Signed in as:
filler@godaddy.com
Noteworthy Releases from the FDA
April 1, 2021
Exciting news that orphan drug designation has been granted to LNS8801 of Linnaeus Therapeutics, Inc. based on promising data seen in patients during dose escalation in their clinical study. The drug is a highly-specific G protein-coupled estrogen receptor (GPER) agonist currently in clinical development for the treatment of patients with metastatic uveal melanoma. The current study is a phase 1/2 adaptive-design, with LNS8801 being evaluated both as a monotherapy and in combination with pembrolizumab (Keytruda) in patients who previously achieved clinical benefit with immune checkpoint inhibitors and then subsequently progressed.
February 19, 2021
Interesting article about the FDA’s Office of Generic Drugs (OGD) approval rate during 2020, with 948 applications approved or tentatively approved. In response to COVID-19, this office accelerated the assessment of generic drugs to address the crisis, and developed guidance to incentivize the development and approval for generic drugs.
July 28, 2020
Here is some wonderful news in the fight against cancer using a patient’s own immune system. The use of this cell-based gene therapy for treatment of adult patients diagnosed with mantle cell lymphoma (MCL) will be monitored closely using a risk evaluation and mitigation strategy (REMS) to ensure its safe use, and is a huge step forward for cancer research. This team should be very proud.