Sat.Aug 03, 2024 - Fri.Aug 09, 2024

article thumbnail

Sexually Transmitted Infections Are Rising in Older People, And This May Be Why

AuroBlog - Aurous Healthcare Clinical Trials blog

Diagnoses for sexually transmitted infections, or STIs, are increasing in older adults. The Centers for Disease Control and Prevention reports the number of people older than 65 diagnosed with chlamydia, gonorrhea or syphilis in the U.S. increased about three-, five- and sevenfold, respectively, from 2010 to 2023.

article thumbnail

Roche licenses Sangamo’s technology for another shot at Alzheimer’s drugs

Bio Pharma Dive

Through a new deal, Roche has exclusive rights to Sangamo molecules designed to repress the gene that makes “tau,” a protein many scientists view as a main driver of Alzheimer’s.

Licensing 323
Insiders

Sign Up for our Newsletter

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

article thumbnail

US FDA approves Novartis’ Fabhalta in IgAN treatment

Pharmaceutical Technology

Novartis has secured US Food and Drug Administration (FDA) accelerated approval for Fabhalta (iptacopan) to treat igAN.

article thumbnail

August 7, 2024: How to Investigate Whether Buprenorphine Prevents Suicidal Behavior, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Greg Simon and Susan Shortreed of the Kaiser Permanente Washington Health Research Institute (KPWHRI) will present “Does Starting Buprenorphine Prevent Suicidal Behavior? What Trial Should We Emulate?” The Grand Rounds session will be held on Friday, August 9, 2024, at 1:00 pm eastern. Simon is a senior investigator at KPWHRI and a research professor of psychiatry and behavioral sciences at the University of Washington.

article thumbnail

Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

article thumbnail

August 8, 2024: FDA Commissioner and NIH Director Share Thoughts on the Future of Pragmatic Clinical Trials

Rethinking Clinical Trials

Speaking at the NIH Pragmatic Trials Collaboratory’s 2024 Annual Steering Committee Meeting in May, Commissioner of Food and Drugs Robert Califf and NIH Director Monica Bertagnolli discussed the intersection of pragmatic research and national health priorities. Califf and Bertagnolli spoke about the role the NIH Collaboratory can play in promoting scientifically rigorous, pragmatic clinical research that addresses the urgent need for better and faster implementation of research findings into pat

article thumbnail

In tone-setting verdict, FDA rejects MDMA as a therapy aid for PTSD

Bio Pharma Dive

The decision to turn down an application from Lykos Therapeutics comes at a pivotal time for psychedelics research, which, after decades of dismissal, has recently gained momentum.

Research 305

More Trending

article thumbnail

Hospitals Are Running Out of Saline, And It’s a Global Problem

AuroBlog - Aurous Healthcare Clinical Trials blog

Last week, the Australian Therapeutic Goods Administration added intravenous (IV) fluids to the growing list of medicines in short supply. The shortage is due to higher-than-expected demand and manufacturing issues. Two particular IV fluids are affected: saline and compound sodium lactate (also called Hartmann’s solution). Both fluids are made with salts.

article thumbnail

Establishing Effective Adaptive Trial Designs for Oncology in Multi-Regional Studies

Worldwide Clinical Trials

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials. By allowing protocol adjustments based on interim data analysis, these designs preserve the integrity of studies while effectively addressing the unique challenges of multi-regional clinical trials (MRCTs).

Trials 162
article thumbnail

With pharma in ‘catbird seat,’ biotechs get less upfront in drug partnerships

Bio Pharma Dive

Recent data from J.P. Morgan indicates early-stage startups are getting smaller upfront payments in alliances than a few years ago, a trend industry insiders attribute to weaker leverage in deal talks.

Drugs 300
article thumbnail

Eli Lilly boosts sales forecast by $3bn as diabetes and weight loss drugs propel revenue

Pharmaceutical Technology

Days after competitor Novo Nordisk posted underwhelming Wegovy sales, Eli Lilly cited “strong performance” for Zepbound and Mounjaro.

Sales 234
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

Indian healthcare sector concerned on quality & accuracy of Point-of-Care diagnostic test results

AuroBlog - Aurous Healthcare Clinical Trials blog

The Indian healthcare sector is now concerned on quality and accuracy of Point-of-Care (PoC) diagnostic test results. This apprehension is because of limited training or experience with these devices and those handling the same. Hands-on practice and ongoing education to remain updated with changes in technology are issues.

article thumbnail

August 6, 2024: Workshop Materials Now Available From NIH-Hosted Workshop, ‘Going From Zero to 100: Generating Evidence Through Pragmatic Research to Address Pressing Healthcare Issues’

Rethinking Clinical Trials

Materials and videocast recordings are now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Going From Zero to 100: Generating Evidence Through Pragmatic Research to Address Pressing Healthcare Issues. “ The 2-day workshop, hosted by the NIH, featured a keynote address by NIH Director Monica Bertagnolli exploring how to identify high-priority healthcare issues that require the effort, time, and funding of a clinical trial.

Research 147
article thumbnail

Biotech Red Queen launches with $55M to build versatile antivirals

Bio Pharma Dive

The funding from Apple Tree Partners will help the startup advance an antiviral drug pipeline that includes a COVID treatment nearing mid-stage testing.

