Thu.Nov 30, 2023

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Generation bio cuts 40% of staff in blow for non-viral gene therapy sector

Pharmaceutical Technology

The move is a strategic response amid challenges faced by the non-viral gene therapy sector, with several startups closing this year.

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November 30, 2023: HCSRN Calls for Abstracts and Panel Presentations for 2024 Annual Conference

Rethinking Clinical Trials

The Health Care Systems Research Network (HCSRN) is accepting abstract submissions and panel presentation submissions for its 2024 Annual Conference until December 11, 2023. This year’s meeting will be held in Milwaukee, Wisconsin, from April 9 to 11, 2024. The HCSRN is a 20-member research network focused on supporting research institutes aligned with healthcare delivery systems.

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The future of cell and gene therapy manufacturing

Pharmaceutical Technology

As more cell and gene therapies get approved to treat common conditions, scaling them up will be a challenge.

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AbbVie joins ADC dealmaking with $10B ImmunoGen buyout

Bio Pharma Dive

The acquisition of ImmunoGen gives AbbVie an approved medicine for ovarian cancer, and continues a pharma spending spree on antibody-drug conjugates.

Antibody 156
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Gliosarcoma drugs in development, 2023

Pharmaceutical Technology

GlobalData tracks 49 drugs in development for Gliosarcoma by 39 companies/universities/institutes. The top development phase for Gliosarcoma is phase i, with 22 drugs in that stage.

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Flagship outlines plans to raise $3B for new fund

Bio Pharma Dive

The biotech company creator’s last fund, which closed in 2021, brought in $3.4 billion for investing in new drug startups.

Drugs 164

More Trending

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The Role of Process and Technology Innovation in Advanced Biopharmaceutical Manufacturing

Pharma Mirror

By Alexei Voloshin, Global Head of Bioprocess Science, 3M Biopharmaceutical Purification Article Synopsis: Modern biotechnology has brought a revolution in improving the human condition around the world both in terms of quantity and quality. The rapid pace of innovation in biopharmaceutical treatments has enabled the treatment of life-threatening and life-changing conditions such as cancer, inflammation, and infectious disease.

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Pemphigus Vulgaris drugs in development, 2023

Pharmaceutical Technology

GlobalData tracks 13 drugs in development for Pemphigus Vulgaris by 12 companies/universities/institutes. The top development phase for Pemphigus Vulgaris is preclinical, with seven drugs in that stage.

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CRO disputes Acelyrin’s implication of trial misconduct

Bio Pharma Dive

Trial contractor Fortrea is fighting back as Acelyrin unveils a CRO audit in the wake of a major late-stage study failure.

Trials 156
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Bullous Pemphigoid drugs in development, 2023

Pharmaceutical Technology

GlobalData tracks 11 drugs in development for Bullous Pemphigoid by 12 companies/universities/institutes. The top development phase for Bullous Pemphigoid is phase ii, with six drugs in that stage.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Pfizer site in Connecticut in line for layoffs amid $3.5B cost-cutting campaign

Fierce Pharma

With layoffs hitting employees on both sides of the Atlantic, Pfizer’s $3.5 billion cost-cutting spree has kicked it into high gear this month. | The company's Groton, Connecticut, research site is the latest to fall victim to job cuts as part of Pfizer's massive $3.5 billion cost-cutting mission, following layoffs across the U.S. and the U.K.

Research 145
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Where do anti-tumor necrosis factor like cytokine agents go now?

Pharmaceutical Technology

In the past few months, significant interest within the inflammatory bowel disease (IBD) space has been directed towards the therapeutic target, tumour necrosis factor-like cytokine 1A (TL1A).

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AbbVie pays $10B to acquire ImmunoGen, doubling down on red-hot ADC cancer field

Fierce Pharma

The sizzling antibody-drug conjugate (ADC) field is at the center of another major life sciences deal. | The sizzling antibody-drug conjugate field is at the center of another major life sciences deal. Hoping to redeem itself following the epic Rova-T failure, AbbVie is shelling out $10.1 billion in cash to acquire ImmunoGen, maker of the ovarian cancer treatment Elahere.

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Herpes Labialis (Oral Herpes) drugs in development, 2023

Pharmaceutical Technology

The Herpes Labialis (Oral Herpes) drugs in development market research report provides comprehensive information on the therapeutics under development for…

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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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What to know about colon cancer stages

Antidote

Despite the fact that colorectal cancer cases have been declining in the United States since the mid-1980s, it is still the third most common cancer diagnosed each year excluding skin cancer. Often shortened to colon cancer, colorectal cancer occurs when cells in the colon and/or the rectum begin to grow uncontrollably and eventually spread to other parts of the body.

