Bio Pharma Dive

OCTOBER 31, 2022

Bringing more diversity to clinical trials is a slow process and it takes time to get right. Learn how Worldwide Clinical Trials can diversify the reach of your orphan drug trial.

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Clinical Trials Clinical Trials Drug Trials Trials 325

Bio Pharma Dive

DECEMBER 6, 2022

The decision not to run a Phase 3 trial of their medicine is the latest fallout from U.S. regulators’ recent moves to closely evaluate a class of drugs known as PI3 kinase inhibitors.

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Drug Trials Trials Drugs Regulation 173

Bio Pharma Dive

DECEMBER 9, 2023

Study results disclosed at the American Society of Hematology meeting Saturday suggested potential for cell therapy in lupus and pointed out drug trial limitations.

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Drug Trials Trials Drugs 325

Bio Pharma Dive

JULY 28, 2022

Important data from the APOLLO study of the biotech's drug Onpattro are due before the end of August, Alnylam said Thursday.

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Drug Trials Drugs Trials 182

Pharmaceutical Technology

OCTOBER 14, 2024

Digital assessment technologies continue to hold the potential to revolutionise pro-cognitive trials in schizophrenia.

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pharmaphorum

JUNE 26, 2023

FDA sets out its thinking on psychedelic drug trials Phil.Taylor Mon, 26/06/2023 - 07:15 Bookmark this

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Drug Trials Trials Drugs 105

pharmaphorum

AUGUST 17, 2023

Abcuro raises $155m for KLRG1 drug trial Phil.Taylor Thu, 17/08/2023 - 14:54 Bookmark this

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Drug Trials Trials Drugs 97

Pharma Times

SEPTEMBER 13, 2024

Innovative immunotherapy drug HTL0039732 shows potential in trials

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Trials Drug Trials Drugs Research 137

Pharma Times

AUGUST 22, 2024

200,000 people in the UK have what is considered a ‘hidden’ lung condition

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Drug Trials Trials Drugs Research 158

Pharma Times

DECEMBER 4, 2020

LYT-100 will be evaluated in patients with persistent symptoms caused by COVID-19

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Drug Trials Trials Drugs 159

pharmaphorum

MAY 19, 2022

Phase 2 trials of Beckley Psytech’s psychedelic drug candidates will make use of digital technologies for patient monitoring, thanks to a new partnership with Empatica. The post Beckley adds digital element to its psychedelic drug trials appeared first on.

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Drug Trials Trials Drugs Development 105

Bio Pharma Dive

MAY 24, 2022

The biotech plans to seek FDA approval for its soft-tissue tumor treatment after positive study results. But investors still sent the stock down by nearly 10%.

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Drug Trials FDA Approval Trials Drugs 130

pharmaphorum

JANUARY 25, 2021

GlaxoSmithKline has suffered another research setback after it axed a phase 2 trial of an anti-LAG3 drug in patients with ulcerative colitis, following a major disappointment with a key lung cancer drug last week. The post GSK suffers another R&D setback, axing ulcerative colitis drug trial appeared first on.

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Drug Trials Trials Drugs Licensing 103

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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Drug Trials Vaccination Vaccine Trials 146

pharmaphorum

FEBRUARY 21, 2024

Clinical research involves trial and error as part of the drug development process. Learn more about how to optimise drug trials and the important role of participants in clinical research.

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Clinical Research Trials Research Drug Trials 129

Pharmaceutical Technology

APRIL 16, 2024

The US FDA placed the clinical hold based on the preclinical data that showed that Neumora’s NMRA-266 triggered convulsions in rabbits.

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Drug Trials Trials Drugs 130

pharmaphorum

OCTOBER 27, 2020

US biotech BioSig Technologies has abandoned a phase 2 trial of its antiviral drug merimepodib with Gilead’s Veklury in severe COVID-19 patients, after concluding the safety of the combination was in doubt. Merimepodib is the subsidiary’s primary asset, and the biotech now says it is to offers to acquire or license the drug.

