Tue.Feb 06, 2024

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J&J touts success of nipocalimab in two rare disease trials

Pharmaceutical Technology

J&J’s nipocalimab met primary endpoints in Phase III and II trials for myasthenia gravis and Sjogren’s disease, respectively.

Trials 130
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Cystic fibrosis patients ask DPIIT to allow local manufacturing of CFTR modulators to bring down price

AuroBlog - Aurous Healthcare Clinical Trials blog

Patients of cystic fibrosis (CF) and their relatives have requested the Department for Promotion of Industry and Internal Trade (DPIIT) to take steps to provide CF drugs at an affordable cost using the provisions of the Patents Act, 1970, considering that the drugs at present cost anywhere from Rs. 21 lakh to Rs. 2.66 crore.

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Alternative therapies are needed to combat the impending threat of AMR

Pharmaceutical Technology

The potentially disastrous consequences of antimicrobial resistance (AMR) were highlighted at the recent World Economic Forum Meeting 2024.

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US Woman Receives Revolutionary Brain Implant For OCD And Epilepsy

AuroBlog - Aurous Healthcare Clinical Trials blog

American Amber Pearson used to wash her hands until they bled, terrified by the idea of contamination from everyday items, a debilitating result of her obsessive compulsive disorder (OCD).

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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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Health Canada approves Chiesi’s MYALEPTA for lipodystrophy

Pharmaceutical Technology

Health Canada has approved Chiesi Global Rare Diseases’ MYALEPTA as a treatment for individuals with lipodystrophy, an ultra-rare condition.

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Khosla Ventures’ Alex Morgan on biotech’s challenges and solving drug delivery

Bio Pharma Dive

The life sciences investor has backed a number of startups working on technologies for delivering and manufacturing cell and gene medicines.

More Trending

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Eisai falls behind on Leqembi patient goal

Bio Pharma Dive

The Alzheimer’s drug was administered to a total of 2,000 U.S. patients as of Jan. 26, signaling to analysts that an earlier goal of 10,000 may take longer than expected to hit.

Drugs 177
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Mithra sets out plan to rescue cash runway

Pharmaceutical Technology

The Belgian women’s health company is exploring multiple asset and licensing sells as cash reserves diminish.

Licensing 147
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Lilly sales surge on obesity, diabetes drug demand

Bio Pharma Dive

The company also reported trial results suggesting tirzepatide, the drug Lilly now sells as Mounjaro and Zepbound, could treat a common liver disease.

Sales 177
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Novartis eyes $2.9bn MorphoSys buyout to expand oncology pipeline

Pharmaceutical Technology

Pending a successful acquisition, Novartis will obtain pelabresib for myelofibrosis and tulmimetostat for solid tumours or lymphomas.

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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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MorphoSys to sell to Novartis for $2.9B, offloads cancer drug to Incyte

Bio Pharma Dive

The deals hand Novartis a myelofibrosis drug with uncertain regulatory prospects and Incyte a marketed lymphoma medicine that hasn’t sold well.

Drugs 169
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China NMPA grants IND clearance for Fermion’s TYK2 JH2 inhibitor

Pharmaceutical Technology

The China NMPA has granted clearance for the investigational new drug (IND) application of Guangzhou Fermion Technology’s FZ007-119.

Drugs 130
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RWE’s Impact on Product Lifecycle for Biopharma Startups

Pharma Mirror

By Barbara Arone, Vice President, Real World Solutions, IQVIA The use of real-world evidence (RWE) in the development of pharmaceutical treatments has grown exponentially in the past 10 years, fueled by availability of higher quality data, trial competitiveness and growing investments in personalized and rare disease treatments. It has transformed from a “nice-to-have” into a “must-have” part of the evidence package, helping to contextualize clinical research and improve treatment understanding.

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Rani reports positive data for non-injectable Stelara biosimilar

Pharmaceutical Technology

RT-111 could offer an alternative dosing regimen for patients with psoriasis and other conditions compared to injectable biologics.

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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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AstraZeneca brings its cell therapy ambitions to Maryland with $300M plant investment, 150 planned hires

Fierce Pharma

Following a slew of cell therapy biotech team-ups, AstraZeneca is taking manufacturing into its own hands. | AstraZeneca is plugging $300 million into a new facility in Rockville, Maryland, to launch its cell therapy platforms in the United States for cancer trials and future commercial supply. In turn, AZ will create more than 150 new jobs.

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Silence announces $120m private placement for depositary shares

Pharmaceutical Technology

Silence Therapeutics has announced a private placement of its 5,714,286 American depositary shares (ADS) priced at $21 each.

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Already rolling in diabetes and obesity, Eli Lilly touts tirzepatide's midstage MASH win

Fierce Pharma

In a midstage trial, Eli Lilly’s star diabetes and weight-loss drug tirzepatide showed promise in fatty liver disease, a difficult-to-treat condition that doesn’t yet have an FDA-approved therapy.< | Eli Lilly's star diabetes and weight loss drug tirzepatide showed promise in fatty liver disease with a massive anti-MASH benefit accompanied by a "clinically meaningful" anti-fibrosis effect.

