DrugBank

MAY 15, 2024

The binding pockets on KRAS are shallow and polar , not ideal for the kinds of interactions needed for strong, effective drug binding. In fact, it's one of the most exciting areas in drug research today. One approach is to look beyond the traditional drug molecule.

Small Molecule 98

Small Molecule Molecular Biology Drugs Disease 98

Conversations in Drug Development Trends

FEBRUARY 21, 2024

The on-site cGMP Phase 1 pharmacy must have radiolabel drug preparation experience A clinical pharmacology unit (CPU) must be licensed and experienced in handling radioactive investigational drugs in order to complete your AME study.

Clinical Trials 80

Clinical Trials Pharmacy Clinical Pharmacology FDA 80

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. In addition, in order to achieve next level strategic goal of developing global first-in-class product in 5-10 years, Innovent Academy has been established.

Biosimilars 52

Biosimilars Clinical Trials International Clinical Development 52

Advarra

AUGUST 16, 2022

The Orphan Drug Act of 1983 was instrumental in changing the number of orphan drugs approved in the U.S. 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.

Disease 52

Disease Clinical Trials FDA Approval FDA 52

Agency IQ

NOVEMBER 27, 2023

BY KIRSTEN MESSMER, PHD, RAC | NOV 17, 2023 4:46 PM CST Quick background on nitrosamines in global medicinal products Nitrosamines are a large and diverse class of chemicals, with more than 300 different structurally distinct species known today. This was eventually expanded to include biological products as well.

Regulations 40

Regulations Production FDA Packaging 40

Agency IQ

AUGUST 11, 2023

BY KARI OAKES AUG 7, 2023 10:20 PM CDT Quick background on nitrosamines in pharmaceutical products Nitrosamines are a large and diverse class of chemicals, with more than 300 different structurally distinct species known today. In 2018, NDMA was first detected in the active pharmaceutical ingredient (API) for valsartan, a blood pressure drug.

FDA 40

FDA Science Production Regulations 40

Agency IQ

JUNE 9, 2023

The Orphan Regulation entered into force in January, 2000, outlining requirements for orphan designation and incentives, and establishing the EMA Committee for Orphan Medicinal Products (COMP). Unmet medical need requires the disease to remain associated with high morbidity or mortality if a product is approved for that condition.

Marketing 40

Marketing Regulations Biosimilars Drugs 40

Agency IQ

JUNE 7, 2024

The BIMO program’s scope covers all of the FDA’s product Centers – including CDER, CBER, CDRH, CFSAN as well as the Centers for Tobacco Products and Veterinary Medicine. During this timeframe on-site inspections were conducted if deemed mission-critical by both the product center and ORA.”

FDA 40

FDA Compliance Regulations Production 40

Drug Target Review

OCTOBER 26, 2023

Alipogene tiparvovec and voretigene neparvovec-rzyl, two recombinant AAV-based gene therapy products, were approved by the European Medicines Agency (EMA) to treat lipoprotein lipase deficiency in 2012 2 and by the US Food and Drug Administration (FDA) to treat inherited retinal dystrophy in 2017, respectively.

Engineering 105

Engineering Virus Therapies Immune Response 105

Agency IQ

AUGUST 2, 2024

Additionally, the EMA plans to launch further feature of the SPOR (substance, product, organizational, referential) services. The suite of services aims to harmonize the identification of medicinal products and is being rolled out in an iterative fashion.

Regulations 40

Regulations Clinical Trials Production Trials 40

The Pharma Data

JANUARY 26, 2021

Breastfeeding There are no available data on the presence of bamlanivimab in human or animal milk, the effects on the breastfed infant, or the effects on milk production. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug research, development and commercialization.

Hospitals 52

Hospitals Treatment Trials Long-Term Care Facilities 52

Codon

JUNE 2, 2024

However, the original research mission was a casualty of this pivot, as the top priority of JAX became the mass production of standardized mice for sale. This is in contrast to even the best colony management production practices, which result in about 3 generations per year—about 300 generations over a 100-year period.

Laboratories 130

Laboratories Research Disease Science 130

Codon

JANUARY 21, 2024

In some cases, I’d argue that a malaria challenge trial is safer than a typical oncology phase 1 drug trial, where you're taking people who don't have cancer and testing the safety of a drug that has maybe been tested in mice but has never been used in humans. That's not coincidental. Just understand what you're getting into.

Vaccine 126

Vaccine Trials Disease Treatment 126

Common Sense for Drug Policy Blog

NOVEMBER 26, 2024

The tusi phenomenon also has the potential to complicate drug research. Most drug surveys do not query the use of actual 2C series drugs, so it is unlikely that such surveys will begin to ask specifically about tusi. In this case, currently, ketamine appears to be the most common and most abundant drug present in tusi.

Production 52

Production Drugs Science Drug Research 52

Drug Target Review

FEBRUARY 11, 2025

The ongoing transformation is leading to the gradual replacement of traditional processes with more dynamic and data-driven models, with the primary objective of improving clinical success rates and productivity. Briefings in Bioinformatics , 2024, 25(5) Minikel E, Painter J, Dong C, Nelson M.

Drug Development 59

Drug Development Bioinformatics Drugs Small Molecule 59