Ämnen: Farmaci

US FDA approves Lumoxiti (moxetumomab pasudotox-tdfk) for certain patients with relapsed or refractory hairy cell leukaemia

13 September 2018 22:18

AstraZeneca and MedImmune, announced today that the US FDA has approved Lumoxiti (moxetumomab pasudotox-tdfk) for the treatment of adult patients with relapsed or refractory hairy cell leukaemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog.Lumoxiti is not recommended in patients with severe renal impairment (CrCl ≤ 29 mL/min).

AstraZeneca to present Fasenra long-term safety and efficacy data at European Respiratory Society International Congress 2018

13 September 2018 08:04

AstraZeneca and MedImmune, today announced that new data from the BORA Phase III extension trial of Fasenra (benralizumab) is among 43 company abstracts accepted for oral and poster presentation at the European Respiratory Society (ERS) International Congress 2018, 15-19 September in Paris.

Tezepelumab granted Breakthrough Therapy Designation by US FDA

7 September 2018 08:03

AstraZeneca and its partner Amgen Inc. (Amgen) today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype, who are receiving inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids and additional asthma controllers.

Update on TULIP 1 Phase III trial for anifrolumab in systemic lupus erythematosus

31 Augusti 2018 08:04

AstraZeneca and MedImmune, today announced top-line results from the TULIP 1 Phase III trial for anifrolumab in adult patients with moderate-to-severe systemic lupus erythematosus (SLE). The trial did not meet the primary endpoint of a statistically-significant reduction in disease activity in patients with SLEas measured by the SLE Responder Index 4 (SRI4)at 12 months.

European Commission approves new easy-to-use, once-weekly Bydureon BCise device for patients with type-2 diabetes

30 Augusti 2018 08:02

AstraZeneca today announced that the European Commission (EC) has approved Bydureon BCise (exenatide 2mg prolonged-release suspension for injection in pre-filled pen) as a new formulation within the marketing authorisation for Bydureon (exenatide extended release) for the treatment of patients with type-2 diabetes.

AstraZeneca provides update on AERISTO Phase IIIb trial for Bevespi Aerosphere in chronic obstructive pulmonary disease

23 Augusti 2018 14:08

AstraZeneca today announced top-line results from the AERISTO Phase IIIb trial for Bevespi Aerosphere (glycopyrronium/formoterol fumarate) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).

Tagrisso approved in Japan for 1st-line treatment of EGFR-mutated non-small cell lung cancer

21 Augusti 2018 08:01

AstraZeneca today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Tagrisso (osimertinib) for the 1st-line treatment of patients with inoperable or recurrent epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC), following priority review.

AstraZeneca is advancing understanding of cardio-renal-metabolic interconnectivity with new evidence at ESC 2018

20 Augusti 2018 08:02

New evidence of the persistency of ischaemic risk in post-heart attack patients, highlighting specific risk factors that may help identify patients for extended DAPT Latest data on the links between RAAS inhibitor dose reduction and increased risk of mortality and MACE in heart failure patients with hyperkalaemia

Selumetinib granted orphan designation in Europe for neurofibromatosis type 1

3 Augusti 2018 08:19

AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (known as MSD outside the US and Canada) today announced that the European Medicines Agency (EMA) has granted orphan designation to selumetinib, a MEK 1/2 inhibitor, for the treatment of neurofibromatosis type 1 (NF1).

Imfinzi receives positive EU CHMP opinion for locally- advanced, unresectable non-small cell lung cancer

27 Juli 2018 15:03

Recommended marketing authorisation for patients whose tumours express PD-L1 on ≥1% of tumour cells Imfinzi is the first immunotherapy recommended for approval for the treatment of locally-advanced, unresectable NSCLC

AstraZeneca PLC:s resultatrapport för första halvåret och andra kvartalet 2018

26 Juli 2018 08:06

Starka resultat från nya läkemedel och tillväxtmarknaderna stödjer återgång till tillväxt under 2018

Atacand to be divested to Cheplapharm in Europe

24 Juli 2018 08:12

AstraZeneca has agreed to sell the commercial rights to Atacand(candesartan cilexetil)and AtacandPlus (fixed-dose combination of candesartan cilexetil and hydrochlorothiazide) in Europe to CheplapharmArzneimittel GmbH (Cheplapharm). Atacand is a prescription medicine for the treatment of heart failure and hypertension.

Katarina Ageborg ny VD för AstraZeneca i Sverige

16 Juli 2018 13:22

AstraZeneca meddelar i dag att Katarina Ageborg utsetts till ny VD för AstraZeneca AB. Hon tar över efter Jan-Olof Jacke den 1 augusti 2018 och kommer även fortsättningsvis rapportera till koncernchef Pascal Soriot.

Lynparza approved in Japan for BRCA-mutated metastatic breast cancer

2 Juli 2018 08:03

Lynparza is the first and only PARP inhibitor approved for use beyond ovarian cancer Second approval in Japan for AstraZeneca and MSD’s Lynparza

Imfinzi approved in Japan for unresectable Stage III non-small cell lung cancer

2 Juli 2018 08:02

AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the Japanese Ministry of Health, Labour and Welfare approved Imfinzi (durvalumab) as maintenance therapy after definitive chemoradiation therapy (CRT) in locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC).

Bydureon receives positive EU CHMP opinion for new BCise device for patients with type-2 diabetes

29 Juni 2018 16:09

AstraZeneca today announced that the CHMP of the European Medicines Agency (EMA) has adopted a positive opinion, recommending inclusion of Bydureon (2mg prolonged-release suspension for injection) BCise device as a new formulation within the marketing authorisation for Bydureon (exenatide extended-release) for the treatment of type-2 diabetes.

Lynparza significantly delays disease progression in Phase III 1st-line SOLO-1 trial for ovarian cancer

27 Juni 2018 08:02

AstraZeneca and MSD today announced positive results from the randomised, double-blinded, placebo-controlled, Phase III SOLO-1 trial of Lynparza (olaparib) tablets.

AstraZeneca to share latest data from an industry-leading portfolio that aims to advance clinical understanding of diabetes and CV risk management at ADA 2018

19 Juni 2018 08:02

Key data evaluating the efficacy and safety of Farxiga (dapagliflozin) in combination with other type-2 diabetes therapies head-to-head vs. insulin or sulfonylurea Latest data from the DEPICT clinical programme evaluating Farxiga to address an unmet need for oral therapy in adult patients with type-1 diabetes

Update on Phase III clinical trials of lanabecestat for Alzheimer’s disease

12 Juni 2018 08:03

Independent data monitoring committee advises lanabecestat is unlikely to meet primary endpoints, leading to decision to discontinue these trials

The EU approves Tagrisso for 1st-line treatment of EGFR-mutated non-small cell lung cancer

9 Juni 2018 08:15

Today the European Commission has granted marketing authorisation for Tagrisso as monotherapy for the 1st-line treatment of adult patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations. The approval is based on results from the Phase III FLAURA trial published in the New England Journal of Medicine.