Wed.Apr 03, 2024

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Vanda secures FDA approval for Fanapt to treat bipolar I, 15 years after schizophrenia nod

Fierce Pharma

Fifteen years after gaining its first FDA approval for Fanapt (iloperidone) to treat schizophrenia, Vanda Pharmaceuticals has scored again with the same antipsychotic drug. | Fifteen years after gaining its first FDA approval for Fanapt (iloperidone) to treat schizophrenia, Vanda Pharmaceuticals has scored again with the same antipsychotic drug. The FDA has signed off on Fanapt tablets to treat adults with manic or mixed episodes associated with bipolar I disorder.

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As antimicrobial resistance looms large, a nonprofit teams up with Big Pharma to intervene

PharmaVoice

AMR is a growing threat, but with little financial incentive to pick up the torch, government and nonprofit collaborations are keeping the R&D flames burning.

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Thermo Fisher plots layoffs at California plasmid manufacturing site as demand swings

Fierce Pharma

Demand fluctuations have spurred Thermo Fisher Scientific to downsize at the plasmid DNA manufacturing facility the company opened a little less than three years ago, putting jobs on the chopping b | Demand fluctuations have spurred Thermo Fisher Scientific to downsize at the plasmid DNA manufacturing facility the company opened a little less than three years ago, putting jobs on the chopping block.

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200 Stakeholders Push DEA for Updated Proposed Rule on Virtual Prescribing of Controlled Substances

MedCity News

In a letter, several stakeholders urged the Drug Enforcement Administration to release a revised proposed rule on the virtual prescribing of controlled substances. This comes as Covid-19 flexibilities that allow controlled substances to be prescribed via telehealth without an in-person exam are set to expire at the end of the year. The post 200 Stakeholders Push DEA for Updated Proposed Rule on Virtual Prescribing of Controlled Substances appeared first on MedCity News.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Medicare price negotiations carry on as HHS responds to Big Pharma's IRA counteroffers

Fierce Pharma

Medicare drug price negotiations under the Inflation Reduction Act are steadily progressing after drugmakers recently submitted their counteroffers to the government's initial pricing proposals.

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Eko Health Gains FDA Clearance For Cardiology Algorithm That Can Detect Heart Failure in 15 Seconds

MedCity News

This week, Eko Health received FDA clearance for a new AI-powered tool that aids in the early detection of low ejection fraction, a key indicator of heart failure. The tool, which was developed in collaboration with Mayo Clinic, is embedded into Eko’s digital stethoscopes. The post Eko Health Gains FDA Clearance For Cardiology Algorithm That Can Detect Heart Failure in 15 Seconds appeared first on MedCity News.

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Supplemental Benefits Must Return to Value

MedCity News

In a new era of cost-conscientiousness in MA, supplemental benefits will be assessed on their usefulness — to both payers and beneficiaries The post Supplemental Benefits Must Return to Value appeared first on MedCity News.

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Study reveals new liquid biopsy test could benefit thousands of lung cancer patients

PharmaTimes

The third most common and serious form of cancer affects over 43,000 people every year in the UK

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Genmab Adds More ADC Firepower With $1.8B ProfoundBio Acquisition

MedCity News

Antibody specialist Genmab makes most of its money from drugs developed and commercialized by partners. Acquiring ProfoundBio brings antibody drug conjugates that Genmab can develop on its own as it continues diversifying its business beyond strategic alliances. The post Genmab Adds More ADC Firepower With $1.8B ProfoundBio Acquisition appeared first on MedCity News.

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The future of the IP legal profession: new strategies, new technologies

Clarivate

The business world is experiencing rapid, profound and unprecedented change—from the “great retirement” of the baby boom generation to the impact of artificial intelligence (AI). How will corporate and law firm intellectual property (IP) professionals navigate this shifting landscape successfully? We explored these timely topics with a panel of experts, capturing their insights in a new white paper entitled “The future of the IP legal profession: Balancing the rise of artificial intelligence wit

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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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A Conversation About Modular Content and the Relationship with MLR

Eversana Intouch

When we hear the topic “Modular Content and MLR Relationship,” we think and hear of the challenges with medical, legal and regulatory (MLR). Marketers are under immense pressure because omnichannel puts more demands on marketing to produce more content. But what’s really exciting is that AI is going to create the efficiencies that finally enable us to pull through that content.

