AstraZeneca

Faslodex receives US FDA approval for the treatment of advanced breast cancer in combination with abemaciclib

15 November 2017 08:03

Faslodex in combination with abemaciclib showed 16.4 months of progression-free survival (PFS)

Second approval in three months expands treatment options for women with HR+, HER2- advanced breast cancer
AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved a new indication for Faslodex (fulvestrant), expanding the indication to include use with

Fasenra (benralizumab) receives US FDA approval for severe eosinophilic asthma

15 November 2017 08:01

AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has approved Fasenra (benralizumab) for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.

Benralizumab får positivt CHMP-utlåtande i EU för behandling av svår, okontrollerad eosinofil astma

10 November 2017 13:05

Benralizumab riktar sig mot och avlägsnar snabbt eosinofiler och är det första biologiska läkemedlet för sjukdomar i andningsvägarna med en 8-veckorsdosering för underhållsbehandling

Rekommendationen är baserad på omfattande fas III-program som uppvisar betydande minskningar av astmaanfall, förbättrad lungfunktionoch minskad användning av orala steroider
AstraZeneca och MedImmune, bolage

AstraZeneca PLC:s resultatrapport för första nio månader och tredje kvartalet 2017

9 November 2017 08:39

Pascal Soriot, koncernchef, kommenterar resultatet:
”Våra ekonomiska resultat under kvartalet ligger i linje med förväntningarna och återspeglar bra genomförande på marknadssidan, inklusive stark tillväxt på tillväxtmarknaderna med enastående försäljning i Kina.
Det mest anmärkninsvärda är dock mängden nyheter och godkännanden. I synnerhet kompenserade den positiva utvecklingen för Tagrisso

AstraZeneca shares scientific updates from its extensive cardiovascular, renal and metabolic diseases (CVMD) portfolio at AHA 2017

8 November 2017 08:02

AstraZeneca and MedImmune, its global biologics research and development arm, will be underlining its scientific focus on cardiovascular, renal and metabolic diseases (CVMD) with 28 presentations, including two late-breaking trials, at the American Heart Association (AHA) Scientific Sessions, November 11-15, 2017 in Anaheim, California.

AstraZeneca provides update on tralokinumab Phase III Programme in severe, uncontrolled asthma

1 November 2017 08:06

AstraZeneca and its global biologics research and development arm, MedImmune, today announced the top-line results of the Phase III STRATOS 2 and TROPOS trials for tralokinumab, an anti-interleukin-13 (IL-13) human monoclonal antibody, in severe, uncontrolled asthma.
In STRATOS 2, tralokinumab did not achieve a statistically-significant reduction in the annual asthma exacerbation rate (AA

FDA godkänner AstraZenecas Calquence (acalabrutinib) för vuxna patienter med tidigare behandlad mantelcellslymfom

31 Oktober 2017 18:23

AstraZeneca och dess FoU-center för hematologi, Acerta Pharma, meddelar idag att den amerikanska läkemedelsmyndigheten FDA har godkänt Calquence(acalabrutinib) inom ramen för så kallat ”påskyndat godkännande” Calquence är en tyrosinkinashämmare och indikationen gäller behandling av vuxna patienter med mantelcellslymfom (MCL) som har fått minst en tidigare behandling. 1

AstraZeneca and Incyte enter clinical trial collaboration in early lung cancer

31 Oktober 2017 08:14

AstraZeneca and MedImmune, its global biologics research and development arm, today announced the expansion of their clinical collaboration with Incyte Corporation.

AstraZeneca and MSD rapidly advance Lynparza in Japan with a second regulatory submission

23 Oktober 2017 08:14

AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US today announced that they have submitted a new drug application (NDA) to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for the use of Lynparza(olaparib) tablets in unresectable or recurrent BRCA-mutated breast cancer, with a decision expected in the second half of 2018.

US FDA approves new easy-to-use, once-weekly Bydureon BCise injectable medicine for patients with type-2 diabetes

23 Oktober 2017 08:06

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Bydureon BCise (exenatide extended-release) injectable suspension, a new formulation of Bydureon in an improved once-weekly, single-dose autoinjector device for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines in addition to diet and exercise

US FDA accepts regulatory submission for Lynparza in metastatic breast cancer and grants priority review

18 Oktober 2017 08:03

Lynparza has the potential to offer a new treatment option for patients with germline BRCA-mutated, HER2-negative metastatic breast cancer Regulatory submission acceptance is first for a PARP inhibitor beyond ovarian cancer

US FDA accepts supplemental biologics license application for Imfinzi in locally advanced unresectable non-small cell lung cancer

17 Oktober 2017 08:05

Imfinzi granted Priority Review Acceptance follows FDA’s Breakthrough Therapy Designation

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