BioPharma Reporter

JULY 11, 2024

Amid a period of clinical holds and legal tangles, the US antibody specialist CytoDyn has reached a settlement to resolve legal disputes with its former contract research organization (CRO) Amarex Clinical Research.

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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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Pharma Times

AUGUST 15, 2024

Children accounted for the majority of mpox cases and deaths in the DRC since June 2023

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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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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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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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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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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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pharmaphorum

AUGUST 6, 2020

When Lundbeck began the trial at the beginning of last year, it said the drug could be a new approach to treating schizophrenia. The company hoped to tackle persistent symptoms by inhibiting the activity of the PDE10-enzyme in the brain with Lu AF11167, which was invented by Lundbeck’s in-house research operation.

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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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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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World of DTC Marketing

APRIL 20, 2022

The feedback suggests that pharma has significant opportunities to get closer to HCPs via more transparency about drug trials and data. The most likely reason to visit a pharma website for HCPs is to download the product label. Will they transform their HCP marketing or stick to dated models?

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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. The post Scepticism in press over Kintor’s COVID-19 US drug trial appeared first on.

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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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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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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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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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pharmaphorum

FEBRUARY 19, 2021

With the acquisition MindMed gains access to HealthMode’s intellectual property, platforms for clinical drug trials, and its entire 24-strong digital medicine team. Karlin will serve as chief medical officer of MindMed after holding several leadership roles at Pfizer’s Neuroscience Research Unit.

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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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pharmaphorum

OCTOBER 27, 2020

Analysing real-world health data could help overcome the bias towards men in traditional medical research, says Sensyne Health’s Dr Lucy Mackillop. Medical research has often focused on men, meaning that the insights gained have not always been reflective of how women would react to a treatment or disease.

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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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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.

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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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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. Looking to diversify the reach of your orphan drug trial?

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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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Pharmaceutical Technology

JUNE 15, 2023

The process of drug development typically starts with the identification of a potential target for a drug. Once the target is identified, researchers work to develop a compound that can interact with it. AI-based analysis can provide insight into participant behavior that informs how researchers design trials.

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Velocity Clinical Research

OCTOBER 21, 2024

At the beginning of September, Velocity Clinical Research topped Business North Carolina ’s 2024 Fast 40 list. For a clinical trials organization to achieve this level of scale is notable. This is vital if we’re to ensure that drug trials are inclusive and deliver results that are representative of the entire population.

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pharmaphorum

DECEMBER 1, 2022

A recent survey of clinical trial professionals found that more than two-thirds of respondents (61%) believe giving patients choice will have a positive impact on clinical research, and well over half (58%) said that their organisations plan to give patients the option to choose how they participate in clinical trials moving forward.

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The Pharma Data

DECEMBER 8, 2020

The FDA has issued a clinical hold on Bellicum Pharmaceuticals for its ongoing phase 1/2 trial evaluating CAR-T therapy BPX-601 in patients who received prior treatment for metastatic pancreatic or prostate cancer, following the death of a trial participant. The Houston, Tex.,

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XTalks

MAY 16, 2023

RELATED: New Report Highlights Major Barriers to IPF Disease Management Clinical trials for pulmonary fibrosis play a crucial role in advancing our understanding of the disease and developing new treatment options. Researchers continue to explore new anti-fibrotic agents and combinations to enhance treatment outcomes.

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pharmaphorum

OCTOBER 1, 2020

Researchers at the University of Oxford in the UK have started a trial of TNF inhibitor adalimumab for COVID-19 patients in care homes and other community settings.

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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.

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XTalks

APRIL 26, 2021

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease.

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XTalks

SEPTEMBER 11, 2020

Expanding minority Americans’ access to care and clinical trials isn’t just the right thing to do. Clinical Trials Don’t Reflect Demographics. Disease doesn’t discriminate, and researchers understand different populations react differently to drugs. Why, then, are clinical trials so stubbornly homogeneous?

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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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pharmaphorum

SEPTEMBER 27, 2021

In the UK, research found that even among people working within the healthcare sector, there was greater vaccine hesitancy among every minority of healthcare workers (HCW) than among white HCWs. In 2020, 53 novel medicines were approved by the FDA and of the patients who took part in trials, just 8% were black and 6% were Asian.

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Delveinsight

AUGUST 12, 2021

The company’s founders have confirmed this role in recent research out of Beth Israel Deaconess Medical Center and Massachusetts General Hospital, LQTT said. AbbVie reported the success of two phase 3 trials of its drug trial in October and filed for FDA approval in February. Anthony Rosenzweig, M.D.,

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