Mon.Feb 26, 2024

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Bristol Myers blueprints $400M Ireland expansion with plans to add sterile drug firepower and hire 350

Fierce Pharma

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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Tampa General Hospital CEO on Change Healthcare Breach: They Are Going To Have To Give an Update Soon

MedCity News

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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Amgen boots up Ohio 'smart facility' where it plans to employ 400—and a trio of robots, too

Fierce Pharma

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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At ViVE 2024, Panelists Share Prior Authorization Progress and Frustration in Payer Insights Program [Sponsored]

MedCity News

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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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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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With global expansion planned, Krystal lays out blockbuster ambitions for topical gene therapy

Fierce Pharma

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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Highmark Health Collaborates with Epic, Google Cloud To Improve Payer/Provider Coordination

MedCity News

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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Bayer wins FDA breakthrough therapy designation for NSCLC candidate

Pharmaceutical Technology

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

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Sanofi CEO Hudson takes another small dip in pay to €10.57M

Fierce Pharma

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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Sanofi trumpets win for oral BTK drug in chronic hives

pharmaphorum

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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Preventing Toxic Productivity and Toxic Positivity

ALULA

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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How Machine Learning Drives Clinical Trial Efficiency

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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What to Expect from Your Language Services Provider during CMS Test Call Season

MedCity News

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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GSK antibiotic gepotidacin clears phase 3 gonorrhoea trial

pharmaphorum

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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Boehringer Ingelheim’s Liver Drug Data Position It for MASH Clash With Eli Lilly

MedCity News

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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Merck’s Keytruda regimen gains positive EMA CHMP opinion

Pharmaceutical Technology

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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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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16 Health Systems Help Launch Health & Wellness Marketplace

MedCity News

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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Boehringer reveals major data from liver disease trial

European Pharmaceutical Review

[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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Small Press Values

Copyright Clearance Center

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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CHMP meeting highlights: February 2024

European Pharmaceutical Review

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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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.

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CHMP backs AZ’s danicopan for anaemia in patients with PNH

pharmaphorum

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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SK bioscience’s typhoid vaccine receives WHO prequalification

Pharmaceutical Technology

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

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Shionogi takes Akili’s ADHD digital therapy to Japan

pharmaphorum

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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Breaking Silos: The Power of Collaboration in Minimizing Denials for Better Revenue Cycle Performance

MedCity News

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

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Accelerating Clinical Supply Through Integrated Drug Development

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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Boehringer’s survodutide shows monster MASH potential

pharmaphorum

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

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PhaSER Biomedical receives $2.3m drug discovery grant from the Gates Foundation

PharmaTimes

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

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The Perks of Medicare Advantage Versus Traditional Medicare

Pharmaceutical Commerce

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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Researchers develop terahertz biosensor to detect skin cancer for early diagnosis

PharmaTimes

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

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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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Sales Role-Play Scenarios That Help Your Sales Team Succeed

Quantified

“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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How to Set Territory-Level Goals for Rare Disease Products

The Marketing Advantage

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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The Future of Sales Training: Immersive Experiences with Apple’s Vision Pro

Quantified

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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Streamlining supply chain operations in focus at Clinical Trial Supply Europe 2024 

Pharmaceutical Technology

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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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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.