Wed.Mar 27, 2024

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Oncology in 2024: The clinical trial trends reshaping the role of CROs

Pharmaceutical Technology

CROs are fundamental to the development of cancer treatments but face multiple challenges. We analyze the biggest trends in oncology and the technological solutions available to CROs to optimize efficiencies.

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European study finds popular ALS drug ineffective

Bio Pharma Dive

The failure of a medicine known as TUDCA is yet another disappointment for ALS patients, as it comes just after Amylyx’s therapy Relyvrio proved unsuccessful in confirmatory testing.

Drugs 189
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March 27, 2024: A Cluster Randomized Trial to Improve Kidney Transplant Access, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Drs. Amit Garg and Stephanie Dixon In this Friday’s PCT Grand Rounds, Amit Garg and Stephanie Dixon of Western University’s Schulich School of Medicine and Dentistry will present “Effect of a Multicomponent Intervention to Improve Patient Access to Kidney Transplant and Living Kidney Donation: A Pragmatic, Cluster-Randomized Trial.” The Grand Rounds session will be held on Friday, March 27, 2024, at 1:00 pm eastern.

Trials 161
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Moderna gets Blackstone backing for flu vaccine R&D

Bio Pharma Dive

An arm of the private equity firm pledged up to $750 million in funding for Moderna’s flu shot development, in exchange for milestones and royalties.

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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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Which drugs are most likely to be approved in Cryopyrin-Associated Periodic Syndromes?

Pharmaceutical Technology

Cryopyrin-Associated Periodic Syndromes disease is an indication for drug development with over 10 pipeline drugs currently active according to GlobalData.

Drugs 130
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Boundless Bio breaks IPO lull with $100M fundraise

Bio Pharma Dive

The startup’s performance will test investors’ appetite for early-stage drugmakers, as Boundless has only advanced as far as Phase 1 clinical trials.

More Trending

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Akebia’s CKD Anemia Drug Ends Tough Regulatory Path with FDA Approval

BioSpace

After an initial rejection due to safety issues, followed by a dispute and deferred actions, Akebia Therapeutics on Wednesday finally won the FDA’s nod for vadadustat as a treatment for anemia caused by chronic kidney disease.

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Avenzo Therapeutics secures $150m to progress oncology pipeline

Pharmaceutical Technology

Avenzo Therapeutics has secured $150m in Series A-1 financing round to progress the development of its oncology pipeline.

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Brainomix AI shows its worth in AZ pulmonary fibrosis trial

pharmaphorum

Brainomix's e-Lung AI can accurately identify idiopathic pulmonary fibrosis patients most likely to progress and could inform the clinical trial design for new therapies

Trials 121
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J&J’s nipocalimab gains FDA fast track status for FNAIT risk reduction

Pharmaceutical Technology

Johnson & Johnson (J&J) has obtained US FDA fast track status for nipocalimab to lower foetal and neonatal alloimmune thrombocytopenia risk.

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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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Boundless Bio Launches $100M IPO to Advance Cancer Therapy Candidates

BioSpace

Continuing 2024’s biotech initial public offering rally, Boundless Bio will debut Thursday on the Nasdaq with the proceeds used to advance its pipeline of extrachromosomal DNA cancer assets.

DNA 119
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Which drugs are most likely to be approved in Respiratory Tract Infections?

Pharmaceutical Technology

Respiratory Tract Infections disease is an indication for drug development with over 120 pipeline drugs currently active according to GlobalData.

Drugs 130
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Building the patient experience into observational studies produces stronger real-world evidence

pharmaphorum

Incorporating the patient experience into observational studies can enhance the quality of real-world evidence gathered. Learn how patient-centred approaches can lead to stronger research outcomes.

Research 119
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Which drugs are most likely to be approved in Labor And Delivery?

Pharmaceutical Technology

Labor And Delivery disease is an indication for drug development with over 10 pipeline drugs currently active according to GlobalData.

Drugs 130
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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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Akebia's Vafseo finally gets its shot at US chronic kidney disease market after FDA approval

Fierce Pharma

Akebia never lost confidence in its oral chronic kidney disease (CKD) anemia drug Vafseo, even after the FDA nixed its first approval bid two years ago with a complete response letter.

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Takeda’s ADZYNMA gains Japanese approval for cTTP treatment

Pharmaceutical Technology

Takeda has announced that the Japanese MHLW approved its ADZYNMA to treat congenital thrombotic thrombocytopenic purpura (cTTP).

