Regulation

01 Oct 2020
- Regulation
- Drug Filing
Baylx receives US FDA clearance of Covid-19 IND application for umbilical cord tissue mesenchymal stem cells product

By PBR Staff Writer

Baylx, a clinical-stage stem cell biopharmaceutical company focused on developing living stem cell products to address unmet medical needs, announced that the US Food and Drug Administration (FDA) has cleared Baylx's Investigational New Drug (IND) application for BX-U001, a fresh, non-frozen human umbilical cord tissue mesenchymal stem cells (hUC-MSC) product in patients with COVID-19.
30 Sep 2020
Regulation
Approvals
Infinity receives fast track designation for eganelisib in combination with checkpoint inhibitor and chemotherapy for advanced TNBC

By PBR Staff Writer

Infinity Pharmaceuticals announced today that the US Food and Drug Administration (FDA) has granted Fast Track designation for eganelisib (IPI-549) in combination with a checkpoint inhibitor and chemotherapy for the treatment of patients with inoperable locally advanced or metastatic triple-negative breast cancer (TNBC), in the first-line setting. Infinity is currently enrolling patients in MARIO-3, the Company’s ongoing Phase 2 study in collaboration with Roche/Genentech to evaluate eganelisib in a novel triple combination front-line regimen with Tecentriq and Abraxane in TNBC.
29 Sep 2020
Regulation
Approvals
AVROBIO receives orphan drug designation from European Medicines Agency for AVR-RD-02

By PBR Staff Writer

AVROBIO, a leading clinical-stage gene therapy company with a mission to free people from a lifetime of genetic disease, announced that the European Commission (EC) has granted orphan drug designation for AVR-RD-02, the company’s investigational gene therapy for the treatment of Gaucher disease.
29 Sep 2020
Regulation
Approvals
Pfizer gets FDA nod for Xeljanz to treat juvenile idiopathic arthritis

By PBR Staff Writer

Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Xeljanz (tofacitinib) to treat children and adolescents two years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA).
28 Sep 2020
Regulation
Approvals
EC grants marketing authorisation for Jyseleca to treat adults with moderate to severe active rheumatoid arthritis

By PBR Staff Writer

Gilead Sciences and Galapagos announced that the European Commission (EC) has granted marketing authorization for Jyseleca (filgotinib 200 mg and 100 mg tablets), a once-daily, oral, JAK1 inhibitor for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately to, or are intolerant to, one or more disease modifying anti-rheumatic drugs (DMARDs). Jyseleca may be used as monotherapy or in combination with methotrexate (MTX).
28 Sep 2020
Regulation
Approvals
GSK gets FDA approval for Nucala to treat hypereosinophilic syndrome

By PBR Staff Writer

GlaxoSmithKline (GSK) has secured approval from the US Food and Drug Administration (FDA) for its Nucala (mepolizumab) for the treatment of hypereosinophilic syndrome (HES), a rare and under-diagnosed disorder.
25 Sep 2020
Regulation
Drug Filing
Anokion announces FDA clearance of IND application for ANK-700 to treat multiple sclerosis

By PBR Staff Writer

Anokion SA, a Swiss biotechnology company focused on treating autoimmune disease by restoring normal immune tolerance, announced that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application for ANK-700, an antigen-specific drug candidate for the treatment of multiple sclerosis (MS).
23 Sep 2020
Regulation
Drug Filing
BMS, bluebird get FDA priority review for ide-cel in multiple myeloma

By PBR Staff Writer

Bristol Myers Squibb (BMS) and bluebird bio have secured priority review from the US Food and Drug Administration (FDA) for their co-developed investigational cell therapy idecabtagene vicleucel (ide-cel; bb2121) for the treatment of multiple myeloma.
16 Sep 2020
Regulation
Drug Filing
Gilead gets FDA breakthrough therapy status for magrolimab in MDS

By PBR Staff Writer

Gilead Sciences has been given breakthrough therapy designation for magrolimab from the US Food and Drug Administration (FDA) for the treatment of myelodysplastic syndrome (MDS) in newly diagnosed patients.
14 Sep 2020
Regulation
Approvals
Sanofi, Regeneron get FDA breakthrough therapy status for Dupixent to treat eosinophilic esophagitis

By PBR Staff Writer

Sanofi and Regeneron Pharmaceuticals have secured breakthrough therapy status from the US Food and Drug Administration (FDA) for Dupixent (dupilumab) to treat patients 12 years and older with eosinophilic esophagitis (EoE).

Drug Discovery

Research & Development

Aligos and Xiamen Amoytop sign deal for HBV therapy

Daiichi Sankyo and Interna partner for MNM-targeted delivery solutions

Clinical Trials

Patient Enrollment

US FDA approves Avacta Group’s IND application for AVA6000

AM-Pharma enrols first patients in Covid-19 phase III trial

Regulation

Drug Filing

Viatris files applications in Japan for approval of Effexor to treat GAD

Scholar Rock submits application of SMA therapy to FDA

Production & Sales

Manufacturing

ENCell and Lucy Biotech forge alliance for mesenchymal stem cell therapy

Merck introduces single-use reactor to accelerate ADC manufacturing

Packaging & Supply Chain

Packaging

Gerresheimer at CPHI Frankfurt 2025

Gerresheimer

Suppliers

No data found

Regulation

Baylx receives US FDA clearance of Covid-19 IND application for umbilical cord tissue mesenchymal stem cells product

Infinity receives fast track designation for eganelisib in combination with checkpoint inhibitor and chemotherapy for advanced TNBC

AVROBIO receives orphan drug designation from European Medicines Agency for AVR-RD-02

Pfizer gets FDA nod for Xeljanz to treat juvenile idiopathic arthritis

EC grants marketing authorisation for Jyseleca to treat adults with moderate to severe active rheumatoid arthritis

GSK gets FDA approval for Nucala to treat hypereosinophilic syndrome

Anokion announces FDA clearance of IND application for ANK-700 to treat multiple sclerosis

BMS, bluebird get FDA priority review for ide-cel in multiple myeloma

Gilead gets FDA breakthrough therapy status for magrolimab in MDS

Sanofi, Regeneron get FDA breakthrough therapy status for Dupixent to treat eosinophilic esophagitis

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Research & Development

Patient Enrollment

Drug Filing

Manufacturing

Packaging

No data found