Drugs and Trials - Clinical Research Informer

New HIV Prevention Drug Shows 100% Efficacy in Clinical Trial

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 14, 2024

A large clinical trial in South Africa and Uganda has shown that a twice-yearly injection of a new pre-exposure prophylaxis drug gives young women total protection from HIV infection. All three medications […]

Clinical Trials

Clinical Trials Clinical Trials Trials Drugs

Lilly obesity drug shows heart benefit in late-stage trial

Bio Pharma Dive

AUGUST 1, 2024

The drug led to a 38% reduction in the risk of death or complications from a type of heart failure, a finding that compared favorably to available treatments.

Drugs

Drugs Trials

Obesity drug from Zealand shows potential in early trial

Bio Pharma Dive

JUNE 20, 2024

Interim study data suggest the Danish drugmaker can remain in the race to develop new kinds of weight loss drugs as doctors seek alternatives to the now dominant GLP-1s.

Doctors

Doctors Doctor Drugs Trials

Intra-Cellular builds case for depression drug with late-stage trial win

Bio Pharma Dive

APRIL 16, 2024

Shares of the biotech rose 25% after a large trial found adding its drug Caplyta onto antidepressant therapy significantly helped people with major depression.

Trials

Trials Drugs

Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials.

Clinical Supply

Alnylam details anticipated results from heart disease drug trial

Bio Pharma Dive

SEPTEMBER 8, 2022

Fuller data from Alnylam’s APOLLO-B trial confirm the success reported by the company last month, but won’t end a debate on the degree of benefit offered by its drug.

Drug Trials

Drug Trials Trials Drugs

Bristol Myers says KRAS drug succeeds in key trial

Bio Pharma Dive

MARCH 29, 2024

Confirmatory results for Krazati, which Bristol Myers acquired via its buyout of Mirati, could help the drug win full approval while Amgen has been set back.

Drugs

Drugs Trials

Merck KGaA abandons Phase III trial for $1.08bn head & neck cancer drug

Pharmaceutical Technology

JUNE 25, 2024

Merck’s decision follows the independent committee's analysis that the trial is unlikely to meet its primary endpoints.

Trials

Trials Drugs

Biogen, Sage tremor drug fails key trial

Bio Pharma Dive

JULY 24, 2024

Known as SAGE-324, the drug was one of the key assets Biogen gained rights to through a billion-dollar research deal inked back in 2020.

Drugs

Drugs Trials Research

Commercial Drug Sourcing for Clinical Trials

The sourcing of commercial drugs for use in clinical trials either as a comparator, rescue or co-medication can be a complex process. Watch this video to learn more about what to look for when selecting a commercial drug sourcing specialist, as well as Catalent’s approach to this process.

Clinical Trials

Obesity drug from Boehringer, Zealand succeeds in MASH trial

Bio Pharma Dive

FEBRUARY 26, 2024

Zealand shares rose by more than one-third on the data, which provide further evidence so-called incretin drugs could help treat people with the liver disease.

Drugs

Drugs Trials

Clinical Trial Shows One Drug Performs Better Than Ozempic For Weight Loss

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 18, 2024

Patients taking Eli Lilly’s new drug Mounjaro achieved significantly greater weight loss than those on Novo Nordisk’s Ozempic, a head-to-head study published Monday showed.

Clinical Trials

Clinical Trials Clinical Trials Drugs Trials

Establishing Effective Adaptive Trial Designs for Oncology in Multi-Regional Studies

Worldwide Clinical Trials

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

Trials

Trials Clinical Trials Clinical Trials Regulation

Ionis plots next steps for Angelman drug Biogen passed on

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

Drugs Trials

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.

Clinical Trials

Novartis pauses some trials of cancer drug Kisqali to fix manufacturing

Bio Pharma Dive

APRIL 10, 2024

The company said the pause is necessary to meet regulatory limits on nitrosamine, but added it will not affect commercial supply nor regulatory review of the drug in early breast cancer.

Manufacturing

Manufacturing Drugs Trials

Novo nixes trial of blood pressure drug it bought in deal worth $1.3B

Bio Pharma Dive

JUNE 26, 2024

The failure of a Phase 3 trial led the Wegovy maker to take an accounting charge that will hit its operating profit growth this year.

