Wed.Mar 20, 2024

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Clasp launches with $150M and a plan for precision cancer immunotherapies

Bio Pharma Dive

The company claims its approach could yield more effective and safer T-cell engagers, a type of cancer medicine that’s attracted significant interest from drugmakers in recent years.

Medicine 278
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Johnson & Johnson’s paediatric HIV-1 treatment secures FDA approval

Pharmaceutical Technology

Johnson & Johnson has received approval from the FDA for EDURANT PED to treat human immunodeficiency virus-1 (HIV-1) in children.

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Orchard sets out to sell world’s priciest gene therapy

Bio Pharma Dive

Orchard is counting on the long-term data it’s accrued to convince insurers to cover Lenmeldy’s $4.25 million list price, the highest of any genetic medicine to come to market.

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Breakthrough Therapy Obliterates Deadly Brain Tumor in Days

AuroBlog - Aurous Healthcare Clinical Trials blog

Brain scans of a 72-year-old man diagnosed with a highly aggressive form of cancer known as a glioblastoma have revealed a remarkable regression in his tumor’s size within days of receiving an infusion of an innovative new treatment.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Acelyrin eye drug heads to late-stage testing after trial win

Bio Pharma Dive

The biotech, which raised $540 million in an initial public offering last year, is pitching the medicine as a potential challenger to Amgen’s blockbuster eye drug Tepezza.

Drugs 171
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Voice AI is reshaping the landscape of healthcare: Rustom Lawyer

AuroBlog - Aurous Healthcare Clinical Trials blog

Rustom Lawyer, co-founder & CEO of Augnito, a leading voice AI solutions provider, has unveiled profound insights into the potential of voice artificial intelligence (AI) in healthcare. Emphasizing its transformative role, Lawyer shed light on how voice AI is reshaping the landscape of healthcare, empowering a new generation of healthcare professionals – the ‘superclinicians.

More Trending

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March 20, 2024: Early Diagnosis and Assessment of Autism to Be Featured in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Dr. Warren Jones In this Friday’s PCT Grand Rounds, Warren Jones of Emory University will present “Early Diagnosis and Assessment of Autism via Objective Measurements of Social Visual Engagement.” The Grand Rounds session will be held on Friday, March 22, 2024, at 1:00 pm eastern. Jones is the director of research at the Marcus Autism Center and the Norman Nien Distinguished Chair in Autism and an associate professor of pediatrics at the Emory University School of Medicine.

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FDA approves Boehringer’s SPEVIGO for psoriasis treatment

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Boehringer Ingelheim's SPEVIGO injection to treat generalised pustular psoriasis (GPP).

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How Pharmacogenomics Can Benefit Your Clinical Trial

Worldwide Clinical Trials

In the increasingly advancing world of medicine, personalized care is a key factor that can progress your drug development efforts. One way to ensure customized disease management is to utilize pharmacogenomics (PGx) in your clinical trial. As the study of how an individual’s genes affect their response to drugs, pharmacogenomics is a critical factor in developing effective and safe drugs and dosages in clinical trials. 6 Ways Pharmacogenomics Helps Your Clinical Trial Enhances Drug Safety PGx a

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Inherited Mitochondrial Disorders drugs in development, 2023

Pharmaceutical Technology

GlobalData tracks 22 drugs in development for Inherited Mitochondrial Disorders by 19 companies/universities/institutes. The top development phase for Inherited Mitochondrial Disorders is preclinical, with 13 drugs in that stage.

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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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Bayer Eliminates Nearly Half of Its Executive Positions in Major Overhaul

BioSpace

As part of a sweeping reorganization, Bayer Pharmaceuticals on Wednesday shuffled its leadership roster, which included the creation of a new unit and role changes for its executives.

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Conjunctivitis drugs in development, 2023

Pharmaceutical Technology

GlobalData tracks 59 drugs in development for Conjunctivitis by 51 companies/universities/institutes. The top development phase for Conjunctivitis is preclinical, with 20 drugs in that stage.

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BioNTech's shares tumble—again—amid continued COVID vaccine sales slide

Fierce Pharma

Four months ago, when BioNTech slashed its 2023 revenue projection from 5 billi | When BioNTech reported its fourth-quarter earnings Wednesday, it was another harsh reminder of the plummeting demand for COVID-19 vaccines. Sales came to 1.5 billion euros ($1.6 billion) for the fourth quarter and 3.8 billion euros ($4.1 billion) for 2023, coming up short of expectations.

Sales 132
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Gastroesophageal (GE) Junction Carcinomas drugs in development, 2023

Pharmaceutical Technology

GlobalData tracks 150 drugs in development for Gastroesophageal (GE) Junction Carcinomas by 115 companies/universities/institutes. The top development phase for Gastroesophageal (GE) Junction Carcinomas is phase ii, with 72 drugs in that stage.

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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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Employee experience in healthcare: The importance of EX for patient experience

pharmaphorum

Understanding the employee experience in healthcare is essential for improving the patient experience. Learn more about the importance of employee experience in healthcare and how it impacts patient care.

