Pharmaceutical Technology
MARCH 13, 2024
As the demand for medical devices continues to rise, manufacturers are increasingly turning to automation during the assembly process to get their products to market faster. But how can the risks involved be mitigated?
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 13, 2024
A recent study of US veterans found that 10% of those diagnosed with dementia actually had a liver condition called hepatic encephalopathy (HE) – a treatable condition. The liver can be damaged by several things, including alcohol, fatty deposits and hepatitis viruses.
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Pharmaceutical Technology
MARCH 13, 2024
Bright Green has announced plans to expand its controlled substances drug production facility in New Mexico, US with an investment of $250m.
Bio Pharma Dive
MARCH 13, 2024
Briefing documents posted ahead of Friday’s advisory panel zeroed in on increased rates of early death in tests of cell therapies from Bristol Myers Squibb and Johnson & Johnson.
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 13, 2024
In order to set in pioneering progress in Eastern India’s laboratory standards, the National Accreditation Board for Testing and Calibration Laboratories (NABL) Kolkata office has orchestrated a ground-breaking virtual awareness program, revolutionizing perspectives on calibration within the Eastern India region’s laboratories.
Rethinking Clinical Trials
MARCH 13, 2024
Dr. Edward Qian In this Friday's PCT Grand Rounds, Edward Qian of Vanderbilt University will present "The Effect of Antibiotic Choice on Renal Outcomes: The ACORN Trial." The Grand Rounds session will be held on Friday, March 15, 2024, at 1:00 pm eastern. The ACORN trial compared the effects of cefepime vs piperacillin-tazobactam on the incidence of acute kidney injury among acutely ill adults.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
MARCH 13, 2024
Belcesiran is an antisense rnai oligonucleotide commercialized by Novo Nordisk, with a leading Phase II program in Alpha-1 Antitrypsin Deficiency (A1AD).
BioSpace
MARCH 13, 2024
Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) is the first-ever approved therapy for metabolic dysfunction-associated steatohepatitis—a decision experts say could signal a sea change in treatment of the disease.
Pharmaceutical Technology
MARCH 13, 2024
Lamassu Bio has received a $2.05m grant from the US National Institutes of Health (NIH) and National Cancer Institute (NCI) for the development of SA53, a new therapeutic for p53 wild-type sarcomas.
Fierce Pharma
MARCH 13, 2024
As CDMO giants Wuxi AppTec and WuXi Biologics come under mounting scrutiny for their alleged ties to Chinese government officials, they are losing a key ally in Washington, D.C. | As CDMO giants Wuxi AppTec and WuXi Biologics come under mounting scrutiny for their alleged ties to Chinese government officials, they are losing a key ally in Washington, D.C.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharmaceutical Technology
MARCH 13, 2024
AZD-3427 is commercialized by AstraZeneca, with a leading Phase II program in Pulmonary Hypertension.
pharmaphorum
MARCH 13, 2024
Transitioning patient-reported outcomes (PROs) from paper to digital (ePRO) is crucial for maintaining data integrity and improving the patient experience. Learn how to seamlessly make this transition and optimise your data collection process.
Pharmaceutical Technology
MARCH 13, 2024
Pearl Bio has signed an agreement with Merck for the discovery of biologics that incorporate non-standard amino acids to treat cancer.
BioSpace
MARCH 13, 2024
In a change of position as congressional scrutiny of WuXi AppTec grows, the Biotechnology Innovation Organization announced it is taking steps to separate from the China-based biotech.
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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
Pharmaceutical Technology
MARCH 13, 2024
Allumiqs has entered into a long-term strategic collaboration with Prolytix to expedite the discovery and development of new drugs.
BioSpace
MARCH 13, 2024
At the center of the deal is Amolyt Pharma’s late-stage candidate eneboparatide for the rare disease hypoparathyroidism. AstraZeneca also gains ownership of AZP-3813, which is being assessed for acromegaly in a Phase I trial.
Pharmaceutical Technology
MARCH 13, 2024
In T-cell manufacturing, the historical issue of maintaining the quality of materials when scaling up production is changing.
BioSpace
MARCH 13, 2024
Wednesday’s FDA approval expands Mirum’s Livmarli into the rare genetic disorder that causes progressive liver disease. The biotech has also filed a supplemental New Drug Application for a higher dose of the drug and allowing its use in younger patients.
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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.
Pharmaceutical Technology
MARCH 13, 2024
The dermatology-centric pharma company is likely set for one of the biggest public listings in Europe since 2022.
Fierce Pharma
MARCH 13, 2024
The FDA has raised concerns about early clinical trial deaths as part of two applications that aim to move the CAR-T therapies Carvykti and Abecma into earlier lines of treatment for multiple myelo | Ahead of an important advisory committee meeting, the FDA has raised concerns about early trial deaths for multiple myeloma cell therapies. At the meeting, experts will discuss applications that aim to move the CAR-T therapies Carvykti and Abecma into earlier lines of treatment.
Pharmaceutical Technology
MARCH 13, 2024
Cretostimogene Grenadenorepvec is an oncolytic virus commercialized by Kissei Pharmaceutical, with a leading Phase III program in Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer).
BioSpace
MARCH 13, 2024
Merck is looking to expand its offerings in the human papillomavirus space with a new vaccine and to study a single-shot variant of Gardasil 9, both of which will start trials toward the end of 2024.
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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.
Pharmaceutical Technology
MARCH 13, 2024
(Insulin icodec + Semaglutide) is a recombinant peptide and recombinant protein commercialized by Novo Nordisk, with a leading Phase III program in Type 2 Diabetes.
BioSpace
MARCH 13, 2024
A lawsuit filed by the Pharmaceutical Research and Manufacturers of America failed to block an Arkansas law that empowers hospitals to use outside pharmacies to dispense discounted drugs.
Pharmaceutical Technology
MARCH 13, 2024
Nipocalimab is a monoclonal antibody commercialized by Johnson & Johnson, with a leading Phase III program in Acquired (Autoimmune) Hemolytic Anemia.
BioPharma Reporter
MARCH 13, 2024
Kate Broderick takes us on her intriguing journey - from being drawn to how science was applied within a medical setting, to the enormous challenge of working around the clock when the pandemic began.
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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.
Fierce Pharma
MARCH 13, 2024
After Takeda’s unsuccessful attempt to sell an Austrian manufacturing and development site, the Japan-based company is calling it quits on much of the operations at the facility. | After Takeda’s unsuccessful attempt to sell an Austrian manufacturing and development site, the Japan-based company is calling it quits on much of the operations at the facility.
XTalks
MARCH 13, 2024
World Glaucoma Week is an initiative that began with the collaborative efforts of the World Glaucoma Association (WGA) and the World Glaucoma Patient Association (WGPA). It evolved from World Glaucoma Day, which was first commemorated on March 6, 2008. The theme for World Glaucoma Week 2024 is “Uniting for a Glaucoma-Free World.” This year’s week-long campaign is a platform for eye care professionals, health organizations and the medical device and healthcare industry to share the latest knowled
Pharmaceutical Technology
MARCH 13, 2024
PN-235 is a synthetic peptide commercialized by Johnson & Johnson, with a leading Phase III program in Plaque Psoriasis (Psoriasis Vulgaris).
Fierce Pharma
MARCH 13, 2024
It didn’t take long for Johnson & Johnson CEO Joaquin Duato to catch up to his predecessor. | It didn’t take long for Johnson & Johnson CEO Joaquin Duato to catch up to his predecessor. After paying Duato $13.1 million in his first year as CEO, the pharma giant more than doubled his compensation to $28.4 million last year, according to a regulatory filing.
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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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