023
At HLTH 2023, I had dozens of conversations with providers, digital health investors, startup CEOs and other players in the healthcare industry. When I got home, I compiled seven refreshingly honest takes I heard from them while at the conference.
PharmExec
OCTOBER 13, 2023
Stephen Rivera, vice president, global technical accounting advisory services and policy, Johnson & Johnson, capitalizes on his lively personality—and a courageous career journey—to bring people together to shape the future of biopharma.
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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
OCTOBER 13, 2023
If you could only do one thing to improve the health of children in the U.S., it would have to be in the behavioral health sphere, Nemours Children’s Health CEO Lawrence Moss declared at HLTH. The state of youth mental health has reached a crisis point in the U.S., and Moss’ health system is working hard to address this. Some of its efforts include embedding behavioral health into primary care and deploying behavioral health workers in schools.
PM360
OCTOBER 13, 2023
Is the metaverse a worthwhile investment for pharma? Is the metaverse even a worthwhile investment for Meta? In July, Meta’s second-quarter earnings report revealed its Reality Labs unit, which is responsible for developing its virtual reality (VR) and augmented reality (AR) technologies, lost $3.7 billion—and $21.3 billion in total over the last year.
European Pharmaceutical Review
OCTOBER 13, 2023
A paper published in Pharmaceuticals has reported the first demonstration of the possibility of using fluorescent optical respirometry (FOR) to detect aerobic bacteria in selected sterile pharmaceutical products. Rapid , real-time measurement of living aerobic microorganism cells was achieved using the fluorescent sensor tris-[(4,7-diphenyl-1,10 phenanthroline)ruthenium(II)] dichloride (Ru(DPP) 3 Cl 2 ).
Eversana Intouch
OCTOBER 13, 2023
Social determinants of health (SDOH) are the non-medical factors that affect people’s health. They can include the conditions in which people are born, live, learn, work, play, worship, and age 1,2 — as well as factors like economic policies and systems, development agendas, social norms, social policies and political systems. 1 Why are SDOH important?
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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
OCTOBER 13, 2023
The Phase IIb SurVaxM vaccine study will enrol 265 patients and has an estimated completion date in Q2 2024.
PharmaTimes
OCTOBER 13, 2023
Automated analysis of language could help diagnose and assess psychiatric conditions - News - PharmaTimes
Pharmaceutical Technology
OCTOBER 13, 2023
Amneal adds Prolia and Xgeva biosimilars to its oncology portfolio which already has three biosimilars products launched in the US.
PharmaTimes
OCTOBER 13, 2023
The projects will support the development of new and longer-lasting vaccines - News - PharmaTimes
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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.
Copyright Clearance Center
OCTOBER 13, 2023
Tracie D. Hall was a prominent spokesperson for the freedom to read, well-known for her mantra “free people read freely.
PM360
OCTOBER 13, 2023
For the next 12 to 24 months, the media landscape is set to drastically change and pharma marketers can’t miss this hidden opportunity. If you are a challenger brand in the midst of defining yourself, leap-frogging your competition, and cementing yourself as king of the jungle, this is the type of opportunity that comes around, once, maybe twice in a career.
Pharmaceutical Commerce
OCTOBER 13, 2023
CDMO’s Heidelberg facility will house the newly-completed manufacturing line.
PM360
OCTOBER 13, 2023
To discover how technology is affecting the jobs of life sciences marketers we turned straight to the source—our readers. We asked them about three key areas: How can they best utilize the power of artificial intelligence (AI) immediately? What technology will have the biggest impact on the industry within the next three years? Will Big Tech’s moves within healthcare force the industry to change how it operates?
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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
pharmaphorum
OCTOBER 13, 2023
Lilly to file mirikizumab in Crohn’s after FDA colitis snub Phil.
PM360
OCTOBER 13, 2023
Last year was historic for the television industry. Why, you ask? In 2022, every streaming service backed by a major U.S. network embraced an ad-supported subscription option. While this feels just as momentous as the first TV ad’s debut in 1941, it shouldn’t be surprising. According to Samba TV , ad-supported subscriptions (AVOD) are the fastest growing category in Connected Television (CTV), and they’re closely followed by free ad-supported television (FAST), which one in three U.S. consumers
pharmaphorum
OCTOBER 13, 2023
Santhera closes on first approval for DMD drug vamorolone Phil.
PM360
OCTOBER 13, 2023
Doctor Docs: Targeting Trust Between Pharma and HCPs A new study shows the crucial link in pharma marketers’ digital engagement strategy with HCPs is in jeopardy—trust. Graphite Digital’s newest whitepaper reveals the daily experiences with and current perceptions of HCPs across the U.K., U.S., and France regarding pharma-provided digital platforms.
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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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