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Science Daily: Pharmacology News
MAY 17, 2024
An HIV vaccine candidate triggered low levels of an elusive type of broadly neutralizing HIV antibodies among a small group of people enrolled in a 2019 clinical trial.
337 
BioPharma Drive: Drug Pricing
SEPTEMBER 26, 2024
The withdrawal comes as trial results indicate safety concerns with the drug, Oxbryta, which was first approved in the U.S.
277
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ProRelix Research
JUNE 6, 2023
Being the second most populous country in the world with skilled labor and good infrastructure, India is a favorable destination for clinical trials for a wide variety of diseases.
BioPharma Drive: Drug Pricing
AUGUST 28, 2023
The treatment, developed by a biotech Bayer acquired in 2019, appeared safe in a small trial and showed signs of an effect on disease progression.
246 
Broad Institute
FEBRUARY 26, 2025
So the researchers used a method developed at the Broad Institute in 2019 called consensus non-negative matrix factorization (cNMF) , which can define cells by their identity and activity independently. With this approach, the team identified four programs shaping the immune system.
132 
Conversations in Drug Development Trends
AUGUST 23, 2023
Patients are the backbone of clinical trials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.
96 
Antidote
JULY 29, 2022
In 2019 alone, research and development spending totaled $186 billion for the global pharmaceutical industry. Between 2009 and 2018, U.S. biopharmaceutical companies spent about $1 billion per drug according to an analysis published in JAMA , and other studies have found that it can cost up to $2.8 billion to bring a new therapy to market.
SCIENMAG: Medicine & Health
JULY 14, 2023
billion in project funding for phased clinical trials involving drugs approved by the FDA from 2010-2019, according to a new study from Bentley University’s Center for Integration of Science and Industry. BENTLEY UNIVERSITY Credit: Bentley University BENTLEY UNIVERSITY The U.S. National Institutes of Health (NIH) contributed $8.1
The Pharma Data
MAY 27, 2022
billion in Medicare funds in 2019 on drugs whose clinical benefits have yet to be confirmed by the Food and Drug Administration, a new study led by researchers from the Johns Hopkins Bloomberg School of Public Health suggests. billion on 36 of these drugs across 55 indications in 2019. federal government spent an estimated $1.8
Reprocell
JANUARY 18, 2023
Today, clinical trials are conducted to aid our understanding of, and to assess new treatments for, medical conditions or disorders that affect the human population. Considered the gold standard for medical research, the modern clinical trial is a well-controlled, but complex process that functions within a strict regulatory environment.
PPD
NOVEMBER 7, 2023
Food and Drug Administration (FDA) draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.” Strategies to Increase Diverse Populations in Dermatology Clinical Trials 1. ” Adding to this momentum, in December 2022 the U.S.
Alta Sciences
MARCH 4, 2025
We are the leading organization in conducting substance abuse clinical trials, with principal investigators who collectively bring over 50 years of experience in the field of substance abuse, and with a team of physicians who have extensive expertise in identifying participants for substance abuse studies. Tags Clinical Trials Weight 16
Drug Target Review
NOVEMBER 1, 2023
2 Implication of ATX in a large range of human diseases have been highlighted by both fundamental research and clinical trials. 1-5 Implication of ATX in a large range of human diseases have been highlighted by both fundamental research and clinical trials. Andrew McCarthy Andrew is a Team Leader at EMBL Grenoble since 2007.
134 
FDA Law Blog: Biosimilars
JANUARY 15, 2024
FDA published a June 2019 guidance , which stated that manufacturers would not need to perform long-term studies or submit long-term data in PMTAs. FDA said randomized clinical trials could be used, but so could observational studies with respect to cessation data. FDA also directed manufacturers to produce detailed marketing plans.
115 
FDA Law Blog: Biosimilars
MAY 13, 2024
FDA has even gone so far as to maintain that the “real-life clinical performance of a medical product might be more clearly demonstrated through RWD/RWE because a controlled clinical trial often cannot evaluate all applications of a product in clinical practice across the full range of potential users.”
111 
The Pharma Data
APRIL 3, 2021
The CoVIg-19 Plasma Alliance today announced that the Phase 3 Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) clinical trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), did not meet its endpoints. About the ITAC Trial.
Drug Target Review
NOVEMBER 17, 2023
Up until 2023 around 600 NK cell clinical trials have been reported and some 200 are clinically active and still recruiting patients. The vast majority (65/74; 88%) of those trials involved NK cells without CARs; while only 12 percent were CAR-NK studies. CAR-NK cell trials only commenced in 2017 and most are still recruiting patients.
