Tue.Mar 05, 2024

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Biotech IPOs heated up to start 2024. Will the surge last?

Bio Pharma Dive

Following the sector’s best IPO start in three years, BioPharma Dive spoke with industry insiders about what they expect to see in the months ahead.

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UK NHS introduces new endometrial cancer immunotherapy

Pharmaceutical Technology

The UK NHS has introduced the new checkpoint inhibitor immunotherapy dostarlimab (Jemperli) for women with advanced endometrial cancer.

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Alnylam, Roche blood pressure drug scores in second mid-stage trial

Bio Pharma Dive

The study results further validate Roche’s recent decision to acquire rights to the drug, which is being developed for people with a stubborn form of hypertension.

Drugs 287
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Cheap Daily Supplement Seems to Boost Brain Function in Older Adults

AuroBlog - Aurous Healthcare Clinical Trials blog

What’s good for your aging gut may also be good for your aging brain. The first twin study of its kind suggests that taking daily protein and prebiotic supplements can improve scores on memory tests in people over the age of 60.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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March 5, 2024: Registration Opens for Pragmatic Trials Workshop at SCT 45th Annual Meeting

Rethinking Clinical Trials

The NIH Pragmatic Trials Collaboratory will offer a preconference workshop at the 45th Annual Meeting of the Society for Clinical Trials in Boston. Registration for the workshop is now open. The workshop, “Patient-Centered Research in Real-World Settings: Essentials of Embedded Pragmatic Clinical Trials,” will introduce concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a particular focus on engaging stakeholders and

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SEC recommends approval for Astrazeneca’s anti-hyperkalaemia drug Lokelma in India

AuroBlog - Aurous Healthcare Clinical Trials blog

The Subject Expert Committee (SEC) which advises the national drug regulator on drug approvals and clinical trials has recommended grant of permission to drug major Astrazeneca for import and marketing of two strengths of anti-hyperkalaemia therapy drug Lokelma (sodium zirconium cyclosilicate for oral suspension).

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Unveiling the Power of Holistic Wellness: A Path to Better Sleep

Pharma Mirror

Presented by BetterHelp. Wellness is an important focus for most people. The concept of holistic wellness involves taking care of the mind and body. It can include conventional modern medicine, psychotherapy, and various activities to bring calm and balance to one’s life. The term ‘’mind, body, and spirit’’ is sometimes used to illustrate this holistic approach to health.

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F. Hoffmann-La Roche in artificial intelligence: theme innovation strategy

Pharmaceutical Technology

How many patents did F. Hoffmann-La Roche submit related to artificial intelligence last quarter, and how many were granted? Discover the latest information here.

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Apogee data hint at potential for long-lasting eczema drug

Bio Pharma Dive

The biotech, which raised $300 million in an IPO last year, disclosed early results suggesting its therapy could be dosed less frequently than medicines from Eli Lilly and Regeneron.

Medicine 131
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Telix to acquire Canadian radioisotope tech company ARTMS

Pharmaceutical Technology

Telix Pharmaceuticals has signed an agreement for the acquisition of ARTMS, a Canadian radioisotope production technology company.

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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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Dragons' Den investment spurs innovation in dementia-friendly finance

Outsourcing Pharma

Jayne Sibley, the mastermind behind Sibstar, a debit card and mobile app aimed at those with dementia has secured a substantial Â125K investment from BBC Dragonsâ Den investors Sara Davies and Deborah Meaden.

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A2 Bio’s cell therapy gains FDA orphan drug status for colorectal cancer

Pharmaceutical Technology

A2 Bio has received the US FDA's orphan drug designation for its cell therapy, A2B530, to treat colorectal cancer patients.

Drugs 130
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Clerkenwell Health calling for volunteers with PTSD to trial new psychoactive drug

Outsourcing Pharma

Clerkenwell Health, a company that delivers clinical trials for the treatment of complex mental health volunteers for trials into the use of psychoactive medications for treating PTSD, is in search of 40 ex-military volunteers.

Trials 111
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Nocion secures Series B funds to develop cough treatment

Pharmaceutical Technology

Nocion has secured $62m in Series B financing round to advance its lead programme, Taplucanium, into later-stage development.

