EMA validates application for Byondis’ trastuzumab duocarmazine
The submission follows positive results of phase 3 trial focusing on breast cancer therapy
Read More
Tag: trastuzumab
US nod for Roche’s breast cancer combo
The therapy marks Roche’s first combination of two monoclonal antibodies administered in a single subcutaneous injection
Read More
New vaccine for Ebola among CHMP recommendations
The vaccine could be Janssen’s first to win EU approval
Read More
New Herceptin combo could keep breast cancers at bay
Guiding chemotherapy to a tumour by attaching it to the antibody-based target drug Herceptin is effective at treating women with breast cancer who have no other treatment options.
Read More
EMA gives trastuzumab biosimilar Marketing Authorisation Application
The drug is Prestige’s lead development candidate biosimilar to Roche’s Herceptin.
Read More
Roche’s Kadcyla cuts risk of breast cancer recurrence after surgery
Roche’s Kadcyla was significantly better than Herceptin at reducing the risk of breast cancer recurrence in certain patients with residual disease after surgery, according to new study findings presented at the San Antonio Breast Cancer Symposium.
Read More
Roche’s Kadcyla shows promise in early breast cancer
Roche has announced that its antibody drug conjugate Kadcyla cut the risk of disease recurrence when given after neoadjuvant treatment and surgery to certain breast cancer patients with residual disease.
Read More
Novartis’ Aimovig leads CHMP recommendations
The European Medicines Agency’s Committee for Medicinal Products for Human Use has endorsed nine medicines for approval at its May meeting, including Novartis’ Aimovig, the first human monoclonal antibody for migraine prevention.
Read More
FDA rejects Pfizer’s Herceptin biosimilar
US regulators have issued a complete response letter regarding Pfizer’s filing for a biosimilar version of Roche’s blockbuster cancer drug Herceptin.
Read More
US delay for Celltrion’s Rituxan, Herceptin biosimilars
The US Food and Drug Administration has rejected Celltrion’s submissions for biosimilars to Roche drugs Rituxan and Herceptin.
Read More
Six new therapies backed for EU approval
Six medicines have taken a big step towards European approval having been recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use.
Read More
Napp secures distribution rights to Celltrion’s Herzuma
Napp Pharmaceuticals has secured itself exclusive UK distribution rights to Celltrion Healthcare’s Herceptin biosimilar Herzuma.
Read More
- HUTCHMED begins global trial of novel attc therapy hmpl‑a580 in solid tumours
- Theolytics awarded €8 million Horizon Europe grant to fund ovarian cancer study
- AI system aims to uncover Alzheimer’s earlier and take on diagnostic delays
- Quell launches chill phase 1/2 trial for novel cartreg therapy
- Bioxytran reports positive phase 1b/2a results for antiviral ProLectin‑M