118 
Codon
JANUARY 21, 2024
Human challenge trials were an indispensable part of the development of the malaria vaccine, R21/Matrix-M, endorsed by the World Health Organization last October. But for all of their benefits, human challenge trials have their drawbacks. Jake himself has participated in both Zika and Shigella challenge trials.
126 
The Pharma Data
AUGUST 22, 2021
The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442. The trial included 5,197 participants in a 2:1 randomisation AZD7442 to placebo. The trial was conducted in 87 sites in the US, UK, Spain, France and Belgium.
52 
The Pharma Data
MAY 31, 2022
the completion of enrollment of its Phase 1 (Ph1), open-label trial of pluripotent stem cell-derived dopaminergic neurons in patients with Parkinson’s disease (PD). Ph1 clinical trial is to evaluate the safety, tolerability, and?preliminary?efficacy?of The company was fully acquired by Bayer in 2019. AG, announced?the
52 
The Pharma Data
JANUARY 19, 2021
The Phase 1 clinical trial is planned to be conducted in Canada and targeted to recruit up to 48 and 24 healthy volunteers for the single-ascending dose (SAD) and multiple- ascending dose (MAD) cohorts, respectively. This press release is provided “as is” without any representation or warranty of any kind. Source link.
The Pharma Data
JANUARY 17, 2021
Aruvant has chosen Lonza to help develop and manufacture ARU-1801 for its upcoming pivotal trial. As we advance our gene therapy through clinical trials, this partnership signifies a critical milestone in the development pathway.” Once complete, Lonza will deliver cGMP material supply for the pivotal clinical trial.
52 
FDA Law Blog: Drug Discovery
OCTOBER 2, 2023
Just as the original 1962 efficacy standard makes scientific judgment central to a determination of substantial evidence, the 1997 amendment makes scientific judgment central to a determination of what constitutes sufficient confirmatory evidence to substantiate a single adequate and well-controlled trial.
64 
PLOS: DNA Science
OCTOBER 19, 2023
Last week DNA Science covered a setback in a clinical trial of a gene therapy for Duchenne muscular dystrophy (DMD). The two conditions and the therapeutic approaches differ, but their clinical trials illustrate the importance of selecting patients whose characteristics suggest that they are the most likely to respond.
107 
The Pharma Data
JANUARY 17, 2021
The clinical trial to evaluate the safety and efficacy of the plasma-derived medicine will have doctors Oriol Mitjà and Bonaventura Clotet as the principal researchers and is expected to begin in early 2021. In 2019, Grifols’ economic impact in its core countries of operation was 8.5 BARCELONA, Spain , Jan.
The Pharma Data
JANUARY 31, 2021
Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. EMERYVILLE, Calif. and CHENGDU, China , Feb.
52 
Agency IQ
APRIL 19, 2024
Meet C3TI, FDA’s new clinical trial innovation hub On April 14, FDA announced that its Center for Drug Evaluation and Research (CDER) is launching a new clinical trial innovation hub, the CDER Center for Clinical Trial Innovation (C3TI). set specific standards and expectations for discrete components of clinical trials (e.g.,
The Pharma Data
AUGUST 9, 2021
Positive high-level results from the head-to-head DESTINY-Breast03 Phase III trial showed that Enhertu (trastuzumab deruxtecan), the AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) HER2-directed antibody drug conjugate (ADC), demonstrated superiority over trastuzumab emtansine (T-DM1).
52 
New Drug Approvals
SEPTEMBER 29, 2024
gingivalis DNA was detected in postmortem cortices from people with AD and healthy controls, and in CSF of AD patients ( Jan 2019 news on Dominy et al., Findings Two Phase 1 trials of atuzaginstat were completed by June 2019. This trial involves 93 sites in the U.S. In the same study, they show that in mice, oral P.
Agency IQ
APRIL 12, 2024
Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic.
40 
Drug Target Review
MAY 18, 2023
Tedesco Distinguished Chair of Paediatric Haematology and Oncology, are collaborating as co-principal investigators on a new clinical trial, which has been awarded a $2.3 The trial represents an early-stage effort to determine the viability of this approach. million grant from the National Heart, Lung and Blood Institute.