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Researchers suggest form of Alzheimer’s is transmissible via bone marrow transplants

PharmaTimes

The progressive neurodegenerative disease is estimated to affect 24 million people globally

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Cold Chain, PBMs, and More

Pharmaceutical Commerce

An exploration of the new demands in cold-chain visibility and sustainability—and the resulting tech-driven efforts to address them—leads off our coverage in this month's issue.

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Biopharmaceuticals contributing to manufacturing outsourcing trend

European Pharmaceutical Review

Research by Roots Analysis predicts the pharmaceutical contract manufacturing market will value $140 billion by 2030. As such, the sector is expected to grow at a compounded annual growth rate (CAGR) of 6.5 percent between 2022-2030. The report noted that there has been “considerable” merger and acquisition activity in recent years within the pharmaceutical contract manufacturing market.

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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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Ethical Considerations in Medical Sales: Maintaining Integrity in a Competitive Industry

Rep-Lite

The medical sales industry plays a crucial role in connecting healthcare providers with innovative medical products and technologies. While the goal is ultimately to improve patient outcomes, the competitive nature of the industry can sometimes lead to ethical dilemmas. Ethical considerations in medical sales require constant vigilance and a commitment to putting patient well-being at the forefront of every interaction.

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Unleash Your Team's Potential: The T.I.E. Leadership Approach

ALULA

Tired of managing a team that goes through the motions? You’re not alone. This year’s global trends confirm that leaders understand the value of human performance for enterprise strength as well as business success. How can you unlock the true potential of your team to create a powerhouse of innovation and engagement?

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The Pharma Cold Chain: More Visible, More Sustainable—and Colder

Pharmaceutical Commerce

Although time has welcomed novel advances in the space, new challenges pertaining to data and the physical technology, along with visibility and sustainability, are emerging.

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Abbott Receives FDA Approval for TriClip, a Medical Device for Repairing Tricuspid Regurgitation

PharmExec

Approval comes amid positive results from TRILUMINATE trial, which demonstrated improvement in 90% of participants treated for a leaky tricuspid heart valve.

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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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Looking Ahead to LogiPharma Europe

Pharmaceutical Commerce

We'll be back in Lyon, France, this month to capture the latest insights and advances in pharma logistics—as leaders seek to build the supply chains of the future.

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Mark Cuban’s Cost Plus Drugs Partners with Price.com

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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Does Biosimilar Competition Result in Lower Out-of-Pocket Costs for Patients?

Pharmaceutical Commerce

Cohort study examines the potential for spending to significantly decrease for individuals who use these generic versions of biologics.

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Non-Gene Edited Therapeutics: Q&A with Jeffrey Erickson, Vice President of Business Development at Triumvira

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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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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An 'Access' Double-Take: Fresh Views on PAPs and Patient Hubs

Pharmaceutical Commerce

Pharma Commerce makes a return trip to Philly for insights on the latest approaches in patient assistance and adherence.

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Pharma Pulse 4/3/24: Making AI Images Look Less Like AI, Ozempic Babies & more

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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Pharmaceutical Commerce - April 2024 Issue (PDF)

Pharmaceutical Commerce

Click the title above for a link to open the Pharmaceutical Commerce April 2024 issue in an interactive PDF format.

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In the Wake of the Great Resignation, Can Employees Realistically Expect Any Good Jobs for 2024?

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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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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Novartis Invests in UK’s Largest Health Research Program

PharmaTech

Our Future Health, a health research program in the UK, has welcomed Novartis as a new industry partner.

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Use Real-World Data to Optimize Design of Your Oncology Clinical Trials

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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Mark Cuban’s Cost Plus Drugs Partners with Price.com

Pharmaceutical Commerce

The two company’s will provide consumers with a platform where they can compare drug prices.

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FDA Approves Vanda Pharmaceuticals' Fanapt to Treat Adults with Bipolar I Disorder

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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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.