The Pharma Data

JANUARY 20, 2021

” “Dynacure is a leader in rare disease drug development, as evidenced by its lead product candidate DYN101, which is in clinical development for the treatment of Myotubular and Centronuclear Myopathies for which there are no FDA or EMA approved therapeutics,” said Ms. ” Ms. Before these roles, Ms.

Treatment 40

Treatment Pharmaceuticals Drug Development Science 40

Agency IQ

APRIL 12, 2024

Draft guidance on potency assays for CGT products garners extensive stakeholder input Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. As a result, the 2011 guidance was generally seen as basic and outdated.

Production 40

Production FDA Therapies Biochemical Assays 40

The Pharma Data

NOVEMBER 5, 2020

Taveras will lead all research and non-clinical development functions supporting the company’s pipeline of investigational therapies. Denner has been with Sarissa since 2011. From 2006 to 2011, Denner served as a senior managing director at Icahn Capital L.P. Before GSK, Rosén was senior vice president, U.S.

Analytical Chemistry 40

Analytical Chemistry Pharmaceuticals Small Molecule Therapies 40

Drug Target Review

OCTOBER 3, 2024

The creation of sophisticated human antibody libraries covering a vast immune repertoire through de novo synthesis, such as HuCAL (human combinatorial antibody library), 7 combined with phage display technology and optimised for in vitro expression, have revolutionised the development of recombinant monoclonal anti-idiotypic antibodies.

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

The Pharma Data

AUGUST 17, 2021

Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.

Treatment 52

Treatment Immune Response Trials FDA Approval 52

The Pharma Data

NOVEMBER 10, 2020

. Inspired by the spirit of “Start with Integrity, Succeed through Action,” Innovent’s mission is to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people.

Clinical Trials 52

Clinical Trials Treatment Trials Disease 52

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.

Disease 111

Disease Clinical Trials Therapies Science 111

Agency IQ

SEPTEMBER 22, 2023

An AgencyIQ analysis from May 2020 found that a quarter of all New Molecular Entities (NMEs) approved since 2011 had relied upon a single pivotal trial, and that this reliance had remained relatively stable between 2011-2019 despite some year-to-year variability. When should this occur? at the end-of-phase 2 meeting).

FDA 40

FDA Science Trials Clinical Trials 40

Agency IQ

APRIL 8, 2024

Since these issues could occur during the investigational phase of clinical development as well as in the post-marketing setting—and product status could very well differ by country/region—ICH members determined that these guidelines should be developed to facilitate the exchange of information in both settings.

FDA 40

FDA Production Regulations Vaccine 40

The Pharma Data

SEPTEMBER 8, 2021

Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.

Research 52

Research Immune Response Treatment Trials 52

LifeSciVC

APRIL 27, 2023

By the time Chapter 1 was nearing its end, Project Troubled Water, then Nimbus Discovery, became Nimbus Therapeutics as we took a further step to forward integrate into clinical development. Our long-time clinical development lead, Bhaskar Srivastava, an M.D. dermatologist, could not contain his excitement.

Small Molecule 40

Small Molecule Computational Chemistry Engineering Clinical Development 40

Agency IQ

SEPTEMBER 15, 2023

Since the 2007 NDAC meeting, several clinical trials have been conducted by industry to assess new phenylephrine doses and formulations—consistently failing to outperform placebo. This new body of data includes environmental exposure studies and clinical trials from Merck and Johnson and Johnson collected between 2011 and 2018.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

The Pharma Data

NOVEMBER 15, 2020

Prior to Celgene, she held leadership roles in marketing, sales and new business development from 2002 to 2011 at Johnson & Johnson. Most recently, she was a senior executive at Celgene Corporation, where she led corporate strategy from 2012 to 2017. Before that, Ms. About MultiStem ®.

Clinical Trials 40

Clinical Trials Trials Production Therapies 40

The Pharma Data

JUNE 26, 2021

By the time of its completion, more than 275,000 patients will have participated in the EXPLORER clinical development program, other completed and ongoing clinical trials, investigative registries, and non-interventional studies. WHAT IS XARELTO ® (rivaroxaban)?

Doctors 52

Doctors Treatment Hospitals Clinical Trials 52

The Pharma Data

OCTOBER 25, 2020

About Global Blood Therapeutics Global Blood Therapeutics (GBT) is a biopharmaceutical company dedicated to the discovery, development and delivery of life-changing treatments that provide hope to underserved patient communities.

Treatment 40

Treatment Disease FDA FDA Approval 40

Agency IQ

JANUARY 4, 2024

Other centers, like the Center for Biologics Evaluation and Research (CBER), instead have a bi-weekly meeting to discuss guidance development, while the Oncology Center of Excellence makes use of an “internal database platform.” That sort of information is extremely important for some stakeholders.

FDA 40

FDA Science Regulations International 40

The Pharma Data

AUGUST 11, 2020

Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.

Therapies 52

Therapies Trials Disease Treatment 52

The Pharma Data

AUGUST 11, 2020

Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.

Treatment 52

Treatment Trials Therapies Clinical Trials 52

Sygnature Discovery

FEBRUARY 17, 2025

He has championed numerous programs into clinical development and fostered cross-functional collaboration across diverse therapeutic areas and drug modalities. Since 2011, Sygnature Discovery has delivered 50 novel pre-clinical and 30 clinical compounds, with its scientists named on over 170 patents.

Clinical Development 52

Clinical Development Disease Pharmaceuticals Drugs 52

Drug Patent Watch

JANUARY 8, 2025

The First-to-File System Since the America Invents Act of 2011, the U.S. Clinical Development Success Rates and Contributing Factors 2011-2020. Filing too early might mean your patent expires before you’ve had a chance to fully commercialize your drug. has operated under a first-to-file system.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceuticals Licensing Licensing 52