CAR-Ts have been hailed as game-changers for patients with relapsed/refractory blood cancers that...
- Checkpoint inhibitors continue to show benefits in a range of tumours
- Clinical trials for oncology biosimilars: for which indications can we expect approvals?
- Yervoy’s expanded indication will advance treatment for paediatric melanoma patients
- Novaliq’s NovaTears+Omega-3 represents the first-in-class omega-3-containing eye drop for evaporative dry eye
- Varubi IV’s second-try FDA approval provides CINV patients with a new option
CAR-T approvals fuel optimism in difficult-to-treat disease
CAR-Ts have been hailed as game-changers for patients with relapsed/refractory blood cancers that are resistant to standard treatments.
Checkpoint inhibitors continue to show benefits in a range of tumours
During 2017, two new programmed death-ligand 1 inhibitors, Pfizer and Merck’s Bavencio and AstraZeneca’s Imfinzi, were added to the growing list of marketed checkpoint inhibitors.
FDA approves Vertex’s cystic fibrosis combo therapy
The US Food and Drug Administration (FDA) has given its approval to Vertex’s combination treatment for cystic fibrosis (CF).
NICE approves treatment for advanced renal cell carcinoma
The National Institute for Health and Care Excellence (NICE) has given its backing for EUSA Pharma’s drug Fotivda (tivozanib) as a first-line treatment for advanced renal cell carcinoma (RCC).
Opdivo (Nivolumab) for the Treatment of Unresectable or Metastatic Melanoma
Opdivo (nivolumab) is indicated for the treatment of unresectable or metastatic melanoma in patients with a positive BRAF V600 mutation who were previously treated and made progresssion with Yervoy (ipilimumab).
FDA approves Zytiga combo for castration-sensitive prostate cancer
The US Food and Drug Administration (FDA) has approved Johnson & Johnson’s (J&J) drug Zytiga (abiraterone acetate) in combination with prednisone as an effective treatment for metastatic high-risk castration-sensitive prostate cancer (CSPC).
Kevzara (sarilumab) for the Treatment of Rheumatoid Arthritis
Kevzara® (sarilumab) is a human monoclonal antibody indicated for the treatment of adult patients with moderate-to-severely active rheumatoid arthritis (RA).
Clinical trials for oncology biosimilars: for which indications can we expect approvals?
Over the past few years, biosimilars have been a hot topic in autoimmunity, and development has recently gained significant momentum in the oncology sector. With the first biosimilar approvals in oncology won in 2017, GlobalData expects this topic to gain significant attention in the year to come. While many questions regarding pricing, reimbursement, uptake, and acceptance among patients and oncologists are yet to be answered, the FDA and EMA guidelines on product development and approval have made significant progress in recent years.
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