ACTO

SEPTEMBER 11, 2024

The life sciences industry is actively looking for new ways to leverage AI to bring drugs to market faster to patients waiting in need,” said Parth Khanna, CEO of ACTO. ACTO has dedicated US$10M to GenAI, focused on its LAICA suite of products, announced in 2022.

Science 52

Science Pharma Companies Production Marketing 52

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

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. FDA Expedited Programs.

Disease 52

Disease Clinical Trials FDA Approval FDA 52

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

Agency IQ

JUNE 7, 2024

FDA’s new guidance explains what to do during a BIMO inspection Under the FDA’s Bioresearch Monitoring (BIMO) program, the agency oversees the operation of regulated research. In short, the BIMO program oversees regulated research – both human and animal – in a variety of ways.

FDA 40

FDA Compliance Regulations Production 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

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

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). Additionally, the smaller potential customer base may provide an insufficient return on the investment into research. member states.

Marketing 40

Marketing Regulations Biosimilars Drugs 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

Codon

JUNE 2, 2024

It took another five years for a pair of American researchers to come up with an explanation before going on to pioneer the mouse as biomedicine’s premier model organism. It took another century after Mendel’s pea experiments for the mouse to become an established presence in research labs.

Laboratories 136

Laboratories Research Disease Science 136

The Pharma Data

JANUARY 26, 2021

Lilly’s chief scientific officer and president of Lilly Research Laboratories. 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. have reached record highs. patients who recovered from COVID-19. .

Hospitals 52

Hospitals Treatment Trials Long-Term Care Facilities 52

Codon

JANUARY 21, 2024

When a vaccine fails, that can have downstream effects on how other researchers in the field approach their own vaccine development, and how funding gets moved around. If a Shigella vaccine fails, researchers save a lot of money by not testing it in the field and having it fail there. But it's hard to find the counterfactual.

Vaccine 128

Vaccine Trials Disease Treatment 128

Common Sense for Drug Policy Blog

NOVEMBER 26, 2024

"Pink Cocaine", Otherwise Known As Tusi "The tusi phenomenon complicates the drug landscape because it has the potential to confuse both people who use and researchers alike. With respect to people who use, given the drug concoction’s name, people may assume the drug is 2C/2C-B.

Production 52

Production Drugs Science Drug Research 52

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. Furthermore, uneven access to genomic data amplifies inequalities in research. Refining the impact of genetic evidence on clinical success.

Drug Development 59

Drug Development Bioinformatics Drugs Small Molecule 59