Biologics License Application (BLA)

MacroGenics and EVERSANA Announce Deal for Margetuximab

Biologics License Application (BLA), Biopharma, Business, Commercialization, FDA, HER2-positive breast cancer, Monoclonal Antibodies, Partnerships, Sales & Marketing

MacroGenics Inc. announced a partnership with Eversana to commercialize margetuximab in the United States, if approved.

November 30, 2020/by Andrew Humphreys

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, Sanofi

The 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.

November 18, 2020/by BioSpace

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), Texas

Bristol 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.

November 16, 2020/by Reuters Health

FDA Places New CMC Demands on bluebird’s Sickle Cell Treatment

Biologics License Application (BLA), Business, Clinical Data, Clinical Trials, FDA, Gene Therapy, Investors, Premarket Trading, Quarterly results, R&D, Sickle Cell Disease

Shares of bluebird bio fell in trading after the company announced that the sickle cell disease gene therapy treatment bb1111 will not be submitted to the U.S. Food and Drug Administration for two more years.

November 5, 2020/by Andrew Humphreys

Spectrum Pharmaceuticals Sees Delay from FDA on Eflapegrastim BLA

Biologics License Application (BLA), Business, Clinical Data, Clinical Trials, Coronavirus Disease (COVID-19) Pandemic, FDA, Granulocyte colony-stimulating factor (G-CSF), Inspections, Manufacturing Plants, Neutropenia, R&D

Spectrum Pharmaceuticals announced that an inspection of the Hanmi Bioplant in South Korea will be necessary before the U.S. Food and Drug Administration can approve the company’s Biologics License Application for Rolontis (eflapegrastim).

October 26, 2020/by Andrew Humphreys

Junshi’s Checkpoint Inhibitor Ready to Head to Regulators for Throat Cancer

Biologics License Application (BLA), Checkpoint Inhibitors, China, China National Medical Products Administration (NMPA), Clinical Trials, Conditional Approval, FDA/Regulatory, Interim Analysis, Nasopharyngeal Carcinoma (NPC), Progression-Free Survival (PFS), R&D, Throat Cancer

Junshi Biosciences, based in Shanghai, China, announced that an Independent Monitoring Committee (IDMC) decided the company’s Phase III JUPITER-02 trial had met the pre-specified primary endpoint at the interim analysis.

September 29, 2020/by Andrew Humphreys

FDA Accepts BLA for bluebird and BMS’ Multiple Myeloma CAR-T Treatment

B-cell maturation antigen (BCMA), Biologics License Application (BLA), Biologics License Application (BLA) Review Acceptance, CAR-T Therapy, Clinical Trials, FDA/Regulatory, Immunotherapies, PDUFA, Priority Review Status, R&D

Bristol Myers Squibb and bluebird bio are eying a potential quick approval for a CAR-T treatment for multiple myeloma after the U.S. Food and Drug Administration accepted the Biologics License Application under priority review for idecabtagene vicleucel.

September 22, 2020/by BioSpace

ADC Therapeutics Submits BLA to U.S. FDA

Antibody-Drug Conjugates (ADCs), B Cells, Biologics License Application (BLA), Diffuse Large B-Cell Lymphoma (DLBCL), DNA, FDA, FDA/Regulatory, Safety Data

ADC Therapeutics SA announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration for loncastuximab tesirine (Lonca) for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma.

September 21, 2020/by Andrew Humphreys

bluebird bio Presents New Results from Clinical Development Program of eli-cel Gene Therapy for CALD

Biologics License Application (BLA), Cerebral Adrenoleukodystrophy (CALD), Clinical Trial Endpoints, Clinical Trials, Committee for Medicinal Products for Human Use (CHMP), Data, Efficacy, European Medicines Agency (EMA), Gene Therapy, Major Functional Disabilities (MFDs), Marketing Authorization Application (MAA), Neurological function, R&D, Rare Metabolic Disorders

bluebird bio Inc. announced updated results from the clinical development program for the company’s investigational elivaldogene autotemcel (eli-cel, Lenti-D) gene therapy in patients with cerebral adrenoleukodystrophy (CALD), including long-term results from the Phase 2/3 Starbeam study and data from the Phase 3 ALD-104 study.

August 29, 2020/by Andrew Humphreys

FDA Action Alert: Bristol Myers Squibb/Juno, Seattle Genetics, BioMarin and Tricida

Adeno-Associated Virus (AAV), B Cell Lymphomas, Biologics License Application (BLA), Brain Metastases, CAR-T Therapy, Chronic Kidney Disease, Diffuse large B-cell lymphoma (DLBCL), FDA, FDA/Regulatory, Hemophilia A, HER2-positive breast cancer, Immunotherapy, New Drug Applicationa, Project Orbis, Quarterly results, T-Cells

The U.S. Food and Drug Administration’s approval-review schedule for August includes the Biologics License Application for Bristol Myers Squibb and Juno Therapeutics’ lisocabtagene maraleucel (liso-cel) for relapsed or refractory large B-cell lymphoma after at least two previous therapies.

August 17, 2020/by Andrew Humphreys