Astralis, Ltd.
Questions?
Please contact Sales at: (212) 520-2765 or email [email protected]
Latest From Astralis, Ltd.
Accelerated Approval: Withdrawing Gene Therapies Could Be Easier Than Small Molecules
The FDA would only withdraw a rare disease gene therapy for “pretty clear” reasons, such as when there is minimal benefit with extensive side effects. The one-and-done nature of administration also makes withdrawal easier, CBER Director Peter Marks says.
Overall Survival Is Not A Required Primary Endpoint In All Cancer Trials, US FDA Says
Seeking to clear up a ‘misconception,’ Oncology Center of Excellence officials say earlier endpoints, such as progression-free survival and overall response, continue to be useful in getting therapies to market quicker, but sponsors still should plan to systematically collect OS data to ensure there is no detriment to survival.
Venture Capital Fundraising Rebounds In Q1 As Mega-Rounds Dominate
Biopharma firms raised $6bn in the first quarter of 2024, the most of any quarter since Q2 2022. But without an increase in the number of companies raising funds, the rebound remains uneven.
AstraZeneca’s Next-Gen PARP Inhibitor Hints At Better Safety And Efficacy In Breast Cancer
Early signs of improved safety and efficacy should set up PARP1 inhibitor for potential combinations and future broader use, but the true extent of its benefits remain to be seen.
Company Information
- Industry
- Biotechnology
- Pharmaceuticals
You must sign in to use this functionality
Authentication.SignIn.HeadSignInHeader
Email Company
All set! This article has been sent to my@email.address.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
DCD.EmailPopout.Notice