biopharmaceutical

AstraZeneca to sublicense its global rights to Movantik to RedHill Biopharma

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AstraZeneca (LON:AZN) has today announced that it has agreed to sublicense its global rights to Movantik (naloxegol), excluding Europe, Canada and Israel, to RedHill Biopharma (RedHill). Movantik is a peripherally acting mu-opioid receptor antagonist indicated for the treatment of opioid-induced constipation. Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, said: “This divestment supports our strategy to realise value from medicines in our portfolio that …

Pharma

AstraZeneca deliver strong revenue growth

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AstraZeneca plc (LON:AZN) has today announced its full year and Q4 2019 results. AstraZeneca delivered a year of strong revenue growth, supported by the launch of new medicines1 and further good progress on its pipeline, with several approvals and data readouts. These trends are set to continue in 2020, accompanied by growth in earnings and cash. In maintaining its focus on …

Pills

AstraZeneca’s Brilinta met primary endpoint in Phase III trial

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High-level results from the Phase III THALES trial showed AstraZeneca (LON:AZN) Brilinta (ticagrelor) 90mg used twice daily and taken with aspirin for 30 days, reached a statistically significant and clinically meaningful reduction in the risk of the primary composite endpoint of stroke and death, compared to aspirin alone. THALES was conducted in over 11,000 patients who had a minor acute ischaemic stroke or high-risk …

AstraZeneca meets primary endpoint for Enhertu phase II trial

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High-level results from the positive registrational Phase II trial DESTINY-Gastric01 showed AstraZeneca (LON:AZN) and Daiichi Sankyo Company, Limited’s Enhertu, achieved a statistically significant and clinically meaningful improvement in objective response rate and overall survival in patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction cancer that had progressed following two or more treatment regimens including trastuzumab and chemotherapy. The trial …

Astrazeneca plc

AstraZeneca Imfinzi and tremelimumab granted Orphan Drug Designation in the US

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AstraZeneca (LON:AZN) Imfinzi (durvalumab) and tremelimumab, an anti-CTLA4 antibody and potential new medicine, have both been granted Orphan Drug Designation (ODD) in the US for the treatment of hepatocellular carcinoma, the most common type of liver cancer. The US Food and Drug Administration (FDA) grants ODD to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect …

AstraZeneca Lynparza granted Priority Review by FDA

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AstraZeneca (LON:AZN) and MSD Inc., Kenilworth, N.J., US (known as Merck & Co., Inc. inside the US and Canada) today announced that a supplemental New Drug Application for Lynparza has been accepted and granted Priority Review in the US for patients with metastatic castration-resistant prostate cancer and deleterious or suspected deleterious germline or somatic homologous recombination repair gene mutations, who have progressed following prior …

Astrazeneca plc

AstraZeneca to close Phase III STRENGTH trial for Epanova

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Following the recommendation from an independent Data Monitoring Committee, AstraZeneca (LON:AZN) has decided to close the Phase III STRENGTH trial for Epanova (omega-3 carboxylic acids) due to its low likelihood of demonstrating a benefit to patients with mixed dyslipidaemia (MDL) who are at increased risk of cardiovascular (CV) disease. STRENGTH is a large-scale, global CV outcomes trial designed to evaluate the safety …

AstraZeneca’s Lynparza granted FDA Priority Review for PAOLA-1

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AstraZeneca (LON:AZN) and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) has today announced that a supplemental New Drug Application for Lynparza (olaparib) in combination with bevacizumab has been accepted and granted Priority Review in the US for the maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response to 1st-line …

Astrazeneca plc

AstraZeneca’s Lokelma approved in China

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AstraZeneca (LON:AZN) has announced today that Lokelma has been approved in China for the treatment of adult patients with hyperkalaemia. The approval by the National Medical Products Administration (NMPA) was based on positive results from the extensive Lokelma clinical trial programme and a pharmacodynamic study in China which showed that patients receiving Lokelma experienced a significant, rapid and sustained reduction of potassium in the …

AstraZeneca’s Farxiga granted FDA Priority Review

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AstraZeneca (LON:AZN) has today announced the US Food and Drug Administration has accepted a supplemental New Drug Application and granted Priority Review for Farxiga to reduce the risk of cardiovascular death or the worsening of heart failure in adults with heart failure with reduced ejection fraction with and without type-2 diabetes. Farxiga is a first-in-class, oral once-daily selective inhibitor of human sodium-glucose co-transporter 2. The …