Tue.Jan 28, 2025

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Enhertu, with new FDA OK, set to supplant chemo in HER2-low breast cancer

Bio Pharma Dive

The clearance is a step forward in AstraZeneca and Daiichi Sankyo’s plan to position antibody-drug conjugates like Enhertu ahead of chemotherapy in a variety of tumors.

Antibody 200
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AB2 Bio and Nippon Shinyaku enter Tadekinig alfa licensing deal

Pharmaceutical Technology

AB2 Bio has made an option and licensing agreement with Nippon Shinyaku, granting the latter the option to commercialise Tadekinig alfa.

Licensing 162
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Atalanta banks $97M to send RNAi drugs into the brain

Bio Pharma Dive

The startup says its specially constructed RNAi therapies can get deep into brain tissue, yielding new ways to treat neurological conditions like Huntington’s.

Drugs 200
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ITM’s radiotherapeutic beats out standard-of-care in Phase III trial

Pharmaceutical Technology

the company announced that its Phase III trial examining its gastroenteropancreatic tumour treatment, ITM-11, met its primary endpoint.

Trials 147
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Rival radiopharma drug to Novartis’ Lutathera succeeds in trial, ITM says

Bio Pharma Dive

ITM's lutetium-containing therapy extended progression-free survival versus everolimus in patients with a specific kind of neuroendocrine tumor.

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Allakos cuts 75% of workforce after chronic hives trial failure 

Pharmaceutical Technology

A year after reducing half of its workforce, Allakos will downsize to just 15 employees as it halts the development of AK006.

Trials 147

More Trending

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GLP-1RA developer Metsera targets $289m IPO

Pharmaceutical Technology

Metsera is aiming to put its weight loss drug MET-097i, which boasts of a longer half-life, through Phase III trials.

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FDA approves new Alzheimer’s treatment regimen

Pharma Times

Patients and care partners may find once every four weeks maintenance dosing easier

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Can-Fite BioPharma secures US patent for Namodenoson

Pharmaceutical Technology

Can-Fite BioPharma has secured a US patent for Namodenoson, its lead drug candidate, for use as an anti-obesity treatment.

Drugs 147
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Is VR the answer to the great wait?

pharmaphorum

Bring your waiting experience to life with Virtual Reality (VR)! Discover how VR technology is revolutionising the way we pass the time and enhancing customer satisfaction.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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OCT West Coast 2025: Efficient trials will help at all levels

Pharmaceutical Technology

Arena Internationals Outsourcing in Clinical Trials West Coast 2025 will discuss patient centricity, diversity, and regulatory shifts.

Trials 147
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Cartesian Therapeutics announces FDA agreement for new trial

Pharma Times

Phase 3 trial of Descartes-08 in myasthenia gravis to start in 1H25

Trials 79
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Sage rejects Biogen’s $469m takeover bid

Pharmaceutical Technology

Sages board of directors said that the proposal significantly undervalues the company and is not in the best interest of shareholders.

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AI in medical imaging company Quibim raises $50m

pharmaphorum

Quibim has raised $50 million in first-round financing to support the rollout of its AI biomarkers for use in the analysis of medical imaging.

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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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AI-driven virtual CGM data boosts understanding of T1D risks

Pharmaceutical Technology

This study reinforces the significance of intensive glycaemic control and is a paradigm shift in managing the disease and its complications.

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Veru shares plunge despite positive data in obesity trial

pharmaphorum

Veru's obesity candidate achieved the objective of preserving muscle in people taking weight-loss drug Wegovy, but its share price still fell sharply.

Trials 66
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GSK and University of Oxford partner for cancer vaccine research

Pharmaceutical Technology

GSK and the University of Oxford have entered a new research partnership to launch an immuno-prevention programme.

Research 147
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Research, Innovation, and Compliance in the EU and UK: A Data Privacy Roadmap

ACRP blog

Collection of sensitive personal data is a cornerstone of clinical research involving drugs and medical devices. However, if the personal data relates to European Union (EU) or United Kingdom (UK) residents, this raises particular legal and compliance issues due to the General Data Protection Regulation (GDPR). Securing, anonymizing, and transferring personal data is complex and challenging in these regions, especially when there is a need to share personal data with vendors and research partner

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Novo Nordisk’s next-generation obesity drug shows promise in early clinical trials

Outsourcing Pharma

Novo Nordisks amycretin shows 22% weight loss over 36 weeks, potentially surpassing Eli Lillys Zepbound. Further trials are planned.

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Enhertu gets first okay for HER2-ultralow breast cancer

pharmaphorum

Enhertu gets much-anticipated new FDA approval in breast cancer that expands its label and makes it an earlier option in the treatment pathway.

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Women in Science: Émilie Barré on her passion for applying data to real-world challenges

Outsourcing Pharma

Throughout her career, One2Treats milie Barr has focused on developing both the analytical and leadership aspects necessary for success in the field.

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Sage rejects Biogen takeover and launches review

pharmaphorum

Sage Therapeutics has unanimously rejected Biogen's acquisition offer of around $469 million, saying it "significantly undervalues" the company.

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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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Manas AI bags $24.6 million to turbocharge drug discovery

Outsourcing Pharma

Manas AI secures funding led by General Catalyst to scale AI-driven drug discovery, tackling cancer and rare diseases.

Drugs 52
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JP Morgan Week 2025 – Trân Lê and Sohit Gatiganti

pharmaphorum

Watch the exclusive video interview of Tran Le and Sohit Gatiganti discussing JPM 2025 and their insights into the future of technology and innovation.

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How Dual-Eligible Special Needs Plans Affect Medicaid Spending

Pharmaceutical Commerce

A study explores dual-enrollment in these planscompared to other Medicare Advantage plans impacts North Carolinas Medicaid fee-for-service spending.

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Akero Therapeutics succeeds with MASH liver treatment at phase 2

BioPharma Reporter

Akero Therapeutics announced statistically significant results from a Phase 2b trial of efruxifermin this week, a fibroblast growth factor 21 analog, designed to treat patients with biopsy-confirmed compensated cirrhosis due to MASH.

Trials 52
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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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Trust by design: Crafting authentic connections through digital

pharmaphorum

Craft authentic connections by design with digital content that resonates. Develop strategies, create engaging content, and build trust with your audience. Explore the power of content in crafting authentic connections.

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A Closer Look Into the Role of Compounding Pharmacies

Pharmaceutical Commerce

Donald Prentiss discusses the value of these pharmacies, especially during shortages.

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Stopwatch starts on reviews of GSK's long-acting asthma drug

pharmaphorum

Regulators have started reviews of GSK's depemokimab, aiming to become the first drug for asthma that can be dosed twice a year.

Drugs 45
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Pharma Pulse 1/28/25: Exploring Biopharma's Dealmaking Terrain, Pharmacovigilance in Digital Therapeutics & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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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.