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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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Surprise Enhertu rejection follows NICE process change

pharmaphorum

NICE has rejected the use of AstraZeneca and Daiichi Sankyo’s Enhertu as an NHS treatment for advanced HER2-low breast cancer, a decision that the companies have described as “devastating”.

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UK Spring Budget allocates funds to life sciences manufacturing

Pharmaceutical Technology

The UK Government announced plans to bolster the UK life science manufacturing industry through increased investment.

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NICE backs frontline use of Jemperli in endometrial cancer

pharmaphorum

GSK’s PD-1 inhibitor Jemperli has been cleared for use by the NHS as a first-line treatment for a specific type of endometrial cancer, making it an option for around 580 women across England, Wales and Northern Ireland.

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F. Hoffmann-La Roche in future of work: theme innovation strategy

Pharmaceutical Technology

How many patents did F. Hoffmann-La Roche submit related to future of work last quarter, and how many were granted? Discover the latest information here.

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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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Novo Nordisk's success with Ozempic in diabetes and kidney disease patients isn't enough for investors

Fierce Pharma

A trial of Novo Nordisk's Ozempic on diabetes and kidney disease patients found that it reduced the risk of disease progression and death by 24%.

Trials 112
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Amgen in artificial intelligence: theme innovation strategy

Pharmaceutical Technology

How many patents did Amgen submit related to artificial intelligence last quarter, and how many were granted? Discover the latest information here.

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Vanda's jet-lag approval hopes for Hetlioz quashed with FDA hearing rejection

Fierce Pharma

Vanda has been waiting years for an FDA hearing to contest the agency’s 2019 rejection of its sleep drug Hetlioz in jet lag disorder. | Vanda has been waiting years for an FDA hearing to contest the agency’s 2019 rejection of its sleep drug Hetlioz in jet lag disorder. Now, following a lawsuit and a protracted back-and-forth with the U.S. regulator, the FDA has crushed Vanda’s bid.

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Azenta in future of work: theme innovation strategy

Pharmaceutical Technology

How many patents did Azenta submit related to future of work last quarter, and how many were granted? Discover the latest information here.

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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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Form Bio and Ginkgo Bioworks collaborate to revolutionize AAV gene therapy development

BioPharma Reporter

Form Bio and Ginkgo Bioworkshave joined forces in what they call a groundbreaking partnership aimed at advancing AAV gene therapy design and development.

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Amgen in digitalization: theme innovation strategy

Pharmaceutical Technology

How many patents did Amgen submit related to digitalization last quarter, and how many were granted? Discover the latest information here.

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Bayer CEO launches ‘full-scale effort’ to rejuvenate pharma pipeline, tables split-up but warns not never

Fierce Pharma

Bill Anderson, nine months into Bayer’s CEO role, has laid out his priorities for the troubled German conglomerate in the next few years—and it doesn’t involve an immediate business split-up as man | Bill Anderson, nine months into Bayer’s CEO role, has laid out his priorities for the troubled German conglomerate in the next few years—and it doesn’t involve an immediate business split-up as many investors had hoped for.

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Amgen in future of work: theme innovation strategy

Pharmaceutical Technology

How many patents did Amgen submit related to future of work last quarter, and how many were granted? Discover the latest information here.

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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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Can creative analytics solve your D2C paid search headache?

pharmaphorum

Learn how creative analytics can help solve your Direct-to-Consumer paid search challenges. Discover how data-driven insights can optimise your performance with HCPs.

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Amgen in social media: theme innovation strategy

Pharmaceutical Technology

How many patents did Amgen submit related to social media last quarter, and how many were granted? Discover the latest information here.

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Novo Nordisk looks set to add another string to Ozempic bow

pharmaphorum

Novo Nordisk’s GLP-1 agonist Ozempic has shown efficacy in yet another indication, achieving a 24% reduction in kidney disease-related events in people with type 2 diabetes and chronic kidney disease (CKD) in the FLOW trial.

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Azenta in robotics: theme innovation strategy

Pharmaceutical Technology

How many patents did Azenta submit related to robotics last quarter, and how many were granted? Discover the latest information here.

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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.