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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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

Drug Discovery World

JULY 4, 2023

“Given the prevalence of obesity and its many disease-related complications, there is a dire need for treatments that can help treat the disease of obesity effectively,” said Carel le Roux, Professor at University College in Dublin, Ireland, and Principal Investigator of the trial.

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Drug Trials Trials Drugs 94

Drug Discovery World

NOVEMBER 30, 2023

Biotechnology company Certa Therapeutics has revealed positive Phase II clinical trial data for FT011 in patients with scleroderma. The US Food and Drug Administration (FDA) recently granted Orphan Drug Designation for FT011 for the treatment of systemic sclerosis (scleroderma).

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Drug Trials Trials Drugs Clinical Trials 59

Bio Pharma Dive

JANUARY 10, 2023

Moderna’s Stéphane Bancel and Pfizer’s Albert Bourla hinted Monday at greater dealmaking to come for their companies, while Gilead gave investors an update on an important cancer drug trial.

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Trials Drug Trials Development Vaccination 285

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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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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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 169

Drug Discovery World

JUNE 9, 2023

The REBUILD clinical trial was designed as a randomised, double-blind, placebo-controlled Phase III study evaluating the safety and efficacy of INOpulse for the treatment of patients with fILD. The post Phase III pulmonary fibrosis drug trial fails appeared first on Drug Discovery World (DDW).

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Drug Trials Trials Drugs Clinical Trials 52

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 317

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 104

Bio Pharma Dive

AUGUST 23, 2021

The decision, which follows the recommendation of a data monitoring committee, is yet another setback in the search for more treatments for the neurological disease.

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Drug Trials Trials Drugs 258

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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Drug Discovery World

MARCH 29, 2023

A Phase I clinical trial has begun evaluating Direct Biologics’ ExoFlo for the treatment of patients with medically refractory ulcerative colitis (UC). The primary objective of the trial is to evaluate the safety of intravenous ExoFlo.

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Drug Trials Trials Drugs Clinical Trials 52

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

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

Roots Analysis

FEBRUARY 29, 2024

Shares of Zealand Pharma experienced a significant surge, jumping 16% as the market opened on Monday, following the release of groundbreaking phase II trial results for an experimental obesity treatment being developed in collaboration with Boehringer Ingelheim. The trial, conducted by Boehringer Ingelheim, revealed that up to 83.0%

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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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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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Clinical Trials Clinical Trials Trials Development 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. Moreover, as an orally-active drug merimepodib could also have found a role outside the hospital setting.

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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

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 317

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

DMT is a powerful hallucinogenic drug found in several plants including the South American plant chacruna and when used recreationally is mixed with the ayahuasca plant to make the shamanic brew of the same name. 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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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

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

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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Drug Trials Trials Clinical Trials Clinical Trials 97

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 114

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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Drug Trials Drugs Trials Research 89

Scienmag

JUNE 15, 2022

A novel staging framework that assesses the progression of Huntington’s disease (HD), similar to the way cancer is staged 0 to 4, has been developed by UCL scientists as part of an international consortium; this ‘significant’ step paves the way for clinical trials of drugs in the earliest phase of disease.

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Drug Trials Trials Drugs Clinical Trials 59

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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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 96

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. But Reuters reported that the doctor identified as its principal clinical trial investigator has said he is not in charge of the trial.

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Drug Trials Trials Drugs Dermatology 52

Outsourcing Pharma

JANUARY 16, 2023

A Florida doctor has been sent to prison after submitting a false affidavit claiming she had screened children in a clinical study looking at the effectiveness of drugs given to children with asthma when she had not.

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Drug Trials Doctors Doctor Drugs 59

Outsourcing Pharma

AUGUST 29, 2022

The company reports dosing of the first subject in a Phase IIa proof-of-concept study investigating a drug for an autism spectrum disorder related condition.

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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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Scienmag

JULY 18, 2021

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

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