Sat.Mar 09, 2024 - Fri.Mar 15, 2024

article thumbnail

Breaking Down Barriers to International Clinical Trials

ACRP blog

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.

article thumbnail

Enhancing clinical trials: The case for algorithmic prespecification in subgroup analysis

pharmaphorum

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Medable's Colin Weller addresses challenges and future of clinical trials

Outsourcing Pharma

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.

article thumbnail

eClinical innovations streamline clinical trial processes: Insights from Dawn Kaminski

Outsourcing Pharma

In the fast-evolving landscape of clinical trials, technological advancements play a vital role in streamlining processes, enhancing efficiency, and ultimately improving patient outcomes.

article thumbnail

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

article thumbnail

Extreme Case of Man Who Had 217 COVID Vaccines Surprises Scientists

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

Scientist 214
article thumbnail

ALS body takes digital approach to clinical trials access

pharmaphorum

The ALS Association is partnering with myTomorrows to connect patients and physicians with clinical trials using a digital platform.

More Trending

article thumbnail

What’s next for AAV gene therapies in 2024?

Pharmaceutical Technology

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.

article thumbnail

Many Dementia Cases Could Actually Be a Hidden Form of Liver Disease

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

article thumbnail

March 13, 2024: In This Friday’s PCT Grand Rounds, a Pragmatic Trial of Antibiotic Choice on Renal Outcomes

Rethinking Clinical Trials

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.

Trials 177
article thumbnail

Madrigal wins FDA approval of first drug for MASH

Bio Pharma Dive

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.

article thumbnail

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

article thumbnail

EMA pins lack of long-term data as rationale for Novartis’ failed Vijoice bid

Pharmaceutical Technology

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.

246
246
article thumbnail

NABL Kolkata spearheads cutting-edge awareness programme on calibration of medical devices

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

article thumbnail

Making Informed Decisions in Your Oncology Study: Understanding Biomarkers

Worldwide Clinical Trials

Every step in a successful oncology study requires critical and carefully thought-out decisions. Biomarkers provide a rapid way to inform many clinical oncology study development decisions, including study endpoints. What are they, how do they work, and how can they benefit your oncology study? What Are Biomarkers, and How Are They Used in Oncology?

article thumbnail

Biotech stock fundings headed for best quarter in 3 years, Jefferies says

Bio Pharma Dive

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.

320
320
article thumbnail

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.

article thumbnail

With FDA greenlight, BMS Breyanzi brings CAR-T cell therapy to CLL and SLL

Pharmaceutical Technology

Amidst the many BTK inhibitors, Breyanzi will be the first and only CAR-T cell therapy available for the treatment of CLL and SLL.

264
264
article thumbnail

Should You Let Your Dog Lick Your Face? Here’s The Science

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

article thumbnail

With Pfizer struggling in 2023, CEO Bourla hit with 35% pay cut to $21.6M

Fierce Pharma

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.

article thumbnail

Madrigal, FDA approval in hand, outlines plan to sell MASH drug

Bio Pharma Dive

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.

article thumbnail

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

article thumbnail

Eli Lilly-backed Zephyr AI secures $111m for precision medicine tech

Pharmaceutical Technology

The funds will be used to expand Zephyr AI's headcount and enhance datasets.

Medicine 312
article thumbnail

Plastic Found Inside More Than 50% of Plaques From Clogged Arteries

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

Research 176
article thumbnail

FDA Approves Madrigal’s Rezdiffra as First MASH Therapy

BioSpace

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.

article thumbnail

German biotech Tubulis cashes in on ADC ‘momentum’ with €128M financing

Bio Pharma Dive

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.

Antibody 309
article thumbnail

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.

article thumbnail

Bright Green invests $250m to expand facility in New Mexico, US

Pharmaceutical Technology

Bright Green has announced plans to expand its controlled substances drug production facility in New Mexico, US with an investment of $250m.

article thumbnail

Blocking a Single Protein Could Prevent Nerve Damage Responsible For Alzheimer’s

AuroBlog - Aurous Healthcare Clinical Trials blog

Scientists have identified a key protein in the development of Alzheimer’s disease which could prove critical in slowing or even halting the condition’s progress.

Protein 181
article thumbnail

FDA approves first MASH drug: Madrigal's Rezdiffra breaks ground in notorious biopharma graveyard

Fierce Pharma

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.

article thumbnail

Amylyx CEOs look for a path forward following major setback

Bio Pharma Dive

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.

article thumbnail

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.

article thumbnail

Terns scores FDA orphan designation for CML therapy

Pharmaceutical Technology

TERN-701 is a BCR-ABL tyrosine-kinase inhibitor being studied in a Phase I study, with data expected in H2 this year.

264
264
article thumbnail

DTAB recommends formation of a sub-committee on classification of OTC drugs

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

Drugs 165
article thumbnail

BMS’s Breyanzi Becomes First CAR-T Therapy for Two Types of Leukemia

BioSpace

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.

article thumbnail

BIO changes stance, backs bill to limit China’s role in US biotech

Bio Pharma Dive

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.

article thumbnail

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.