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CTO Europe 2023: Fostering diverse oncology trials remains a challenge

Pharmaceutical Technology

Experts at the clinical conference continued to explore ways to improve representation in clinical trials and the regulatory push behind it.

Trials 130
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World AIDS Day 2023: New and Promising Treatments for HIV/AIDS

XTalks

Tomorrow is World AIDS Day 2023. Every December 1, the global community comes together to observe World AIDS Day. Originating in 1988, this day serves as a crucial platform for increasing awareness about human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) and paying tribute to those whose lives have been impacted by the epidemic.

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AbbVie diversifies oncology portfolio with $10.1 bn ImmunoGen acquisition

Pharmaceutical Technology

The acquisition allows AbbVie to establish its presence in the ovarian cancer market with Immunogen’s Elahere.

Marketing 147
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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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AbbVie agrees $10.1bn deal to buy ImmunoGen

pharmaphorum

AbbVie has moved to shore up its pipeline following the loss of patent protection for its top-selling drug with a $10.1 billion deal to buy ImmunoGen and its marketed ovarian cancer drug.

Marketing 109
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Amgen and MSD-backed start-up wins $10m for drug and device development

Pharmaceutical Technology

Culmination Bio has a library of electronic health records and biospecimen data that help in drug and diagnostic device development.

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Altimmune Joins Weight-Loss Race with Phase II Win, Stock Jumps on News

BioSpace

Patients treated with Altimmune’s investigational GLP-1/glucagon dual receptor agonist saw up to 15.6% weight loss, and nearly a third of those taking the highest dose lost at least 20% of their body weight.

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MSD reinforces Amazon partnership for faster AI-led drug discovery and development

Pharmaceutical Technology

MSD is one of many pharma companies migrating IT applications to the cloud to transform value chains and harness new technologies.

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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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Thankful for Opportunities to Stay INTOUCH  

Intouch Solutions

Some EVERSANA INTOUCH colleagues around the globe observe and celebrate the national holiday of Thanksgiving. In our U.S.-based offices, we gathered for in-office potluck celebrations. During the gatherings, team members exchanged recipes, brought a dish to share with others, and, most importantly, spent time together! “The EVERSANA INTOUCH Friendsgiving potluck was a delight!

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CTO Europe 2023: EU’s IVD guidelines continue affecting early clinical work

Pharmaceutical Technology

Since its implementation in 2022, new EU regulation for IVDs remains an obstacle for companies in the precision medicine sector.

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GSK Pulls Ahead of Pfizer in RSV Vaccine Market as Arexvy Nears Blockbuster Status

BioSpace

CEO Emma Walmsley projects that the British biopharma’s Arexvy sales will exceed £1 billion in its first year on the market, leaving Pfizer’s Abrysvo respiratory syncytial virus vaccine far behind in the race.

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Pharma’s engagement with healthcare providers has slipped in recent years

Pharmaceutical Technology

Changing trends show a reduction in HCP contact with the pharma industry and an increased prioritisation of in-person contact.

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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 elevates chief scientist Bumpus to the number two role

pharmaphorum

FDA chief scientist Namandjé Bumpus has been named as principal deputy commissioner, replacing long-serving Janet Woodcock when she steps down early next year. Bumpus is heading for the number two position at the FDA – second only to Commissioner Robert Califf who announced the appointment on X (formerly Twitter) – just over a year after she joined the agency.

Scientist 104
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Waning focus on abuse potential may negatively affect pipeline non-stimulants for ADHD

Pharmaceutical Technology

Four non-stimulants are currently marketed in at least one of the 7MM: guanfacine, clonidine, atomoxetine and viloxazine.

Marketing 130
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Ogsiveo Receives FDA Approval as First Therapy for Desmoid Tumors

XTalks

Pfizer spinout SpringWorks Therapeutics’ Ogsiveo (nirogacestat) has received US Food and Drug Administration (FDA) approval for the treatment of desmoid tumors, an ultra-rare subtype of non-cancerous soft tissue sarcomas that can cause severe pain and disfigurement. Ogsiveo is indicated for adult patients with progressing desmoid tumors who require systemic treatment.

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Pepper wins $6.5m to develop ‘transomic’ drug discovery platform

Pharmaceutical Technology

Pepper’s Compass platform offers insight into the real-time function of proteins which can help in drug discovery.

Drugs 130
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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.