Drugs 319
article thumbnail

Malaysia approves Antengene’s XPOVIO NDA for multiple myeloma

Pharmaceutical Technology

Antengene received approval from the Malaysian National Pharmaceutical Regulatory Agency for XPOVIO NDA for two multiple myeloma indications.

243
243
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

The Starting Point of Schizophrenia May Have Been Found in Brain Scans

AuroBlog - Aurous Healthcare Clinical Trials blog

Scientists think they may have found locations in the brain where schizophrenia first emerges, potentially making the neurological disorder’s onset easier to diagnose from a standard MRI brain scan.

Scientist 192
article thumbnail

BioNTech posts €808M loss as company continues to come to grips with seasonal COVID vaccine market

Fierce Pharma

While Pfizer’s German mRNA partner BioNTech has high hopes for its post-COVID future, the company continues to feel the squeeze from the changeover to a seasonal vaccine market. | While Pfizer’s German mRNA partner BioNTech has high hopes for its post-COVID future, the company continues to feel the squeeze from the changeover to a seasonal vaccine market.

article thumbnail

Lilly boosts outlook on rising Zepbound revenue

Bio Pharma Dive

Sales of the in-demand obesity drug crested $1 billion in the second quarter as improved Lilly production helped the company fulfill wholesaler backorders.

Sales 280
article thumbnail

Amneal’s CREXONT gains FDA approval for Parkinson’s treatment

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals' CREXONT extended-release capsules for PD.

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

Most of The UK Predicted to Have Dental Disease by 2050, Study Finds

AuroBlog - Aurous Healthcare Clinical Trials blog

Oral diseases, such as tooth decay and gum disease, are among the the most widespread chronic illnesses globally – affecting an estimated 3.5 billion people. They pose a significant problem not just because of how common they are, but because they can cause serious health complications.

article thumbnail

Novartis and Viatris sued by estate of Henrietta Lacks, whose cells were extracted for research in 1951

Fierce Pharma

The family of a Baltimore woman whose cells were extracted for medical research without her consent more than 70 years ago has filed another lawsuit against drugmakers that allegedly profited from | The family of a Baltimore woman whose cells were extracted for medical research without her consent more than 70 years ago has filed another lawsuit against drugmakers that allegedly profited from the discoveries they made using her genetic material.

Research 142
article thumbnail

Merck bets $700M on an antibody drug’s potential in immune diseases

Bio Pharma Dive

The deal hands Merck a cancer medicine already in human testing, but that the company sees as a potential treatment for autoimmune conditions, too.

Antibody 268
article thumbnail

Conduit acquires three first-in-class assets from AstraZeneca 

Pharmaceutical Technology

Conduit plans to advance two assets, AZD1656 and AZD5658, into Phase II testing for autoimmune disorders.

264
264
article thumbnail

2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

article thumbnail

Need for systemic reform to address India’s low organ donation rates: Dr. Rahul Pandit

AuroBlog - Aurous Healthcare Clinical Trials blog

India continues to face significant challenges in boosting its organ donation rates, currently languishing at just over one per million population. Despite widespread public support, the country struggles to increase its organ donation rates, due in part to a combination of legal misconceptions, lack of awareness within the medical community, and cultural barriers.

article thumbnail

Pfizer to create 500 new jobs as it upgrades Australia manufacturing plant to help fight antimicrobial resistance

Fierce Pharma

Warning of a "silent pandemic" spreading across the globe, Pfizer is taking the fight against antimicrobial resistance (AMR) Down Under. | Pfizer announced Tuesday that it has invested 150 million Australian dollars (about $98 million) to build a new manufacturing facility at its Australian site in Melbourne, where the company will help produce new antimicrobial treatments aimed at addressing the rising tide of antimicrobial resistance.

article thumbnail

Amgen talks obesity drug ‘differentiation’; Servier brain cancer drug approved by FDA

Bio Pharma Dive

Executives at Amgen had few updates on their drug MariTide, but defended what they see as the once-monthly shot’s competitive profile.

Drugs 287
article thumbnail

EC grants orphan drug status for Amylyx’s Wolfram treatment

Pharmaceutical Technology

The European Commission (EC) has granted orphan drug designation (ODD) for Amylyx Pharmaceuticals’ AMX0035 to treat Wolfram syndrome.

Drugs 246
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

Cranberry Juice Really Does Have Promising Benefits For UTIs

AuroBlog - Aurous Healthcare Clinical Trials blog

For thousands of years, Native Americans have used cranberries as a remedy for bacterial infections, like those of the bladder.

Doctors 157
article thumbnail

Embracing innovation to drive clinical change in UK stroke care

pharmaphorum

Discover how the innovative geko device is driving clinical change in UK stroke care. Learn how this technology is revolutionising the treatment and management of stroke patients.

127
127
article thumbnail

Why pharma should invest in evidence-based physician education

Bio Pharma Dive

For years, many manufacturers have assumed that pre-market physician education was not strictly necessary unless their brand was the first to market or had a novel mechanism of action. With the advent of precision medicine, however, ongoing disease state education has become increasingly critical.

Branding 256
article thumbnail

GSK announces victory in Zantac cancer claim lawsuit

Pharmaceutical Technology

GSK has announced the win in the latest trial concerning allegations that its heartburn medication Zantac was linked to cancer.

Trials 242
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.