Fierce Pharma

FEBRUARY 26, 2024

Bristol Myers Squibb’s first drug substance facility outside the United States is now set to become the company’s inaugural sterile drug product (SDP) facility in Europe, thanks to a multi-million- | Bristol Myers Squibb’s first drug substance facility outside the United States is now set to become the company’s inaugural sterile drug product (SDP) facility in Europe, thanks to a multi-million-dollar expansion expected to add hundreds of new jobs in the coming years.

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MedCity News

FEBRUARY 26, 2024

In an interview at the Vive conference in Los Angeles, John Couris said that while he is sympathetic toward Change Healthcare’s current woes, he wants definitive answers soon.

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Healthcare Healthcare 129

Fierce Pharma

FEBRUARY 26, 2024

Amgen is now open for business in Central Ohio after cutting the ribbon at its “most advanced facility to date.” | Amgen is now open for business in Central Ohio after cutting the ribbon at its “most advanced facility to date.” Dubbed “Amgen Ohio,” the nearly 300,000-square-foot biomanufacturing plant in New Albany, Ohio, is set to employ 400 full-time employees and leverage the “latest innovation and technology.

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MedCity News

FEBRUARY 26, 2024

At the Payer Insights sessions on Day 1 of ViVE 2024, a panel on prior authorization offered compelling insights from speakers who shared the positive developments in this area after years of mounting frustration. Speakers also shared challenges as they work with providers to figure out how policy developments and technology will work in practice.

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Fierce Pharma

FEBRUARY 26, 2024

Not even one year after becoming a commercial biotech, Krystal Biotech has blockbuster dreams for its flagship product. | In its first six months of commercial availability, Krystal's topical gene therapy Vyjuvek raked in more than $50 million. Now, the company is looking toward bringing the drug to Europe and Japan and testing a new eye-drop formulation.

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MedCity News

FEBRUARY 26, 2024

Epic’s Payer Platform is being integrated with Highmark’s claims data on Google Cloud, the companies announced Monday at ViVE. This will give providers better insight into patients’ health.

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Patients 112

MedCity News

FEBRUARY 26, 2024

Performance on these test calls impacts the organization’s Star Rating, which is a marker of plan quality published on the Medicare Pathfinder. A lower rating can mean the loss of millions of dollars in reimbursements.

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Patients 102

Fierce Pharma

FEBRUARY 26, 2024

For the third straight year, Sanofi CEO Paul Hudson has seen a slight dip in his compensation. | For the third straight year, Sanofi CEO Paul Hudson has seen a slight dip in his compensation. For 2023, Hudson will receive 10.57 million euros ($11.44 million) in total pay, according to the company’s annual filing.

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MedCity News

FEBRUARY 26, 2024

Preliminary Phase 2 results show 83% of those treated with Boehringer Ingelheim and Zealand Pharma drug survodutide met the main goal of improvement in the fatty liver disease MASH. Boehringer contends this drug has best-in-class potential in a competitive field that includes an Eli Lilly drug that recently posted positive Phase 2 results.

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Competition Pharma Biopharma 101

Pharmaceutical Technology

FEBRUARY 26, 2024

Bayer’s oral tyrosine kinase inhibitor is currently in a Phase I trial estimated to enrol 460 patients.

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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.

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ALULA

FEBRUARY 26, 2024

Re cen t global increases in e mployee engagement have been music to the ears of hard-working, mindful leaders. But here’s the thing about a good thing – it merits vigilance.

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MedCity News

FEBRUARY 26, 2024

Vale Health announced its launch on Monday at ViVE. The startup’s platform helps health systems connect their patients to health and wellness products, which are becoming increasingly interesting to consumers. Vale has 16 founding health systems partners that will go live with the platform, with the Froedtert & the Medical College of Wisconsin health network being the first.

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Networking Medical Patients 97

pharmaphorum

FEBRUARY 26, 2024

Sanofi gets a win for its oral BTK inhibitor rilzabrutinib in chronic hive disorder CSU, setting up a phase 3 programme as it chases after Novartis’ remibrutinib in this indication.

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Pharmaceutical Technology

FEBRUARY 26, 2024

Merck's KEYTRUDA has received a positive opinion from the EMA CHMP for use in combination with chemotherapy for non-small cell lung cancer.

