KIF1A

JUNE 17, 2023

Research to develop new rare disease therapies underway at The Jackson Laboratory In the rare disease space, it takes a village – only through collaboration between clinicians, researchers, regulators, and patients can we develop effective treatments for devastating disorders.

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FDA Law Blog: Biosimilars

JUNE 28, 2023

In accordance with amendments made to section 514 by the FDA Reauthorization Act of 2017 (FDARA), and as part of the enactment of the Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA was directed to issue guidance regarding the goals and implementation of the ASCA Pilot.

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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. Food and Drug Administration (FDA).

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Drug Target Review

NOVEMBER 17, 2023

CAR-NK cell trials only commenced in 2017 and most are still recruiting patients. Alan founded the Monash Immunology and Stem Cell Laboratories at Monash University (2004-7). He was the founding CEO of the Australian Stem Cell Centre. He is presently the founding CEO/President of the start-up company Cartherics Pty Ltd.,

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Drug Patent Watch

JANUARY 9, 2025

In 2017, small and medium-sized biotech companies accounted for 51% of FDA market approvals, while large pharma companies were the originators in only 28% of approvals[4]. A CDMO should have a mature data integrity program in place, especially in the laboratory.

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Metabolite Tales Blog

MAY 31, 2023

A recent paper by Kevin Kobylinski and colleagues looks at the activity of key metabolites of ivermectin to explain why the mosquito-lethal effect of ivermectin in clinical trials exceeds that predicted from in vitro laboratory experiments [3]. J Antibiot 70 , 495–505 (2017). Download the paper to find out more. and Rabinovich, N.R.

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Drug Target Review

SEPTEMBER 4, 2023

He has over two years of experience in research and laboratory work. 2017): Antitrypanosomatid drug discovery: an ongoing challenge and a continuing need, Nature Review Microbiology, 15(4): 217–231. References: Antunes Luisa (2023). doi.org/10.5772/intechopen.770301 770301 Mark, C. Michael, A. and Ian, H. doi:10.1038/nrmicro.2016.193.

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Common Sense for Drug Policy Blog

JUNE 6, 2024

Analogous substances like post-cycle therapy drugs and human growth hormone, on the other hand, are generally produced in licit pharmaceutical laboratories in jurisdictions with more lax regulations and subsequently imported or removed from domestic pharmaceutical supply chains by illicit actors (Fink et al. 2017 ; Greenway and Price 2018 ).

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NIH Director's Blog: Drug Development

DECEMBER 4, 2018

National Laboratory, which is orbiting about 400 kilometers above Earth. To find out, NIH-funded researchers are loading a few dozen human tissue chips—tiny, 3D devices bioengineered to model different tissues and organs—onto a SpaceX Dragon cargo spacecraft that will ferry supplies to the International Space Station (ISS) U.S.

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The Pharma Data

JUNE 7, 2023

PREVYMIS is an antiviral agent that was initially approved by the FDA in 2017 for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). PREVYMIS is administered once-daily as an oral tablet or as an injection for intravenous infusion.

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The Pharma Data

OCTOBER 21, 2020

DeFord, who joined BD through the 2017 acquisition of C. Dave’s leadership in the Diagnostics space has been on full display during the pandemic, as his team rallied around our purpose and delivered innovative laboratory and point-of-care COVID-19 testing solutions in record time.” John DeFord to retire.

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Agency IQ

FEBRUARY 2, 2024

one of the major headlines for diagnostic regulation is the proposed rule for laboratory developed tests (LDTs). Historically, LDTs were considered to be “home brewed” tests – that is, they were made and intended for use in a single clinical laboratory, and therefore were used in a small volume of patients. That depends.

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The Pharma Data

NOVEMBER 25, 2020

2017 Oct;92(10):1068-1078. Pica associated with iron deficiency or depletion: clinical and laboratory correlates in 262 non-pregnant adult outpatients. Last accessed: June 2018. Cappellini MD et al. Iron deficiency across chronic inflammatory conditions: International expert opinion on definition, diagnosis, and management.