Trials

Trials Drugs

Alnylam, Roche blood pressure drug scores in second mid-stage trial

Bio Pharma Dive

MARCH 5, 2024

The study results further validate Roche’s recent decision to acquire rights to the drug, which is being developed for people with a stubborn form of hypertension.

Drugs

Drugs Trials Development

GSK cancer drug Blenrep gets surprise trial win

Bio Pharma Dive

NOVEMBER 27, 2023

drugmaker withdrew the multiple myeloma drug from the U.S. One year after the U.K. market because of negative data, new study results might crack open the door to a relaunch.

Drugs

Drugs Trials Marketing

Amgen to test new way to lower heart risk with large drug trial

Bio Pharma Dive

NOVEMBER 7, 2022

Buoyed by strong mid-stage study results, the biotech will soon start a cardiovascular outcomes trial of a drug designed to target a genetic risk factor called lipoprotein(a).

Drug Trials

Drug Trials Trials Genetics Drugs

Biohaven sends latest drug to FDA, despite past trial setback

Bio Pharma Dive

MAY 31, 2023

The biotech, best known for its success developing migraine medicines, will seek approval of a treatment that failed a Phase 3 trial but showed signs of a positive effect.

Trials

Trials Medicine Drugs Development

Trial failures end latest hope for Roche’s Alzheimer’s drug

Bio Pharma Dive

NOVEMBER 14, 2022

Eight years after gantenerumab failed a Phase 3 study, the drug came up short in late-stage testing again, proving unable to meaningfully slow cognitive decline in two closely watched trials.

Trials

Trials Drugs

Non-opioid drug from Vertex cuts pain in major trial tests

Bio Pharma Dive

JANUARY 30, 2024

The company plans to soon ask the FDA for approval of the drug, which it has pitched as a safer alternative to addictive opioid painkillers.

Drugs

Drugs Trials

New Alzheimer’s Drug Shows 35% Reduction in Cognitive Decline in Late-Stage Trial

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 17, 2023

American pharmaceutical company Eli Lilly announced last week that it had seen encouraging clinical trial results of its new Alzheimer’s medication. According to the company, their experimental drug, donanemab, was shown in a late-stage trial to slow cognitive decline by 35 percent.

Trials

Trials Clinical Trials Clinical Trials Drugs

Schizophrenia trials continue to test drug candidates as Covid-19 pandemic continues

Pharmaceutical Technology

JULY 29, 2022

For the last five years (2017 to 2021), there has been a steady increase in the total number of schizophrenia clinical trials by trial start year, apart from 2020, a decrease that may be due to the focus on Covid-19 relief. Last year saw the most with 167 trials. The other top sponsors can be seen in Figure 1.

Trials

Trials Drugs Clinical Trials Clinical Trials

Including Patients with Borderline Personality Disorder in Clinical Trials

Worldwide Clinical Trials

MAY 10, 2024

Over the past two decades, industry-sponsored clinical trials have targeted treatments for BPD, yielding some promising outcomes; however, broader psychiatric research often excludes BPD patients, a trend that extends to the emerging field of psychedelic studies.

Clinical Trials

Clinical Trials Clinical Trials Trials Research

After IPO success, Acelyrin hits trial setback with inflammation drug

Bio Pharma Dive

SEPTEMBER 12, 2023

Acelyrin’s share value collapsed Tuesday after its lead drug fell short in the company’s first big trial test since it raised $540 million in a May IPO.

Trials

Trials Drugs

New Weight Loss Drug May Launch in US After Promising Clinical Trial

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 3, 2023

Pharmaceutical giant Eli Lilly said Thursday it will seek approval to add its diabetes drug to the buzzy US weight loss market after achieving promising results in a new clinical trial. Tirzepatide, currently approved to treat type 2 diabetes under the name Mounjaro, is taken once a week as an injection. Eli Lilly said its […]

Clinical Trials

Clinical Trials Clinical Trials Trials Drugs

Women want to participate in clinical trials. Lack of flexibility is still a problem.

