Fri.Mar 15, 2024

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With Pfizer struggling in 2023, CEO Bourla hit with 35% pay cut to $21.6M

Fierce Pharma

Pfizer knew 2023 was going to be a challenging year of transition. But even the drugmaker was surprised by the plummeting demand for its COVID-19 products, missing badly on its 2023 guidance. | After a difficult year for Pfizer, in which its share price fell by 44%, CEO Albert Bourla’s compensation fell by 35% from $33 million in 2022 to $21.6 million in 2023.

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A Startup’s Flexibility With ADC Cancer Drugs Attracts €128M for Clinical Trials

MedCity News

Tubulis’s next-generation ADC cancer drugs are designed to overcome limitations of currently available therapies in this drug class. The new financing will support clinical trial plans, but first, preclinical proof-of-concept data will be presented during the American Association for Cancer Research annual meeting.

Biopharma 111
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Despite early death concerns, FDA advisers back J&J and Legend's Carvykti for earlier myeloma

Fierce Pharma

Even though the BCMA CAR-T therapy Carvykti showed a potential problem of early patient deaths in a trial, experts on the FDA’s Oncologic Drugs Advisory Committee (ODAC) still believe that the drug | Even though the BCMA CAR-T therapy Carvykti showed a potential problem of early patient deaths in a trial, experts on the FDA’s Oncologic Drugs Advisory Committee still believe that the drug’s long-term benefits outweigh its risks.

FDA 305
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Hackensack Meridian Health CEO: These 4 Priorities Should Guide AI Strategy

MedCity News

During a keynote address at HIMSS, Hackensack Meridian Health CEO Robert Garrett outlined four priorities that should guide healthcare organizations’ AI strategies. He said that healthcare leaders need to take care to ensure their AI efforts seek to address one if not all of these.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Novartis lays out $256M for antibody plant expansion in Singapore, plots 100 hires

Fierce Pharma

Over the years, Singapore has attracted a suite of biopharma majors, and Novartis is no exception. | Novartis broke ground on a $256 million expansion of its biopharmaceutical production facility in Singapore. The project will introduce digitalization and automation at the site in a bid to boost manufacturing productivity and to help upskill the company’s workforce.

Biopharma 290
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The Case for Domestic Sourcing to Establish Reliable Pharmaceutical Supply Chains in the United States

Pharmaceutical Commerce

Reliance on foreign imports means that disruptions in the supply chain can profoundly impact the ability of individuals in the United States to get access to the medications they need.

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After Amylyx drug failure, what’s next for ALS?

PharmaVoice

The company’s combo treatment Relyvrio was approved in 2022, but after failing a phase 3 trial, may be pulled from the market.

Marketing 119
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BioDesign: Accelerating the Momentum of Bioconjugate Therapeutics

Fierce Pharma

Over the last several decades, mounting interest has positioned bioconjugate therapeutics as one of the most promising biopharmaceutical modalities. | Antibody-drug conjugates are a promising biopharma modality but specialized expertise is instrumental for successfully bringing drugs to the clinic.

Biopharma 199
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Gonorrhea, Chlamydia and Syphilis Rates Are Exploding. Here’s How AI Can Help.

MedCity News

The emergence of artificial intelligence (AI) offers a glimmer of hope in the fight against STDs and has the power to revolutionize the landscape of STD detection, treatment, and prevention.

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Merck's Keytruda excels in cervical cancer trial, showing an ability to extend lives. Will a broader FDA approval follow?

Fierce Pharma

Merck's Keytruda excels in cervical cancer trial, showing an ability to extend lives. Will a broader FDA approval follow?

FDA 143
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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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ALS body takes digital approach to clinical trials access

pharmaphorum

The ALS Association is partnering with myTomorrows to connect patients and physicians with clinical trials using a digital platform.

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EuroAPI's troubles mount as audit reveals manufacturing lapses in Italy, spurring 2024 guidance suspension

Fierce Pharma

Beleaguered Sanofi spinout EuroAPI can’t seem to catch a break. | Beleaguered Sanofi spinout EuroAPI can’t seem to catch a break. After reporting ballooning losses and a four-year restructuring plan last month, the company revealed Thursday that manufacturing lapses at an Italian plant have temporarily derailed its guidance for the year.

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Solera Health, Aon Join Forces to Simplify Employee Healthcare

MedCity News

Solera Health and Aon are collaborating to help employers manage point solution fatigue, engage members and measure ROI.

