Mon.Oct 21, 2024

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From Data Silos to Unified Insights: The Power of AI in Clinical Trials

Crucial Data Soutions

Managing and analyzing massive amounts of data from multiple sources is one of the most pressing challenges faced by clinical. The post From Data Silos to Unified Insights: The Power of AI in Clinical Trials appeared first on Crucial Data Solutions.

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PureTech thinks the ‘hub-and-spoke’ startup model is still a good bet. If only investors agreed.

Bio Pharma Dive

Shares in the Boston-based biotech creator, which had a standout success in forming Karuna Therapeutics, trade around cash levels — a "huge value disconnect" its leaders are trying to bridge.

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October 21, 2024: BEST-ICU and Chat 4 Heart Health Have Updated Study Snapshots, Ethics and Regulatory Documentation

Rethinking Clinical Trials

Updated study snapshots and ethics and regulatory documentation are now available for the BEST-ICU and Chat 4 Heart Health trials. Both of these NIH Collaboratory Trials are supported by awards from the National Heart, Lung, and Blood Institute. BEST-ICU transitioned from the planning phase to the implementation phase during the summer. As part of the transition, the study team reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core.

Trials 147
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Brain drug developer Seaport raises another $225M

Bio Pharma Dive

Launched by PureTech and backed by well-known venture capital firms, the startup has raised $325 million since its debut this spring.

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

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FDA approves Astellas’ VYLOY for gastric cancer treatment

Pharmaceutical Technology

Astellas Pharma has received approval from the FDA for VYLOY in conjunction with chemotherapy, for the treatment of advanced gastric cancer.

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Oral version of Novo diabetes drug protects heart health in large study

Bio Pharma Dive

The medicine, which Novo sells as Rybelsus, cut the risk of cardiovascular complications by 14% when added to standard therapies in people with diabetes and heart disease.

Medicine 157

More Trending

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Sanofi moves ahead with CD&R deal for stake in consumer business

Bio Pharma Dive

Under the proposed deal, the PE firm would take a controlling 50% stake in Sanofi’s Opella unit, with state-owned Bpifrance taking a minority 2% position.

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Sanofi’s $17bn sale of Opella to US investors advances following government deal

Pharmaceutical Technology

A stake by France-owned Bpifrance and promise of local job retention have allayed political backlash over the sale of Sanofi’s consumer health business.

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Pharmaceutical research on mRNA and CAR T-cell therapy in cancer: Pioneering the future of oncology

Bio Pharma Dive

Immunotherapy and precision medicine show promise in better fighting cancer. What else does the research tell us?

Research 130
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Health Canada approves Arcutis’ ZORYVE foam for seborrheic dermatitis 

Pharmaceutical Technology

Arcutis Canada, has received Health Canada's approval for ZORYVE to treat seborrheic dermatitis in patients aged nine years and above.

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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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Harnessing the power of upstream platform integration to accelerate biopharma innovation

Bio Pharma Dive

Learn how Syngene’s integrated strategy can enhance your mAb production capabilities.

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AAO 2024: Nanoscope Therapeutics’ MCO-010 RESTOREs vision in RP patients

Pharmaceutical Technology

This trial investigated the potential of Nanoscope Therapeutics' MCO-010 to restore vision in patients with retinitis pigmentosa (RP).

Trials 130
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Novo plots US, EU approval filings after oral semaglutide shows cardio benefits in certain diabetes patients

Fierce Pharma

As Novo Nordisk’s injectable diabetes-obesity duo Ozempic and Wegovy grab all the limelight, an oral version of the semaglutide drug showed it can provide heart-related benefits, too. | As Novo Nordisk’s injectable diabetes-obesity duo Ozempic and Wegovy grab all the limelight, an oral version of the semaglutide drug showed it can provide heart-related benefits, too.

Drugs 73
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Seaport raises $225m to advance portfolio of neuropsychiatric prodrugs

Pharmaceutical Technology

The funding will support Seaport’s technology platform, which helps drugs be absorbed more efficiently through the lymphatic system.

Drugs 130
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Sanofi in 'exclusive negotiations' to sell 50% stake in €16B consumer health unit Opella

Fierce Pharma

Sanofi is now in “exclusive negotiations” with U.S. | Sanofi is now in “exclusive negotiations" with U.S. private equity firm Clayton, Dubilier & Rice to sell a 50% controlling stake in its consumer health business Opella, the company said. The deal values the consumer group at 16 billion euros.

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ImmunoPrecise touts potential of rabbit monoclonal antibodies in oncology

Pharmaceutical Technology

In an exclusive interview, the CEO of ImmunoPrecise Antibodies described the benefits of rabbit monoclonal antibodies in oncology.

