New Drug Approvals

SEPTEMBER 13, 2024

14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] 21] In August 2017, it was announced that Cerecor had sold its rights to aticaprant to Janssen Pharmaceuticals. [22] 22] [21] Janssen was also experimenting with esketamine for the treatment of depression as of 2017. [21] Dhir A (January 2017).

Treatment

PPD

OCTOBER 12, 2023

Since chimeric antigen receptor T cell (CAR-T) therapy was first approved in 2017, there has been a marked increase of cell and gene therapy studies resulting in significant changes in the way diseases are treated as well as patient outcomes. However, key differences between PCR assays and immunotherapeutic assays must be considered.

Laboratories

The Pharma Data

JANUARY 19, 2021

The secondary objective is to assess the pharmacokinetic profile of SAD and MAD of ALS-4 administered orally to healthy subjects. Aptorum also has projects focused on microbiome research and the commercialization of a natural supplement product targeted for women undergoing menopause and experiencing related symptoms. About ALS-4.

Small Molecule

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Alternative methods will require significant research investment to demonstrate their utility for a particular context of use and inform regulatory decision-making. In 2019, FDA formed an agency-wide Alternative Methods Working Group indicating that it viewed the applicable scope of alternative methods to go beyond just toxicology research.

Animal Testing

The Pharma Data

MARCH 22, 2021

In December 2017, Roche licensed the investigational molecule from Ionis Pharmaceuticals. Neuroscience is a major focus of research and development at Roche. GEN-EXTEND: an open label extension study for participants coming from any Roche HD study. Participants receive 120mg tominersen every-2-months or every-4-months in the study.

Disease

The Pharma Data

DECEMBER 20, 2020

Pending Health Canada’s approval, the Phase 1 trial is designed to test the safety, tolerability and pharmacokinetics of ALS-4 in healthy volunteers. The secondary objective is to assess the pharmacokinetic profile of SAD and MAD of ALS-4 administered orally to healthy subjects. About ALS-4.

Small Molecule

The Pharma Data

JANUARY 3, 2021

With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company. Inozyme Pharma was founded in 2017 by Joseph Schlessinger, Ph.D., Demetrios Braddock, M.D.,

Clinical Trials

The Pharma Data

DECEMBER 15, 2020

Researchers are aware of more than 80 diseases that occur when the immune system attacks the body’s own organs, tissues and cells. The researchers regulated the abnormal immunological memory processes found in these patients. The secondary outcome involves pharmacokinetic endpoints. It may be life-threatening.

Disease

Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

Drug Development

Metabolite Tales Blog

DECEMBER 13, 2023

8(2):3640-3648; [link] [11] Pharmacokinetics of the Multi-kinase Inhibitor Pexidartinib: Mass Balance and Dose Proportionality. Chemical Research in Toxicology 36 (8), 1427-1438; [link] [13] Oxetane Promise Delivered: Discovery of Long-Acting IDO1 Inhibitors Suitable for Q3W Oral or Parenteral Dosing. J Pharm Biomed Anal. Oncotarget.

Small Molecule

Agency IQ

AUGUST 16, 2024

The road to research on psychedelic products is paved with obstacles. This means that research programs are subject to additional oversight from U.S. FDA released a draft guidance in June 2023 attempting to address many of these unique aspects of clinical research on psychedelic substances.

FDA

The Pharma Data

APRIL 8, 2021

We are proud to collaborate with patient advocates, academia, industry and the broader healthcare community through cutting-edge research and partnerships to advance the scientific understanding of neurological conditions, which have historically been among the hardest disorders to study, diagnose and treat.”. Claims Database.

Clinical Trials

Agency IQ

SEPTEMBER 15, 2023

In 2017, the FDA expanded the restrictions , which include behind-the-counter sale requiring photo identification with a per-month individual purchase quota, to products containing ephedrine and phenylpropanolamine — effectively narrowing the decongestant drugs approved for over-the-counter sale.

Science

New Drug Approvals

JANUARY 31, 2024

citation needed ] The pharmacokinetic properties of obeldesivir and improved was first published by Chinese researchers in May 2022. 2017, 60, 1648-1661) in tetrahydrofuran (THF) was added N,N-dimethylaminopyridine (DMAP) (0.03 The Chinese group pursued investigation of obeldesivir independently from Gilead Sciences.

RNA

Metabolite Tales Blog

MARCH 1, 2023

Bicyclic structures containing five membered rings such as indoles, consisting of a six-membered benzene ring fused to a five-membered pyrrole ring, are also increasingly relevant as growing research fields such as psychedelics make use of these scaffolds, often found in natural products. 2017, 30, 1, 13–37 [link] 2a Drug Metab.

Metabolic Stability

Agency IQ

FEBRUARY 23, 2024

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

Science

The Pharma Data

OCTOBER 27, 2020

and RESEARCH TRIANGLE PARK, N.C. , Research and development expense. The table below summarizes research and development expense by major category (dollars in millions): . Research and development projects. SILVER SPRING, Md. .

