Fierce Pharma

SEPTEMBER 4, 2024

Over the last decade, three blockbuster drugs—Biogen’s Spinraza, Roche’s Evrysdi and Novartis’ gene therapy Zolgensma—have transformed the treatment landscape for spinal muscular atrophy (SMA). | Biogen revealed that a portion of its phase 2/3 DEVOTE study met its primary endpoint, as a higher dose of Spinraza improved the motor function of treatment-naive infants with spinal muscular atrophy.

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MedCity News

SEPTEMBER 4, 2024

Eli Lilly now offers vials of obesity medication Zepbound directly to self-pay patients at a nearly 50% discount off the drug’s list price. But more than offering patients a lower-cost alternative, this move represents a strategic stance against certain pharmaceutical industry players. The post With Direct-to-Patient Zepbound, Eli Lilly Takes a Stand Against Compounders and PBMs appeared first on MedCity News.

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Fierce Pharma

SEPTEMBER 4, 2024

Several months after its parent company unveiled new labs and office space to unite cell and gene therapy research on the West Coast, Astellas Gene Therapies is turning out the lights at a Californ | Several months after its parent company unveiled new labs and office space to unite cell and gene therapy research on the West Coast, Astellas Gene Therapies is turning out the lights at a California production plant.

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MedCity News

SEPTEMBER 4, 2024

Health systems’ financial results suggest the start of sustained recovery, but persistent challenges remain, including rising expenses and less-than-ideal reimbursement rates from payers. The post How Have Hospitals Fared Financially So Far in 2024? appeared first on MedCity News.

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Fierce Pharma

SEPTEMBER 4, 2024

With a shortage of ADHD drugs persisting, the DEA has raised production limits on Takeda’s Vyvanse and its generic versions by 24%, the agency said.

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MedCity News

SEPTEMBER 4, 2024

In this episode, we’re joined by Carolee Lee, CEO and founder of Women’s Health Access Matters (WHAM), and Ash Shehata, KPMG U.S. sector leader for healthcare. The two discuss WHAM and KPMG’s new partnership that aims to advance women’s health research and investment. The post MedCity FemFwd: Inside WHAM & KPMG’s Women’s Health Partnership appeared first on MedCity News.

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Healthcare Healthcare 107

pharmaphorum

SEPTEMBER 4, 2024

Data from a phase 2 trial of Roche's oral BTK inhibitor fenebrutinib have shown "near-complete suppression" of disease activity and disability progression in relapsing multiple sclerosis (MS).The full results of the FENopta open-label extension study are due to be reported in full at the ECTRIMS congress in Copenhagen later this month, but top-line findings include that 99% of patients treated with fenebrutinib were free of T1 gadolinium-enhancing lesions, markers of active inflammation, at 48 w

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Patients 104

Clarivate

SEPTEMBER 4, 2024

The Web of Science Research Assistant, a generative AI-powered tool built with and for researchers, is now available to the global research community. After extensive collaboration and testing with the research community that began in December 2023, we are pleased to announce the global launch of the Web of Science Research Assistant. The research assistant combines the power of generative artificial intelligence (AI), the Web of Science knowledge graph and an all-new chat interface to provide r

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Pharmaceutical Technology

SEPTEMBER 4, 2024

By integrating the best practices from decentralized trials, CROs can optimize efficiencies and streamline site-based operations, ensuring that site-centric trials remain effective and innovative.

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MedCity News

SEPTEMBER 4, 2024

Wearable technology seems to offer great potential for early detection and management of agitation experienced by people with communication-impaired neurological disorders, allowing caregivers to provide personalized interventions that could significantly improve patients’ lives. The post Digital Biomarkers in Agitation Detection: Enhancing Care for Communication-Impaired Neurological Disorders appeared first on MedCity News.

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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.

Safety

Pharmaceutical Technology

SEPTEMBER 4, 2024

Actimed says S-oxprenolol shares a similar pharmacology to its lead product S-pindolol, which is being studied in cachexia.

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MedCity News

SEPTEMBER 4, 2024

Healthcare organizations should work proactively with experts in the relevant domains to recognize and mitigate potential cybersecurity risks. Here’s what to do to mitigate risk. The post Recognizing and Mitigating Cybersecurity Risks: Strategies for Healthcare Organizations appeared first on MedCity News.

