Krystle Vermes

FDA
The FDA approval was based on results from the largest studies conducted to date in obesity associated with POMC, PCSK1 or LEPR deficiency.
MediciNova announced today that it received positive Optical Coherence Tomography (OCT) results from its SPRINT-MS Phase IIb trial of MN-166 (ibudilast) in multiple sclerosis (MS) subjects.
As of late, the company has already tested almost 15,000 of its 75,000 employees in a pilot program.
Scientists in Israel have used the CRISPR Cas-9 gene editing system to destroy cancerous cells in mice without damaging other cells.
Eli Lilly and Company and Precision BioSciences, Inc. announced today that they have entered a research collaboration and exclusive license agreement.
Researchers from the University of Birmingham, UK, announced today that they have developed a nasal spray that can potentially provide protection against COVID-19. Additionally, it is formulated using materials that have already been cleared for use in humans.
A settlement valued at $8.34 billion was reached between Purdue Pharma and the Justice Department on Tuesday, which required the drug company to plead guilty to three felonies related to its marketing and distribution of OxyContin.
The two companies received Complete Response Letters from the FDA this week, along with Sanofi.
Travere Therapeutics will also begin trading under the new ticker symbol, “TVTX” on the Nasdaq Global Select Market beginning on Nov. 19.
Synairgen announced today that its data from the SG016 trial was published in the journal The Lancet Respiratory Medicine. The trial, which included 101 hospitalized COVID-19 patients, looked at SNG001 as a potential treatment.
Vaxart announced new data from its Hamster Challenge Study today, showing that its oral COVID-19 vaccine candidate can potentially reduce viral load and induce a significant immune response.
Pfizer announced today that it has received positive top-line results from the Phase III JADE REGIMEN study, examining abrocitinib for the treatment of severe atopic dermatitis.
Merck and Eisai announced today that they have new investigational data demonstrating positive top-line results from the Phase III KEYNOTE-581/CLEAR trial (Study 307).
With the opinions that were expressed by the advisory committee, along with the data presented, the FDA will continue onward with its review process. It is expected to determine whether to approve the aducanumab Biologics License Application by March 7, 2021.
Assembly Biosciences, Inc. provided an update on Nov. 5 of its ongoing Phase 2 extension study, Study 211, examining vebicorvir (VBR, or ABI-H0731) in patients with hepatitis B virus infection.