STAT News

MARCH 29, 2023

And hopeful patients, many of them young women of color, are waiting — just three lupus drugs have been approved by the Food and Drug Administration in six decades.   On Wednesday, the nonprofit Lupus Research Alliance announced it was entering into a public-private partnership with the FDA.

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Scienmag

JANUARY 19, 2022

New research suggests manufacturers of newly developed antidepressant drugs have become more forthcoming about clinical trials that don’t pan out.

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pharmaphorum

MAY 7, 2021

Small Pharma is following the trend for development of psychedelic medicines, a field where research has been suppressed for years because of legal restrictions on use of these compounds in many countries. The goal of the trial is for proof of concept of the drug as a wrap-around therapy for Major Depressive Disorder.

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Medical Xpress

DECEMBER 29, 2022

A new drug designed to ward off Alzheimer's is being tested at more than 100 sites around the world, including the University of Pennsylvania.

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STAT News

FEBRUARY 17, 2023

Pfizer and partner Valneva are scrapping data from roughly half of the participants in a Phase 3 trial of a Lyme disease vaccine candidate after uncovering quality issues with a third-party clinical trial operator.

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pharmaphorum

AUGUST 6, 2020

Lundbeck has axed a phase 2 trial of a schizophrenia drug, saying that the study was unlikely to meet its efficacy target. The company said it made the decision after a futility analysis indicated that the trial was not likely to succeed, when measured against a standard scale.

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Drug Discovery World

JUNE 20, 2024

A new UK research partnership In June, UK charity LifeArc pledged £1.5 This Phase II clinical trial of drug candidate NX210c in patients with ALS is the first to target the integrity of the blood brain barrier (BBB).

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pharmaphorum

MAY 14, 2021

China’s Kintor Pharmaceutical has begun late-stage US clinical development of its potential COVID drug proxalutamide – but there is scepticism over the company’s claims about its research. Reuters quoted Kintor’s chief financial officer Lucy Lu, who said that Kayali was one of its trial investigators.

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Pharmaceutical Technology

JUNE 15, 2023

The need for new medical treatments and drugs has never been greater. But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S.

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Scienmag

JULY 18, 2021

Researchers are using computer models to simulate COVID-19 infections on a cellular level – the basic structural level of the human body. The models allow for virtual trials of drugs and vaccines, opening the possibility of pre-assessment for drug and vaccine efficacy against the virus.

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BioTech 365

JULY 19, 2021

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Troubled Cytokinetics’ stock soars as gets much needed phase 2 heart drug trial win, plans late-stage effort by year’s end.Troubled Cytokinetics’ stock soars as gets much needed … Continue reading →

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Drug Discovery World

NOVEMBER 29, 2023

Researchers have created a mathematical model that can accurately depict Alzheimer’s disease progression in individual patients, paving the way for personalised treatment and faster development of therapies. These findings closely matched the results of the corresponding real-life clinical trials.

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Advarra

JUNE 27, 2023

Clinical trials are studies involving human volunteers to research ways to prevent, detect, and treat various medical conditions. The goal is to identify safer, more effective methods of treating illnesses using new drugs or new combinations of existing drugs.

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Medical Xpress

DECEMBER 21, 2022

An international research group including scientists from Italy, the United States, Ireland, and Israel have published a three-year analysis of the Mesothelioma (Me) drug trial, Check-Mate 743 (CM-743).

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Drug Discovery World

JUNE 9, 2023

There has been some interesting news related to clinical trials this week, with the announcement that the FDA has published draft guidance to modernise the design and conduct of studies, and the failure of Bellerophon Therapeutics’ Phase III study in fibrotic Interstitial Lung Disease.

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Drug Discovery World

FEBRUARY 10, 2023

Clinical drug trials have made the headlines this week, as it was revealed that breast cancer still tops the bill for number of clinical studies and the shortcomings in current methods to ensure representation of patient populations in trials were exposed.

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The Pharma Data

JANUARY 20, 2021

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to. Become a subscriber to Drug Industry Daily today. No questions asked.

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Outsourcing Pharma

NOVEMBER 1, 2021

A former employee of Tellus Clinical Research in Miami has admitted to charges related to a conspiracy to falsify data on a list of clinical drug trials.

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Scienmag

JULY 8, 2021

Researchers, including academics from the University of York, analysed systematic reviews of 1,200 Randomised Controlled Trials (RCTs) to assess whether reporting had improved over time.

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The Pharma Data

OCTOBER 26, 2020

based aTyr Pharma has finalized enrollment for a phase 2 trial to evaluate an investigational anti-inflammatory drug in COVID-19 patients with severe respiratory complications. San Diego, Calif.-based ATYR1923 is meant to reduce inflammation and restore the lung’s immune balance.

