Rethinking Clinical Trials

JULY 23, 2024

In an invited commentary published this month in Circulation: Cardiovascular Quality and Outcomes , authors from the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core describe the recurring and emerging ethical issues in pragmatic clinical trials. Coauthors Caleigh Propes, Stephanie Morain, and Pearl O’Rourke discuss 3 key challenges facing pragmatic trials researchers: waivers and alterations of informed consent and their implications for transparency managing and resp

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Trials Clinical Trials Clinical Trials Doctors 317

Pharmaceutical Technology

JULY 23, 2024

Johnson & Johnson is seeking approval for SPRAVATO for treatment-resistant depression with the submission of an sNDA to the US FDA.

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Bio Pharma Dive

JULY 22, 2024

The company plans to start a late-stage study next year, after a smaller trial found its drug offered “robust and consistent” benefits on communication, cognition and motor function.

Drugs 293

Drugs Trials 293

Pharmaceutical Technology

JULY 23, 2024

The latest resubmission addressed remaining CMC concerns, with the FDA confirming that the Phase III data was “sufficient”.

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Gene Therapy Gene 162

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Clinical Supply

Rethinking Clinical Trials

JULY 24, 2024

In this Friday’s PCT Grand Rounds, Gregg Fonarow of the University of California, Los Angeles, will present “Interventions for Optimization of Guideline-Directed Medical Therapy.” The Grand Rounds session will be held on Friday, July 26, 2024, at 1:00 pm eastern. Fonarow is the Eliot Corday Professor of Cardiovascular Medicine and Science at UCLA, director of the Ahmanson-UCLA Cardiomyopathy Center, and codirector of the UCLA Preventative Cardiology Program.

Cardiology 147

Cardiology Clinical Trials Clinical Trials Medicine 147

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 25, 2024

Ahead of the upcoming Union Budget, prominent voices in the healthcare sector are urging the government to allocate substantial funds to support early diagnosis and intervention for children with autism and neurodevelopmental delays, alongside enhanced training for medical personnel on early disease detection.

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Clinical Trials Clinical Trials Clinical Research Trials 184

Pharmaceutical Technology

JULY 22, 2024

As the use of AI soared across healthcare, NVIDIA fit the bill in providing the necessary technology – and its stock tells the same story.

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Marketing 272

Worldwide Clinical Trials

JULY 26, 2024

At Worldwide Clinical Trials’ bioanalytical lab, we view challenges as opportunities to excel and set new standards. The path to drug approval is complex, with many variables and potential delays. That’s why our team is committed to continuous improvement through our initiative, WorldwideEdge, where we optimize everything from our processes to our teams’ performance for each drug development program.

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Clinical Trials Clinical Trials Trials Development 130

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 23, 2024

Ultra long, thick eyelashes might be in vogue but are they worth the expense – and the risk to health? Our natural eyelashes perform important functions. The eye is exposed to the elements so it’s a window for bacteria and viruses to enter the body – potentially causing death.

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Bacteria Clinical Trials Clinical Trials Trials 178

Bio Pharma Dive

JULY 22, 2024

Serum-based glycoproteins demonstrate success in predicting immune checkpoint inhibitor therapy outcomes.

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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

Clinical Trials

Pharmaceutical Technology

JULY 25, 2024

JNJ-2056 is being investigated in the Phase IIb ReTain study which enrols participants who are yet to show Alzheimer’s symptoms.

Vaccination 237

Vaccination Vaccine 237

Fierce Pharma

JULY 25, 2024

Three months after bagging FDA approval, Pfizer’s hemophilia B gene therapy has been cleared to expand its reach across the pond. | The company's first gene therapy will debut in Europe as Durveqtix. In the U.S., the drug is approved under the brand name Beqvez.

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Gene Therapy Gene FDA Approval Branding 111

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 25, 2024

The search for alcohol hangover cures is as old as alcohol itself. Many cures and remedies are sold, but scientific evidence for their effectiveness is lacking. Recently, the notion that taking a shot of olive oil before consuming alcohol can prevent hangovers has garnered attention.

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Clinical Trials Clinical Trials Clinical Research Trials 154

Bio Pharma Dive

JULY 26, 2024

Eisai plans to appeal the EMA’s negative recommendation, hoping to break into a market analysts expect could eventually bring billions of dollars in sales for the Alzheimer’s drug.

Regulation 169

Regulation Sales Marketing Drugs 169

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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.

Clinical Trials

Pharmaceutical Technology

JULY 24, 2024

BioNTech and Triastek have entered a research partnership focusing on the development of 3D-printed oral RNA therapeutics.

