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 : 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) […]
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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 […]
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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 […]
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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 […]
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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 […]
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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 […]
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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 […]
Continue reading …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 […]
Continue reading …Pharma giant AstraZeneca has reported that its ovarian cancer drug Lynparza (olaparib) as a maintenance therapy has considerably improved the survival chances of patients with germline BRCA-mutations (gBRCA) who had a relapse of the disease, who did not respond to platinum-based chemo. Phase 3 Trial of Astrazeneca Ovarian Cancer Drug Lynparza The observation of the […]
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Eiger bags FDA breakthrough therapy status for HDV drug candidate Lambda
NKMax America launches SNK01-MX03 clinical trial in plaque psoriasis
Mexican pharma company Sanfer secures $500m investment from CDPQ
Nabriva secures Xenleta FDA approval for community-acquired pneumonia
Celgene bags Inrebic FDA approval for myelofibrosis
Alfasigma USA launches IBS-C drug ZELNORM in US
AbbVie secures Rinvoq FDA approval for rheumatoid arthritis
FDA approves CVRx Barostim Neo System for advanced heart failure symptoms
Bio-Thera Solutions begins phase 1 trial for Simponi biosimilar BAT2506
Neuropore gets FDA orphan drug designation for NPT520-34 for ALS
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