Astrazeneca

AstraZeneca, a global, science-led biopharmaceutical business, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorisation of Tagrisso (AZD9291, osimertinib) 80mg once-daily tablets for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).

AstraZeneca  announced that it has entered into an agreement with Perrigo Company plc for the divestment of US rights to Entocort® (budesonide), a gastroenterology medicine for patients with mild to moderate Crohn’s disease, an area of medicine outside AstraZeneca’s strategic focus.

AstraZeneca, a global, innovation-driven biopharmaceutical business, announced three new partnerships that will deliver industry-leading technologies to drive the AstraZeneca MRC UK Centre for Lead Discovery in the search for novel small molecule medicines. The partnerships will ensure state-of-the-art screening and compound management at the facility, which will be located within the company’s new global R&D centre at the Cambridge Biomedical Campus. It will screen around 2 million chemical structures per target to find new compounds for disease targets.

AstraZeneca announced that the US Food and Drug Administration (FDA) has approved TAGRISSO (AZD9291) 80mg once-daily tablets for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.

AstraZeneca, along with its global biologics research and development arm, MedImmune, will present positive data today from the Phase II trial of anifrolumab for the treatment of moderate-to-severe systemic lupus erythematosus (SLE or lupus) at the American College of Rheumatology (ACR) 2015 Annual Scientific Meeting in San Francisco.

AstraZeneca, a global, innovation-driven biopharmaceutical business acquire ZS Pharma, a biopharmaceutical company based in San Mateo, California. ZS Pharma uses its proprietary ion¬-trap technology to develop novel treatments for hyperkalaemia (high potassium levels), a serious condition of elevated potassium in the bloodstream, typically associated with chronic kidney disease (CKD) and chronic heart failure (CHF).

US Food and Drug Administration’s (FDA) Arthritis Advisory Committee (AAC) voted 10 to 4 to recommend the approval of lesinurad 200mg tablets for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor (XOI). All 10 who backed the drug, lesinurad, qualified their vote by urging the FDA to ask AstraZeneca for studies after the drug's launch to gauge its long-term effectiveness and safety.

AstraZeneca and Eli Lilly deepening their collaboration in cancer immunotherapy by testing new drug combinations for treating solid tumours.

U.S. health regulators declined to approve a fixed-dose diabetes drug combination from AstraZeneca, delaying its launch and dealing a blow to an important plank of the drugmaker's business. Food and Drug Administration (FDA) stating that more clinical data were required before it could approve the combination of saxagliptin and dapagliflozin.

AstraZeneca, a global, innovation-driven biopharmaceutical business, and The University of Manchester, a member of the prestigious Russell Group of British universities collaborate to deliver personalised healthcare for cancer patients. The five-year agreement will see the organisations apply clinical trial bioinformatics to better identify the right cancer treatment for the right patient at the right time. As part of the collaboration, AstraZeneca will provide a total of £11.5 million.