Fri.Apr 19, 2024

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Roche wins FDA OK for targeted drug in early lung cancer

Bio Pharma Dive

The new label for Alecensa makes it the first targeted treatment available after surgery for people with ALK-positive lung tumors, who are at high risk for brain metastases.

Drugs 286
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AskBio’s AB-1002 gene therapy receives FDA fast-track status

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted fast-track designation to Bayer subsidiary Asklepios BioPharmaceutical’s (AskBio) investigational gene therapy AB-1002, aimed at treating congestive heart failure (CHF).

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Alvotech deal could heighten biosimilar pressure on Humira

Bio Pharma Dive

The agreement may help Alvotech capitalize on a recent policy shift by CVS that has driven major market share declines for AbbVie’s blockbuster drug.

Marketing 189
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Q&A: Cell and gene therapy value assessments need a rework to allow access

Pharmaceutical Technology

Paolo Morgese, vice president of European public affairs at the Alliance for Regenerative Medicine, discusses the barriers affecting access to gene therapies.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Reuters Pharma USA 2024 – Serena Goodwin

pharmaphorum

Stay updated on the latest STEM Healthcare news from Reuters Pharma USA 2024, featuring insights from global account lead at STEM, Serena Goodwin on the impact of AI in healthcare.

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FDA approves Takeda’s ENTYVIO SC for Crohn’s disease

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Takeda’s ENTYVIO subcutaneous (SC) administration as a maintenance therapy to treat adults with moderately to severely active Crohn's disease (CD).

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NIH team develops AI tool to predict cancer drug response

Pharmaceutical Technology

Researchers at the National Cancer Institute, a unit of the National Institutes of Health (NIH) in the US, have developed an AI tool that can predict drug responses in cancer treatment.

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LogiPharma Europe 2024: Niklas Adamsson Discusses Ways to Improve Visibility and Risk Management for Cold Chain Shipping

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Niklas Adamsson, COO, Environtainer, suggests how to improve visibility and risk management for cold chain shipping.

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The next phase for mRNA: Looking beyond COVID-19

Pharmaceutical Technology

Following the success of the COVID-19 vaccines, there has been an increasing focus on mRNA’s potential to address a wide range of diseases, including cancer.

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FDA clears Roche’s Alecensa for adjuvant use in NSCLC

pharmaphorum

Roche's Alecenesa has become the first ALK inhibitor to be approved by the FDA for adjuvant use in early-stage, ALK+ NSCLC

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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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Rhenium (186Re) obisbemeda by Plus Therapeutics for Head And Neck Cancer: Likelihood of Approval

Pharmaceutical Technology

Rhenium (186Re) obisbemeda is under clinical development by Plus Therapeutics and currently in Phase II for Head And Neck Cancer.

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Cerevel Parkinson’s data adds lustre to AbbVie acquisition

pharmaphorum

Cerevel's first phase 3 trial of Parkinson's drug tavapadon is positive - good news for AbbVie which is trying to buy the biotech for $8.

Trials 104
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Clinical trial packaging services in contract manufacturing for the pharmaceutical industry

Pharmaceutical Technology

Pharmaceutical Technology Has Listed Some of the Leading Providers of Clinical Trial Packaging Services. Download For Free Here.

Packaging 130
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Hyundai Bio plans trials of antiviral for dengue fever

pharmaphorum

Hyundai Bioscience is preparing to start clinical trials of what it hopes could become the first antiviral treatment for dengue fever

Trials 109
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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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GH-21 by HUYA Bioscience International for Non-Small Cell Lung Cancer: Likelihood of Approval

Pharmaceutical Technology

GH-21 is under clinical development by HUYA Bioscience International and currently in Phase I for Non-Small Cell Lung Cancer.

