Thu.Apr 18, 2024

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Novo Nordisk attracts lawmakers' scrutiny after dropping discounted insulin product Levemir

Fierce Pharma

Novo Nordisk is receiving pushback from a trio of lawmakers over its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year | Novo Nordisk is receiving pushback from a trio of lawmakers on its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year.

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In the World of Interoperability, How to Meaningfully Strengthen Cybersecurity

MedCity News

Achieving strong cybersecurity is a vast, interconnected web that must incorporate the correct software, procedures, and workflows and take into account the human element across an entire organization. The post In the World of Interoperability, How to Meaningfully Strengthen Cybersecurity appeared first on MedCity News.

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Sanofi, busy with cost-savings campaign, restructures US commercial vaccine group

Fierce Pharma

During a busy period of overhaul at Sanofi, the company is restructuring its U.S. vaccine commercial group. | During a busy period of overhaul at Sanofi, the company is restructuring its U.S. vaccine commercial group. A spokesperson said the company would offer affected employees a chance to apply for new roles, plus "outplacement services.

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Included Health Announces New Specialty Care Offering

MedCity News

Included Health’s new specialty care clinic, which will become available in 2025, is starting by offering three centers: the Cancer Center, the Center for Women’s Health and the Center for Metabolic Health. The post Included Health Announces New Specialty Care Offering appeared first on MedCity News.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Amgen CEO nabs pay raise thanks to Horizon deal. Does that incentivize aggressive M&A?

Fierce Pharma

Amgen CEO Robert Bradway scored a 5.8% increase in overall compensation last year mostly thanks to the company’s acquisition of Horizon Therapeutics. | Amgen CEO Robert Bradway scored a 5.8% increase in overall compensation last year mostly thanks to the company's acquisition of Horizon Therapeutics.

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Hospital M&A Activity in 2024: What to Expect

MedCity News

Q1 2024 saw a significant rise in the number of hospital M&A deals compared to the past three Q1s. Experts believe this M&A activity will continue to climb throughout this year and next — motivated by both financial distress and hospitals’ desire to improve strategic business lines like value-based care and digital healthcare services. The post Hospital M&A Activity in 2024: What to Expect appeared first on MedCity News.

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Novel Parkinson’s Disease Drug Will Join AbbVie With Positive Phase 3 Data In Hand

MedCity News

Cerevel Therapeutics drug tavapadon met the main and secondary goals of a pivotal Parkinson’s disease clinical trial. That drug and others will join the neuroscience portfolio of AbbVie, which is in the process of acquiring Cerevel. The post Novel Parkinson’s Disease Drug Will Join AbbVie With Positive Phase 3 Data In Hand appeared first on MedCity News.

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Vanda turns back on hostile takeover bid by CDMO Future Pak

Fierce Pharma

Two weeks after gaining a hard-earned FDA label expansion for its long-established antipsychotic drug Fanapt (iloperidone), Vanda Pharmaceuticals has derailed a hostile takeover bid. | Two weeks after gaining a hard-earned FDA label expansion for its long-established antipsychotic drug Fanapt (iloperidone), Vanda Pharmaceuticals has rejected a hostile takeover bid.

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Outrun Therapeutics announces launch with $10m seed funding

Pharmaceutical Technology

Outrun Therapeutics announced its launch with $10m seed funding to advance a protein stabilisation pipeline focused on E3 ligase inhibitors.

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AbbVie touts Rinvoq win in giant cell arteritis, potentially teeing up another label expansion

Fierce Pharma

Less than a year ago, AbbVie's star immunology drug Rinvoq picked up its seventh FDA approval< | AbbVie's Rinvoq has racked up seven FDA approvals in recent years, and another expansion into giant cell arteritis could be in the cards after a positive trial.

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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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23andMe: What If …

MedCity News

A much diminished 23andMe exists today, a far cry from the phenomenon that it was in the world consumer DNA testing. Could things have unfolded differently under a different leader with a different vision? The post 23andMe: What If … appeared first on MedCity News.

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After coming up short in COVID, Valneva focuses on chikungunya vaccine launch

Fierce Pharma

After striking out in an attempt to create a niche for its COVID-19 vaccine, Valneva is taking its swings at what it does best—developing, manufacturing and commercializing vaccines for a variety o | After striking out in an attempt to create a niche for its COVID-19 vaccine, Valneva is back to doing what it does best—developing, manufacturing and commercializing vaccines for a variety of infectious diseases with unmet needs.

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Healthcare Docket: Help Wanted — Doctor Expert Witnesses

MedCity News

Major malpractice verdicts have spiked in recent years. The post Healthcare Docket: Help Wanted — Doctor Expert Witnesses appeared first on MedCity News.

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Heart disease risk ‘calculator’ could save lives

pharmaphorum

UK researchers describe an algorithm that is more accurate than current tools at predicting an individual’s risk of developing cardiovascular disease in the next 10 years.

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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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Inflammation among current dementia research focus, says Alchemab CSO

Pharmaceutical Technology

Inflammation, cell metabolism and neuronal health are current key areas of focus for dementia researchers, according to Jane Osbourn, chief scientific officer (CSO) at Alchemab.