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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. Continue to STAT+ to read the full story…

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Trials Drug Trials Clinical Trials Clinical Trials 119

pharmaphorum

MAY 7, 2021

Proceeds from the fundraiser will go towards the phase 1/2a clinical trial the company began in February this year of the lead candidate codenamed SPL026. 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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STAT News

MARCH 29, 2023

Lupus is a disease long-plagued by failed clinical trials. 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. A key partnership is looking to change that.  

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Bio Pharma Dive

JULY 17, 2023

The results come about two years after negative findings from an earlier phase of the study, and position the company to seek an approval in transthyretin amyloidosis cardiomyopathy.

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Drug Trials Trials Drugs 130

BioSpace

JANUARY 28, 2021

Food and Drug Administration (FDA) has cleared an Investigational New Drug application that will allow Boston-based Vertex Pharmaceuticals to proceed with a clinical trial of its investigational stem cell-derived, fully differentiated pancreatic islet cell treatment for type 1 diabetes (.

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Drug Trials Trials Drugs Clinical Trials 111

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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Trials Drug Trials Clinical Trials Clinical Trials 83

pharmaphorum

DECEMBER 28, 2023

Cytokinetics rises on report that its aficamten drug improved symptoms in people with rare disease obstructive hypertrophic cardiomyopathy

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Drug Trials Drugs Trials 103

Outsourcing Pharma

APRIL 6, 2023

TWO US clinical investigator sites have been opened for a phase 1 clinical trial for patients with soft tissue sarcoma and the first patient has been dosed.

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BioSpace

FEBRUARY 15, 2021

According to a statement made by Cortexyme, the partial hold was placed on the development program for atuzaginstat after an FDA review of the trial data identified hepatic adverse events.

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Drug Trials Trials Drugs Development 88

BioSpace

AUGUST 17, 2020

Food and Drug Administration halted a cancer drug trial due to safety concerns. Shares of Poseida Therapeutics plunged more than 20% in premarket trading this morning after the company announced the U.S.

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Trials Drug Trials Drugs 110

pharmaphorum

JANUARY 19, 2021

A survey by rare disease patient network Raremark found that 86% of the community members asked were interested in taking part in clinical trials. CEO Jeremy Edwards looks at how decentralised trial models can solve some of the challenges for clinical trial recruitment in rare disease.

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BioPharma Reporter

OCTOBER 4, 2022

Kibow Biotech is celebrating its 25th anniversary as the company pivots toward developing a drug based on its proprietary probiotic strains that benefit kidney disease suffers.

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Drug Trials Drugs Trials Development 98

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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Trials Drug Trials Clinical Research Drugs 95

STAT News

MARCH 27, 2023

Food and Drug Administration proposed cancer drug developers in most cases conduct more rigorous trials to seek accelerated approval for their candidates , Reuters tells us. Continue to STAT+ to read the full story…

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Trials Drug Trials Drugs Clinical Trials 98

Scienmag

DECEMBER 20, 2021

A clinical trial in which two test drugs failed to help patients with mild COVID-19 nevertheless had a silver lining: It proved the viability of a study model in which a medication’s potential arrhythmic side effects are safely, effectively monitored without the participants ever setting foot in a hospital or clinic.

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Drug Trials Trials Drugs Clinical Trials 79

BioPharma Reporter

JULY 4, 2023

Sosei Heptares has dosed the first subject in a phase 1 trial evaluating HTLâ149, a first-in-class GPR52 agonist, which represents a novel mechanism of action for the treatment of schizophrenia and related neurological diseases.

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Drug Trials Trials Drugs Development 78

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. The post LSD biotech MindMed buys digital trial firm HealthMode appeared first on.

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Trials Medicine Engineer Drug Trials 134

BioSpace

OCTOBER 19, 2021

?SURPASS-4 is part of the Phase III trial evaluating tirzepatide as a possible treatment for type 2 diabetes.

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Drug Trials Trials Drugs 79

BioSpace

OCTOBER 11, 2020

was convicted on 47 counts of fraud and drug related charges on Oct. A 41-year-old man from Richland, Wash. 1, according to the U.S. Justice Department’s Eastern District of Washington.

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Drug Trials Drugs Trials 99

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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