Approvals

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).
07 Sep 2020
Regulation
Approvals
FDA approves Roche’s Gavreto to treat metastatic RET fusion-positive NSCLC

By PBR Staff Writer

Roche has secured approval from the US Food and Drug Administration (FDA) for its Gavreto (pralsetinib) to treat adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.
04 Sep 2020
Regulation
Approvals
Eli Lilly gets FDA nod for additional doses of Trulicity to treat type 2 diabetes

By PBR Staff Writer

Eli Lilly has secured approval from the US Food and Drug Administration (FDA) for two additional doses of Trulicity to treat type 2 diabetes.
02 Sep 2020
Regulation
Approvals
FDA approves Onureg as continued treatment for adults in first remission with AML

By PBR Staff Writer

Bristol Myers Squibb announced that the US Food and Drug Administration (FDA) has approved Onureg (azacitidine 300 mg tablets, CC-486) for the continued treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission (CR) or CR with incomplete blood count recovery (CRi) following intensive induction chemotherapy and who are not able to complete intensive curative therapy.

Drug Discovery

Research & Development

SciNeuro and Novartis sign global licensing deal for Alzheimer’s antibody

Atara receives FDA complete response letter for Ebvallo BLA application

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

Approvals

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

FDA approves Roche’s Gavreto to treat metastatic RET fusion-positive NSCLC

Eli Lilly gets FDA nod for additional doses of Trulicity to treat type 2 diabetes

FDA approves Onureg as continued treatment for adults in first remission with AML

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Research & Development

Patient Enrollment

Drug Filing

Manufacturing

Packaging

No data found