Thu.Oct 19, 2023

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What Are Common Pitfalls in Writing PCT Grant Applications?

Rethinking Clinical Trials

The post What Are Common Pitfalls in Writing PCT Grant Applications? appeared first on Rethinking Clinical Trials.

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Beam to lay off 100 employees, seek partners in research restructuring

Bio Pharma Dive

The base editing specialist will prioritize medicines for sickle cell and alpha-1 antitrypsin deficiency, while trimming its plans for other programs in cancer and hepatitis B.

Research 273
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EC expands Takeda’s Adcetris label for advanced Hodgkin lymphoma treatment

Pharmaceutical Technology

Adcetris/AVD is already approved as a first-line treatment for patients with CD30+ Stage IV Hodgkin lymphoma.

Drugs 264
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Spicy Food Can Be Extremely Painful, But Is It Actually Dangerous?

AuroBlog - Aurous Healthcare Clinical Trials blog

Everyone has a different tolerance for spicy food — some love the burn, while others can’t take the heat. But the scientific consensus on whether spicy food can have an effect — positive or negative — on your health is pretty mixed.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Roche eye drug sales grow as Regeneron plays catch-up

Bio Pharma Dive

The Swiss pharma reported expanding U.S. market share for its new AMD drug Vabysmo as Regeneron tries to rebound from a now-resolved delay for its high-dose Eylea.

Sales 148
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Neuronopathic therapies are a serious unmet need in the treatment of Gaucher disease

Pharmaceutical Technology

KOLs interviewed by GlobalData emphasised a significant lack of neuronopathic therapies in the Gaucher disease landscape.

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AN2 Therapeutics receives licence to develop Chagas disease therapy

Pharmaceutical Technology

AN2 Therapeutics has signed an agreement for advancing the development of a new boron-containing small molecule to treat Chagas disease.

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Parliamentary panel asks govt to consider comprehensive policy framework to eliminate TB

AuroBlog - Aurous Healthcare Clinical Trials blog

A Parliamentary panel that looked into the implementation of Pradhan Mantri TB Mukt Bharat Abhiyan (PMTBMBA) has recommended to the government to consider developing a comprehensive policy framework emphasising on public-private partnership to eradicate Tuberculosis from the country.

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Laronde, Senda Biosciences merge to create new Flagship company

Bio Pharma Dive

The troubled RNA biotech is merging with Senda, another Flagship company that has drawn hundreds of millions of dollars in investment.

RNA 139
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How did hiring in the North American pharma industry perform in Q3 2023?

Pharmaceutical Technology

The North American pharma industry experienced a 26% drop in hiring activity in Q3 2023, led by CSL's 11% share, according to GlobalData

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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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Is It Important to Explain the Definition of Pragmatic to Grant Reviewers?

Rethinking Clinical Trials

Is It Important to Explain the Definition of Pragmatic to Grant Reviewers? Description Dr. Wendy Weber discusses if it is important to explain the definition of pragmatic to grant reviewers. Speaker Wendy Weber, ND, PhD, MPH Branch Chief, Clinical Research Branch Division of Extramural Research National Center for Complementary and Integrative Health (NCCIH) The post Is It Important to Explain the Definition of Pragmatic to Grant Reviewers?

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How did hiring in the North American pharma industry perform in Q3 2023?

Pharmaceutical Technology

The North American pharma industry experienced a 26% drop in hiring activity in Q3 2023, led by CSL's 11% share, according to GlobalData

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What Are the “Must Dos” of Writing PCT Grant Applications?

Rethinking Clinical Trials

What Are the “Must Dos” of Writing PCT Grant Applications? Description Dr. Wendy Weber discusses the "must dos" of writing PCT grant applications. Speaker Wendy Weber, ND, PhD, MPH Branch Chief, Clinical Research Branch Division of Extramural Research National Center for Complementary and Integrative Health (NCCIH) The post What Are the “Must Dos” of Writing PCT Grant Applications?

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Q3 2023 update: environmental sustainability related hiring actvity in the pharma industry

Pharmaceutical Technology

The global pharmaceutical industry recorded a 11% drop in environmental sustainability hiring activity in Q3 2023, according to GlobalData

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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 Should I Avoid When Writing PCT Grant Applications?

Rethinking Clinical Trials

What Should I Avoid When Writing PCT Grant Applications? Description Dr. Wendy Weber discusses what to avoid when writing PCT grant applications. Speaker Wendy Weber, ND, PhD, MPH Branch Chief, Clinical Research Branch Division of Extramural Research National Center for Complementary and Integrative Health (NCCIH) The post What Should I Avoid When Writing PCT Grant Applications?

