Fri.Apr 05, 2024

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Bristol Myers’ Abecma wins FDA nod in earlier multiple myeloma with updated boxed warning on secondary cancer

Fierce Pharma

After a short period of doubt, the FDA has followed the opinion of its advisers and moved Bristol Myers Squibb’s CAR-T therapy Abecma into the earlier treatment of multiple myeloma. | After a short period of doubt, the FDA has followed the opinion of its advisers and moved Bristol Myers’ CAR-T therapy Abecma into the earlier treatment of multiple myeloma.

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Biolinq Snags $58M for ‘Smallest Biosensor in the World’

MedCity News

Biolinq raked in $58 million in capital this week. The company is developing a wearable patch that uses electrochemical sensors to measure a person’s glucose levels from the intradermal space just beneath the surface of their skin. The post Biolinq Snags $58M for ‘Smallest Biosensor in the World’ appeared first on MedCity News.

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High-flying Vertex hikes CEO Reshma Kewalramani's pay by 30% to $20.6M

Fierce Pharma

Vertex CEO Reshma Kewalramani, M.D., made $20.6 million in 2023, which was an increase of 30% from her $15.9 million pay in 2022.

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StartUPDATES: New developments from Healthcare Startups

MedCity News

Check out news from Alpha Sophia, Biolinq, EarliTec Diagnostics, and Nourish. The post StartUPDATES: New developments from Healthcare Startups appeared first on MedCity News.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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AstraZeneca’s Imfinzi tackles another type of lung cancer with latest trial win

Fierce Pharma

AstraZeneca's Imfinzi has delivered positive clinical data in another type of lung cancer, building on the immunotherapy’s existing FDA clearance in stage 3 non-small cell lung cancer and extensive | AstraZeneca's Imfinzi has delivered positive clinical data in another type of lung cancer, building on the immunotherapy’s existing FDA clearance in stage 3 non-small cell lung cancer and extensive-stage small cell lung cancer.

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J&J-Partnered Contineum Corrals $110M From IPO for Clinical Trials in Fibrosis & MS

MedCity News

Contineum Therapeutics plans to spend most of its IPO cash on clinical testing of a lead drug candidate in development for idiopathic pulmonary fibrosis and multiple sclerosis. This small molecule blocks a competitive target pursued by several other companies, including Bristol Myers Squibb and AbbVie. The post J&J-Partnered Contineum Corrals $110M From IPO for Clinical Trials in Fibrosis & MS appeared first on MedCity News.

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Ed Schoonveld Discusses List Prices for Pharmaceuticals in the US Compared to Other Countries

Pharmaceutical Commerce

In an interwith with Pharma Commerce Editor Nicholas Saraceno, Ed Schoonveld, Value and Access Advisor, Schoonveld Advisory, explains why pharmaceutical products tend to cost more in the US than the rest of the world.

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As Humira biosim sales languish, Boehringer Ingelheim plots layoffs in pivot to hybrid sales model

Fierce Pharma

Despite Boehringer Ingelheim’s 2021 Humira biosimilar approval being heralded by some analysts as a “landmark achievement” for the field, the drug—dubbed Cyltezo—has struggled to gain traction than | Facing lackluster Cyltezo sales, Boehringer Ingelheim will prune its ranks in the U.S. and adopt a different way of marketing its Humira biosimilar.

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Smarter Aging: The Importance of Health Tech Planning

MedCity News

In today’s tech-savvy world, weaving Health Tech Planning into the fabric of care for older adults is essential. The post Smarter Aging: The Importance of Health Tech Planning appeared first on MedCity News.

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In refiling $16.5B Catalent buyout pitch, Novo gives FTC more time for review

Fierce Pharma

After Novo Holdings set the stage for a $16.5 billion buyout of contract manufacturing giant Catalent earlier this year, its parent company is giving antitrust officials more time for their review | After Novo Holdings pitched a $16.5 billion buyout of Catalent in February, the companies have given the FTC extra time to review the deal.

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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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FDA Approves New Antibiotic to Treat Three Different Bacterial Infections

PharmaTech

Zevtera has been approved to treat three types of bacterial infections and has been granted Priority Review and Fast Track and Qualified Infectious Disease Product designations.

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Inclusive Innovation: Key to the Future of Healthcare

Fierce Pharma

Inclusive Innovation: Key to the Future of Healthcare jpiatt Fri, 04/05/2024 - 10:37

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Startup Launches Out of Redesign Health To Help Employees Build Their Own Benefits

MedCity News

Beanstalk Benefits vets benefits solutions and aggregates them into a single platform. Employees can build their own benefits portfolio using the platform. The post Startup Launches Out of Redesign Health To Help Employees Build Their Own Benefits appeared first on MedCity News.