FDA

The Premier Consulting Blog

APRIL 25, 2023

In silico population pharmacokinetic (popPK) and physiologically-based pharmacokinetic (PBPK) modeling can reduce or eliminate certain clinical studies, as was done with the 505(b)(2) approval of the long-acting injectable Aristada® (aripiprazole lauroxil). [8] Applications covered by Section 505(b)(2) – draft guidance for industry.

FDA

The Pharma Data

NOVEMBER 6, 2020

Since October 2017 Biogen and Eisai have collaborated on the development and commercialization of aducanumab globally. Secondary outcomes were: (1) the effect of aducanumab on brain amyloid plaque content as measured by [18F]-florbetapir PET, (2) the pharmacokinetics of aducanumab and (3) the immunogenicity of aducanumab. About Biogen.

Disease

Agency IQ

DECEMBER 11, 2023

Oncology at FDA in 2023: A quick glance at the numbers First created under the 21st Century Cures Act of 2016 and launched in 2017, FDA’s Oncology Center of Excellence (OCE ) “unites experts across the FDA to conduct expedited review of medical products for oncologic and hematologic malignancies.” months, according to the GSK presentation.

FDA

The Pharma Data

MARCH 16, 2021

Vice President, Rheumatology Disease Area Leader, Janssen Research & Development, LLC. for the treatment of adults with moderate to severe plaque PsO in July 2017 and in July 2020 for adults with active PsA. TREMFYA was approved in the U.S. 4,5 Complete study results were previously published in The Lancet.

Treatment

The Pharma Data

MARCH 16, 2021

Evrysdi was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by FDA and EMA in 2017 and 2019, respectively. Neuroscience is a major focus of research and development at Roche. The study met its primary endpoint. The study has completed recruitment (n=174). About Roche in Neuroscience.

Pharmacokinetics

Agency IQ

FEBRUARY 15, 2024

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

FDA

The Pharma Data

SEPTEMBER 15, 2020

I am proud of the truly transformational science that our research and clinical teams are bringing to the fight against disease, as well as the unprecedented speed with which we are advancing our clinical programs in the battle against COVID-19. THERAPEUTIC AREAS OF FOCUS.

Vaccine

Drug Target Review

OCTOBER 4, 2023

The research community pressed on, turning to novel compounds that were substantially more potent than those used in the first generation. Some researchers are now investigating ways to interrupt protein synthesis and catabolism within tumours. These developments give researchers the tools to craft better therapeutics.

Small Molecule

Agency IQ

AUGUST 16, 2024

What came before this final guidance Dose optimization for oncology products has been an issue flagged for improvement even prior to the creation of FDA’s Oncology Center of Excellence (OCE) in 2017. In parallel, stakeholders have advocated for recognizing the importance of treatment tolerability when determining doses and regimens.

Production

The Pharma Data

FEBRUARY 25, 2021

The researchers also assessed motor function with the Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND), a scale used for infants with Type 1 SMA. Neuroscience is a major focus of research and development at Roche. months after receiving the last dose of study drug. mg/kg for Part 2.

FDA Approval

The Pharma Data

FEBRUARY 8, 2021

Vice President, Late Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. “In In our commitment to advance the science and treatment of prostate cancer, these findings will help inform our research efforts in developing novel approaches and combinatory regimens to improve outcomes for these patients.”.

Pharmaceutical Companies

The Pharma Data

SEPTEMBER 27, 2020

Risdiplam was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by FDA and EMA in 2017 and 2019, respectively. About Roche in Neuroscience Neuroscience is a major focus of research and development at Roche. The study met its primary endpoint.

FDA Approval

The Pharma Data

OCTOBER 6, 2021

Safety, tolerability, and pharmacokinetics of MEDI8897, the respiratory syncytial elixir prefusion F-targeting monoclonal antibody with an extended half- life, in healthy grown-ups. 2017; 61 (3) e01714-16. Griffin MP, et al. Antimicrob Agents Chemother. Yu XQ, et al. Antimicrob Agents Chemother. 2016; 61 (1) e01020-16.

Pharmacokinetics

The Pharma Data

AUGUST 22, 2021

Safety, Tolerability, and pharmacokinetics of MEDI8897, the respiratory syncytial virus prefusion F-targeting monoclonal antibody with an extended half-life, in healthy adults. 2017; 61(3): e01714-16. Griffin MP, et al. Antimicrob Agents Chemother. Yu XQ, et al. Antimicrob Agents Chemother. 2016; 61 (1): e01020-16.

Trials

New Drug Approvals

MAY 30, 2025

hashtag#Lotilaner For more information blog: [link] Research Tarsus Pharmaceuticals has conducted phase II studies of lotilaner as a remedy to prevent tick bites in humans. [16] Kuntz EA, Kammanadiminti S (November 2017). 2017 Nov 1;10(1):530. 26 July 2023. Retrieved 17 March 2024. 29 April 2024. Retrieved 17 June 2024.

FDA Approval

Drug Target Review

APRIL 25, 2025

19 Multi-organ CIVMs provide several new opportunities in ADME including in vitro bioavailability predictions, assessment of the effect of gut microbiome on hepatic drug metabolism, and prediction of the pharmacokinetic (PK) profile in humans in early pre-clinical stage. Nature Communications 2017 8:1 8 (2017) 18.

Clinical Development