Thu.May 09, 2024

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Pfizer puts 74 Swiss jobs on chopping block as it folds Seagen into its cancer operations

Fierce Pharma

After telegraphing more than a hundred potential layoffs in March in connection with plans to stop construction of a massive Seagen facility, Pfizer is plowing ahead with efforts to streamline its | Pfizer has proposed another round of staff reductions and role changes at legacy Seagen, this time hitting Seagen’s European headquarters in Switzerland, where 74 positions could be up for the chop.

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AlphaFold 3 takes structure predictions well beyond proteins

pharmaphorum

Google DeepMind and Isomorphic Labs' newly launched AlphaFold 3 extends the power of the AI model to 'all life’s molecules'

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As Vyvanse generics bite, Takeda sets out on $900M restructuring plan

Fierce Pharma

In response to rapidly declining profits and the downfall of ADHD drug Vyvanse, Takeda is planning to throw 140 billion Japanese yen ($899 million) toward a company-wide restructuring campaign. | In a multi-year overhaul, the Japanese drugmaker plans to prioritize "organizational agility," procurement savings and tech efficiencies. It's all part of an effort to boost profit margins.

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Oxford/AZ Covid-19 vaccine to be discontinued

European Pharmaceutical Review

Withdrawal of the marketing authorisation for the COVID-19 vaccine (ChAdOx1-S [recombinant]) Vaxzevria (SRD) by the European Medicines Agency on 7 May, follows a request by AstraZeneca. “Global demand for all COVID vaccines is now much lower and overall supply exceeds demand. This is in marked contrast to the early part of the pandemic when supply was limited and distribution very limited, especially in poorer countries.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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In gene therapy race, bluebird leads Vertex in activating treatment centers but trails in patient starts

Fierce Pharma

Five months out from their twin FDA approvals in sickle cell disease (SCD), who’s winning the race to treat patients with their respective gene therapies—bluebird bio or partners Vertex Pharmaceuti | Five months out from their twin FDA approvals in sickle cell disease (SCD), who’s winning the race to treat patients with their respective gene therapies—bluebird bio or partners Vertex Pharmaceuticals and CRISPR Therapeutics?

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Report warns economic instability has hit UK drug discovery

pharmaphorum

A UK report has said that inflation and geopolitical instability have led to a “dramatic drop” in investment in smaller companies developing new medicines, with a knock-on effect on the entire life sciences industry.

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New metric predicts burden of participating in trials

pharmaphorum

A new metric developed by Phesi can predict the burden that clinical trials will impose on patients, allowing amendments that can improve the design, efficiency and cost

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US gene therapy approvals create a big problem for Brazil. Regulators have to come together, FDA's Peter Marks says

Fierce Pharma

US gene therapy approvals create a big problem for Brazil.

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Biologics on Target for the Future

PharmaTech

A greater understanding of molecular and cellular biology and technological advancements are revolutionizing the field of biologics.

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Ensuring Global Access to LP-284

PharmExec

In this Pharmaceutical Executive video interview, Panna Sharma, CEO, Lantern Pharma, talks about ensuring global access to LP-284, particularly in regions with limited resources

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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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OneChain’s CAR T trial treats its first cortical T-cell ALL patient

PharmaTimes

The subtype accounts for 20% of all T-cell leukaemias, a rare form of blood cancer which produces too many abnormal T-cells

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US agencies collaborate to address regulation for biotechnology products

European Pharmaceutical Review

Regulatory agencies in the US across three sectors: agriculture and environmental, have produced a joint plan to “update, streamline, and clarify” regulations and oversight mechanisms for biotechnology products. The plan, developed by the US Environmental Protection Agency (EPA), the US Food and Drug Administration (FDA), and the US Department of Agriculture (USDA), helps to address US President Biden’s related goals, including and improving the “transparency, predictability, coordination, and

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Why Personalized Medicine Should Not Be Too Personalized

MedCity News

One irony of personalized or precision medicine (PM) is that it aims, against the advice of Hippocrates and Osler, to treat the disease, not the patient. The post Why Personalized Medicine Should Not Be Too Personalized appeared first on MedCity News.

