Astrazeneca

FDA approves Zurampic to treat high blood uric acid levels associated with gout

  • Posted on: 24 December 2015
  • By: Shalini.Sharma

The U.S. Food and Drug Administration approved Zurampic (lesinurad) to treat high levels of uric acid in the blood (hyperuricemia) associated with gout, when used in combination with a xanthine oxidase inhibitor (XOI), a type of drug approved to reduce the production of uric acid in the body. Zurampic is manufactured by AstraZeneca Pharmaceuticals LP, based in Wilmington, Delaware.

Brilique receive positive opinion of EMA committee for extended treatment of patients with history of heart attack

  • Posted on: 23 December 2015
  • By: Shalini.Sharma

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Astrazeneca's Brilique (ticagrelor) 60mg for the treatment of patients with a history of heart attack and at high risk of having a further atherothrombotic event. The opinion states that, treatment may be started as continuation therapy after an initial one-year treatment with dual anti platelet therapy.

EMA committee recommends marketing approval for AstraZeneca's Tagrisso

  • Posted on: 23 December 2015
  • By: Shalini.Sharma

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 buys 55% share in Acerta Pharma

  • Posted on: 18 December 2015
  • By: Gayatri Mahajan

AstraZeneca has entered into an agreement to invest in a majority equity stake in Acerta Pharma, a privately-owned biopharmaceutical company based in the Netherlands and US. The transaction provides AstraZeneca with a potential best-in-class irreversible oral Bruton's tyrosine kinase (BTK) inhibitor, acalabrutinib (ACP-196), currently in Phase III development for B-cell blood cancers and in Phase I/II clinical trials in multiple solid tumours.

AstraZeneca enters into agreement with Perrigo for rights to Entocort® in the US

  • Posted on: 26 November 2015
  • By: Shalini.Sharma

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 inks 3 technology partnerships to strengthen its Cambridge lead discovery centre

  • Posted on: 25 November 2015
  • By: Shalini.Sharma

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.

FDA grants approval for Tagrisso (AZD9291) to treat patients with EGFR T790M mutation-positive metastatic non-small cell lung cancer

  • Posted on: 16 November 2015
  • By: Shalini.Sharma

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 presents positive new data on anifrolumab in lupus

  • Posted on: 13 November 2015
  • By: Shalini.Sharma

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 acquire ZS Pharma

  • Posted on: 9 November 2015
  • By: Shalini.Sharma

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).

FDA panel recommend approval of AstraZeneca's gout drug

  • Posted on: 24 October 2015
  • By: Shalini.Sharma

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.

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