Drug Target Review

JUNE 16, 2025

Bioanalysis 2019, 11 (11), 1099–1116. Barry JA, Groseclose MR, Castellino S. Quantification and Assessment of Detection Capability in Imaging Mass Spectrometry Using a Revised Mimetic Tissue Model. Cheng S-H, Groseclose MR, Mininger C, et al.

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Drugs Organic Chemistry Laboratories Pharmaceuticals 52

The Pharma Data

JUNE 12, 2025

All participants met the ACR/EULAR 2019 diagnostic criteria for IgG4-RD and had a minimum IgG4-RD Responder Index (RI) score of 2 or greater at baseline. Importantly, most participants presented with active disease in at least one organ , with the exception of the lymph nodes.

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Disease Clinical Development Treatment Medical Schools 40

Broad Institute

NOVEMBER 4, 2024

Kasper Lage, a Danish-born researcher at Broad, and Niels-Henrik von Holstein-Rathlou, then senior vice president, biomedicine and health sciences, at the Novo Nordisk Foundation (NNF), began chatting in 2019 about the state of the research ecosystem in Denmark and recent scientific advances at Broad.

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Disease Research Science International 72

DrugBank

JUNE 18, 2025

In 2019, the FDA issued a warning letter to Novartis after discovering data integrity violations in its gene therapy submission for Zolgensma , highlighting the need for transparency in regulatory submissions. A lapse in GMP compliance can result in product recalls, production halts, or regulatory warnings.

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Drug Development Clinical Trials Compliance Drugs 52

The Open Targets Blog

JULY 17, 2025

In 2019, as part of David Goldstein’s group, he created ATAV , a population-scale genomic-analysis platform aiming to speed up gene discovery and improve care for patients at Columbia University Medical Center. Nick Ren is an engineer with a lot of experience working alongside geneticists.

Engineering 52

Engineering Research Drugs 52

New Drug Approvals

JULY 25, 2025

Alliance 2019, 2, No. Alliance 2019, 2,No. February 2019). September 2019). July 2019). 2019 Feb 11;2(1). .; Uaesoontrachoon, K.; Srinivassane, S.; Damsker, J. Hoffman, E.P.; Vamorolone targets dual nuclear receptors to treat inflammation and dystrophic cardiomyopathy. e201800186. (76)Boger, e201800186.

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Alta Sciences

MARCH 4, 2025

Beatrice Setnik, PhD, joined Altasciences in 2019, and has been working in clinical drug development and abuse potential assessment since 2005. About the Author Beatrice Setnik, PhD, Chief Scientific Officer.

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Clinical Trials FDA Drug Development Trials 52

The Premier Consulting Blog

APRIL 13, 2025

In 2019, we published a detailed peer-review article outlining this process based on our long history of leveraging existing animal and human data to streamline drug development programs and reduce or eliminate animal testing under the 505(b)(2) pathway.[ 3] Salminen et al.

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New Drug Approvals

MAY 9, 2025

1] [4] It is taken by mouth. [1] 1] [4] Elacestrant is an antiestrogen that acts as an antagonist of estrogen receptors , which are the biological targets of endogenous estrogens like estradiol. [1] 2] Elacestrant was approved for medical use in the United States in January 2023, [1] [2] [5] [6] and in the European Union in September 2023. [3]

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FDA Pharmacokinetics Therapies Treatment 62

Alta Sciences

JULY 18, 2025

ABOUT THE AUTHORS Jean-François Larocque, Principal Scientist, Mass Spectrometry, Altasciences Jean-François joined Altasciences in 2019 and is based in the Greater Montréal Area (Canada). Get in touch with us or one of our colleagues to see how our innovative solutions can speed up your drug development process.

Assay Development 52

Assay Development Small Molecule Laboratories Regulations 52

New Drug Approvals

APRIL 25, 2025

. ^ Han C, Kelly SM, Cravillion T, Savage SJ, Nguyen T, Gosselin F (2019). 20 May 2019. “Synthesis of PI3K inhibitor GDC-0077 via a stereocontrolled N-arylation of -amino acids” Tetrahedron. Elsevier BV: 43514357. doi : 10.1016/j.tet.2019.04.057. 2019.04.057. ISSN 0040-4020. Retrieved 21 September 2023. ^

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Drug Target Review

JUNE 2, 2025

Since 2019, Bertholjotti has played a pivotal role in steering the commercial development of Lonzas bioconjugates sector. His journey began in the early stages of his career, initially working with small molecules as a chemical engineer in development and manufacturing.