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A step by step guide to creating new promotional claims

Vodori

Adding a new claim to your campaign requires careful handling to ensure it's not only medically sound but also fits well with your campaign's goals. This guide will walk you through seven crucial steps to evaluate, fine-tune, and smoothly integrate new claims. From gauging relevance to assessing value, confirming reliability, and crafting clear messages, each step plays a vital role in shaping the outcome and effectiveness of your campaign.

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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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Verona Pharma Receives $650M Investment from Oaktree Capital Management and OMERS Life Sciences

PharmExec

Strategic financing from Oaktree Capital Management and OMERS Life Sciences is expected to support the US launch of ensifentrine, Verona’s promising chronic obstructive pulmonary disease treatment.

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The growth of clinical trials in Africa

Pharmaceutical Technology

Clinical trials are growing across Africa as the immense potential of the continent starts to be realised. Sponsors and CROs are tapping into the unsaturated patient pools, more diverse populations, and competitive operations costs.

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Honoring Asian American, Native Hawaiian, and Pacific Islander Heritage Month (Part 1 of 4)

ALULA

In the US alone, 6.2 percent of the total population identify as AANHPI (Asian American, Native Hawaiian, Pacific Islander). May is dedicated to honoring people in the US with AANHPI heritage , so it’s a great time to celebrate their voices and experiences – and to reflect on how we can integrate their stories into our lives all year long , especially with our colleagues and teams.

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Drug Recalls: Q&A with Beth Riggio

PharmExec

Cencora’s vice president of product management, global products & solutions Beth Riggio discusses the issues the industry faces with recalls and how it can improve.

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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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Honoring Asian American, Native Hawaiian, and Pacific Islander Heritage Month (Part 2 of 4)

ALULA

Welcome back to our series, begun here , on what today’s leaders and workers can learn from AA and NHPI people whose work demonstrates a profound commitment to behaviors with a lasting positive impact.

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PCI Pharma Services Begins Expansion Project

Pharmaceutical Commerce

The CDMO’s Bedford, NH facility will welcome a new isolator filling line—along with twin lyophilizers—as part of a multi-year, $100 million capital investment project.

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Honoring Asian American, Native Hawaiian, and Pacific Islander Heritage Month (Part 3 of 4)

ALULA

We enjoyed exploring the story of Shuji Nakamura here , and we’re grateful to you for reading our series on what today’s leaders and workers can learn from AA and NHPI people whose work demonstrates a profound commitment to behaviors with a lasting positive impact.

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Lilly’s donanemab will face an Alzheimer’s adcomm in June, setting the stage for a Leqembi showdown

PharmaVoice

The FDA announced a June advisory committee date, potentially introducing a new Alzheimer’s treatment to compete with Eisai and Biogen’s Leqembi.

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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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Honoring Asian American, Native Hawaiian, and Pacific Islander Heritage Month (Part 4 of 4)

ALULA

It was an honor to explore the story of Nainoa Thompson here , and we’re thrilled you’re following our series on what today’s leaders and workers can learn from AA and NHPI people whose work demonstrates a profound commitment to behaviors with a lasting positive impact.

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Oregon and Lantern collaborate to develop drug candidate for various cancer indications

PharmaTimes

Anticancer drugs will be responsible for 90% of nearly 612,000 predicted US cancer deaths in 2024

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Takeda tackles $900m restructuring plan after generics hurt annual profits

Pharmaceutical Technology

Workforce optimisation, R&D prioritisation and technology investments are on Takeda’s agenda.

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Michael Jordan and Novant Health Open New Facility in Basketball Player’s Hometown

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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Rakovina expands collaborations to leverage AI platform

Pharmaceutical Technology

Rakovina has expanded research collaborations with Pharma Inventor and the University of British Columbia to identify novel drug candidates.

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Pharma Pulse 5/9/24: 7 Everyday Work Problems AI Helps Solve, Positive Outcomes of Rituximab Use in Multiple Sclerosis & 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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Marinus parts ways with 20% of its workforce

Pharmaceutical Technology

Marinus expects to share data from the Phase III RAISE trial of IV ganaxolone for the treatment of status epilepticus later in the summer.

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Regeneron Presents Update on Gene Therapy for Genetic Deafness at ASGCT

PharmaTech

The company’s presentation at ASGCT includes preliminary data results for a child who received the gene therapy.

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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.