Drug Target Review

MARCH 3, 2025

This approach has the potential to revolutionise clinical trial design and lead to more effective, personalised treatments. Since 2013, Jens has been the head of the Developmental and Cellular Biology group at the Luxembourg Centre for Systems Biomedicine (LCSB) and a Professor at the University of Luxembourg.

Disease

Codon

JUNE 2, 2025

A decade passed before, in 2013 , scientist Mark Post would famously create and consume a burger grown from stem cells. The use of this therapy, at this point only authorized in the United States for compassionate use trials for specific, degenerative diseases, was legally allowed in this sculpture due to its “nonliving nature.”

Engineering

New Drug Approvals

JULY 8, 2025

Clinical Trials: Pritelivir is currently in phase II clinical trials, with ongoing research into its effectiveness and safety. Clinical Trials: Pritelivir mesylate is currently under extensive study to evaluate its efficacy and safety profile, with promising results in early clinical trials. References ^ Wilck, M.B.;

Virus

New Drug Approvals

JUNE 25, 2025

PAPER [link] PAPER Bioorganic & Medicinal Chemistry Letters (2013), 23(16), 4571-4578 [link] Figure 1. clinical candidate currently in Phase 2 development. The resulting solid was dried in a vacuum oven overnight to afford the desired material (50.0g) in 81% yield. 1 H NMR (400MHz, CDCl3) δ 9.54 (d, J = 1.56 Hz, 1H), 6.28 (t, J = 0.98

Small Molecule

Codon

NOVEMBER 1, 2024

Although Amodei does acknowledge some real-world issues limiting scientific progress — such as the slow growth of organisms and tedious clinical trials — he mostly passes over the more general tools that will be required to accelerate research in the near term. This essay focuses on how we might do both, specifically for the cell.

DNA

BioPharma Drive: Drug Pricing

JUNE 26, 2025

During Hervé’s tenure, Incyte launched six novel medicines plus two new indications for Jakafi, expanded commercial operations into Europe, Japan and Canada and grew revenues from $355 million dollars in 2013 to $4.2 Incyte expects multiple pivotal trial readouts this year, along with proof-of-concept data for several pipeline candidates.

Therapies

New Drug Approvals

JULY 28, 2025

2] Chiglitazar is under investigation in clinical trial NCT06125587 (Chiglitazar/ metformin in Non-obese Women With PCOS). Efficacy and safety of chiglitazar, a novel peroxisome proliferator-activated receptor pan-agonist, in patients with type 2 diabetes: a randomized, double-blind, placebo controlled, phase 3 trial (CMAP).

Trials

Drugs.com

MARCH 8, 2024

FRIDAY, March 8, 2024 -- Ever since one child, dubbed the 'Mississippi baby,' went into drug-free remission of HIV in 2013, experts have wondered if giving treatment within hours of birth might do the same for others.The results of a new trial.

Treatment

Drug Target Review

MARCH 7, 2024

In 2013 2 , Dr Shokat and his team developed the first cancer drugs to stop a different K-Ras mutation, G12C. Their 2013 research allowed them to develop a template for chemicals that reliably found their way into that corner of the protein. Nature [Internet] 2013 November 20 [2024 March 6]; 503:548-51. Available from: [link]

Treatment

PPD

SEPTEMBER 25, 2023

As the clinical trial landscape evolves, drug developers are faced with novel challenges and changes in study recruitment, trial size and structure, and more. Decentralized Trials Digital and decentralized clinical trials  (DCTs) continue to expand and have become a standard solution for drug developers.

Drug Development

Broad Institute

NOVEMBER 2, 2023

Established in 2013, the Bayer-Broad collaboration is uniquely structured to encourage close coordination and ongoing, face-to-face interactions between researchers at both organizations. As a result of this collaboration, Bayer’s mutant EGFR/HER2 inhibitor is currently in Phase I of clinical trials.

Therapies

The Pharma Data

DECEMBER 23, 2020

In the context of a substantial amount of COVID-19-related research and the launch of numerous clinical trials, the French government created this steering committee to prioritize and accelerate high potential clinical trials. This Phase IIa trial follows a preliminary study conducted by Prof. www.inotrem.com.