80 
Eye on FDA
JULY 5, 2022
The most obvious impact is that of COVID-19 to recruiting and maintaining clinical trials. And then there is the fact that a number of clinical trials were being conducted either in Russian or in Ukraine prior to the outbreak of the war. This is not to say that the balance of the year might not make up for the slow first half.
The Pharma Data
AUGUST 3, 2021
Food and Drug Administration (FDA) has determined that OAV-101 intrathecal (IT) clinical trials for spinal muscular atrophy (SMA) patients may proceed, thereby lifting the partial clinical trial hold initiated in October 2019. Novartis today announced that the U.S. SVP, Chief Medical Officer, Novartis Gene Therapies. “We
Perficient: Drug Development
AUGUST 2, 2023
SVS is designed to work with a command line in the background and also provides an interactive interface in Visual Studio 2019. For learning purposes, you can request a trial license as well. Note: Sitecore TDS trial version is valid for 30 days. It provides all the features required for the serialization.
52 
The Pharma Data
MARCH 25, 2021
The approval is based on efficacy and safety from the TRANSCEND NHL 001 trial in patients with R/R B-cell non-Hodgkin lymphoma (NHL) and the TRANSCEND WORLD trial in patients with R/R aggressive B-cell NHL. TRANSCEND NHL 001 / TRANSCEND WORLD Trial Key Results. 78.0] (August 12, 2019 data cutoff). and 70.0% [34.8,
52 
New Drug Approvals
AUGUST 21, 2023
7] A one-year trial did not demonstrate a significant benefit on lung density in moderate-to-severe emphysema secondary to severe α(1)-antitrypsin deficiency. [8] 18] In December 2022, the FDA declined to approve palovarotene for the fibrodysplasia ossificans progressive without additional clinical trial data. [19] Grogan, D.
52 
The Pharma Data
JANUARY 25, 2021
The pharma titan said it will continue its work on clinical trials and manufacturing scale-up for two investigational coronavirus meds, MK-7110 and MK-4482, the latter of which is being developed in collaboration with Ridgeback Bio. Merck obtained the potential COVID-19 treatment in its $425 million acquisition of OncoImmune ( DID , Nov.
52 
The Pharma Data
APRIL 7, 2021
Blood 2019; 134 (Supplement_1): 4790. Blood Adv 2019; 3 (20): 2980–2985. Hill, Rajeshwari Punekar, Jaime Morales Arias, Catherine M Broome, Jun Su; Mortality Among Patients with Cold Agglutinin Disease in the United States: An Electronic Health Record (EHR)-Based Analysis. Berentsen S, et al.
52 
National Institute on Drug Abuse: Nora's Blog
JULY 22, 2024
A study using data from the National Survey on Drug Use and Health (NSDUH) from 2019—that is, pre-pandemic—found that only slightly more than a quarter (27.8%) of people who needed OUD treatment in the past year had received medication to treat their disorder. in that period.
78 
The Pharma Data
JANUARY 17, 2021
Supported by positive clinical, safety, and effectiveness data from clinical trials and real-world evidence reported by leading U.S. This selection method, using criteria validated in the EMPROVE trial, does not require more invasive patient selection methods. 1354-1362, 2019. 548-557, 2019.
52 
The Pharma Data
JANUARY 22, 2021
from the University of Kansas City in Kansas, and colleagues conducted a systematic review of all MM randomized clinical trials (RCTs) from 2005 to 2019 to examine reporting of prevalence, eligibility criteria, and outcomes of patients with RI and MM. Ghulam Rehman Mohyuddin, M.D., Data were included for 123 RCTs.
The Pharma Data
MAY 7, 2021
The US Food and Drug Administration (FDA) announced the awarding of two grants under its Clinical Outcome Assessments (COAs) program to inform the selection of clinical trial endpoints for drugs to treat neurodevelopmental disorders (NDDs) and nephrotic syndrome. . Eglovitch . million for FY21 to fund up to three awards. . Source link.
52 
Vial
MAY 15, 2024
Vial | Pros and Cons The unprecedented consequences of the COVID-19 pandemic gave rise to the advent of decentralized clinical trials (DCTs), which are studies that use telemedicine and remote or local healthcare professionals to enable participants to join from different locations. billion and now functions as a subsidiary.
Metabolite Tales Blog
AUGUST 3, 2023
Active Aldehyde Oxidase Metabolite Who knew that this active hydroxylated metabolite discovered during clinical trials would help unearth some previously unknown structure-activity relationships?
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