Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. The average annual growth in non-orphan pharmaceutical expenditure in the same period was only 3%. member states.

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Marketing Regulations Biosimilars Drugs 40

DrugBank

MARCH 22, 2024

There are many obstacles that you have to overcome on the road to success in early-stage drug discovery and drug repurposing research. As a result, the industry is turning to managed data sources and are having to weigh the costs and benefits of open data sources versus enterprise research tools.

Licensing 74

Licensing Licensing Research Production 74

Advarra

AUGUST 16, 2022

Orphan drugs have historically faced a number of barriers, such as limited research and development (R&D) investment due to an expected lack of profitability as well as challenges in clinical trial design and recruitment. Before 1983, only 38 orphan drugs had received U.S. Food and Drug Administration (FDA) approval.

Disease 52

Disease Clinical Trials FDA Approval FDA 52

Agency IQ

AUGUST 2, 2024

Positive August 2024 Eurneffy (epinephrine) Ars Pharmaceuticals Irl Limited Positive August 2024 MResvia (Respiratory Syncytial Virus mRNA vaccine) Moderna Biotech Spain S.L. Positive August 2024 Balversa (erdafitinib) Janssen-Cilag International N.V.

Regulations 40

Regulations Clinical Trials Production Trials 40

The Pharma Data

NOVEMBER 10, 2020

Growing into a biopharmaceutical company, Innovent has built an integrated platform covering from drug discovery, CMC, clinical development and commercialization. Dr. Liu shared his over 30 years of R&D experience in drug development both in the global pharmaceutical companies and world renowned scientific research institutions.

Biosimilars 52

Biosimilars Clinical Trials International Clinical Development 52

The Pharma Data

MAY 19, 2023

HIGH SCHOOL SCIENTISTS AND ENGINEERS WIN NEARLY $9 MILLION AT THE REGENERON INTERNATIONAL SCIENCE AND ENGINEERING FAIR 2023 Regeneron Pharmaceuticals, Inc. Her work suggests that high levels of the protein claudin-5 could serve as pre-markers for suicide and that certain anti-inflammatory drugs might decrease claudin-5 levels.

Engineering 52

Engineering International Science Virus 52

Codon

JANUARY 21, 2024

yellow fever, malaria, and dengue), evaluating new drugs or treatments, and studying pathogenesis, the process by which a disease develops. treats a new challenge agent—the standardized infectious sample—like it’s a new drug. There have been deaths in phase 1 medical and drug research among healthy participants.

Vaccine 108

Vaccine Trials Disease Treatment 108

Drug Target Review

APRIL 17, 2023

This ebook deep dives into adoption and optimization of label-free hit-to-lead (HTL) technologies, including advanced surface plasmon resonance (SPR) applications for hit identification and validation.

Pharmaceutical Companies 52

Pharmaceutical Companies Laboratories Drugs Drug Research 52

Agency IQ

AUGUST 11, 2023

FDA lays out new assessment framework for certain nitrosamines Late last week, the FDA addressed developing knowledge – and concern – about nitrosamine drug substance related impurities (NDSRIs) in a final, immediately-in-effect guidance for industry. However, manufacturers face tight timelines for implementing them.

FDA 40

FDA Science Production Regulations 40

Agency IQ

NOVEMBER 27, 2023

In recent years, nitrosamines, and most commonly N-nitrosodimethylamine (NDMA), have been found in finished drug products in several classes, including medicines used for diabetes, hypertension, acid reflux, and smoking cessation. [ In a study of more than 12,000 small molecule drugs , researchers found 40.4%

Regulations 40

Regulations Production FDA Packaging 40