Approvals

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.
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).
11 Sep 2020
Regulation
Approvals
Terns Pharmaceuticals Receives Fast Track Designation for TERN-201 as a Treatment for NASH

By PBR Staff Writer

Terns Pharmaceuticals, Inc., a biopharmaceutical company focused on developing best-in-class single-agent and combination therapies to treat liver disease, announced that TERN-201, a semicarbazide-sensitive amine oxidase (SSAO) inhibitor, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of non-alcoholic steatohepatitis (NASH).
10 Sep 2020
Regulation
Approvals
FDA approves Trelegy Ellipta as once-daily single inhaler triple therapy for asthma and COPD

By PBR Staff Writer

GlaxoSmithKline and Innoviva announced the US Food and Drug Administration (FDA) has approved a new indication for Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol ‘FF/UMEC/VI’) for the treatment of asthma in patients aged 18 years and older adding to its current license for use in patients with chronic obstructive pulmonary disease (COPD). Trelegy Ellipta is not indicated for relief of acute bronchospasm.
08 Sep 2020
Regulation
Approvals
Ascentage Pharma’s Bcl-2 inhibitor APG-2575 granted orphan drug Designation by FDA to treat chronic lymphocytic leukaemia

By PBR Staff Writer

Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that the US Food and Drug Administration (FDA) has granted APG-2575, a novel Bcl-2 inhibitor being developed by the company, an Orphan Drug Designation (ODD) for the treatment of chronic lymphocytic leukemia (CLL). This is the second ODD granted for APG-2575, following the previous ODD granted by the FDA in July for the treatment of Waldenström Macroglobulinemia (WM).
08 Sep 2020
Regulation
Approvals
Janssen gets expanded EC nod for blood cancer combo drug Imbruvica plus rituximab

By PBR Staff Writer

Janssen Pharmaceutical, part of Johnson & Johnson, has secured approval from the European Commission (EC) for expanded use of Imbruvica (ibrutinib) in combination with rituximab for previously untreated adult patients with chronic lymphocytic leukaemia (CLL).

Drug Discovery

Research & Development

Parvus and Resilience expand partnership to develop IBD drug candidate

Ring Therapeutics signs partnerships to advance R&D in biomedical sciences

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

Torii submits NDA for molluscum contagiosum treatment therapy in Japan

Neuvivo files NDA seeking FDA approval for ALS treatment

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

PCI Pharma announces bottling line expansion at Rockford site

Suppliers

No data found

Approvals

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

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

Terns Pharmaceuticals Receives Fast Track Designation for TERN-201 as a Treatment for NASH

FDA approves Trelegy Ellipta as once-daily single inhaler triple therapy for asthma and COPD

Ascentage Pharma’s Bcl-2 inhibitor APG-2575 granted orphan drug Designation by FDA to treat chronic lymphocytic leukaemia

Janssen gets expanded EC nod for blood cancer combo drug Imbruvica plus rituximab

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Research & Development

Patient Enrollment

Drug Filing

Manufacturing

Packaging

No data found