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Meibomian Blepharitis drugs in development, 2023

Pharmaceutical Technology

GlobalData tracks 5 drugs in development for Meibomian Blepharitis by six companies/universities/institutes. The top development phase for Meibomian Blepharitis is phase ii, with three drugs in that stage.

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Researchers suggest treatments for rare diseases could reduce burden of kidney disease

Pharma Times

Rare kidney diseases are a group of conditions which account for over 5% of people living with chronic kidney disease

Research 134
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Blepharospasm drugs in development, 2023

Pharmaceutical Technology

GlobalData tracks 5 drugs in development for Blepharospasm by four companies/universities/institutes. The top development phase for Blepharospasm is phase ii, with two drugs in that stage.

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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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Xtalks People in Life Sciences Series: Day-in-the-Life of a Pharmacovigilance Professional – Interview with Ashish Jain, Senior Director of Clinical Safety and PV, Curis – Xtalks Life Science Podcast Ep. 151

XTalks

In this featured episode of Xtalks People in Life Sciences, Ayesha spoke with Ashish Jain, Senior Director of Clinical Safety and Pharmacovigilance (PV) at Curis , a pioneering biotech company specializing in cutting-edge cancer therapies. Jain shared his journey into clinical safety and PV, highlighting key milestones along the way. Delving into his daily work at Curis, he revealed his strategies for prioritizing tasks and staying informed of the latest developments in PV.

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Retinal Degeneration drugs in development, 2023

Pharmaceutical Technology

GlobalData tracks 76 drugs in development for Retinal Degeneration by 63 companies/universities/institutes. The top development phase for Retinal Degeneration is preclinical, with 40 drugs in that stage.

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Johnson & Johnson accuses former employee of taking thousands of files to new role at Pfizer

Fierce Pharma

As two of the world’s largest pharmaceutical companies, Johnson & Johnson and Pfizer have long been rivals in various therapeutic areas. | The company is accusing former employee Andrew Brackbill of downloading thousands of confidential strategy-related files before leaving for rival Pfizer.

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Retinopathy drugs in development, 2023

Pharmaceutical Technology

GlobalData tracks 198 drugs in development for Retinopathy by 163 companies/universities/institutes. The top development phase for Retinopathy is preclinical, with 131 drugs in that stage.

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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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World Water Day 2024: The Importance of Water Filtration and Reuse

XTalks

World Water Day , observed annually on March 22, serves as a poignant reminder of the essential role water plays in our survival, prosperity and the health of our planet. As we approach World Water Day 2024, the theme “Water For Peace” underscores the intrinsic link between water management and conflict prevention. This year’s observance not only highlights the critical importance of water but also urges us to reflect on our relationship with this invaluable resource.

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Lewy Body Dementia drugs in development, 2023

Pharmaceutical Technology

GlobalData tracks 46 drugs in development for Lewy Body Dementia by 36 companies/universities/institutes. The top development phase for Lewy Body Dementia is preclinical, with 21 drugs in that stage.

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Merck’s Keytruda Continues NSCLC Losing Streak with Phase III Flop

BioSpace

Keytruda, when used with AstraZeneca’s Lynparza, did not significantly improve overall and progression-free survival in specific patients with metastatic non-squamous non-small cell lung cancer.

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Choriocarcinoma (Gestational Trophoblastic Neoplasia) drugs in development, 2023

Pharmaceutical Technology

GlobalData tracks 5 drugs in development for Choriocarcinoma (Gestational Trophoblastic Neoplasia) by four companies/universities/institutes. The top development phase for Choriocarcinoma (Gestational Trophoblastic Neoplasia) is phase i, with four drugs in that stage.

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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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Medicare Likely to Negotiate Prices for Obesity Drugs in Next Few Years: CBO

BioSpace

A new analysis from the Congressional Budget Office predicts that Novo Nordisk’s semaglutide will likely be subjected to Medicare’s Drug Price Negotiation Program under the Inflation Reduction Act.

Drugs 109
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Everest receives Singapore HSA approval for NEFEGAN to treat IgAN

Pharmaceutical Technology

Everest Medicines has received approval from the Singapore Health Sciences Authority (HSA) for NEFEGAN to treat primary immunoglobulin A nephropathy (IgAN) in adults at disease progression risk.

Medicine 130
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Idorsia's Tryvio crosses FDA finish line, offering new mechanism to treat hypertension

Fierce Pharma

After Johnson & Johnson last year changed its mind on its 2017 purchase of ap | Idorsia's Tryvio is the first oral anti-hypertensive therapy that uses a new therapeutic mechanism in nearly 40 years, suggesting the dawn of "a new era of endothelin research," the company said.

Research 105
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IO360: first allogeneic dual CAR-T shows promise in B-cell Non-Hodgkin lymphoma

Pharmaceutical Technology

Cellectis presented promising data with UCART20x22, which represents a pioneering allogeneic dual CAR T-cell product designed to target two established antigens.

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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.