ACRP blog
MARCH 12, 2024
This is a sponsored message. Global Disruptions, Health Equity, and Data Sharing International clinical trials are essential to evaluating the safety and efficacy of new treatments, but their success can be hampered by a variety of challenges. A recent McKinsey analysis of drugs and vaccines developed since 2000 shows that it takes nearly 10 years to go from clinical testing to approval.
pharmaphorum
MARCH 11, 2024
Enhancing clinical trial outcomes through algorithmic prespecification in subgroup analysis can provide valuable insights for the FDA and medical community. Learn more about this practice and its importance in clinical research.
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Outsourcing Pharma
MARCH 11, 2024
A conversation between Colin Weller, VP and GM of the evidence platform at Medable and Liza Laws, senior editor, at Outsourcing Pharma, was held at this yearâs SCOPE 2024 in Orlando.
Outsourcing Pharma
MARCH 13, 2024
In the fast-evolving landscape of clinical trials, technological advancements play a vital role in streamlining processes, enhancing efficiency, and ultimately improving patient outcomes.
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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
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 12, 2024
Two hundred and seventeen. That’s how many vaccines a man in Germany claims to have received for COVID-19 in just 29 months – and his body isn’t reacting the way some scientists thought it would.
pharmaphorum
MARCH 15, 2024
The ALS Association is partnering with myTomorrows to connect patients and physicians with clinical trials using a digital platform.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
MARCH 11, 2024
Upcoming regulatory events for pipeline AAV gene therapies, with a focus on neuromuscular and blood disorders, are setting high expectations for the space in 2024.
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.
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.
Bio Pharma Dive
MARCH 14, 2024
Rezdiffra’s clearance is a turning point in the fight against the liver disease. But its sales potential is unclear, and competition could emerge from popular weight loss drugs.
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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 14, 2024
The EMA raised concerns about the lack of long-term data for Novartis Vijoice in its initial bid, as the Swiss company prepares for a new regulatory submission.
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.
Fierce Pharma
MARCH 15, 2024
Pfizer knew 2023 was going to be a challenging year of transition. But even the drugmaker was surprised by the plummeting demand for its COVID-19 products, missing badly on its 2023 guidance. | After a difficult year for Pfizer, in which its share price fell by 44%, CEO Albert Bourla’s compensation fell by 35% from $33 million in 2022 to $21.6 million in 2023.
Bio Pharma Dive
MARCH 11, 2024
Publicly traded companies raised nearly $10 billion in follow-on stock offerings in January and February, a financing surge that’s driving a “sector recovery,” the investment bank said.
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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.
Pharmaceutical Technology
MARCH 15, 2024
Amidst the many BTK inhibitors, Breyanzi will be the first and only CAR-T cell therapy available for the treatment of CLL and SLL.
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 12, 2024
Any dog owners reading this will know the joy of getting home and being greeted with utter delight by their pet – tail wagging wildly before enthusiastic but face-drenching licks.
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.
Bio Pharma Dive
MARCH 15, 2024
The company expects initial uptake of Rezdiffra, which costs $47,400 per year, to be slow as doctors and insurers establish the protocols needed to find patients eligible for treatment.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 14, 2024
Plastics are now everywhere, with tiny fragments found in several major organs of the human body, including the placenta. Given how easily the microscopic particles infiltrate our tissues, it’s vital that we learn exactly what kinds of risks they could pose to our health.
Fierce Pharma
MARCH 11, 2024
The decades-long wait for an effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) has ended, as the FDA has approved the first drug for the fatty liver disease. | The decades-long wait for an effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) has ended. The FDA has approved Madrigal's resmetirom under the brand name Rezdiffra as the first drug for the fatty liver disease.
Bio Pharma Dive
MARCH 14, 2024
The funding for the startup, which partnered with Bristol Myers Squibb last year, adds to a surge of recent investments in developers of antibody-drug conjugates.
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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 14, 2024
The funds will be used to expand Zephyr AI's headcount and enhance datasets.
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 14, 2024
In continuation to the efforts of the drug regulatory experts to amend the Drug Rules, 1945 and incorporate necessary provisions to decide a drug to be declared as over-the-counter (OTC), the Drugs Technical Advisory Board (DTAB) has recommended to constitute a sub-committee.
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.
Bio Pharma Dive
MARCH 11, 2024
Justin Klee and Joshua Cohen spoke to BioPharma Dive about the next steps for their company, which is considering pulling its only product from market after the drug failed a confirmatory study in ALS.
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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 12, 2024
TERN-701 is a BCR-ABL tyrosine-kinase inhibitor being studied in a Phase I study, with data expected in H2 this year.
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 10, 2024
In a remarkable display of scientific prowess and commitment to public health, the Indian Council of Medical Research (ICMR) has spearheaded a series of ground-breaking initiatives aimed at tackling infectious diseases and bolstering diagnostic capabilities nationwide, according to its Annual Report 2023.
BioSpace
MARCH 14, 2024
The FDA approved Bristol Myers Squibb’s Breyanzi for chronic lymphocytic leukemia and small lymphocytic leukemia prior to Friday’s adcomm for the company’s other CAR-T therapy, Abecma.
Bio Pharma Dive
MARCH 14, 2024
Pressed by lawmakers, the lobbying group is also “taking steps” to end its relationship with Wuxi-AppTec, a major contract manufacturer to the biopharmaceutical industry.
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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.
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