Tue.Dec 26, 2023

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BMS agrees to acquire Karuna Therapeutics for $14bn

Pharmaceutical Technology

Bristol Myers Squibb (BMS) has signed a definitive agreement for the acquisition of Karuna Therapeutics for $14bn in cash.

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KarXT: A New Hope for Schizophrenia Patients, Phase III Trial Data Reveals

XTalks

Karuna Therapeutics, a biopharmaceutical company dedicated to uncovering, advancing and providing groundbreaking medicines for individuals facing psychiatric and neurological conditions, has recently disclosed encouraging outcomes from the Phase III EMERGENT-2 trial of KarXT (xanomeline-trospium) in adults diagnosed with schizophrenia. “New treatments and novel mechanisms are urgently needed for people with schizophrenia because many don’t respond to their therapy and others only have a partial

Trials 105
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ABBV-400 by AbbVie for Head And Neck Squamous Cell Carcinoma (HNSC): Likelihood of Approval

Pharmaceutical Technology

ABBV-400 is under clinical development by AbbVie and currently in Phase I for Head And Neck Squamous Cell Carcinoma (HNSC).

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Investing in healthspan: A prescription for prosperity

pharmaphorum

Exploring the powerful collaborations between scientists, investors, and the medical community in finding breakthrough treatments for major diseases, and the notion of 'healthspan'

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Exarafenib by Kinnate Biopharma for Non-Small Cell Lung Cancer: Likelihood of Approval

Pharmaceutical Technology

Exarafenib is under clinical development by Kinnate Biopharma and currently in Phase I for Non-Small Cell Lung Cancer.

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Exploring the reasons behind increasing burdens on clinical research sites

pharmaphorum

In the first of a five-part festive instalment of the pharmaphorum podcast, web editor Nicole Raleigh speaks with Advarra’s chief product officer, Elisa Cascade, about the reasons behind increasing burdens on clinical research sites over the last five years.

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New patent for Purdue Pharma drug HYSINGLA ER

Drug Patent Watch

Annual Drug Patent Expirations for HYSINGLA+ER Hysingla Er is a drug marketed by Purdue Pharma Lp and is included in one NDA. It is available from one supplier. There are… The post New patent for Purdue Pharma drug HYSINGLA ER appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 59
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Difficult biotech investment ecosystem forces focus on value

Pharmaceutical Technology

In 2023, investors pursued pharmaceutical assets with value amidst an unstable economic environment.

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New patent for Blueprint Medicines drug AYVAKIT

Drug Patent Watch

Annual Drug Patent Expirations for AYVAKIT Ayvakit is a drug marketed by Blueprint Medicines and is included in one NDA. It is available from one supplier. There are three patents… The post New patent for Blueprint Medicines drug AYVAKIT appeared first on DrugPatentWatch - Make Better Decisions.

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NVG-111 by NovalGen for Mantle Cell Lymphoma: Likelihood of Approval

Pharmaceutical Technology

NVG-111 is under clinical development by NovalGen and currently in Phase I for Mantle Cell Lymphoma.

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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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New patent expiration for Woodward drug COREG CR

Drug Patent Watch

Annual Drug Patent Expirations for COREG+CR Coreg Cr is a drug marketed by Woodward and is included in one NDA. It is available from four suppliers. There are two patents… The post New patent expiration for Woodward drug COREG CR appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 59
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AWT-020 by Anwita Biosciences for Sarcomas: Likelihood of Approval

Pharmaceutical Technology

AWT-020 is under clinical development by Anwita Biosciences and currently in Phase II for Sarcomas.

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Key industry partnerships advancing drug discovery

Drug Discovery World

Otsuka Pharmaceutical and Ionis Pharmaceuticals Otsuka Pharmaceutical and RNA therapy company Ionis have entered into a licence agreement for Otsuka to acquire exclusive marketing rights to Ionis’ hereditary angioedema (HAE) drug candidate donidalorsen in Europe. Donidalorsen is an investigational ligand-conjugated antisense (LICA) medicine designed to target the prekallikrein, or PKK, pathway.

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Sacituzumab tirumotecan by Merck for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer): Likelihood of Approval

Pharmaceutical Technology

Sacituzumab tirumotecan is under clinical development by Merck and currently in Phase II for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer).

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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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AZ makes another cell therapy play with $1.2bn Gracell buy

pharmaphorum

AstraZeneca agrees a $1.