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Stuart Therapeutics and Glaukos sign deal for glaucoma drug candidate

Pharmaceutical Technology

Stuart Therapeutics and Glaukos have signed a licence agreement for the former’s ST-113 drug candidate for neuroprotection in glaucoma.

Drugs 130
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What Are Some Success Strategies for Writing PCT Grant Applications?

Rethinking Clinical Trials

What Are Some Success Strategies for Writing PCT Grant Applications? Description Dr. Wendy Weber discusses success strategies for writing PCT grant applications. Speaker Wendy Weber, ND, PhD, MPH Branch Chief, Clinical Research Branch Division of Extramural Research National Center for Complementary and Integrative Health (NCCIH) The post What Are Some Success Strategies for Writing PCT Grant Applications?

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Cessation receives grant to develop anti-fentanyl mAb formulation

Pharmaceutical Technology

Cessation Therapeutics has received a grant from NIDA to develop a subcutaneous formulation of the anti-fentanyl mAb, CSX-1004 SQ.

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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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Is a PCT Right for Your Research Question?

Rethinking Clinical Trials

Is a PCT Right for Your Research Question? Description Dr. Wendy Weber discusses how to know if a PCT is right for your research question. Speaker Wendy Weber, ND, PhD, MPH Branch Chief, Clinical Research Branch Division of Extramural Research National Center for Complementary and Integrative Health (NCCIH) The post Is a PCT Right for Your Research Question?

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Novavax obtains full marketing authorisation in UK for Nuvaxovid

Pharmaceutical Technology

Novavax has received full marketing authorisation from the UK’s MHRA for its prototype Covid-19 vaccine Nuvaxovid (NVX-CoV2373).

Marketing 130
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Key breast cancer facts for Breast Cancer Awareness Month

Antidote

Since 1985, Breast Cancer Awareness Month has been held every October with the goal of raising awareness about the importance of breast cancer screening and prevention. Catching breast cancer early is one of the best ways to increase a person’s prognosis — though one in 8 women in the United States will be diagnosed with breast cancer in their lifetime , when caught in early stages, the 5-year survival rate is 99%.

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How did hiring in the French pharma industry perform in Q3 2023?

Pharmaceutical Technology

The French pharma industry experienced a 39% drop in new job postings in Q3 2023 compared with the previous quarter,…

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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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Merck Pays $4B Upfront for Daiichi Sankyo’s DXd-Based ADCs

BioSpace

Seeking to deepen its immuno-oncology business, Merck has closed a deal potentially worth $22 billion across three of Daiichi Sankyo’s DXd antibody-drug conjugates for various solid tumor indications.

Antibody 113
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How did hiring in the Canadian pharma industry perform in Q3 2023?

Pharmaceutical Technology

The Canadian pharma industry experienced a 26% drop in hiring activity in Q3 2023, led by Charles River Laboratories International's 9% share, according to GlobalData

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The Role of Financial Management and GAAP in Clinical Research

ACRP blog

This is a sponsored message. Research sites play a pivotal role in clinical trials in that they are responsible for participant recruitment, data collection, safety monitoring, regulatory management, overall trial conduct, and more. However, in order to maintain a successful research program and ensure long-term growth, a site also needs to focus on running itself as a business.

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How did hiring in the pharma industry perform in Q3 2023?

Pharmaceutical Technology

The global pharma industry recorded a 31% drop in hiring activity in Q3 2023, led by CSL's 7% share, according to GlobalData

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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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Funding of $6 million raised for Gero to find root causes of aging and age-related diseases

Outsourcing Pharma

Physics-powered GenAI Biotech, Gero, announced yesterday (October 18) that it had closed a $6 million series A extension round with funding from Melnicheck Investments and other investors.

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Hiring activity in the European pharma industry decreased in Q3 2023

Pharmaceutical Technology

The European pharma industry experienced a 33% drop in hiring activity in Q3 2023, led by Novo Nordisk's 12% share, according to GlobalData

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Amgen’s T-Cell Engager Shows Phase II Promise in Tough to Treat Lung Cancer

BioSpace

Tarlatamab achieved a 40% objective response rate in small cell lung cancer patients with advanced disease who had failed two or more prior lines of treatment, the company announced Friday.

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Hiring activity in the European pharma industry decreased in Q3 2023

Pharmaceutical Technology

The European pharma industry experienced a 33% drop in hiring activity in Q3 2023, led by Novo Nordisk's 12% share, according to GlobalData

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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.