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Levo Health Sponsors Tampa Bay Wave’s HealthTech|X Accelerator Program

LEVO Health

At Levo Health, we’re always on the lookout for opportunities to push the boundaries of healthcare marketing and support innovations that can transform the industry. This year, we’re thrilled to take our commitment a step further by sponsoring the 2024 HealthTech|X Accelerator program hosted by Tampa Bay Wave. Tampa Bay Wave has a proven track record of fostering startup success, having supported 527 startups, collectively raising over $900 million in capital and creating more than 5

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A Work in Progress: CCC and Artificial Intelligence

Copyright Clearance Center

In a recent town hall webinar, The Heart of the Matter: Copy­right, AI Training and LLMs, CCC (Copyright Clearance Center) made the case that current artificial intelligence (AI) technology infringes copyrights, both in the way its underlying large language models (LLMs) are developed, or trained, and in the outputs it enables users to create.

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Antibiotic demonstrates non-inferiority to a leading gonorrhoea treatment

European Pharmaceutical Review

New trial results for GSK’s oral gepotidacin, a potential first-in-class oral antibiotic, has shown that it was non-inferior with 92.6 percent success rates in patients with uncomplicated urogenital gonorrhoea (GC). “These results highlight the potential of gepotidacin as a new oral treatment option given the rising incidence of gonorrhoea worldwide” In the pivotal EAGLE-1 Phase III trial, comparatively, intramuscular ceftriaxone (500mg) plus oral azithromycin (1,000mg) combined therapy, a

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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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Ireland sets out its stall as Europe’s medtech hotspot

pharmaphorum

Ireland makes the case for its role as Europe's medtech hotspot, helping companies tackle emerging challenges like digitalisation and sustainability.

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Clearmind licenses psychedelic compounds for mental disorders

Pharmaceutical Technology

Clearmind Medicine has entered into a licensing agreement with Yissum to develop Generation 3.0 psychedelic compounds for mental disorders.

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Metsera lands with $290m to take on obesity giants

pharmaphorum

New obesity biotech Metsera formally launches, led by Clive Meanwell and with a $290m warchest to take on the likes of Novo Nordisk and Eli Lilly.

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Monitoring pharmaceuticals in the environment

European Pharmaceutical Review

What are the three main challenges of monitoring pharmaceuticals in the environment? Andreas Häner (AH): Roche, along with other pharmaceutical companies, acknowledges concerns about pharmaceuticals in the environment (PiE). While pharmaceutical manufacturing’s overall contribution is small compared to patient use and inappropriate disposal of pharmaceuticals, inadequately managed manufacturing emissions can impact local environments and receiving waters.

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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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FDA fast-tracks AskBio’s heart failure gene therapy

pharmaphorum

A gene therapy for heart failure being developed by Bayer’s AskBio unit has been granted fast-track status by the FDA.

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Researchers introduce new AI tool to help clinicians capture uncertainty in medical images

PharmaTimes

The Tyche model could help clinicians and researchers capture crucial information in images

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LogiPharma Europe 2024: Properly Applying Diversity, Equity, and Inclusion Initiatives Within the Life Sciences Supply Chain

Pharmaceutical Commerce

Panel discussion addresses how DE&I can successfully tackle systemic biases and more.

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Medicare’s Push To Improve Chronic Care Attracts Businesses, but Not Many Doctors

MedCity News

Medicare’s Chronic Care Management program reduced emergency room and in-patient hospital visits and lowered total health spending, but uptake has been sluggish for a variety of reasons. The post Medicare’s Push To Improve Chronic Care Attracts Businesses, but Not Many Doctors appeared first on MedCity News.

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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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Pharma Pulse 4/18/24: Certain Biotech Investors Get an Early Look at Results, An Ethical Outlook for Obesity Drugs & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Coya Therapeutics CEO Discusses Recent Data Discovery from a Study of Coya 302, a Potential Treatment for ALS

PharmExec

In an interview with Pharm Exec Associate Editor Don Tracy, Howard Berman, Chairman, CEO, Coya Therapeutics, provides an update on the progress of Coya 302 as a treatment for ALS.

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Five Ways ASCs Can Use Price Transparency to Strengthen Their Market Position

Clarify Health

As both government and commercial payers direct a greater share of volume to out-patient facilities and patient demand for same-day service increases, opportunity and competition in the ambulatory surgical center (ASC) space are increasing. The U.S. ASC market size is projected to grow to more than $75 billion by 2030 and in January 2024, CMS announced the addition of 41 new billing codes for covered procedures for ASCs.

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Colorless and Soluble High-Performance PFAS-free Polyimides from Aliphatic Anhydrides

PharmaTech

Polyimide materials, as Kapton®, are widely used for flexible electronics substrates or as insulators, thanks to their wide range of thermal stability as well as excellent dielectric and mechanical properties. However, there are limitations in their processability and employment in new technologies due to their low solubility and deep amber staining, resulting from charge transfer interactions, established between polymer rigid chains.

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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.