Clinical Trials

Vial

JUNE 12, 2024

PROs in clinical trials are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated. What are PROs in clinical trials? In a study on cancer clinical trials, Pe et al. From a regulatory standpoint, agencies like the U.S.

Clinical Trials

LifeSciVC

APRIL 26, 2024

While it may help shake out some incremental advances for the therapeutic armamentarium, this dynamic also clearly creates inefficiencies and waste – both in terms of capital deployment, but also for patients’ engagement and clinical trial activity. Fewer startups over time should ameliorate this crowding dynamic to some extent.

DNA

Drug Hunter

AUGUST 21, 2023

Overall, only a few prodrugs for CNS disorders have even reached clinical trials , so for the most part traditional property-based drug design remains the best bet for the vast majority of programs. 2013 , 56 (1), 2-12. He worked at the University of Kyoto in 2011 and at the University of Münster in 2013. What is K p,uu ?

Drugs

NIH Director's Blog: Drug Development

FEBRUARY 4, 2014

References: [1] Trial watch: phase II and phase III attrition rates 2011-2012. 2013 August. [2] 2013 Apr 11. [3] 2013 August. We just need to assemble the right teams to help us find the right targets—and AMP has the right stuff to do that. Arrowsmith J, Miller P. Nat Rev Drug Discov. 2] Genetics: a gene of rare effect.

Drug Development

Drug Target Review

JUNE 12, 2023

With 13 preclinical candidates and three AI-designed drugs currently undergoing clinical trials, Insilico is spearheading a revolution in cancer treatment and beyond. 2021 – and a robust pipeline that includes 3 AI-designed drugs (for IPF, COVID-19 and cancer) currently in clinical trials.

Metabolic Stability

H1 Blog

NOVEMBER 29, 2023

Breaking the Barriers: How Inaccurate Trial Records Are Delaying Drug Development and Limiting Diverse Patient Populations In an October 2023 report , BMC Medicine completed a follow-up on a 10-year effort to understand, report on and track data sharing challenges with big pharma, specifically for clinical trials.

Clinical Trials

Drug Target Review

NOVEMBER 6, 2023

Throughout his career, he has published more than 300 papers in peer-reviewed journals, served as the principal investigator of more than 60 clinical trials and led two independent National Cancer Institute–funded Specialized Programs of Research Excellence at MDACC and MSKCC. 2013); 108(3): 479-485. Cancers (Basel). 2022;14(9):2182.

Small Molecule

The Pharma Data

AUGUST 5, 2020

Ofatumumab versus teriflunomide in relapsing multiple sclerosis: Analysis of no evidence of disease activity (NEDA-3) from ASCLEPIOS I and II trials. Ofatumumab versus teriflunomide in relapsing multiple sclerosis: baseline characteristics of two pivotal phase 3 trials (ASCLEPIOS I and ASCLEPIOS II). Hauser S, Bar-Or A, Cohen J, et al.

Trials

Drug Target Review

NOVEMBER 1, 2023

The mission of the CCDD is to discover novel small-molecule therapeutics for the treatment of cancer and progress them to hypothesis testing phase 1 clinical trials. 2013) 56, 2059-2073. I work in the Centre for Cancer Drug Discovery (CCDD) at The Institute of Cancer Research in London, which is an academic drug discovery centre.

Fragment Screening

FDA Law Blog: Drug Discovery

DECEMBER 13, 2023

As the Agency fills out GeMDAC’s roster, particularly with those knowledgeable in the fields of small population trial design and other areas related to rare disease medical product development more broadly, it is a significant opportunity for FDA to leverage this expertise beyond products overseen by DRDMG.

Disease

Advarra

JUNE 14, 2022

Often, low accrual or delays in clinical trials stem from an undersized pipeline of potential participants. When site staff must manually find participants for trials, or even when automated recruitment solutions don’t deliver as promised, it puts the trial’s viability at stake, with sites and sponsors in the hot seat.

Clinical Trials

The Pharma Data

NOVEMBER 18, 2021

A private,non-profit institution, LabCentral was innovated in 2013 as a helipad for high implicit life- lores and biotech startups. Each point has a complete molecular biology core installation that allows companies to do trials on day one. Since opening in 2013, MBC BioLabs has helped launch and grow 230 companies.

