Tue.Jan 02, 2024

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Millions of doses of Pfizer's Paxlovid will go to waste in UK, EU as COVID demand plummets

Fierce Pharma

On the heels of a major Paxlovid inventory write-off in the United States, many more doses of Pfizer's COVID-fighting antiviral are going to waste overseas. | At the end of November, more than 1.5 million courses of Pfizer’s Paxlovid had expired unused in European countries, analysts at Airfinity said in a new report. The total tally of expired doses in Europe is expected to hit 3.1 million by the end of next month, representing a value of $2.2 billion.

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STOP SETTLING: How Playing it Safe is Killing Your Medical Rep Career in 2024

Medical Sales Guru

The role of a medical sales representative involves navigating intricate dynamics with healthcare professionals. These professionals hold significant authority in determining a salesperson’s access and the fate of a product. Consequently, many representatives opt to play it safe , fearing potential alienation that might hinder future sales opportunities.

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Inside AbbVie's $10B buyout of ImmunoGen—and the bidding war it swooped in on

Fierce Pharma

AbbVie is entering 2024 with a foothold in the antibody-drug conjugate (ADC) field thanks to its late-2023 buyout of ImmunoGen worth more than $10 billion. | According to a recent securities filing, AbbVie only entered the ImmunoGen bidding war after other buyout interest led the ADC specialist to widen its pool of potential purchasers. When it came down to the final three players, AbbVie's offer blew the others out of the water.

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Report: Improving Health Equity is a Top-10 Goal for Most Healthcare Execs in 2024

MedCity News

A recent Deloitte report found that improving health equity is a top-10 goal for 83% of life sciences and healthcare C-suite executives in 2024. The report also laid out factors that will likely influence health equity in 2024, including AI.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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AstraZeneca, Sanofi win nod in China for RSV antibody Beyfortus

Fierce Pharma

AstraZeneca and Sanofi have scored first in | AstraZeneca and Sanofi have scored first in China with an approval for their respiratory syncytial virus (RSV) immunization Beyfortus for infants, with the companies expecting the shot to be available there for the 2024-25 season. Beyfortus is the only immunization approved for babies entering their first RSV season to protect them against lower respiratory tract infection.

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Longboard Pharma Trial Data Show How It Could Stand Out in the Epilepsy Field

MedCity News

Longboard Pharmaceuticals’ epilepsy drug candidate bexicaserin met the main efficacy goal of its Phase 1b/2a study along with safety data suggesting a potential edge over current treatments. With Longboard now preparing to advance to Phase 3 testing, its stock price soared more than 300%.

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More Trending

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Private Equity Ownership Leads to Worse Patient Outcomes at Hospitals, Study Shows

MedCity News

Yet another study has been published showing that patients receiving care at PE-owned hospitals experienced a higher rate of hospital-acquired adverse events, like infections and falls, than patients receiving care at hospitals that are not PE-owned. The research comes as concerns about PE-owned hospitals are intensifying — from leaders both within and outside of the healthcare industry.

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'Faster, Please': Key Challenges in Chemicals and Materials R&D

PharmExec

Companies must address myriad challenges to improve upon issues such as data quality and transparency, process efficiency, and artificial intelligence/machine learning preparedness.

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Are Rare Brain Diseases the Next Commercial Frontier for Gene Therapy?

MedCity News

The biggest trend in gene therapy development is the potential of several treatments for rare neurological diseases to move from the bench to the bedside.

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AstraZeneca Reaches Agreement to Acquire Cell Therapy Specialist Gracell Biotechnologies

Pharmaceutical Commerce

Agreement includes novel cell therapy for hematology that has the opportunity to bring a potential best-in-class treatment to patients with blood cancers.

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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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Novartis Returns to Voyager Therapeutics to Reach New Gene Therapy Destinations

MedCity News

Novartis is paying Voyager Therapeutics $100 million up front to collaborate on gene therapies for Huntington’s disease and spinal muscular atrophy. The deal builds on a relationship the companies started in 2022.

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Driving QbD as a quality standard in drug development

European Pharmaceutical Review

A paper published in the European Journal of Pharmaceutics and Biopharmaceutics has reviewed the current application status of Quality by Design (QbD) within the framework of the ICH guidelines (ICH Q8(R2) – Q14 and ICH Q2(R2)). Over the past several years, the pharmaceutical industry has faced challenges regarding quality assurance in drug development, the author asserted.

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Oliver Wyman: 5 ACA Trends To Watch Over the Next Decade

MedCity News

A recent Oliver Wyman report laid out five Affordable Care Act trends to watch, including the rise of ICHRAs and the need for a “seamless member experience.