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mRNA therapy could provide intracellular protein replacement for rare disease

European Pharmaceutical Review

Interim data from a Phase I/II clinical trial suggest that mRNA-3927, an investigational mRNA therapy from Moderna, could be a promising treatment for propionic acidaemia. A 70 percent reduction in the risk of metabolic decompensation events was reported by eight participants in the 12-month pretreatment period, according to the trial results published in Nature. “We are excited to share the first published clinical data utilising an mRNA therapy for intracellular protein replacement,̶

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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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Orchestrating Care in the New World of Distributive Access

MedCity News

The challenge with the emerging model of “distributive access” is that there isn’t any one individual or entity coordinating everything; patients are left to navigate their own care journeys. And while health systems invested billions of dollars in technology, little of it is well-coordinated or well-orchestrated for the health system, for healthcare workers, or for patients.

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Aardvark said to be planning IPO, plus other bio financings

pharmaphorum

Our regular round-up of financings in the biotech sector is headed by rumours of a $150 to $200 million initial public offering (IPO) for Aardvark Therapeutics, an emerging player in the weight-loss category, alongside a trio of big private rounds.

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MiNA and Nippon Shinyaku enter RNAa therapeutics deal

Pharmaceutical Technology

MiNA Therapeutics has entered into an agreement with Nippon Shinyaku to develop RNAa therapeutics for rare neurodegenerative ailments.

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ADRIATIC buoys Imfinzi’s prospects in early lung cancer

pharmaphorum

ADRIATIC trial finds AstraZeneca's cancer immunotherapy Imfinzi improves survival in patients with limited-stage small cell lung cancer (SCLC)

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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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Key mechanism controlling bone marrow stem cells could lead to new therapies

PharmaTimes

Hoxa9 and b-catenin molecules are a rare population of self-renewing HSCs found in bone marrow

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Merck taps Caris’ AI expertise in ADC-focused alliance

pharmaphorum

Germany's Merck partners Caris Discovery on artificial intelligence-powered discovery of antibody-drug conjugates in a $1.

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myTomorrows and brainstrust partner to support patients living with brain cancer

PharmaTimes

Affecting 80,000 people in England, 12% of brain tumour patients survive beyond five years of diagnosis

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Viral return: 3 U.S. cases concerning experts

PharmaVoice

Infectious diseases that were “off the playing field” are now making a comeback.

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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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Pharma Pulse 4/5/24: Is 2024 the Year for Psychedelic Medicine? Barriers Impacting Enrollment in Lung Cancer Trials & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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VR Patient Education: Overcoming Challenges and Opportunities

Infuse Medical

Virtual Reality (VR) technology has revolutionized various industries, including healthcare. In patient education, VR offers a dynamic platform for delivering immersive and interactive experiences. Understanding the fundamentals of VR and its integration into healthcare settings is crucial for maximizing its potential. Understanding Virtual Reality (VR) VR refers to a simulated environment created using computer technology, where users can interact with digital objects and experience sensory fee

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FDA Approves Abecma for Patients with Relapsed or Refractory Multiple Myeloma Following Two Prior Lines of Therapy

PharmExec

Abecma was found to triple progression-free survival compared to standard regimens with a 51% decline in the risk of disease progression or death in patients with relapsed or refractory multiple myeloma who were previously administered two or more lines of therapy.

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Make Health a Habit: Actionable Tips for World Health Day and Beyond

ALULA

World Health Day, on April 7th, is a global call to action for prioritizing well-being. In our constantly connected world, self-care is no longer a luxury, it's a necessity. By making small, sustainable changes to your daily routines, you can significantly improve your physical and mental health. Here are three self-care shifts that can help you develop habits to support a more fulfilling life.

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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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A Decade of Data Under the Belt

PharmExec

In this Pharmaceutical Executive video interview, Currax Pharmaceuticals, CEO, George Hampton, discusses their drug Contrave and the data they have to show after a 10 years in the weight loss/obesity space.

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Creating Data-Driven Sales Enablement Strategies

Infuse Medical

Sales enablement is a multifaceted approach to equipping sales teams with the resources, tools, and information necessary to engage with prospects and close deals effectively. It encompasses a wide range of strategies, technologies, and processes designed to streamline the sales process and drive revenue growth. What is Sales Enablement? Sales enablement can be defined as the strategic alignment of people, processes, and technology to empower sales teams and enhance their productivity and effect

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Amylyx Begins Process of Discontinuing Relyvrio/Albrioza for Treatment of ALS

PharmExec

Decision to discontinue marketing authorizations for Relyvrio/Albrioza comes as a result of topline results from the Phase III PHOENIX trial in patients with amyotrophic lateral sclerosis.

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The Role of Medical Sales Associates: Key Responsibilities and Skills

Rep-Lite

Medical sales associates play a vital role in the healthcare ecosystem. They act as a bridge between innovative medical products and technologies and the healthcare professionals who utilize them to improve patient care. Understanding the roles and responsibilities of medical sales associates sheds light on the multifaceted nature of this essential profession.

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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.