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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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 246
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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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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva 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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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 258
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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.

More Trending

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FibroBiologics and Charles River link for chronic disease therapies manufacture

Pharmaceutical Technology

FibroBiologics has entered a master services agreement with Charles River Laboratories to develop and manufacture cell-based therapies.

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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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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.

Sales 130
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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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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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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 152
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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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FDA’s GLP-1 decision kicks off ‘unprecedented’ tussle over shortage

Bio Pharma Dive

After initially declaring the shortage of Eli Lilly’s diabetes and weight loss drugs over, the FDA has re-opened the door for GLP-1 compounders.

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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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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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 121
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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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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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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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 108
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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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Seaport docks $225m for its improved neuropsychiatry drugs

pharmaphorum

Seaport Therapeutics completes a $225m Series B to fund its improved therapies for depression and anxiety, just months after raising $100m on its debut

Drugs 114
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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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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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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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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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Novo Nordisk closes on EU okay for haemophilia antibody

pharmaphorum

Novo Nordisk's TFPI drug concizumab has been backed for approval in the EU to prevent bleeding episodes in people with haemophilia and inhibitors

Antibody 104
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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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ICER raises cost-effective price for Pfizer's ATTR drug in final analysis but still calls for hefty discount

Fierce Pharma

After calling for a major discount for Pfizer’s popular transthyretin amyloid cardiomyopathy (ATTR-CM) med tafamidis, a U.S. | After calling for a major discount for Pfizer’s popular transthyretin amyloid cardiomyopathy (ATTR-CM) med tafamidis, a U.S. drug cost watchdog has provided a final analysis that includes a smaller—yet still hefty—price reduction demand.

Drugs 90
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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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Takeda details another round of layoffs in Massachusetts as restructuring drive rolls on

Fierce Pharma

Following a series of layoff rounds this year, Takeda is once again pruning its headcount in the Bay State. | As part of a new round of layoffs, certain Takeda staffers at two Massachusetts sites are set to lose their jobs. This marks the third round of job cuts Takeda has initiated in the state since it revealed a large restructuring drive in May.

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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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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.