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Agency IQ

NOVEMBER 3, 2023

Top questions on FDA’s proposed LDT rule: Carve outs, capacity and quality systems A month after the FDA published its proposed rule to enforce regulatory requirements on laboratory developed tests (LDTs), AgencyIQ has some outstanding questions. IVDs are regulated as medical devices in the U.S.,

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Drug Target Review

SEPTEMBER 19, 2023

Some of the complex 3D models such as organoids and organ-on-chips have brought in realistic make-over to the drug screening and paved way into implementing high content screening, laboratory automation and miniaturisation in primary drug screening process.

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The Pharma Data

NOVEMBER 19, 2020

Clinically, he is the Medical Director of the Cochlear Implant Team and faculty in the Auditory Genetics Laboratory of the Ear and Hearing Center. Dr. Greinwald received his undergraduate B.S. degree from Wofford College and his M.D. degree from the Medical University of South Carolina.

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Drug Target Review

DECEMBER 5, 2024

1 In 2017, the US Food and Drug Administration (FDA) approved the first AAV-based gene replacement therapy (Luxturna), for Leber congenital amaurosis type 2. Available from: [link] About the author Dr Chelsea B Pratt, BioPharma Segment Marketing Manager at Bio-Rad Laboratories Inc. Bio-Rad, Bulletin 3725 [cited 2024 Oct 28].

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Drug Target Review

MAY 23, 2023

Regulation (EU) 2017/2470 maintains this list within the novel food catalogue. Dr Federica Ungaro Federica is head of the Experimental Gastroenterology Laboratory at San Raffaele Hospital, Italy. The legislation governing this list is for consumer protection and also applies to algae that are intended for use as food.

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Agency IQ

AUGUST 18, 2023

BY COREY JASEPH, MS, RACAUG 11, 2023 4:47 PM CDT Quick refresher on the European regulations Europe enacted the medical device and IVD regulations in May 2017 but gave manufacturers and other stakeholders, including the regulators themselves, time to implement them. reference laboratories. regulators. implementing acts on E.U.

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The Pharma Data

APRIL 4, 2022

Dupixent was also granted Orphan Drug designation for the potential treatment of EoE in 2017. FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients aged 12 years and older with EoE. Regulatory filings around the world are also planned in 2022.

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The Pharma Data

MARCH 16, 2022

Johnsson has been Director of the Chemical Biology Department at the Max Planck Institute for Medical Research in Heidelberg since 2017. They could also make it possible to further develop sustainable food systems and achieve ambitious CO2 reduction targets. He is also a co-founder of several companies.

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Broad Institute

OCTOBER 4, 2023

In this case the prize is designed to honor not just technologies that are exciting in the laboratory but technologies that have had an impact on public health and clinical care.” “There are a lot of prizes in biomedical science, but very few of them are focused on technology,” he said.

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The Pharma Data

DECEMBER 17, 2020

Martin Carter Professor in Clinical Investigation and Head of the Laboratory of Investigative Dermatology at The Rockefeller University and Weinblatt is the co-director of Clinical Rheumatology at the Brigham and Women’s Hospital. Smith joined SpringWorks at the company’s inception in 2017 and was a founding member of the management team.

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Agency IQ

NOVEMBER 27, 2023

The most common way that chemicals are added into Proposition 65 is through the Labor Code mechanism , which requires the addition of chemicals identified as causing cancer in human or laboratory animals by the World Health Organization’s International Agency for Research on Cancer (IARC).

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The Premier Consulting Blog

JULY 9, 2023

Impurities or degradants that exceed qualification thresholds and have not been adequately tested in Good Laboratory Practices (GLPs) toxicology studies are often encountered during development. As they increase further in amount, then they may need to be qualified. link] ICH M7 (R2)- Q&A.