Small Molecule 52

Small Molecule Engineering Therapies Drugs 52

The Pharma Data

JUNE 15, 2025

Roche entered into a global collaboration agreement with Sarepta Therapeutics in 2019 to commercialize Elevidys in markets outside the United States. The two companies collaborate closely on the ongoing clinical trials evaluating Elevidys’ safety, tolerability, and efficacy in DMD patients across a range of ages and disease severity.

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Regulations Clinical Trials Trials Treatment 40

New Drug Approvals

JUNE 11, 2025

Archived from the original (PDF) on 18 February 2019. July 2019). . “Azapirone 5-HT1A receptor partial agonist treatment for major depressive disorder: systematic review and meta-analysis” (PDF). Psychological Medicine. 44 (11): 2255–2269. doi : 10.1017/S0033291713002857. PMID 24262766. S2CID 20830020. 55 (7): 423–437.

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FDA FDA Approval Treatment Clinical Trials 62

New Drug Approvals

MAY 17, 2025

Liu A (1 May 2019). . ^ Jump up to: a b New Drug Therapy Approvals 2023 (PDF). Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 10 January 2024. Retrieved 9 January 2024. ^ “Biogen’s antisense ALS drug shows promise in early clinical trial” FierceBiotech. Retrieved 25 April 2023.

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Drug Target Review

MARCH 3, 2025

In 2019, Jens co-founded OrganoTherapeutics SARL, where he currently serves as CEO. 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 52

Disease Treatment Cell Biology Therapies 52

Alta Sciences

JULY 9, 2025

ABOUT THE AUTHOR: KAYLN KOENIG Kaylyn Koenig first joined Altasciences in 2019 as a scientist and was promoted to Principal Scientist in 2023. Contact me or one of my colleagues to see how we could help—we would be happy to answer any of your questions!

Therapies 52

Therapies Molecular Biology Science RNA 52

Codon

JUNE 5, 2025

” Four years earlier, in 2019, Gray had become the first patient with sickle cell anemia — a genetic disorder that causes red blood cells to become sticky and rigid — to receive an experimental treatment using CRISPR genome editing. While crossing Trafalgar Square, Gray paused briefly to reflect on her experience.

DNA 81

DNA RNA Clinical Trials Engineering 81

New Drug Approvals

JUNE 28, 2025

Jump up to: a b “Coronavirus disease 2019 (COVID-19) emerging treatments” BMJ Best Practice US. . “Second Generation Oral Mpro Inhibitor for COVID-19 Treatment Proceeds in Phase 3 Study” Precision Vaccinations. Retrieved 27 December 2023. Archived from the original on 27 December 2023. Retrieved 27 December 2023.

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Clinical Trials Production Treatment Trials 57

thought leadership

MAY 29, 2025

On Wednesday, August 1 st , FDA released a notice with updated prescription drug user fee rates for fiscal year 2019.

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FDA Drugs 52

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.

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Immune Response Treatment RNA Clinical Trials 132

Covalent Modifiers

JULY 8, 2025

2025 [link] The coronavirus disease 2019 (COVID-19) pandemic crisis has been mitigated by worldwide efforts to develop vaccines and therapeutic drugs. However, there remains concern regarding public health and an unmet need for therapeutic options.

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Pharmacokinetics Vaccine Disease Drugs 130

New Drug Approvals

JULY 10, 2025

2019 Feb;40(2):254-263. Petremann M, et al. SENS-401 Effectively Reduces Severe Acoustic Trauma-Induced Hearing Loss in Male Rats With Twice Daily Administration Delayed up to 96 hours. Otol Neurotol. Content Brief] [2]. Petremann M, et al.

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Drugs 62

New Drug Approvals

JUNE 15, 2025

24 September 2024.

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addgene Blog

DECEMBER 12, 2024

But prime editing, a CRISPR technique developed in David Lius lab in 2019, has added considerably more precision and flexibility to the CRISPR editing world. Plus, it can combine different types of edits with one another.

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DNA 98

National Institute on Drug Abuse: Nora's Blog

NOVEMBER 25, 2024

Impact of an unsanctioned safe consumption site on criminal activity, 2010-2019. NSW Bureau of Crime Statistics and Research. 2010 Oct 8; accessed on November 13, 2024: apo-nid22857.pdf pdf Davidson PJ, Lambdin BH, Browne EN, Wenger LD, Kral AH. Drug Alcohol Depend. 2021 Mar 1;220:108521. doi: 10.1016/j.drugalcdep.2021.108521. 2021.108521.

