Approvals

30 Apr 2018
- Regulation
- Approvals
AstraZeneca’s Tagrisso gets positive EU CHMP opinion for first-line treatment of EGFR-mutated NSCLC

By admin

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending a change to the terms of the marketing authorisation for Tagrisso (osimertinib) to include the 1st-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.
27 Apr 2018
Regulation
Approvals
Omeros’ OMS721 gets FDA breakthrough therapy designation for HSCT-TMA

By PBR Staff Writer

Omeros’ MASP-2 inhibitor OMS721 has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for the treatment of patients with high-risk hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
25 Apr 2018
Regulation
Approvals
FDA expands GSK’s Trelegy Ellipta indication in COPD

By admin

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline and Innoviva’s Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’) to treat a broader population of chronic obstructive pulmonary disease (COPD) patients with airflow limitation or who had an acute worsening of respiratory symptoms.
19 Apr 2018
Regulation
Approvals
FDA approves Tagrisso as first-line treatment for EGFR-mutated non-small cell lung cancer

By admin

The US Food and Drug Administration (FDA) has approved AstraZeneca’s Tagrisso (osimertinib) as the first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations.
18 Apr 2018
Regulation
Approvals
Roche’s Hemlibra gets FDA breakthrough status in haemophilia A without inhibitors

By PBR Staff Writer

Roche has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its Hemlibra (emicizumab) to treat people with haemophilia A without factor VIII inhibitors.
17 Apr 2018
Regulation
Approvals
BMS’ Opdivo and Yervoy combo gets FDA approval for firstline RCC

By PBR Staff Writer

The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb’s (BMS) combination of immuno-oncology drugs Opdivo (nivolumab) and Yervoy (ipilimumab) as first-line treatment for patients with a type of advanced renal cell carcinoma (RCC), or kidney cancer.
09 Apr 2018
Regulation
Approvals
FDA approves Clovis’ Rubraca for recurrent ovarian cancer

By admin

The US Food and Drug Administration (FDA) has approved Clovis Oncology’s Rubraca (rucaparib) tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
04 Apr 2018
Regulation
Approvals
US and European regulators accept AstraZeneca’s applications for cancer treatments

By PBR Staff Writer

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted AstraZeneca’s applications for cancer treatments moxetumomab pasudotox and Lynparza (olaparib).
02 Apr 2018
Regulation
Approvals
FDA approves new indication for Amgen’s leukemia drug Blincyto

By admin

The US Food and Drug Administration (FDA) has approved Amgen’s supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab) for B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission in adults and children.
28 Mar 2018
Regulation
Approvals
Fennec Pharmaceuticals’ Pedmark gets FDA breakthrough status

By PBR Staff Writer

Fennec Pharmaceuticals has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for Pedmark to prevent cisplatin-related ototoxicity in pediatric patients with standard risk hepatoblastoma (SR-HB).

Drug Discovery

Research & Development

Apotex and Grünenthal sign deal for Nebido Canadian distribution

PrimeGen US and DT Cloud Star sign $1.5bn merger agreement

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

AstraZeneca’s Tagrisso gets positive EU CHMP opinion for first-line treatment of EGFR-mutated NSCLC

Omeros’ OMS721 gets FDA breakthrough therapy designation for HSCT-TMA

FDA expands GSK’s Trelegy Ellipta indication in COPD

FDA approves Tagrisso as first-line treatment for EGFR-mutated non-small cell lung cancer

Roche’s Hemlibra gets FDA breakthrough status in haemophilia A without inhibitors

BMS’ Opdivo and Yervoy combo gets FDA approval for firstline RCC

FDA approves Clovis’ Rubraca for recurrent ovarian cancer

US and European regulators accept AstraZeneca’s applications for cancer treatments

FDA approves new indication for Amgen’s leukemia drug Blincyto

Fennec Pharmaceuticals’ Pedmark gets FDA breakthrough status

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Research & Development

Patient Enrollment

Drug Filing

Manufacturing

Packaging

No data found