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pharmaphorum

SEPTEMBER 4, 2024

Swiss startup Haya Therapeutics has formed a $1bn partnership with Eli Lilly to look for new therapies for obesity in non-coding DNA

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MedCity News

SEPTEMBER 4, 2024

Nearly all CIOs and other healthcare technology leaders at provider organizations believe that effectively leveraging AI gives them a competitive edge, according to new research. However, the report also found that some organizations still struggle with barriers to adoption, such as the lack of the right talent and concerns about ethics, privacy and security.

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pharmaphorum

SEPTEMBER 4, 2024

Regeneron signs up for access to a study run by Koneksa exploring the use of digital biomarkers to track patients with Parkinson's.

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Patients 96

Pharmaceutical Technology

SEPTEMBER 4, 2024

Merck has gained EC approval for KEYTRUDA plus Padcev for adults with unresectable or metastatic urothelial carcinoma.

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pharmaphorum

SEPTEMBER 4, 2024

Novartis' Fabhalta is first oral monotherapy for paroxysmal nocturnal haemoglobinuria cleared by NICE for NHS use.

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Pharmaceutical Technology

SEPTEMBER 4, 2024

Pfizer Ignite will support Acepodia in developing its pipeline cancer therapeutic candidates.

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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

Pharmaceutical Commerce

SEPTEMBER 4, 2024

The latest news for pharma industry insiders.

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Pharma 104

PharmaVoice

SEPTEMBER 4, 2024

More companies are investing in protein degraders, which leverage a unique approach to harnessing the immune system in cancer, neurological diseases and more.

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Evolve Your Success

SEPTEMBER 4, 2024

Dr. Dan McMahon, a general surgeon with a remarkable blend of military service and expertise in surgical technology, joins us to unravel the future of medical sales. COVID-19 has driven a significant transformation in the industry, pushing digital interactions to the forefront. Dr. McMahon provides an in-depth look at how platforms like LinkedIn and podcasts are not just trendy but essential tools for medical sales reps and physicians striving to stay ahead.

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ALULA

SEPTEMBER 4, 2024

"There isn't a playbook for every challenge," says Tom Frosina, Operations Leader at TD Bank. Tom knows that leadership isn't about following a script. Instead, effective leaders must be able to adapt, innovate, and empower their teams to succeed.

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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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PharmaTech

SEPTEMBER 4, 2024

Among the design features of the machine is software-based tracking that is meant to ensure that products that are temperature-sensitive do not exceed their time limit in the solution.

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European Pharmaceutical Review

SEPTEMBER 4, 2024

The World Health Organization (WHO) has published its first guidance on antibiotic pollution from manufacturing, to help the industry mitigate the global risk of antimicrobial resistance (AMR). It discusses the management of wastewater and solid waste for the manufacture of antibiotics. “Pharmaceutical waste from antibiotic manufacturing can facilitate the emergence of new drug-resistant bacteria… Controlling pollution from antibiotic production contributes to keeping these life-saving m

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PharmExec

SEPTEMBER 4, 2024

Data from the Phase II/III DEVOTE study demonstrated that Spinraza showed significant motor function improvements at six months in infants with spinal muscular atrophy.

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Pharmaceutical Technology

SEPTEMBER 4, 2024

Between 2012 and 2021, outsourcing propensity for FDA NDA injectables approvals averaged 40%, according to GlobalData’s Contract Injectable Packaging Trends…

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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

Leads

PharmExec

SEPTEMBER 4, 2024

Results from the FINE-HEART pooled analysis of three Phase III clinical trials highlighted the potential of finerenone in treating high-risk cardiovascular patients.

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Patients 52

Pharmaceutical Technology

SEPTEMBER 4, 2024

The US Food and Drug Administration (FDA) has granted fast track designation to Innovent Biologics' IBI363 for treating melanoma.

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Food and Drug Administration FDA Food 59

PharmaVoice

SEPTEMBER 4, 2024

Results from Vaxcyte’s clinical pneumococcal vaccine study showed the smaller company could take on Pfizer’s legendary blockbuster.

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Marketing 52

Pharmaceutical Technology

SEPTEMBER 4, 2024

Despite the best efforts of pharmaceutical manufacturers and regulators to improve the security and traceability of drug products, counterfeits continue…

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Pharmaceutical Pharmaceutical manufacturing Manufacturing 52

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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.

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