Molecular Biology

The Pharma Data

JANUARY 4, 2021

was granted with the “Breakthrough Therapy Designation Drug” by the Center for Drug Evaluation (CDE) and currently enter a phase III clinical trial for treatment of patients with small cell lung cancer (SCLC) with disease progression or recurrence after two lines of prior systematic chemotherapy. SHENZHEN, China , Jan.

Therapies

Advarra

JULY 19, 2022

The sponsor is the pharmaceutical company conducting the trial. If you mean using a different contract research organization (CRO) for the different phases of clinical trials – that’s different. Also consider CRO oversight, trial management, data handling and record keeping, as well as allocation of responsibilities.

Packaging

Drug Target Review

FEBRUARY 28, 2024

Preclinical research on γδ T cells has made great strides since the cells were first identified in the 1980s, with γδ T-cell therapies from several companies, including IN8bio, now in or nearing clinical trials for various cancers. Cell Mol Immunol 10(1):21-9 (2013). Chem Immunol Allergy 86:151-183 (2005). Kalyan S, Kabelitz D.

Therapies

The Pharma Data

SEPTEMBER 7, 2020

New pivotal data from ASCLEPIOS trials evaluating the efficacy and safety of Kesimpta in a subgroup of treatment-naïve RMS patients will be presented for the first time 1 . In this extended analysis, Kesimpta showed a safety profile that remains consistent with data reported in the Phase II and III clinical trials 5.

Therapies

New Drug Approvals

SEPTEMBER 13, 2024

2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] hours following a single dose of 10 mg, which supported the 4 mg to 25 mg dosages that aticaprant is being explored at in clinical trials. [13] 2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2]

Treatment

Drug Target Review

SEPTEMBER 26, 2023

This shift occurred following implementation of the Comprehensive in Vitro Proarrhythmia Assay (CiPA) initiative in 2013 and extensive testing of hiPSC-cardiomyocytes with known proarrhythmic drugs. Within the field of drug safety hiPSC-cardiomyocytes are now routinely used for early identification of cardiac liabilities in drug discovery.

Drugs

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] 1 January 2013.

FDA

The Pharma Data

JANUARY 21, 2021

Among his earlier leadership roles in the biotech, pharmaceutical and medical device industries, Caggiano directed the divestiture of Allergan’s LAP-BAND to Apollo Endosurgery in 2013. In 2015, he was hired by Valeant to run the Dendreon business, where he doubled the company’s enterprise value. Caggiano held senior roles at Allergan, Inc.,

Laboratories

The Pharma Data

MARCH 28, 2022

This Phase 1 study was a randomized, placebo-controlled, dose-escalating trial to evaluate BIIB078 administered intrathecally to adults (n=106) with C9orf72-associated ALS. The company has continued to invest in and pioneer research despite making the difficult decision to discontinue a late-stage ALS asset in 2013.

RNA

Drug Target Review

APRIL 8, 2024

Identifying patients who are at high risk for relapse would likely help us isolate those high risk group of patients for more innovative clinical trials. He is the Principal Investigator for the NCI funded ALCHEMIST trial to study the role of erlotinib in patients with early-stage EGFR mutated lung cancer.

Hospitals

The Pharma Data

OCTOBER 14, 2020

Felker’s research focus is on clinical trials in acute and chronic heart failure and the use of biomarkers as diagnostics, prognostic, and therapeutic tools in heart failure. Previously, he was Chief of the Heart Failure Section at Duke University School of Medicine from 2013 to 2020. About Dr. Udelson James E.

Clinical Trials

Drug Target Review

OCTOBER 8, 2024

2013 Aug 20;109(4):934–42. Immuno-PET Using Anticarcinoembryonic Antigen Bispecific Antibody and 68 Ga-Labeled Peptide in Metastatic Medullary Thyroid Carcinoma: Clinical Optimization of the Pretargeting Parameters in a First-in-Human Trial. British Journal of Cancer. Journal of Nuclear Medicine. 2016 May 26;57(10):1505–11.

Pharmacokinetics

The Pharma Data

DECEMBER 20, 2020

Cefepime/enmetazobactam has shown superiority over standard of care in patients with complicated urinary tract infections (cUTIs) in a randomized, controlled, double-blind, global Phase 3 trial. Cefepime/enmetazobactam has been granted Qualified Infectious Disease Product and Fast Track designation by the U.S. and EU based on these results.

Licensing