Bio Pharma Dive

APRIL 8, 2024

Underrepresentation of women in clinical trials affects the resulting drugs that become available later. Even small changes could boost participation.

Clinical Trials

Clinical Trials Clinical Trials Trials Drugs

Could a weight loss drug protect the brain against dementia? Trial results show promise

BioPharma Reporter

AUGUST 1, 2024

Results from a phase 2b clinical trial in the UK have shown that Novo Nordiskâs GLP-1 drug liraglutide can protect the brain against dementia.

Trials

Trials Drugs Clinical Trials Clinical Trials

CTI announces partnership for oncology drug development

Pharmaceutical Technology

AUGUST 22, 2024

CTI Clinical Trial & Consulting Services and Crown Bioscience have announced a strategic partnership to boost oncology drug development.

Development

Development Drugs Clinical Trials Clinical Trials

Axsome drug succeeds in narcolepsy symptoms trial

Bio Pharma Dive

MARCH 25, 2024

One analyst argued that Axsome’s drug has “largely been falling under investor radars.” Despite the late-stage victory, shares of the New York-based biotech dipped more than 3%.

Drugs

Drugs Trials

Relmada sinks further as depression drug fails second large trial

Bio Pharma Dive

DECEMBER 8, 2022

The company claimed an “unplausible” placebo response caused both studies to fail and is making substantive changes to its other remaining late-stage trial as a result.

Trials

Trials Drugs

How Pharmacogenomics Can Benefit Your Clinical Trial

Worldwide Clinical Trials

MARCH 20, 2024

In the increasingly advancing world of medicine, personalized care is a key factor that can progress your drug development efforts. One way to ensure customized disease management is to utilize pharmacogenomics (PGx) in your clinical trial. Reduces Trial Failures Oftentimes, clinical trials may fail due to a lack of efficacy.

Clinical Trials

Clinical Trials Clinical Trials Trials Genetics

Viking data suggest obesity drug could rival Zepbound, Wegovy

Bio Pharma Dive

FEBRUARY 27, 2024

The biotech’s drug led to significant weight loss in a Phase 2 trial, causing shares to double as analysts compared results to the marks set by drugs from Eli Lilly and Novo Nordisk.

Drugs

Drugs Trials

How using AI in clinical trials accelerates drug development

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.

Clinical Trials

Clinical Trials Clinical Trials Trials Development

New cancer drug clinical trials struggling

World of DTC Marketing

OCTOBER 6, 2020

WHAT’S THIS ABOUT THEN : Researchers are rushing to launch clinical trials of experimental vaccines against the coronavirus, and treatments for COVID-19. Eli Lilly recently announced that it would halt enrolment in ongoing studies and delay the launch of new trials.

Clinical Trials

Clinical Trials Clinical Trials Trials Drugs

SEC recommends phase III clinical trial waiver for Emcure’s HIV drug doravirine 100mg & its bulk drug

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 12, 2023

The Subject Expert Committee (SEC), which advises the drug regulator on the approval of drugs and clinical trials of antimicrobial and antiviral drugs, has recommended waiver of phase III clinical trial on Emcure Pharmaceuticals’ application for manufacturing and marketing of HIV drug doravirine 100 mg and its bulk drug in the country.Merck Sharp and (..)

Clinical Trials

Clinical Trials Clinical Trials Trials Drugs

Strategies for Successful Navigation of Complex Radiopharmaceutical Trials

Worldwide Clinical Trials

APRIL 3, 2024

Are you aware of the challenges you must address for a successful radiopharmaceutical trial? Enhancing Patient Participation in Radiopharmaceutical Trials Patient recruitment is a critical yet challenging part of radiopharmaceutical trials.

Trials

Trials Clinical Trials Clinical Trials Compliance

Introduction of new drugs without local trial is unscientific & risky as patients here have different anthropometry: Experts

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 9, 2024

Experts in the life-sciences industry are of the view that doing away with human studies for new drugs in India is unscientific and risky as patients here have different anthropometry.