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KSQ-4279 by F. Hoffmann-La Roche for Ovarian Cancer: Likelihood of Approval

Pharmaceutical Technology

KSQ-4279 is under clinical development by F. Hoffmann-La Roche and currently in Phase I for Ovarian Cancer.

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Top 5 Most Popular Cold Chain Articles of 2023

Pharmaceutical Commerce

Items in this sector ranged touched on topics such as pharma shipping, container technology, and sustainability.

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BI-765179 by Boehringer Ingelheim International for Head And Neck Squamous Cell Carcinoma (HNSC): Likelihood of Approval

Pharmaceutical Technology

BI-765179 is under clinical development by Boehringer Ingelheim International and currently in Phase I for Head And Neck Squamous Cell Carcinoma (HNSC).

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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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Which pharmaceutical companies have the most emulsion dosed drugs?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most emulsion dosed drugs. For a different perspective, see the most popular dosage types. The companies with the most emulsion dosed drugs… The post Which pharmaceutical companies have the most emulsion dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.

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BI-765179 by Boehringer Ingelheim International for Cutaneous Squamous Cell Carcinoma (cSCC): Likelihood of Approval

Pharmaceutical Technology

BI-765179 is under clinical development by Boehringer Ingelheim International and currently in Phase I for Cutaneous Squamous Cell Carcinoma (cSCC).

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DDW readers’ top drug discovery developments of 2023

Drug Discovery World

DDW’s Diana Spencer takes a look at the breaking news stories that were most popular with DDW readers over the last year. Representing a dominant field of drug discovery, it isn’t surprising that breakthroughs in cancer research were popular with DDW readers in 2023, particularly strategies to overcome treatment resistance and prevent the spread of disease.

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BR-790 by Jiangxi Qingfeng Pharmaceutical for Head And Neck Squamous Cell Carcinoma (HNSC): Likelihood of Approval

Pharmaceutical Technology

BR-790 is under clinical development by Jiangxi Qingfeng Pharmaceutical and currently in Phase I for Head And Neck Squamous Cell Carcinoma (HNSC).

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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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Sacituzumab tirumotecan by Merck for Metastatic Transitional (Urothelial) Tract Cancer: Likelihood of Approval

Pharmaceutical Technology

Sacituzumab tirumotecan is under clinical development by Merck and currently in Phase II for Metastatic Transitional (Urothelial) Tract Cancer.

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Sacituzumab tirumotecan by Merck for Adenocarcinoma Of The Gastroesophageal Junction: Likelihood of Approval

Pharmaceutical Technology

Sacituzumab tirumotecan is under clinical development by Merck and currently in Phase II for Adenocarcinoma Of The Gastroesophageal Junction.

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AZD-9550 by AstraZeneca for Metabolic Dysfunction-Associated Steatohepatitis (MASH): Likelihood of Approval

Pharmaceutical Technology

AZD-9550 is under clinical development by AstraZeneca and currently in Phase I for Metabolic Dysfunction-Associated Steatohepatitis (MASH).

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ADRX-0706 by Adcentrx Therapeutics for Head And Neck Squamous Cell Carcinoma (HNSC): Likelihood of Approval

Pharmaceutical Technology

ADRX-0706 is under clinical development by Adcentrx Therapeutics and currently in Phase I for Head And Neck Squamous Cell Carcinoma (HNSC).

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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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HEC-88473 by HEC Pharma for Metabolic Dysfunction-Associated Steatohepatitis (MASH): Likelihood of Approval

Pharmaceutical Technology

HEC-88473 is under clinical development by HEC Pharma and currently in Phase I for Metabolic Dysfunction-Associated Steatohepatitis (MASH).

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TAK-500 by Takeda Pharmaceutical for Head And Neck Squamous Cell Carcinoma (HNSC): Likelihood of Approval

Pharmaceutical Technology

TAK-500 is under clinical development by Takeda Pharmaceutical and currently in Phase II for Head And Neck Squamous Cell Carcinoma (HNSC).

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NT-175 by Neogene Therapeutics for Head And Neck Squamous Cell Carcinoma (HNSC): Likelihood of Approval

Pharmaceutical Technology

NT-175 is under clinical development by Neogene Therapeutics and currently in Phase I for Head And Neck Squamous Cell Carcinoma (HNSC).

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ORB-011 by Orionis Biosciences for Head And Neck Squamous Cell Carcinoma (HNSC): Likelihood of Approval

Pharmaceutical Technology

ORB-011 is under clinical development by Orionis Biosciences and currently in Phase I for Head And Neck Squamous Cell Carcinoma (HNSC).

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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.