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With FDA greenlight, BMS Breyanzi brings CAR-T cell therapy to CLL and SLL

Pharmaceutical Technology

Amidst the many BTK inhibitors, Breyanzi will be the first and only CAR-T cell therapy available for the treatment of CLL and SLL.

FDA 105
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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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Three different ways AI will shape the future of the pharma industry

Impetus Digital

This is a guest article and does not necessarily reflect the views and values of Impetus Digital. When it comes to artificial intelligence (AI), it feels like no industry has been left untouched. Even those that might not feel like a natural fit for computers are being shaped and influenced by this technology, with artists and writers utilizing it in new ways.

Pharma 87
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Mycoplasma testing market expected to value nearly $2 million by 2031

European Pharmaceutical Review

According to research published by Coherent Market Insights, the global mycoplasma testing market is anticipated to reach $1,907.6 million by 2031. The market is set to witness a compound annual growth rate (CAGR) of 9.7 percent during the forecast period, the report predicted. What is driving and limiting growth in the market? Specifically, technology innovations such as sequencing technology, supported by “strong government funding for biomedical research” in the US has driven rapid developmen

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Healthee heads latest crop of digital health financings

pharmaphorum

Our latest round-up of funding rounds in the digital health category features updates from Healthee, Aktiia, Moxe Health, Eleanor Health, Tava Health, BrainCheck, and Redi Health.

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Anocca signs licensing deal for EmendoBio’s gene-editing tech

Pharmaceutical Technology

Anocca has entered a licensing agreement with EmendoBio for the use of the latter’s OMNI-A4 nuclease, a gene editing technology.

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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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Future medicine makers will get VR training at new UK centre

pharmaphorum

Consortium led by Birmingham University unveils a centre of excellence for medicines manufacturing training using VR, to answer a UK skills shortage.

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Navigating the rapidly changing oncology treatment landscape: how digital tools can help

Impetus Digital

A version of this article was previously published in the Journal of mHealth. The field of oncology is rapidly growing and evolving. In 2022, global spending on cancer medicines was approximately 196 billion USD, and this number is forecasted to reach $375 billion by 2027. In fact, for the past five years, the number of treated patients with cancer has seen an average annual increase of 5% globally (1).

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Analytical technique may advance medical cannabis quality control

European Pharmaceutical Review

Researchers have proposed an advanced analytical technology that can rapidly classify medical cannabis plants at production sites. Using the analytical technique, the plants can be classified “by chemotype using hyperspectral imaging and machine learning (ML),” Markel San Nicolas, researcher in the UPV/EHU’s IBeA group of the University of the Basque Country, and first author of the corresponding research paper explained.

Medical 78
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FDA approves Madrigal’s Rezdiffra as the first NASH therapy

Pharmaceutical Technology

Madrigal’s Rezdiffra received an accelerated approval as a treatment for noncirrhotic NASH, also known as MASH.

FDA 98
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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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Getting the Lay of the Land After a Banner Year for Biosimilars

Pharmaceutical Commerce

Biosimilars market experiences massive growth, but regulatory and adoption challenges remain.

Marketing 105
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Madrigal Pharma is first over the MASH finish line

pharmaphorum

Madrigal Pharma is first pharma company to get FDA approval for a drug to treat metabolic dysfunction-associated steatohepatitis (MASH)

Pharma 85
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The Power of Co-Creation in Cultivating Authenticity

Eversana Intouch

In a recent article published by Med Ad News and PharmaLive.com , Hattie Stearns, Senior Director of Experience DesignOps, provides five key takeaways she observed as a brand and design lead at SXSW 2024. In the article, Hattie expands on each takeaway and highlights the responsibility we have as marketers to co-create and cultivate authentically. Art meets tech for healing and community Brands getting real Designing with heart and inclusivity Learning through stories AI with a human touch “Co-c

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NIHR reveals phase 1/2 trial to evaluate an investigational vaccine for mpox in the UK

PharmaTimes

More than 3,700 cases of mpox have been identified in the UK since May 2022

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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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Geron leaps as ODAC backs its MDS drug imetelstat

pharmaphorum

Geron rockets after FDA advisory committee backs imetelstat as a treatment for transfusion-dependent myelodysplastic syndromes

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Pharma Pulse 3/15/24: Elranatamab Maintains or Improves Symptoms of Multiple Myeloma Patients, AI Assistant for Security Products & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

Pharma 105
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NHS to roll out AI to improve waiting times and reduce missed appointments

PharmaTimes

Every year, missed hospital appointments are estimated to cost the NHS £1.

Medical 87
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Digitalization of QbD Risk Assessments

PharmaTech

Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. Their digital transformation can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.

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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.