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Sanofi inks 3 distribution pacts in India and Korea for CNS drugs and vaccines

Fierce Pharma

For various reasons, pharma firms often favor distribution pacts rather than relying on local subsidiaries to market their drugs. | As pharma firms increasingly favor distribution pacts rather than relying on local subsidiaries to market their drugs, French major Sanofi has enlisted local companies to enhance the profile of its medicines across South and East Asia.

Drugs 102
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Which drugs are most likely to be approved in Pneumonia?

Pharmaceutical Technology

Pneumonia disease is an indication for drug development with over 230 pipeline drugs currently active according to GlobalData.

Drugs 130
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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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Sanders Blasts Novo Nordisk for ‘Outrageous’ Price of Ozempic, Wegovy

BioSpace

Citing a JAMA study that found Ozempic could be profitably produced at under $5 per month, Senator Bernie Sanders on Wednesday called on Novo Nordisk to lower prices for the diabetes treatment and the weight-loss drug Wegovy.

Drugs 112
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FDA approves Merck’s WINREVAIR for pulmonary arterial hypertension

Pharmaceutical Technology

The US FDA has approved Merck's sotatercept-csrk (WINREVAIR) for the treatment of pulmonary arterial hypertension (PAH).

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Antidote anecdotes: A conversation with an MS care partner

Antidote

MS is a chronic disease that is estimated to impact over a million Americans. The condition causes damage to the body’s central nervous system, leading to numbness, memory problems, sight issues, and difficulties with coordination.

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Which drugs are most likely to be approved in Cough?

Pharmaceutical Technology

Cough disease is an indication for drug development with over 40 pipeline drugs currently active according to GlobalData.

Drugs 130
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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.

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Women in Science: Follow your passion and you’ll get to where you’re meant to be - Jennifer Visser-Rogers

BioPharma Reporter

From math hater to a leader in clinical data, itâs been a long journey for Jennifer Visser-Rogers, vice president for statistical research and consultancy at Phastar.

Research 119
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Juvisé licenses J&J’s MS drug Ponvory for marketing outside North America

Pharmaceutical Technology

The market for multiple sclerosis therapies is expected to be worth over $41bn by 2030, according to GlobalData.

Marketing 130
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EU Approves Merck’s Keytruda, Chemo Combo for Lung Cancer

BioSpace

Keytruda can now be used in the European Union for patients with resectable non-small cell lung cancer at high risk of recurrence in combination with platinum chemotherapy, then continued as a monotherapy afterwards.

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Which drugs are most likely to be approved in Mixed Pain (Nociceptive Pain/Neuropathic Pain)?

Pharmaceutical Technology

Mixed Pain (Nociceptive Pain/Neuropathic Pain) disease is an indication for drug development with over 270 pipeline drugs currently active according to GlobalData.

Drugs 100
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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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Japan clears first CLDN18.2 drug, Astellas’ Vyloy

pharmaphorum

Astellas has become the first drugmaker to bring a claudin 18.2 (CLDN18.2) targeted therapy to regulatory approval, getting a green light in Japan for Vyloy as a treatment for stomach cancer. The Ministry of Health, Labour and Welfare (MHLW) has cleared Vyloy (zolbetuximab) for use in combination with chemotherapy for patients with HER2-negative CLDN18.2-positive advanced or recurrent gastric cancer that cannot be treated with surgery.

Drugs 111
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Which drugs are most likely to be approved in Hematopoietic Stem Cell Transplantation?

Pharmaceutical Technology

Hematopoietic Stem Cell Transplantation disease is an indication for drug development with over 10 pipeline drugs currently active according to GlobalData.

Drugs 100
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Dissatisfaction with NHS ‘at record high’

pharmaphorum

More than half (52%) of people who participated in a major survey of the GB public were dissatisfied with the NHS, as staff shortages, strikes, and record waiting lists take their toll. The results from the annual British Social Attitudes (BSA) survey came from 3,000 people interviewed across England, Scotland, and Wales and showed that less than a quarter (24%) were satisfied with the health service, a 29 percentage drop in three years.

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Which drugs are most likely to be approved in Primary Mediastinal B-Cell Lymphoma?

Pharmaceutical Technology

Primary Mediastinal B-Cell Lymphoma disease is an indication for drug development with over 140 pipeline drugs currently active according to GlobalData.

Drugs 100
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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.