Trials

Trials Life Science Clinical Trials Clinical Trials

Antibody-drug conjugate for solid tumours enters Phase I trials

Drug Discovery World

AUGUST 9, 2024

The first patient has been dosed in a Phase I clinical trial of AGX101, a novel TM4SF1-directed antibody-drug conjugate being developed for the treatment of solid cancers. AGX101 with its novel and differentiated mechanisms of action represents a first-in-class drug with potential to address high unmet medical needs.

Antibody

Antibody Trials Drugs Clinical Trials

Roche autoimmune disease drug disappoints in closely watched trial

Bio Pharma Dive

MARCH 21, 2024

Though the medicine hit its goal in a Phase 3 study in myasthenia gravis, the results fell short of expectations in a boost to rival drug developers like Argenx and AstraZeneca.

Drugs

Drugs Trials Medicine Development

SEC recommends permission for Roche’s ophthalmic drug faricimab with local phase III trial waiver

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 6, 2023

The expert committee which advises the drug regulator on clinical trials and drug approvals has recommended for grant of permission for import and marketing of Swiss multinational pharma major Roche’s ophthalmic drug faricimab intravitreal injection in India, with waiver of local phase III clinical trial subject to conditions.

Trials

Trials Clinical Trials Clinical Trials Drugs

MEI, Kyowa stop lymphoma drug trials after FDA meeting

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.

Drug Trials

Drug Trials Trials Drugs Regulation

New HIV Prevention Drug Shows 100% Efficacy in Clinical Trial

Lilly obesity drug shows heart benefit in late-stage trial

Trending Sources

Obesity drug from Zealand shows potential in early trial

Intra-Cellular builds case for depression drug with late-stage trial win

Accelerating Clinical Supply Through Integrated Drug Development

Alnylam details anticipated results from heart disease drug trial

Bristol Myers says KRAS drug succeeds in key trial

Merck KGaA abandons Phase III trial for $1.08bn head & neck cancer drug

Biogen, Sage tremor drug fails key trial

Commercial Drug Sourcing for Clinical Trials

Obesity drug from Boehringer, Zealand succeeds in MASH trial

Clinical Trial Shows One Drug Performs Better Than Ozempic For Weight Loss

Establishing Effective Adaptive Trial Designs for Oncology in Multi-Regional Studies

Ionis plots next steps for Angelman drug Biogen passed on

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Novartis pauses some trials of cancer drug Kisqali to fix manufacturing

Novo nixes trial of blood pressure drug it bought in deal worth $1.3B

Alnylam, Roche blood pressure drug scores in second mid-stage trial

GSK cancer drug Blenrep gets surprise trial win

Amgen to test new way to lower heart risk with large drug trial

Biohaven sends latest drug to FDA, despite past trial setback

Trial failures end latest hope for Roche’s Alzheimer’s drug

Non-opioid drug from Vertex cuts pain in major trial tests

New Alzheimer’s Drug Shows 35% Reduction in Cognitive Decline in Late-Stage Trial

Schizophrenia trials continue to test drug candidates as Covid-19 pandemic continues

Including Patients with Borderline Personality Disorder in Clinical Trials

After IPO success, Acelyrin hits trial setback with inflammation drug

New Weight Loss Drug May Launch in US After Promising Clinical Trial

Women want to participate in clinical trials. Lack of flexibility is still a problem.

Could a weight loss drug protect the brain against dementia? Trial results show promise

CTI announces partnership for oncology drug development

Axsome drug succeeds in narcolepsy symptoms trial

Relmada sinks further as depression drug fails second large trial

How Pharmacogenomics Can Benefit Your Clinical Trial

Viking data suggest obesity drug could rival Zepbound, Wegovy

How using AI in clinical trials accelerates drug development

New cancer drug clinical trials struggling

SEC recommends phase III clinical trial waiver for Emcure’s HIV drug doravirine 100mg & its bulk drug

Strategies for Successful Navigation of Complex Radiopharmaceutical Trials

Introduction of new drugs without local trial is unscientific & risky as patients here have different anthropometry: Experts

Antibody-drug conjugate for solid tumours enters Phase I trials

Roche autoimmune disease drug disappoints in closely watched trial

SEC recommends permission for Roche’s ophthalmic drug faricimab with local phase III trial waiver

MEI, Kyowa stop lymphoma drug trials after FDA meeting

Stay Connected