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'The Top Line': Winning formulas for the best biotech and drug names

Fierce Pharma

This week on “The Top Line,” we're joined by Fierce Biotech Senior Editor Annalee Armstrong and Fierce Pharma Marketing Senior Editor Ben Adams. | This week on "The Top Line," we are joined by Annalee Armstrong, Senior Editor at Fierce Biotech, and Ben Adams, Senior Editor of Fierce Pharma Marketing, to discuss Fierce's take on March Madness.

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Evotec and Variant Bio forge antifibrotic drug discovery partnership

Pharmaceutical Technology

Evotec has entered a partnership agreement with Variant Bio aimed at detecting a treatment for ailments caused by fibrosis.

Drugs 130
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Vox Pop Pharma - companies keen to find alternatives to animal testing - read their views

Outsourcing Pharma

Earlier this week, Charles River Laboratories International, Inc. revealed its Alternative Methods Advancement Project (AMAP), which it said is a strong initiative aimed at changing drug discovery and development by exploring alternatives to animal testing.

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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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DF-4101 by AbbVie for Head And Neck Squamous Cell Carcinoma (HNSC): Likelihood of Approval

Pharmaceutical Technology

DF-4101 is under clinical development by AbbVie and currently in Phase I for Head And Neck Squamous Cell Carcinoma (HNSC).

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CureVac and MD Anderson Cancer Center partner to develop new cancer vaccines

Pharma Times

Both will develop cancer vaccine candidates in selected haematological and solid tumour indications

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Pharmaceutical compliance management software for the pharmaceutical industry

Pharmaceutical Technology

Pharmaceutical Compliance Management Software Is Designed to Enhance Patient Safety. Download the Free Buyer’s Guide Here.

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Experimental AI predicts whether cancer drugs will work

pharmaphorum

Researchers in the US have developed an artificial intelligence tool that can predict how a patient will respond to cancer treatment

Drugs 104
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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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Alvotech moves to bring its Humira biosimilar to US market

Pharmaceutical Technology

The long-term agreement will see increased access of Simlandi, a biosimilar to AbbVie’s Humira, in the US market.

Marketing 130
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FibroGen settles with former employees who it claimed stole trade secrets

Fierce Pharma

Nearly a year and a half after FibroGen slapped a pair of former employees with a lawsuit alleging trade secrets theft, both the plaintiffs and the defendants are walking away from the case little | Nearly a year and a half after FibroGen slapped a pair of former employees with a lawsuit alleging trade secrets theft, both the plaintiffs and the defendants are walking away from the case little worse for wear.

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HU-6 by Rivus Pharmaceuticals for Hypertriglyceridemia: Likelihood of Approval

Pharmaceutical Technology

HU-6 is under clinical development by Rivus Pharmaceuticals and currently in Phase II for Hypertriglyceridemia.

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Catching up with LGM Pharma ahead of CPhI North America to find out about its pipeline

Outsourcing Pharma

LGM Pharma is a leading CDMO provider of comprehensive API sourcing and drug product contract development and manufacturing solutions to the pharmaceutical, biotechnology, and compounding pharmacy industries.

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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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PRO-1107 by ProfoundBio Suzhou for Gastric Cancer: Likelihood of Approval

Pharmaceutical Technology

PRO-1107 is under clinical development by ProfoundBio Suzhou and currently in Phase II for Gastric Cancer.

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New clinical trial aims to investigate skin patches to spot lung transplant rejection

Pharma Times

Involving 152 patients, the SENTINEL trial aims to cut lung transplant rejection by up to 50%

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PRO-1107 by ProfoundBio Suzhou for Bladder Cancer: Likelihood of Approval

Pharmaceutical Technology

PRO-1107 is under clinical development by ProfoundBio Suzhou and currently in Phase II for Bladder Cancer.

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Giving the gift of health by finding solutions to the cost and complexity of prescription drugs

Outsourcing Pharma

Gifthealth began operations just under four years ago to provide a scalable solution for the cost and complexity of prescription drugs.

Drugs 80
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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.