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Drugs Treatment Disease Science 119

New Drug Approvals

APRIL 18, 2025

World Health Organization (2019). . ^ “Neurocrine Biosciences Announces FDA Approval of Crenessity (crinecerfont), a First-in-Class Treatment for Children and Adults With Classic Congenital Adrenal Hyperplasia” (Press release). Neurocrine Biosciences. 13 December 2024. Retrieved 16 December 2024 via PR Newswire. 1 November 2022).

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FDA FDA Approval Drugs Trials 62

New Drug Approvals

APRIL 19, 2025

Archived from the original (PDF) on 16 June 2019. Yamashita T, Nakasu Y, Mizutani H, Sumitani K (2019). The synthesis of 3 in high yields starting from 15 and 19 is described in CN100506814. A further publication disclosing it is US5013734. . 42 (5): 373498. doi : 10.1093/eurheartj/ehaa612. hdl : 1887/3279676. PMID 32860505.

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FDA Clinical Trials Treatment Trials 62

BioPharma Drive: Drug Pricing

JUNE 26, 2025

Incyte expects multiple pivotal trial readouts this year, along with proof-of-concept data for several pipeline candidates.

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FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

The answers below are based on my experience as a reviewer and compliance officer at FDA during the 5-week 2018/2019 government shutdown. During the 5-week shutdown in 2018/2019, PDUFA funding was the most robust and could have funded several months of review operations. What does it mean for FDA staff?

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Government Compliance FDA Licensing 76

Molecular Design

DECEMBER 31, 2024

My general criticism of H2024 is not that the analyses presented by its authors are necessarily invalid but that they fail to provide any useful insight and Ill share an insightful observation by Manfred Eigen (1927-2019): A theory has only the alternative of being right or wrong.

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Small Molecule Drugs Production Science 85

Broad Institute

JUNE 4, 2025

Talk title coming soon By Nadya Karpova June 4, 2025 Talk title coming soon Lorin Crawford Microsoft Research New England (MSR) Add to calendar Talks Search - Any - Fall 2025 Spring 2025 Fall 2024 Spring 2024 Fall 2023 Spring 2023 Fall 2022 Spring 2022 Fall 2021 Spring 2021 Fall 2020 Spring 2020 Fall 2019 Spring 2019 Fall 2018 Spring 2018 Fall 2017 (..)

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Research 40

Drug Patent Watch

DECEMBER 18, 2024

A 2019 survey by the World Intellectual Property Organization (WIPO) found that inadequate prior art searches were responsible for 32% of patent application rejections[2]. Sources cited: Tufts Center for the Study of Drug Development, 2021 World Intellectual Property Organization (WIPO), 2019 Source

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Pharmaceuticals Drugs Drug Development Marketing 92

New Drug Approvals

JUNE 18, 2025

Publication numberPriority datePublication dateAssigneeTitle CN1413976A *2002-09-132003-04-30苏州君宁新药开发中心有限公司New process for preparing levo-albuterol US20050261368A1 *2004-05-202005-11-24Valeriano MerliPreparation of levalbuterol hydrochloride CN103951568A *2014-05-192014-07-30苏州弘森药业有限公司New process for synthesizing salbutamol and sulfate of salbutamol (..)

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Production International 62

Conversations in Drug Development Trends

JANUARY 6, 2025

In contrast, an adaptive trial design allows for modifications to an ongoing trial and its analyses under a pre-specified framework, which is outlined in the FDAs Adaptive Designs for Clinical Trials for Drugs and Biologics Guidance for Industry, published in 2019.

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Trials Clinical Trials Treatment Disease 75

FDA Law Blog: Biosimilars

APRIL 8, 2025

Since 2019, when DPD took over this process, the Division has published more than 600 ANDA withdrawals at the request of generic drug manufacturers. Processing voluntary ANDA withdrawals under 21 C.F.R. 314.150(c). Managing the process of issuing Covered Product Authorizations (CPAs) under the CREATES Act.

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The Pharma Data

JUNE 11, 2025

As co-rapporteur of the 2019 IPU resolution on universal health coverage , he reminded participants that many of the lessons from past Assemblies remain relevant today—especially the need for coordinated legislative action in times of crisis.

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