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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

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European Pharmaceutical Review

FEBRUARY 26, 2024

[The Phase II trial showed that] up to 83.0 percent of adults given survodutide (BI 456906) achieved a statistically significant improvement of the liver disease metabolic dysfunction-associated steatohepatitis (MASH)” Up to 83.0 percent of adults given survodutide (BI 456906) achieved a statistically significant improvement of the liver disease metabolic dysfunction-associated steatohepatitis (MASH) versus placebo (18.2 percent) in a Phase II trial.

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Medicine Pharma Patients Leads 92

pharmaphorum

FEBRUARY 26, 2024

GSK has reported topline results from a phase 3 trial of its novel antibiotic gepotidacin that could spell the end of a decades-long drought in new oral therapies for gonorrhoea.

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European Pharmaceutical Review

FEBRUARY 26, 2024

At its February 2024 meeting, the EMA’s human medicines committee (CHMP) recommended the extension of marketing authorisations for six treatments, and positive opinions for the approval of ten medicines. The committee adopted positive opinions for two vaccines intended for active immunisation against the H5N1 subtype of influenza A virus: Celldemic (zoonotic influenza vaccine (H5N1)(surface antigen, inactivated, adjuvanted, prepared in cell cultures)), is intended for immunisation during outbre

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Medicine Patients Marketing Pharmaceutical 90

Copyright Clearance Center

FEBRUARY 26, 2024

SPD takes risks on books by new or marginalized writers, enabling their works to develop an audience and to gain recognition, says Kent Watson.

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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.

Safety

MedCity News

FEBRUARY 26, 2024

The combination of technology and cross-functional collaboration allows providers to address denials and achieve optimal revenue performance.

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Pharmaceutical Technology

FEBRUARY 26, 2024

SK bioscience has achieved a significant milestone with its typhoid conjugate vaccine, SKYTyphoid, receiving WHO prequalification.

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pharmaphorum

FEBRUARY 26, 2024

AstraZeneca has moved a step closer to EU approval of oral Factor D inhibitor danicopan in the EU, after the EMA’s human medicines committee, the CHMP, backed the drug as a treatment for residual haemolytic anaemia in patients with paroxysmal nocturnal haemoglobinuria (PNH).

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Patients Medicine 78

PharmaTimes

FEBRUARY 26, 2024

Every year, tuberculosis, malaria and HIV cause over five million deaths worldwide

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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.

Specialization

pharmaphorum

FEBRUARY 26, 2024

Digital health company Akili expands beyond the US as partner Shionogi files for approval for its ADHD digital therapeutic (DTx) in Japan

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PharmaTimes

FEBRUARY 26, 2024

Results from the study could also be used for other forms of cancer and diseases

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pharmaphorum

FEBRUARY 26, 2024

Boehringer Ingelheim and Zealand Pharma report stellar top-line results for GLP-1/glucagon agonist survodutide in liver disease MASH.

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Pharma 81

Pharmaceutical Commerce

FEBRUARY 26, 2024

A cohort study explores the association of Medicare Advantage enrollment with post-acute care use, along with patient outcomes among retired state employees.

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Patients 59

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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

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Quantified

FEBRUARY 26, 2024

“Practice makes perfect” is a common saying for good reason. Practice aids in information retrieval, muscle memory, confidence, and dozens of other factors that impact the performance of virtually any task. However, it might be more accurate to say “practice makes practiced,” even if it’s less catchy. After all, if people are practicing the wrong skills, the right skills languish.

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Sales Training Prospecting Insurance 52

The Marketing Advantage

FEBRUARY 26, 2024

February 26, 2024 The rare disease and orphan drug space remains one of the most difficult markets in which to set accurate and equitable territory-level goals. Not only does the rare disease space differ considerably from therapeutic areas with much larger patient populations, but the space differs drastically from one rare disease to another. Despite these challenges, the sales force is one of the most important tools a biopharma company has in driving disease awareness and reaching these too

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Sales Consulting Prospecting Biopharma 52

Quantified

FEBRUARY 26, 2024

In the realm of sales enablement, training, and learning and development, the advent of cutting-edge technologies like Apple’s Vision Pro heralds a transformative era. This innovative device, a testament to Apple’s commitment to pushing the boundaries of augmented reality (AR) and virtual reality (VR), stands to radically change the way we think about how sales teams are trained, onboarded, and continually educated.

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Training Sales Specialization Product Knowledge 52

Pharmaceutical Technology

FEBRUARY 26, 2024

The upcoming Clinical Trial Supply Europe 2024 conference will round-up pharma and biotech delegates to discuss the trends and challenges in clinical trial supply industry.

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Pharma 52

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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.

Management