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.

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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.

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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.

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Clinical Trials Trials FDA Clinical Research 52

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.

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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 ?

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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.

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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.

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Disease Treatment Cell Biology Therapies 52

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.

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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.

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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.

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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.

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Trials Treatment Disease Therapies 52

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.

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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

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Small Molecule Treatment Regulations Drugs 62

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.

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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.

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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.

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Molecular Biology Pharmaceuticals Laboratories Clinical Development 52

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.

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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.

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Packaging FDA Trials Regulations 52

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.

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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.

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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.

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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]

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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.,

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Laboratories Pharmaceuticals Clinical Development Engineering 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] 1 January 2013.

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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.

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RNA Therapies Disease Biosimilars 52

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.

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Hospitals Therapies Clinical Trials Molecular Biology 52

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.

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Pharmacokinetics Engineering Treatment Science 52

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.

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Clinical Trials Therapies Clinical Research Trials 40

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.

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The Pharma Data

DECEMBER 15, 2020

months that we observed in this trial. These positive efficacy results across all endpoints give us a high degree of confidence in their repeatability in a randomized trial and we plan to meet with the regulatory authorities in order to agree on the fastest pathway forward in this indication. Kenilworth, N.J. , Kenilworth, N.J. ,

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Clinical Trials Trials Treatment Therapies 40

The Pharma Data

DECEMBER 28, 2020

Neither the CRL nor this subsequent records request identified or raised any concerns about the clinical or non-clinical data in the NDA and the FDA has not asked Alkermes to complete any new clinical trials to support approval of the application. Washington, DC: American Psychiatric Publishing; 2013. 1 An estimated 2.4

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The Pharma Data

SEPTEMBER 10, 2021

Levodopa/Carbidopa Intestinal Gel (LCIG) Reduces Fluctuations and Shortens Time to On Without Troublesome Dyskinesia in Advanced Parkinson’s Disease: Post-Hoc Analyses of 54-week LCIG-Monotherapy Trial. Adult Patients treated for overactive bladder due to neurologic disease: In clinical trials, 30.6% BOTOX ® Abstracts.

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Doctors Clinical Trials Disease Treatment 52

Metabolite Tales Blog

JULY 5, 2023

Still, of the 34 macrocycles currently in clinical trials, only 18% are de novo designed. A multitude of macrocyclic antiviral drugs The antiviral drug simeprevir (TMC435) was approved for the treatment of chronic hepatitis C in 2013 but has since been discontinued in favour of more effective drugs.

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Drugs Metabolic Stability FDA Approval Treatment 52

Metabolite Tales Blog

JULY 5, 2023

Still, of the 34 macrocycles currently in clinical trials, only 18% are de novo designed. A multitude of macrocyclic antiviral drugs The antiviral drug simeprevir (TMC435) was approved for the treatment of chronic hepatitis C in 2013 but has since been discontinued in favour of more effective drugs.

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Metabolic Stability Drugs FDA Approval Treatment 52

LifeSciVC

OCTOBER 13, 2022

At the same time, there are more gene therapies in development overall than antibodies, with 39 Phase 3 trials ongoing and several companies expected to file for approvals over the next 12 months. million price.

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Therapies Disease Marketing Treatment 40

BioPharma Drive: Drug Pricing

JULY 8, 2025

Since Crews launched Arvinas in 2013, various biotechs have set out with their own spins on the idea, chasing different degrader pathways to the lysosome or proteasome. Though it may not be used across a broader patient population, results from Arvinas and Pfizer’s trial of vepdegestrant offer some validation for degraders’ potential.

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Agency IQ

DECEMBER 15, 2023

This includes questions about the scope of the rule itself and the FDA’s plan for implementation and more granular questions about implications for specific product types, including companion diagnostics (CDx) or LDTs used in drug development as clinical trial assays. The comment period for the proposed rule closed on December 4 th , 2023.

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