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Verona cuts $400m loan deal as it preps COPD drug for market

pharmaphorum

Verona Pharma has agreed a new $400 million debt facility with Oxford Finance and Hercules Capital designed to help the company navigate the possible approval and launch of ensifentrine, its therapy for chronic obstructive pulmonary disease (COPD). The Anglo-US company has already tapped $50 million of the funding and can take another $100 million if an ongoing review of ensifentrine by the US FDA results in regulatory approval.

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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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Are You Ready for Inspection?

PharmaTech

Reviewing regulatory documents, such as 483 forms and Warning Letters, can aid in determining a facility’s inspection readiness, says Siegfried Schmitt, vice president, Technical at Parexel.

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AstraZeneca to advance haematology cell therapy

European Pharmaceutical Review

For an upfront price of $1.0 billion, AstraZeneca has agreed to acquire Gracell Biotechnologies, supporting the development of cell therapies in haematology and autoimmune diseases. Gracell’s FasTCAR-enabled B-cell maturation antigen (BCMA)/CD19 dual-targeting autologous CAR-T cell therapy GC012F, is an asset AstraZeneca will gain access to as part of the new acquisition agreement announced on 26 December 2023.

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AstraZeneca Bolsters Cellular Therapy Pipeline With Acquisition of Gracell Biotechnologies

PharmExec

Merger agreement includes the Gracell FasTCAR platform, which could significantly improve the efficacy of CAR T-cell therapies.

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Financial factors to support and challenge Pharma in 2024

European Pharmaceutical Review

According to results from a survey by GlobalData, the top challenges for the pharmaceutical industry in 2024 will be inflation, geopolitical conflict and drug pricing pressures. Data outcomes revealed that most respondents from Pharma considered that drug pricing and reimbursement constraints will have a negative impact in 2024. Inflation and geopolitical pressure The second biggest negative impact was thought to be geopolitical conflicts and inflation.

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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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Healthcare Marketing Trends in 2024: How to StayAhead

Healthcare Success

We hope your holiday season was filled with good cheer and plenty of new business opportunities. Now that the holidays have drawn to a close, it’s time to return to your 2024 marketing plan and make adjustments that ensure your business is taking advantage of the latest trends in healthcare marketing to reach patients and HCPs more effectively and make a lasting impression.

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Novo Nordisk will open AI hub in London

pharmaphorum

Novo Nordisk is planning to open an AI research facility in London, UK, as part of a drive to place the technology at the heart of its drug discovery operations

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Choosing the Right Excipients for MSC and iPSC Therapies

PharmaTech

Buffers, stabilizers, and cryoprotectants play major roles in cell therapy formulations.

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Astellas strikes $1.7bn SIRP drug deal with Elpiscience

pharmaphorum

Astellas has licensed up to four macrophage enhancer drugs with potential as cancer immunotherapies from Elpiscience in a $1.

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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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Proving It’s Clean with Analytics

PharmaTech

Analytical methods and tools play a pivotal role in cleaning validation.

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Anavex hit as Rett syndrome drug flunks test

pharmaphorum

Shares in US biotech Anavex Life Sciences fell sharply this morning after Rett syndrome candidate Anavex 2-73 failed a phase 2/3 trial

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Digital training programme improves quality of life for dementia patients living in care

PharmaTimes

The programme is the only remote, digital delivery nursing home training programme for dementia

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Novartis opens new frontier in Voyager gene therapy alliance

pharmaphorum

Novartis has doubled down on its gene therapy collaboration with Voyager Therapeutics, licensing candidates for Huntington's disease and SMA

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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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The Monthly Marathon of a Sales Superstar

Contrarian Sales Techniques

Embarking on a new month in the sales world is like setting off on an exciting journey, with each phase offering its own unique challenges and opportunities. Let's map out the monthly routine of a sales superstar, broken down into early, mid, and end-of-month rituals. This isn't just about hitting targets. It's about creating a rhythm that keeps our sales champ at the top of their game.

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Age-related macular degeneration market expected to reach $27.5bn across 7MM by 2031

Pharmaceutical Technology

The age-related macular degeneration (AMD) market is expected to grow at a compound annual growth rate of 14.1% throughout the forecast period (2021-2031), reaching $27.5bn across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) according to GlobalData’s report: Age-Related Macular Degeneration: Seven-Market Drug Forecast and Market Analysis - Update.

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AZ, Sanofi’s Beyfortus cleared in China for RSV prevention

pharmaphorum

AstraZeneca and Sanofi’s long-acting antibody Beyfortus has been approved in China for the prevention of respiratory syncytial virus (RSV) infections in newborns and infants

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Nearly three million people received urgent NHS cancer checks in 2023

PharmaTimes

The number of people getting tested over the last decade has increased by 133%

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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.