The U.S. Food and Drug Administration accepted for Priority Review Pfizer Inc.’s Biologics License Application for TicoVac, the company’s tick-borne encephalitis vaccine for active immunization to prevent TBE in individuals 1 year of age and older.
Bristol Myers Takes $470 Million Write-off and Scraps Orva-Cel CAR-T Program
B-cell maturation antigen (BCMA), Biologics License Application (BLA), Bristol Myers Squibb, Business, CAR-T Therapy, Clinical Trials, PDUFA, R&D, Relapsed Or Refractory (R/R) Large B-Cell Lymphoma (LBCL), Therapeutics, Write-offsBristol Myers Squibb reported that the company was abandoning the BCMA CAR-T therapy orva-cel and taking a $470 million write-off.
The U.S. Food and Drug Administration extended the review period for Biogen and Eisai’s Biologic License Application (BLA) for aducanumab for Alzheimer’s disease.
Final Highlights from 2021 J.P. Morgan Healthcare Conference
Biologics License Application (BLA), Biomarkers, Blockbusters, Checkpoint Inhibitors, Clinical Trial Endpoints, Clinical Trials, Covid-19 Data, J.P. Morgan Healthcare Conference, Lung Cancer, Ovarian Cancer, R&D, Solid Tumors, TherapeuticsAs the 2021 virtual J.P. Morgan Healthcare Conference wrapped up, BioSpace reviewed news from companies regarding their deals, pipeline and regulatory updates.
The U.S. Food and Drug Administration accepted for priority review a Biologics License Application (BLA) for Merck’s 15-valent pneumococcal conjugate vaccine V114.
Humanigen and EVERSANA Announce Partnership to Support Launch and Commercialization of Lenzilumab for Treatment of COVID-19
Biologics License Application (BLA), Business, Coronavirus Disease 2019 (COVID-19), Cytokine Storm, Emergency Use Authorization (EUA), Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), Hospitalized COVID-19 Patients, Partnerships, Product LaunchesHumanigen Inc. and EVERSANA announced that they are partnering to make lenzilumab available to hospitalized and hypoxic Covid-19 patients in the event that an Emergency Use Authorization is issued from the U.S. Food and Drug Administration and subsequent BLA.
DBV Technologies unveiled a global restructuring plan that will result in a reduction of more than 200 jobs.
Pfizer and OPKO Health are one step closer to receiving approval for their jointly developed pediatric growth hormone deficiency drug somatrogon after the U.S. Food and Drug Administration accepted the companies’ Biologics License Application (BLA) for the therapy.
Historic First U.S. Authorization of Vaccine to Prevent Covid-19
"Operation Warp Speed" Initiative, Biologics License Application (BLA), BioNTech, BNT162b2 (Pfizer and BioNTech), Clinical Trials, Department of Defense, Emergency Use Authorization, FDA, Messenger RNA (mRNA) Vaccines, Pfizer, R&D, U.S. governmentPfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration authorized the emergency use of the mRNA vaccine, BNT162b2, against Covid-19 in individuals 16 years of age or older.
New York-based TG Therapeutics announced positive topline results from two global Phase III clinical trials, ULTIMATE I and II, of ublituximab in relapsing forms of multiple sclerosis (RMS).