Humanigen 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).
The U.S. Food and Drug Administration accepted for priority review Pfizer Inc.’s Biologics License Application (BLA) for the 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, as submitted for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults ages 18 years and older.
The Janssen Pharmaceutical Companies of Johnson & Johnson submitted a Biologics License Application to the U.S. Food and Drug Administration seeking approval of amivantamab for the treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.
MacroGenics Inc. announced a partnership with Eversana to commercialize margetuximab in the United States, if approved.
Fast Track, Breakthrough and Priority Reviews: Sanofi and ViiV
Acid alpha-glucosidase (GAA) enzyme, Biologics License Application (BLA), Breakthrough Therapy Designation, Bruton's Tyrosine Kinase (BTK) Inhibitors, Chronic Immune Thrombocytopenia (ITP), Clinical Trials, Enzyme Replacement Therapy (ERT), Fast Track Designation, FDA, HIV pre-exposure prophylaxis (PrEP), HIV Prevention, Muscle Disease, Orphan Drug Designation, PDUFA, Pompe disease, Priority Review Status, R&D, SanofiThe U.S. Food and Drug Administration granted various designations for Sanofi’s avalglucosidase alfa for Pompe disease, Sanofi’s rilzabrutinib for immune thrombocytopenia, and ViiV Healthcare’s cabotegravir for HIV prevention.
FDA delays decision on Bristol Myers cancer therapy due to Covid-19 travel curbs
Acquisitions, Biologics License Application (BLA), Blood Cancers, Bristol Myers Squibb, Business, Coronavirus Restrictions, Facilities/Sites/Manufacturing, FDA, Investors, R&D, Relapsed Or Refractory (R/R) Large B-Cell Lymphoma (LBCL), TexasBristol Myers Squibb said the U.S. health regulator deferred a decision on an experimental blood cancer therapy that the company acquired in the $74 billion buyout of Celgene due to coronavirus-related travel restrictions.