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The Pharma Data

MARCH 17, 2021

The approval is also based on supportive data from an updated analysis of the KEYNOTE-087 trial; KEYNOTE-087 was the basis for the 2017 EC approval of KEYTRUDA for the treatment of adult patients with relapsed or refractory cHL who have failed ASCT and BV or who are transplant ineligible and have failed BV. months versus 8.3

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KIF1A

MAY 31, 2024

Advancing Research at the Chung Lab Recent Move to Boston Children’s Hospital Wendy Chung, MD, PhD, and her team have been our leading partners since the founding of KIF1A.ORG in 2017. In 2017, the Chung Lab launched the first and only global KIF1A Patient Registry and Natural History Study with funding from KIF1A.ORG.

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Agency IQ

APRIL 8, 2024

Notably, the MDR allows the Commission to establish fees for provision of scientific advice by expert panels or expert laboratories through the means of implementing acts (via the examination procedure ). BY COREY JASEPH, MS, RAC | APR 3, 2024 6:20 PM CDT Quick background on the expert panels and the scientific advice pilot The E.U.

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The Pharma Data

DECEMBER 3, 2020

Mayes joins Antios following the acquisition of Engage Therapeutics where he served as CEO from 2017 until its acquisition. Previously, he served as president, general counsel and a board member at Unigene Laboratories. Prior to Engage, he was chief operating officer at Advaxis Immunotherapies.

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Agency IQ

AUGUST 18, 2023

EPA labs lack proper inspections, watchdog says The Environmental Protection Agency’s Office of Inspector General has published a new report finding that the agency has consistently failed to verify whether agency laboratories comply with hazardous waste requirements. To contact the author of this analysis, please email Walker Livingston.

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Codon

APRIL 9, 2024

Tu’s laboratory record lists Artemisia annua L. Credit: Tu Youyou Nobel Lecture As part of their effort to thoroughly document this project, Zhang, Li, and Rao published a 500-page oral history in 2015 and a monograph on the Project in 2017 that addressed sources in both Chinese and English. as Experiment No.

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The Pharma Data

JUNE 7, 2022

The investment will expand the production of active pharmaceutical ingredient (API) and registered starting materials (RSMs) used in the manufacture of nirmatrelvir, a novel main protease (M pro ) inhibitor originating in Pfizer’s laboratories, which will create more than 250 additional high-skilled jobs at Pfizer’s Kalamazoo site.

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Agency IQ

AUGUST 16, 2024

Throughout 2017, Lykos sought feedback on the protocol for its first Phase 3 study, MAPP1, via the Special Protocol Assessment (SPA) process. Following some back-and-forth regarding statistical analyses and endpoints and abuse potential studies, the agency agreed to a revised SPA in July 2017.

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The Pharma Data

JANUARY 3, 2021

Preclinical data from our laboratory have shown that the nasal administration of anti-CD3 stimulates Tregs that can suppress inflammation and ameliorate inflammatory diseases. Furthermore, nasal anti-CD3 dampens cytotoxic CD8 T cell responses that are known to cause lung damage in COVID-19 patients.”.

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Agency IQ

JUNE 7, 2024

The report, requested by Congress, reviewed the total BIMO inspections over the last decade, citing an increase annually year-over-year in inspections through 2017, and then decline to a low of 477 inspections in 2021 (notably, the same year that BIMO RRAs peaked).

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Agency IQ

MAY 28, 2024

Medical Device Regulation (MDR; Regulation (EU) 2017/745 ). which now has separate regulations for medical devices and IVDs (IVDR; Regulation (EU) 2017/746 ). In house” devices are those created and used in a single laboratory, and are known in the U.S. as laboratory developed tests (LDTs). “In This differs from the E.U.,

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The Pharma Data

NOVEMBER 10, 2020

This potentially ground-breaking approach for immunotherapies originated in my laboratory and was subsequently reported by other researchers in the field.”. 2017) Oral treatment with foralumab, a fully human anti-CD3 monoclonal antibody, prevents skin xenograft rejection in humanized mice. Clin Dev Immunol 2012, 425021. Shailubhai, K.,

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