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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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.

Vaccine 214
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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 173
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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 200
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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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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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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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Understanding the politics of drug pricing in the United States

pharmaphorum

Brandon Newman, CEO of healthcare analytics firm Xevant, joins host Jonah Comstock on today’s episode of the pharmaphorum podcast.

Drugs 124
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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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PhaSER Biomedical and the Sanders TDI partner for clinical drug discovery research

Pharma Times

PhaSER will provide 8HUM mouse models for the TDI to accelerate a pipeline of novel therapeutic targets

Research 124
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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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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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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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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 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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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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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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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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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 119
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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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LifeArc provides £750,000 fund for clinical trial to treat neuroferritinopathy

Pharma Times

The progressive and incurable brain disorder currently affects approximately 100 patients worldwide

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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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WuXi Biologics stays the course with positive 2024 outlook as national security crackdown threatens business in US

Fierce Pharma

WuXi Biologics stays the course with positive 2024 outlook as national security crackdown threatens business in US fkansteiner Wed, 03/27/2024 - 13:12

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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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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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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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Reuters Pharma USA 2024 - Day 2

pharmaphorum

Get live coverage of the latest updates and developments from Day 2 of Reuters Pharma USA 2024. Stay informed with real-time news and insights from the event.

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More revamp at Bayer as it axes 90 at its U.S. headquarters in New Jersey

Fierce Pharma

At a recent skull session in a conference room at Bayer’s U.S. | Bayer is laying off 90 of its employees at its United States headquarters in Whippany, New Jersey, part of its ongoing restructure which CEO Bill Anderson has said will cost many their jobs.

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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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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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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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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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What Should IVD Manufacturers Look for When Selecting a Lab Testing Partner?

XTalks

In vitro diagnostics, or IVD, is a field where precision, reliability and robust partnerships propel advancement. Each diagnostic evaluation and every lab discovery signify not only technological advancement but also the fruit of integrated teamwork, with decisions made collaboratively. This is where collaboration meets innovation, and an effective strategic partnership can truly spark achievement.

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Teva UK partners Closed Loop on personalised medicine

pharmaphorum

Teva UK has joined forces with techbio company Closed Loop Medicine to develop digital companions for pharma products that could provide personalised medicine

Medicine 105
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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.