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RNA Development Research 182

Fierce Pharma

JULY 22, 2024

As lawmakers and industry groups seek to get a handle on U.S. | As lawmakers and industry groups seek to get a handle on U.S. drug shortages, a new white paper from German market analytics firm QYOBO supports the thesis that disproportionately low prices for generic medicines can make it difficult for drugmakers to keep supplies afloat.

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Medicine Marketing Drugs 118

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 24, 2024

We’ve known for over a century that mice and rats live longer when they are fed less, but a new study reveals the secret might be an imbalance between energy consumed and burned, rather than a lack of energy or protein.

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Protein Research Clinical Trials Clinical Trials 160

Bio Pharma Dive

JULY 25, 2024

CEO Thomas Schinecker claimed the company has “many opportunities” to stand out in the competitive field, and can get to market “much faster” than investors expect.

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Drugs Marketing 177

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.

Clinical Research

Pharmaceutical Technology

JULY 26, 2024

Mankind Pharma has announced a definitive agreement for the acquisition of Bharat Serums and Vaccines (BSV) for Rs136.3bn ($1.6bn).

Vaccination 147

Vaccination Vaccine 147

BioSpace

JULY 23, 2024

AstraZeneca is proposing to use Imfinzi for resectable non-small cell lung cancer in the perioperative setting—both before and after surgical resection of the tumor. However, ahead of Thursday’s advisory committee meeting, FDA staffers have expressed concerns.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 24, 2024

India’s lower-income groups face significant financial challenges when it comes to cancer treatment. High medical costs, lack of insurance coverage, and limited access to quality healthcare services exacerbate the situation. Many families are seen to opt between basic necessities and treatment, leading to increased mortality rates and a higher burden of disease.

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Clinical Trials Clinical Trials Clinical Research Trials 166

Bio Pharma Dive

JULY 25, 2024

Some analysts described Sanofi’s pipeline of immune system therapies, which includes more than half a dozen drugs in mid- to late-stage testing, as “underappreciated” by investors, as sales of Dupixent rose over the last quarter.

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Sales Drugs 169

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Pharmaceutical Technology

JULY 25, 2024

The UK MHRA has authorised Pfizer-BioNTech’s adapted Comirnaty vaccine against the JN.1 Covid-19 subvariant for adults and children.

Vaccination 147

Vaccination Vaccine 147

Fierce Pharma

JULY 24, 2024

From flubbing data to performing aseptic processing with torn and stained gowns, Brassica Pharma’s recent warning letter from the FDA reads like a textbook example of what not to do when the U.S. | From flubbing data to performing aseptic processing with torn and stained gowns, Brassica Pharma’s recent warning letter from the FDA reads like a textbook example of what not to do when the U.S. regulator comes knocking at your facility.

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Regulation 105

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 22, 2024

Scientists have figured out a non-invasive way to determine if a transplanted organ is failing to take in a patient – no matter if it’s a kidney, liver, lung, or heart.

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Scientist Clinical Trials Clinical Trials Clinical Research 142

Bio Pharma Dive

JULY 25, 2024

The drug’s advancement continued what one analyst described as a “torrid” pace for Viking’s closely watched medicine, which started human testing in 2022 and could reach a Phase 3 trial next year.

Drugs 169

Drugs Medicine Trials 169

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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.

Clinical Trials

Pharmaceutical Technology

JULY 26, 2024

The FDA approval is based on data gathered from two Phase III studies where over 30% of the patients gained 80% or more coverage of scalp hair.

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FDA Approval 130

Fierce Pharma

JULY 25, 2024

While manufacturing and supply hitches have troubled the rollout of Sanofi’s key respiratory syncytial virus (RSV) drug, the near-term expected approval of a pair of new filling lines is giving the | While manufacturing and supply hitches have troubled the rollout of Sanofi’s key respiratory syncytial virus drug, the near-term expected approval of a pair of new filling lines is giving the French pharma assurance that its AstraZeneca-partnered antibody Beyfortus can breach the billion-dollar thre

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Sales Drugs Manufacturing Antibody 108

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 23, 2024

Over the last two years, Sahyadri Hospitals in Pune has observed a troubling trend of increase in cases of pulmonary embolism (PE) associated with long-haul international travel. This insight comes after the successful treatment of 17 PE cases through mechanical thrombectomy at the hospital—a procedure chosen for its efficacy when traditional clot-dissolving medications are unsuitable.

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Doctors Doctor Clinical Trials Clinical Trials 142

Bio Pharma Dive

JULY 26, 2024

Glycomimetics and Cue Biopharma both revealed layoffs. Elsewhere, AbbVie’s earnings impressed Wall Street and an FDA panel recommended changing testing requirements for some lung cancer drugs.

Drugs 152

Drugs 152

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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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