FDA rejection AZ’s COPD treatment puts pressure on their competitive edge

FDA has issued a complete response letter for the New Drug Application (NDA) for PT010 (budesonide/glycopyrronium/formoterol fumarate); Paul Jeng, Senior Pharma Analyst at GlobalData, a leading data and analytics company, offers his perspective: “In an attempt to close the gap with chief chronic obstructive pulmonary disease (COPD) rival GlaxoSmithKline (GSK), AstraZeneca pushed to file an

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AZ’s breast cancer treatment gains approval from European Commission

AstraZeneca and MSD‘s Olaparib has been approved by the European Commission for the treatment of germline BRCA-mutated HER2-negative metastatic breast cancer. The approval allows for the first PARP inhibitor approved in Europe for patients with this difficult-to-treat disease, and the third EU approval for Olaparib. The European commission made the approval based on data from

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European Commission approved AZ’s treatment for locally advanced, unresectable NSCLC

AstraZeneca’s durvalumab has been approved in Europe for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC). The decision enables doctors to prescribe the drug for adults with stage III NSCLC whose tumours express PD-L1 on ≥1% of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT). The

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Roche and AstraZeneca gain Breakthrough Designations for Treatments

Roche and AstraZeneca have received US FDA breakthrough therapy designations for treatments in multiple sclerosis (MS) and bladder cancer, respectively. Roche’s Ocrevus (ocrelizumab) has become the first investigational medicine to receive the designation for MS. Specifically, the drug treats primary progressive multiple sclerosis (PPMS), a debilitating form of the disease characterised by steadily worsening symptoms

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