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STAT News

DECEMBER 2, 2022

And a fragmented clinical trials industry has made it a prime target for private equity, which often consolidates markets by merging companies. To date, 11 of the 25 private equity firms identified by industry tracker PitchBook as the top investors in health care have bought stakes in clinical research companies.

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pharmaphorum

AUGUST 4, 2020

New research looks at the factors that speed up and slow down HTA appraisals for rare disease medicines across Europe. Rare diseases drugs have always faced challenges when it comes to HTA approvals, even as governments bring in more regulatory policies that make their path through assessment easier. Source: CRA Analysis.

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pharmaphorum

JANUARY 19, 2021

Sites need to be close enough for travel, and the number of site visits and trial appointments must also be manageable for people living with the complications of having little-known and rarely-researched orphan diseases. In fact, how do rare disease patients even feel about clinical trials?

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pharmaphorum

AUGUST 25, 2022

Cirrhosis is not just an “old drunk guys” disease, a stigma which has long hampered interest and investment in research. But herein lies the dichotomy that medicine has created: By failing to regularly screen to find the early-stage disease, the number of patients who could participate in drug trials is limited.

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The Pharma Data

DECEMBER 8, 2020

The company also said the hold does not interfere with enrollment of an upcoming phase 1/2 trial evaluating similar CAR-T immunotherapy drug BPX-603 in breast cancer patients with solid tumors. The Houston, Tex., Source link.

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World of DTC Marketing

APRIL 20, 2022

This was especially true with new drugs that have a significant competitive market. Trust in pharma did not decline, but they don’t want to be told about the data via charts; they want the ability to read the data for themselves and talk to other HCPs about the data and drug.

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XTalks

JULY 29, 2021

Just as clinical researchers in other therapeutic areas have renewed their commitment to improving participant diversity in clinical trials, so too have those working in Alzheimer’s research. Fortunately, there are a number of researchers working on this issue. Similarly, older Latino and Hispanic individuals are 1.5

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Drug Discovery World

JULY 20, 2023

What are benefits of drug repurposing and why do clinical drug trials so often fail? Diana Spencer summarises the key messages from the ‘Drug Repurposing: Challenges and Opportunities’ Symposium held at the 19th World Congress of Basic & Clinical Pharmacology (WCP) 2023.

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World of DTC Marketing

JULY 19, 2021

CDC and new drugs have fostered an era of mistrust with some people. DTC marketers need to be more forthcoming when it comes to drug trials and side effects. This means that trust will be a huge issue for new drugs that promise breakthrough results. The media stories about the FDA.

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BioSpace

APRIL 1, 2021

One of the common research approaches to treating brain diseases such as Parkinson’s disease (PD) and Alzheimer’s disease (AD) is using antibodies designed to clear the accumulated misfolded proteins implicated in the diseases. To date, these drug trials have not been particularly successful at i.

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The Pharma Data

NOVEMBER 30, 2020

Sponsors of drug trials should determine what effect the use of acid-reducing agents (ARA), such as antacids, proton pump inhibitors and histamine blockers, could have on the solubility of an orally administered drug, according to a new FDA draft guidance released Monday.

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Pharmaceutical Technology

SEPTEMBER 20, 2022

Unlike commercial pharmaceutical packaging, the primary consideration in clinical trial packaging is protecting the product quality and reliability for research. Furthermore, the list includes clinical supply packaging, as well as labelling, storage, and logistics service providers for drug trial projects.

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VirTrial

MAY 26, 2020

The solution enables pharmaceutical sponsors and CROs to evaluate, qualify and routinely monitor research sites for studies without physical travel. COVID-19 spurred a significant increase in Virtual Pre-Site inquiries to accommodate site monitoring for existing studies and to expedite study startups for COVID and other drug trials.

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Worldwide Clinical Trials

NOVEMBER 3, 2022

BioPharma Dive interviewed our Derek Ansel on how to conduct psychedelic clinical research. In April 2022, the Food and Drug Administration (FDA) issued draft guidance on developing a “Race and Ethnicity Diversity Plan” for clinical trials. But in rare disease trials, that can be challenging given the barriers inherent in U.S.

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Advarra

AUGUST 16, 2022

Orphan drugs have historically faced a number of barriers, such as limited research and development (R&D) investment due to an expected lack of profitability as well as challenges in clinical trial design and recruitment. Before 1983, only 38 orphan drugs had received U.S. Food and Drug Administration (FDA) approval.

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pharmaphorum

FEBRUARY 19, 2021

million, which uses artificial intelligence (AI) technology to speed up drug development. With the acquisition MindMed gains access to HealthMode’s intellectual property, platforms for clinical drug trials, and its entire 24-strong digital medicine team.

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pharmaphorum

FEBRUARY 4, 2022

“This way, the control group does not need to recruit patients, which also increases the cost-efficiency of drug development,” according to Aalto’s Prof Harri Lähdesmäki, who also works within the Finnish Center for Artificial Intelligence (FCAI).

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