The Pharma Data

OCTOBER 26, 2020

Fast Track designation allows for early and frequent communication with the FDA throughout the entire drug development and review process. Prevail was founded by Dr. Asa Abeliovich in 2017, through a collaborative effort with The Silverstein Foundation for Parkinson’s with GBA and OrbiMed, and is headquartered in New York, NY.

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The Pharma Data

JANUARY 31, 2021

These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.” Trimer-Tag© is an innovative drug development platform which allows the production of novel, covalently-trimerized fusion proteins. S-Trimer is intended to be adjuvanted. About CEPI.

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The Pharma Data

DECEMBER 8, 2020

AbCellera’s AI-powered antibody discovery platform speeds the otherwise lengthy and grueling process by analyzing the database of natural immune systems to find antibodies that can be developed into drugs. Tackle the toughest problems in drug development.” The promise to partners is to “move quickly. Reduce cost.

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Advarra

AUGUST 10, 2023

Given the relatively small populations affected by any one rare disease or condition, a pharmaceutical company developing an orphan drug may reasonably expect the final approved drug to generate relatively small sales (when compared with the drug development costs) and consequently incur a financial loss.

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Drug Target Review

SEPTEMBER 26, 2023

CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact. CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact.

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Broad Institute

OCTOBER 11, 2023

The team found that deleting the gene Ptpn2 made tumors sensitive to PD-1 therapy, and they published their findings in Nature in 2017. The researchers soon partnered with Calico Life Sciences , which in collaboration with AbbVie , discovered drug candidates that block the PTPN2 protein.

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FDA Law Blog: Drug Discovery

SEPTEMBER 27, 2023

Tobolowsky — Much has changed since the long-gone days of 2017. While the Nats being replaced by the Orioles as the dominant home team did not get a mention in the new Draft Guidance, there were plenty of other interesting changes made to the old 2017 draft guidance. By James E. Valentine & Mark A. Let’s go O’s!

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Drug Target Review

JUNE 21, 2023

Strikingly, a strong genetic link between target and disease biology is emerging as a predictor for success in clinical trials. 2,3 This is exemplified by drugs that target disease-specific genes or genetically distinct patient subsets which are more likely to succeed in demonstrating efficacy in clinical development.

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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.

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The Pharma Data

OCTOBER 28, 2020

GeneTx licensed the rights to antisense technology intellectual property from the Texas A&M University System in December 2017. The company is led by a management team experienced in the development and commercialization of rare disease therapeutics. About Ultragenyx.

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The Pharma Data

NOVEMBER 15, 2020

Most recently, she was a senior executive at Celgene Corporation, where she led corporate strategy from 2012 to 2017. Prior to Celgene, she held leadership roles in marketing, sales and new business development from 2002 to 2011 at Johnson & Johnson. drug development initiative from 2012 to February 2019.

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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.”

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The Pharma Data

OCTOBER 26, 2020

Based on these promising findings, Transgene intends to continue the clinical development of TG4001 in a larger, controlled confirmatory study as we look to provide a better treatment option for this patient population,” added Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene. Cancer Immunol Res 2017; 5: 417 -424.

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The Pharma Data

DECEMBER 15, 2020

1 Macarulla Mercade et al, Pancreas 2020 2 Petrelli et al Eu J Cancer 2017 3 Onivyde prescribing information 4 Wang Gillam Eu J Cancer 2019. a company that supports oncology drug development. . Disease control rate (DCR). 63.2%.

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