Pharma Business - October 10, 2021
AstraZeneca’s Tezepelumab granted Orphan Drug Designation
Tezepelumab has been granted Orphan Drug Designation (ODD) in the US by the Food and Drug Administration (FDA) for the treatment of eosinophilic esophagitis (EoE). Tezepelumab is being developed by AstraZeneca in collaboration with Amgen and is under Priority Review for patients with asthma in the US. The FDA grants ODD status to medicines and […]
Clinical Trials - October 2, 2021
New results about AstraZeneca’s Lynparza
Positive results from the PROpel Phase III trial showed that AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone demonstrated a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) versus standard-of-care abiraterone as a 1st-line treatment for men with metastatic castration-resistant prostate cancer (mCRPC) with or without homologous recombination repair (HRR) gene […]
Acquisition - September 29, 2021
AstraZeneca to fully acquire Caelum Biosciences
AstraZeneca’s Alexion has exercised its option to acquire all remaining equity in Caelum Biosciences for CAEL-101, a potentially first-in-class fibril-reactive monoclonal antibody (mAb) for the treatment of light chain (AL) amyloidosis. CAEL-101 is currently being evaluated in the Cardiac Amyloid Reaching for Extended Survival (CARES) Phase III clinical programme in combination with standard-of-care (SoC) therapy […]
New Market - September 28, 2021
AstraZeneca’s Saphnelo approved in Japan for SLE
Saphnelo (anifrolumab) has been approved in Japan for the treatment of adult patients with systemic lupus erythematosus (SLE), a serious autoimmune disease. The approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) was based on efficacy and safety data from the Saphnelo clinical development programme, including the TULIP Phase III trials and the […]
Pharma Business - September 21, 2021
AstraZeneca invests in manufacturing facility in Ireland
AstraZeneca is to invest 360 million USD in an advanced manufacturing facility in Ireland. The investment will transform development and commercialization of new medicines, states the company. “This is a tremendously proud moment for us all at AstraZeneca and I am delighted that we are bringing this very significant investment to Dublin which, with the […]
Clinical Trials - September 20, 2021
New results from AstraZeneca’s CASPIAN trial
Updated results from the Phase III trial showed that Imfinzi (durvalumab) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin, demonstrated a sustained, clinically meaningful overall survival benefit at three years for adults with extensive-stage small cell lung cancer treated in the 1st-line setting. These data, which show the longest survival […]
