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FDA approves AstraZeneca’s FASENRA self-administration via FASENRA Pen

AstraZeneca has bagged approval from the US Food and Drug Administration (FDA) for the self-administration of FASENRA (benralizumab) through FASENRA Pen, a pre-filled, single-use auto-injector, for the add-on maintenance treatment of severe asthma in patients aged 12 years and older, and with an eosinophilic phenotype. FASENRA is a monoclonal antibody which directly binds to the […]

October 5, 2019No CommentRead More

PAOLA 1 trial results : Lynparza, bevacizumab combo achieves PFS goal in phase 3 trial

August 15, 2019 No Comment

PAOLA 1 trial results : Lynparza (olaparib), a cancer drug which was jointly developed by AstraZeneca and MSD, in combination with bevacizumab, met the primary endpoint of the phase 3 PAOLA 1 clinical trial in patients with advanced ovarian cancer. The PAOLA 1 primary endpoint is the statistically-significant and clinically-meaningful improvement shown by Lynparza plus […]

Tagrisso FLAURA trial results : AstraZeneca NSCLC drug significantly improves OS

August 11, 2019 No Comment

Tagrisso FLAURA trial results : Pharma giant AstraZeneca said that the phase 3 FLAURA trial evaluating Tagrisso (osimertinib) in previously untreated patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) has yielded positive overall survival (OS) results. The randomized, double-blinded, multicenter late-stage trial featured NSCLC patients whose tumors have epidermal growth factor receptor (EGFR) […]

Verdiperstat phase 3 MSA clinical trial : Biohaven enrolls first patient

August 1, 2019 No Comment

Verdiperstat phase 3 MSA clinical trial : US biopharma company Biohaven Pharmaceutical has enrolled the first patient in a phase 3 clinical trial to assess the efficacy and safety of verdiperstat (formerly known as AZD3241) in patients with Multiple System Atrophy (MSA), a rare neurodegenerative disorder. Licensed from AstraZeneca in September 2018, verdiperstat is an […]

Pharma giants bag Lynparza EMA approval for metastatic breast cancer

May 19, 2019 No Comment

Lynparza EMA approval : Pharma giants AstraZeneca and MSD have secured an expansion of the European Medical Agency’s (EMA) approval for their poly ADP-ribose polymerase (PARP) inhibitor Lynparza (olaparib) to be used for the treatment of a type of advanced breast cancer. The expanded Lynparza EMA approval allows the PARP inhibitor to be used as […]

FDA approves AstraZeneca’s Lumoxiti for hairy cell leukaemia treatment

September 14, 2018 No Comment

Lumoxiti FDA approval : AstraZeneca has bagged the US Food and Drug Administration (FDA) approval for its CD22-directed cytotoxin Lumoxiti (moxetumomab pasudotox-tdfk) for the treatment of relapsed or refractory hairy cell leukaemia (HCL). Lumoxiti FDA approval for hairy cell leukaemia treatment is for adult patients who had undergone more than two systemic therapies in the […]

AstraZeneca, Amgen asthma drug tezepelumab secures FDA breakthrough designation

September 9, 2018 No Comment

UK biopharma company AstraZeneca and Amgen have secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for their asthma drug tezepelumab. The FDA breakthrough therapy designation for tezepelumab is for the treatment of patients with severe asthma, without an eosinophilic phenotype, who are administered inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids […]

CHMP recommends AstraZeneca lung cancer drug Imfinzi EMA approval

July 29, 2018 No Comment

Update on Imfinzi EMA approval : The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the approval of AstraZeneca lung cancer drug Imfinzi (durvalumab) for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC). The committee has recommended Imfinzi EMA approval of […]

Acalabrutinib wins US FDA approval for mantle cell lymphoma treatment

November 1, 2017 No Comment

Acalabrutinib FDA approval : AstraZeneca has secured an early approval for its blood cancer drug Calquence (acalabrutinib) for the treatment of mantle cell lymphoma in adult patients who were subjected to a minimum of one prior therapy for the rare type of blood cancer. According to the National Cancer Institute at the National Institutes of […]

AstraZeneca lung cancer drug Tagrisso gets FDA breakthrough therapy designation

October 15, 2017 No Comment

Pharma news updates : Tagrisso (osimertinib), the AstraZeneca lung cancer drug has bagged the breakthrough therapy designation (BTD) from the US FDA for the treatment of non-small cell lung cancer (NSCLC) in a first line setting. The BTD designation for the AstraZeneca cancer drug is specifically for treating metastatic NSCLC patients who have tested positive […]