Approvals

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.
31 Aug 2020
Regulation
Approvals
Gilead gets FDA EUA status for Veklury to also treat patients with moderate Covid-19

By PBR Staff Writer

Gilead Sciences has secured expanded emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its investigational antiviral Veklury (remdesivir) to treat not only hospitalised patients suffering from severe COVID-19, but also those who were moderately afflicted.
28 Aug 2020
Regulation
Approvals
Rocket Pharmaceuticals receives FDA fast track designation for RP-L401 gene therapy for infantile malignant osteopetrosis

By PBR Staff Writer

Rocket Pharmaceuticals, a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to RP-L401, the Company’s lentiviral vector (LVV)-based gene therapy for the treatment of Infantile Malignant Osteopetrosis (IMO), a rare, severe monogenic bone resorption disorder characterized by skeletal deformities, neurologic abnormalities and bone marrow failure.
27 Aug 2020
$GSK gets EC nod for BLENREP to treat relapsed and refractory multiple myeloma$
Regulation
Approvals
GSK gets EC nod for BLENREP to treat relapsed and refractory multiple myeloma

By PBR Staff Writer

GlaxoSmithKline (GSK) has secured conditional marketing authorisation from the European Commission (EC) for its BLENREP (belantamab mafodotin) to treat patients with relapsed and refractory multiple myeloma.
24 Aug 2020
Regulation
Approvals
FDA issues EUA for convalescent plasma as potential promising Covid–19 treatment

By PBR Staff Writer

The US Food and Drug Administration issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the agency’s ongoing efforts to fight COVID-19. Based on scientific evidence available, the FDA concluded, as outlined in its decision memorandum, this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product.

Drug Discovery

Research & Development

Superluminal Medicines secures $60m to advance rare obesity therapy

Takeda and Weave Bio collaborate on AI-driven automation in drug development

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

Uwe Röhrhoff Steps Down as Interim CEO of Gerresheimer AG

Gerresheimer at CPHI Frankfurt 2025

Suppliers

No data found

Approvals

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

Gilead gets FDA EUA status for Veklury to also treat patients with moderate Covid-19

Rocket Pharmaceuticals receives FDA fast track designation for RP-L401 gene therapy for infantile malignant osteopetrosis

GSK gets EC nod for BLENREP to treat relapsed and refractory multiple myeloma

FDA issues EUA for convalescent plasma as potential promising Covid–19 treatment

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Research & Development

Patient Enrollment

Drug Filing

Manufacturing

Packaging

No data found