2027 Drug Development Drugs 
LifeSciVC
JUNE 12, 2025
This ability to activate pathways could be possible for almost all proteins, however the biggest differentiation was to consider areas that were hard to drug – transcription factors, ion channels, intracellular proteins, etc. Is it more important to have a clinical meaningful drug candidate OR convenience?
BioPharma Drive: Drug Pricing
JUNE 26, 2025
Vor Biopharma licensed a drug in June 2025 that targets proteins essential to B cell survival. Love Employee via Getty Images Dive Brief: Vor Biopharma is licensing rights to an immune disease drug from Chinese biotechnology company RemeGen, it said Wednesday, a little over one month after announcing plans to review strategic alternatives.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
FDA Law Blog: Biosimilars
AUGUST 23, 2023
This blog provides an update on the DHT-related PDUFA VII goals that were targeted for completion in the first two quarters of FDA’s Fiscal Year (FY) 2023, including: By the end of Q2 FY 2023, FDA will establish a DHT framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products.
The Premier Consulting Blog
OCTOBER 1, 2023
The FDA introduced the Type D Meeting on October 1, 2022, as part of the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter. Prescription Drug User Fee Act (PDUFA) VII The Prescription Drug User Fee Act (PDUFA VII) is a law that was signed and took effect on September 30, 2022.
Alta Sciences
JANUARY 31, 2025
It owned the societal name of the Canadian Association for Research on Drug Safety. As experts in early-phase drug development , from discovery through Phase II clinical research , we at Altasciences can share with STC members our accumulated knowledge and experience, and provide mentorship for future toxicologists.
Vial
FEBRUARY 29, 2024
Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. A rise of clinical trial outsourcing due to cost management, globalization, and digitalization.
Agency IQ
MAY 17, 2024
How have pre-submission meetings for generic drug applicants changed under GDUFA III? Under GDUFA III, the scope and purpose of pre-submission meetings for generic drug developers has changed. One of the core goals of the GDUFA program has been to increase the efficiency of the generic drug review program.
Expert insights. Personalized for you.
Let's personalize your content