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Incyte acquires global rights to MorphoSys’ tafasitamab

Pharmaceutical Technology

Incyte has acquired sole worldwide rights to tafasitamab immunotherapy through an asset purchase agreement with MorphoSys.

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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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First UK patients receive experimental mRNA therapy for cancer

Drug Discovery World

The first UK patients have received an mRNA cancer therapy – mRNA-4359 – as part of a Phase I/II clinical trial investigating its potential for treating melanoma, lung cancer and other solid tumour cancers. The Mobilize trial is run in partnership between Imperial College London and Imperial College Healthcare NHS Trust, with the first patients in the UK receiving the treatment at the NIHR Imperial Clinical Research Facility at Hammersmith Hospital.

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The Correlation Between a New York State Law Repeal and Vaccine Coverage in Schools

Pharmaceutical Commerce

A cohort study investigates the impact of Senate Bill 2994A and answers the question: does the repeal of school-entry nonmedical vaccination exemptions result in a rise in school vaccinations?

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Eli Lilly mounts clinical and commercial case for tirzepatide as Mounjaro, Zepbound chalk up major gains

Fierce Pharma

Locked in a heated battled with Novo Nordisk’s semaglutide franchise, Eli Lilly’s tirzepatide is beginning to come into its own—both with regards to sales and amid attempts to show the dual GIP/GLP | Locked in a heated battled with Novo Nordisk’s semaglutide franchise, Eli Lilly’s tirzepatide is beginning to come into its own—both with regards to sales and amid attempts to show the dual GIP/GLP-1 agonist can strike out beyond diabetes and obesity.

Sales 106
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A clearer harmony and attractiveness for EU Clinical Trials Regulation

pharmaphorum

For the latest episode of the pharmaphorum podcast, web editor Nicole Raleigh sat down with Chris Bamford, director of clinical trial regulatory management at IQVIA, and Shirley Rutter, associate director and strategic quality lead of global quality management at IQVIA Biotech.

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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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How Good Measures Is Revolutionizing Health with its Good Food Prescription Program

XTalks

Good Measures has made a significant leap forward by showcasing the positive outcomes of its Good Food Prescription program in its first year. This program, designed to combat diet-related conditions, combines expert clinical coaching, personalized meal planning and medically tailored grocery deliveries in partnership with Instacart. The Emergence of Good Measures Founded with a vision to revolutionize the intersection of nutrition and health management, Good Measures has established itself as a

Medicine 104
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Changing Faces: Pharma and biotech hires from January 2024

pharmaphorum

Stay updated with the latest news on hiring trends in the pharmaceutical and biotech industries. Learn about the companies and professionals making waves in the field from January 2024 in a new instalment of Changing Faces.

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Rani Therapeutics announces promising phase 1 results for oral Stelara biosimilar

BioPharma Reporter

Rani Therapeutics, a clinical-stage biotherapeutics company focused on the oral delivery of biologics, has announced encouraging results from its phase 1 study of RT-111, a RaniPill capsule containing an ustekinumab biosimilar, CT-P43.

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Cedars-Sinai mental health app launches on Apple Vision Pro

pharmaphorum

Right after the official launch of the new Apple Vision Pro mixed reality headset, Cedars-Sinai has launched a generative artificial intelligence (genAI) app that will use the technology to provide mental health support for patients.

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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.

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Medable's enhanced electronic consent making patients feel more human and less like study subjects

Outsourcing Pharma

Results from a new research project have been announced by technology provider Medable on the enhanced electronic informed consent (elC) in clinical trials.

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Study reveals blood test can pinpoint cause of brain injury in newborns

Pharma Times

Hypoxic-ischaemic encephalopathy affects around three million babies worldwide every year

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Heart and Kidney Health for All: Expanding Cardiovascular Clinical Trials to Include CKD Patients

XTalks

Chronic kidney disease (CKD), an often silent yet serious medical condition, affects more than 10 percent of the global population. Alarmingly, the cardiac ramifications of CKD are deep and manifold, and with cardiovascular disease (CVD) standing as the leading cause of death worldwide, it has especially important implications among CKD patients. “The prevalence of CVD can be upwards of 30 times higher in those with CKD and also we can see a higher chance of 3 vessel coronary artery disease,” sa

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With Merck, J&J and BMS CEOs set to testify, Sanders releases scathing report on drug prices

Fierce Pharma

Two days ahead of a Senate hearing in which CEOs from three pharma majors will testify, Sen. | Two days ahead of a Senate hearing in which CEOs from three pharma majors will testify, Sen. Bernie Sanders has released a report shedding light on the system that allows the companies to charge more for drugs in the U.S. than in any other country.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.