Antibody 130
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Roche trial confirms Vabysmo efficacy in minorities

pharmaphorum

A study has shown that Roche's diabetic macular oedema (DME) therapy Vabysmo is effective in patients who identify as African American, Black, Hispanic and Latino, plugging a gap in the data for the drug.Vabysmo (faricimab) has been approved by the FDA for treating DME since 2022, quickly becoming one of the Swiss pharma group's fastest-growing products with sales of $1.1 billion in the first half of the year.

Trials 60
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FDA clamps partial hold on Phase III trial of BioNTech & OncoC4’s NSCLC therapy

Pharmaceutical Technology

A partial hold was placed on the trial after results showed variance between squamous and non-squamous NSCLC patient responses.

Trials 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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Filing Drug Patents in Emerging Markets

Drug Patent Watch

The pharmaceutical industry is a significant contributor to the global economy, with a substantial portion of its production costs incurred during the development stage. This makes intellectual property protection crucial for the industry’s success.

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Thermo Fisher’s Oncomine gains FDA approval as brain tumor diagnostic

Pharmaceutical Technology

As a companion diagnostic, Oncomine will be used to identify patients eligible for treatment with Servier’s Voranigo.

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Expecting the Unexpected

Pharmaceutical Commerce

In this video interview with Pharma Commerce Editor Nicholas Saraceno, Jeffrey Bernstein, director of cybersecurity and data privacy for Kaufman Rossin’s risk advisory services, explains the top mistakes healthcare organizations make when building and maintaining their software.

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Learna and University of Wolverhampton launch flexible healthcare courses

Pharma Times

The five new programmes are designed to fit alongside full-time work and clinical practice

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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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Activist investor Starboard sets its sights on J&J spinout Kenvue: WSJ

Fierce Pharma

Activist investor Starboard Value, which picked up a $1 billion stake in Pfizer earlier this month, now reportedly has Johnson & Johnson’s consumer health spinout Kenvue in its sights. | Starboard, which recently pitched turnaround plans to Pfizer, reportedly thinks the J&J consumer health spinout's stocks have underperformed since its market debut over a year ago.

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NICE recommends Santen’s Roclanda to treat glaucoma and ocular hypertension

Pharma Times

Primary open-angle glaucoma affects around 2% of adults aged 40 years and older in the UK

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From Study Design to Submission: The Role of AI Throughout the Clinical Research Journey

Crucial Data Soutions

Artificial intelligence (AI) is transforming the clinical research landscape. It is being used to optimize how data is collected, organized. The post From Study Design to Submission: The Role of AI Throughout the Clinical Research Journey appeared first on Crucial Data Solutions.

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The Human Side of Clinical Trials: Patients, Progress, and Participation

WCG Clinical

Clinical trials are the cornerstone of advancing medical research, but behind the science, the experiences of participants and their families offer invaluable insight into how research impacts real lives. In a recent episode of WCG Talks Trials, WCG experts explored topics like the importance of community engagement, the latest developments in gene and cell therapies, and the challenges of clinical research in rare and chronic diseases like sickle cell disease and melanoma.

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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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The role of quality assurance in accelerating drug development for emerging therapies

pharmaphorum

Discover the crucial role of quality assurance in accelerating drug development for emerging therapies. Learn how this process ensures the safety and effectiveness of new treatments.

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Informa Connect’s Trade and Channel Strategies

Drug Channels

Informa Connect’s Trade and Channel Strategies December 10-12, 2024 at the W Hotel in Philadelphia, PA Drug Channels readers save 10% with code 24DC10 * Pharmacy and distribution models are growing increasingly complex. Stop running in circles—It’s time to unlock proven strategies to propel market access. What is the secret to success? Trade and Channel Strategies is bringing together industry experts to deliver specific strategies and talk best practices in tackling the latest industry challeng

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FDA Rejects Novartis’ Latest Bid to Block Entresto Generic

XTalks

Novartis’s latest attempt to block the US Food and Drug Administration’s (FDA) approval of a generic version of its blockbuster heart failure drug, Entresto (sacubitril/valsartan), has been shot down by a federal court. The court ruled against Novartis’ argument that the generic in question, developed by MSN Pharmaceuticals, infringes on its patents, particularly with respect to a compound used in the drug.

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PursueCare brings Pear addiction DTx apps back to life

pharmaphorum

Two digital therapeutics for addiction are available again through PursueCare, which acquired them from now-defunct Pear Tx last year

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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.