Perficient: Drug Development

JANUARY 30, 2025

Kubernetes was invented by Google in 2013 and was handed over to CNCF (Cloud Native Computing Foundation), which is a part of the Linux Foundation. However, Kubernetes is not handled by a single entity; instead, it is a contribution from a worldwide community or developers.

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The Pharma Data

JANUARY 4, 2021

Chiauranib obtained Phase I clinical trial approval from the former China Food and Drug Administration (CFDA) in August 2013 , and completed multiple Phase II clinical trials with monotherapy or combined therapy for different types of malignant tumors in China , showing positive clinical efficacy and well tolerance in tumor patients.

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FDA Law Blog: Drug Discovery

DECEMBER 13, 2023

Drug development for these conditions has unique and complex challenges, therefore few treatments are available to patients.” GeMDAC’s mandate is to advise the Agency on these complicated issues in this challenging area of medical product development. irritable bowel syndrome, primary biliary cholangitis).

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Drug Target Review

NOVEMBER 6, 2023

Before joining AstraZeneca, he served as the Chief of the Lymphoma Service at Memorial Sloan Kettering Cancer Center (MSKCC) and led a laboratory focused on drug development for patients with lymphoid malignancies. 2013); 108(3): 479-485. Cancers (Basel). 2022;14(9):2182. Published 2022 Apr 27. Br J Cancer.

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NIH Director's Blog: Drug Development

OCTOBER 30, 2018

Now comes word of another absolutely incredible use of cryo-EM: determining with great ease and exquisite precision the structure of the smaller organic chemical compounds, or “small molecules,” that play such key roles in biological exploration and drug development. 2013 Nov 19;2:e01345. [4] Angew Chem Int Ed Engl. 2018 Oct 16.

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NIH Director's Blog: Drug Development

MARCH 11, 2014

Nat Rev Drug Discov. 2013 Aug;12(8):581-94. [3] 2013 Oct 1;123(10):4513-24. [6] In addition to T2D, AMP will initially focus on two other disease areas poised for rapid progress: Alzheimer’s disease and the autoimmune disorders, lupus and rheumatoid arthritis. Flannick J, et al. 2014 Mar 2. [2] J Clin Invest.

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Drug Target Review

NOVEMBER 1, 2023

2013) 56, 2059-2073. What is different though, is that because we are an academic drug discovery centre, publication of our drug discovery research is integral to our mission. In addition, and in line with ICR’s strategy, part of our remit is to train the next generation of cancer drug discoverers. Acta Cryst.

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Drug Target Review

SEPTEMBER 26, 2023

Within the field of drug safety hiPSC-cardiomyocytes are now routinely used for early identification of cardiac liabilities in drug discovery. The CiPA initiative aims to engineer an assay to assess the proarrhythmic potential of new drugs with improved specificity compared to current methods.

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NIH Director's Blog: Drug Discovery

MAY 26, 2016

He envisions generating within a matter of days or weeks the precise structure of an average-sized protein involved in a disease, and then potentially handing it off as an atomic model for drug developers to target for more effective treatment. 2013 Dec 20;342(6165):1484-1490. [2] Earl LA, Milne, JLS, Subramaniam S.

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The Pharma Data

DECEMBER 22, 2020

Since 2013, Rakuten Medical, Inc. has been using an exclusively licensed antibody complex to develop new cancer therapies based on its Illuminox TM technology platform. For more information, visit www.rakuten-med.com. About ASP-1929.

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The Pharma Data

JANUARY 6, 2021

The approach used to turn botulinum toxin into a kind of Trojan horse that delivers a cargo into neurons has enormous potential for future drug development,” noted Thomas C. Südhof, M.D.,

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PPD

JULY 9, 2024

Drug developers need to staff RA teams that can handle regular lifecycle maintenance ebbs and flows across lifecycle maintenance tasks, and plan for a workload that sometimes requires senior-level expertise, while at other times is much more suited to support staff. However, completing this work is only half the challenge.

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Perficient: Drug Development

OCTOBER 7, 2024

Andrea later moved to a different company where she managed projects and helped create a product group that developed software to sell services. That company was acquired by Perficient in 2013. At Perficient, Andrea first served as a Director, managing large client engagements and helping to build the Data Solutions team.

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The Pharma Data

JANUARY 7, 2021

About ASP-1929 Since 2013, Rakuten Medical, Inc. has been using an exclusively licensed antibody complex to develop new cancer therapies based on its Illuminox TM technology platform. For more information, visit www.rakuten-med.com.

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The Pharma Data

JANUARY 13, 2021

Lancet Respir Med 2013. . Secondary Endpoints: Safety and tolerability, time to recovery, duration of hospitalization, improvements in clinical status, supplemental oxygen use, proportion of patients requiring mechanical ventilation and mortality. Franciosi LG, et al., . Verona Pharma plc.

