Advarra

AUGUST 16, 2022

The law established the Office of Orphan Products Development , providing financial incentives for pharmaceutical companies to develop orphan drugs and making it more viable to invest in orphan drug research and development. The impact was clear: Between 1983 and 2020, FDA approved 599 orphan drugs.

Disease 52

Disease Clinical Trials FDA Approval FDA 52

The Pharma Data

NOVEMBER 10, 2020

Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of cancer, metabolic, autoimmune and other major diseases. SAN FRANCISCO and SUZHOU, China , Nov.

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Biosimilars Clinical Trials International Clinical Development 52

The Pharma Data

MAY 19, 2023

Yancopoulos Innovator Award , named in honor of the pioneering drug researcher and Regeneron co-founder, President and Chief Scientific Officer, for finding an efficient way to identify certain exoplanets that orbit very closely around their stars. Kaitlyn Wang won first place and received the $75,000 George D.

Engineering 52

Engineering International Science Virus 52

Agency IQ

JUNE 9, 2023

Commission Regulation (EC) No 847/2000 set the rules, defining an orphan drug as one “that it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10 thousand persons in the Community when the application is made.” no available treatment.

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Marketing Regulations Biosimilars Drugs 40

Drug Target Review

OCTOBER 26, 2023

1 Adeno-associated virus (AAV) vectors are the leading platform for in vivo gene delivery for the treatment of various human diseases. They can accelerate various aspects of drug research and development, providing novel opportunities for faster and more effective solutions to health challenges.

Engineering 105

Engineering Virus Therapies Immune Response 105

The Pharma Data

APRIL 24, 2021

Over the past 20 years, together with our partners, we have delivered nearly 1 billion treatments, including over 430 million pediatric treatments to malaria-endemic countries. Novartis is advancing Research & Development of next-generation treatments to combat emerging drug resistance. 50-51) (PDF 6.3

Clinical Trials 52

Clinical Trials Treatment Trials Disease 52

Agency IQ

AUGUST 2, 2024

(ACT EU) / Clinical Trials Coordination Groups (CTCG) 9/11/2024 9/11/2024 Public launch event on the guideline on good pharmacovigilance practices Module XVI on risk minimization measures and its Addendum II Webinar ( OPEN ) EMA 9/12/2024 9/12/2024 ENVI meeting Committee meeting ( OPEN ) Environment, Public Health and Food Safety (ENVI) 9/13/2024 9/13/2024 (..)

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Regulations Clinical Trials Production Trials 40

NIH Director's Blog: Drug Development

FEBRUARY 16, 2021

Yet the quest to save more lives from COVID-19 isn’t even close to being finished, and researchers continue to work intensively to develop new and better treatments. ACTIV was founded last April to accelerate drug research that typically requires more than a decade of clinical ups and downs to develop a safe, effective therapy.

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Clinical Trials Trials Hospitals Vaccine 52

The Pharma Data

JANUARY 26, 2021

While the preliminary nature of Phase 2 results from COVID-19 neutralizing monoclonal antibodies may have limited acceptance of treatment, these Phase 3 data further strengthen the available evidence,” said Daniel Skovronsky, M.D., Lilly’s chief scientific officer and president of Lilly Research Laboratories.

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Hospitals Treatment Trials Long-Term Care Facilities 52

Codon

JUNE 2, 2024

Without mouse models, we may never have developed polio and meningitis vaccines, organ transplants, GLP-1 drugs, gene therapies , or any other number of transformative treatments. Today, somewhere on the order of 30 million rodents are used yearly in biomedical research in the U.S.

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Laboratories Research Disease Science 136

Codon

JANUARY 21, 2024

yellow fever, malaria, and dengue), evaluating new drugs or treatments, and studying pathogenesis, the process by which a disease develops. Scientists studied black men infected with syphilis for several decades while withholding known treatments. Now, we have upwards of 98 or 99 percent cure rates in some cases.

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Vaccine Trials Disease Treatment 128

Drug Target Review

FEBRUARY 11, 2025

These hurdles not only delay patient access to innovative treatments but also threaten the economic sustainability of research and development (R&D) and the advancement of medical innovation. These failures not only increase overall costs, but also slow down scientific progress, delaying potential treatments for patients.

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Drug Development Bioinformatics Drugs Small Molecule 59