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New Drug Approvals

SEPTEMBER 13, 2024

4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] 12] Positron emission tomography imaging revealed that brain KORs were almost completely saturated by the drug 2.5 March 2013). Drug Discovery.

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LifeSciVC

OCTOBER 13, 2022

Ingredients for success When you think about it, success in gene therapy is not really dependent on patents and traditional drug development methodologies and functions. Now is the time to invest in this space — here are several factors to consider as you weigh your options. million price.

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The Pharma Data

NOVEMBER 29, 2020

Human Cytomegalovirus Resistance to Antiviral Drugs. Available at: [link] 2 Nephrol Dial Transplant (2013) 28: 2908–2918 3 Centers for Disease Control and Prevention. Gilbert C and Boivin G. Antimicrobial Agents and Chemotherapy. 2005; 49(3):873-883. About Cytomegalovirus (CMV). Kidney transplant waiting list.

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The Pharma Data

APRIL 25, 2021

In Japan, nirsevimab was also selected by the Japan Agency for Medical Research and Development (AMED) as “a medicine for prioritized development” under the Project for Drug Selection to Promote New Drug Development in Pediatrics. . About Sanofi. . Antimicrobial Resistance and Infection Control , vol.

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The Pharma Data

DECEMBER 15, 2020

Pancreatic cancer remains an area of unmet medical need, with no new approved therapies since the approval of nab-paclitaxel (Abraxane ® ) in combination with gemcitabine for first-line treatment in 2013 and Onivyde ® in combination with fluorouracil and leucovorin for second-line treatment in 2015. as well as Champions Oncology Inc.,

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Agency IQ

OCTOBER 20, 2023

In terms of general drug development considerations during the early phase, sponsors should consider obtaining Phase 1 data that demonstrate that the candidate drug has adequate penetration to the outer skin layers, after consultation with the agency about drug penetration study technique.

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The Pharma Data

DECEMBER 27, 2020

2013 Feb 7;121(6):893. QARZIBA ® is a registered trademark of EUSA Pharma. i Moreau P, Richardson PG, Cavo M, et al. Proteasome inhibitors in multiple myeloma: 10 years later. 2012 Aug 2;120(5):947-59. ii Kortuem KM and Stewart AK. Carfilzomib. iii Amgen Data on File. View source version on businesswire.com: [link]. Source link.

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Codon

APRIL 9, 2024

Department of Defense administered mefloquine, the synthetic drug developed at Walter Reed in the U.S., only issued “the strongest ‘black box’ warning” against the drug in 2013. only issued “the strongest ‘black box’ warning” against the drug in 2013.

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Agency IQ

AUGUST 9, 2024

EMA’s psychedelic workshop leaves stakeholders with as many questions as answers Earlier this year, the EMA hosted a multi-stakeholder workshop to discuss regulatory issues surrounding drug development of psychedelic products. EMA has now published a report on the workshop; read on for AgencyIQ’s analysis.

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The Premier Consulting Blog

APRIL 25, 2023

Opinions regarding how the new act will impact the industry vary, with predictions ranging from everything remaining at the status quo to the end of animal testing for new drug development and approvals. 6] US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER).

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NIH Director's Blog: Drug Development

SEPTEMBER 18, 2014

Companies could partner with the network, bringing promising drug candidates to patients who need therapeutic options. This approach could help attract private industry drug development while providing desperately needed tools for healthcare practitioners. Note: Anthony S. Fauci, M.D.,

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FDA Law Blog: Drug Discovery

JANUARY 23, 2023

This requirement, enacted under section 3601 of Food and Drug Omnibus Reform Act (FDORA), will apply to clinical trials that commence enrollment 180 days after FDA finalizes guidance on the topic.

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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

JANUARY 16, 2025

Considering the impact drug-like properties have on the chance of success. Drug Discovery Today , 18(13-14):659666, 2013. Journal of Medicinal Chemistry , 59(6):23122327, 2016. Yusof I, Segall MD. Bhardwaj G, OConnor J, Rettie S, et al. Accurate de novo design of membrane-traversing macrocycles. Cell , 185(19):35203532, 2022.

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SugarCone Biotech

MAY 28, 2019

This was an interesting finding and one that I think remains under-appreciated by the immuno-oncology drug development field. Not by coincidence the list overlaps with the phases of the tumor-immunity cycle ( Chen & Mellman, 2013 ). Fifth: associated lymphoid tissues and organs.

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Agency IQ

JULY 28, 2023

DSCSA implementation – Down to the wire as a deadline draws near: The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 as part of the Drug Quality and Security Act (DQSA), following several drug counterfeiting scandals in which falsified medical products entered the supply chain.

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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.

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