AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today announced that the US Food and Drug Administration (FDA) has approved Lynparza (olaparib), for use in patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm),
AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the European Commission (EC) has approved Fasenra (benralizumab) as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting beta-agonists.
Acceptance follows FDA Breakthrough Therapy Designation
Tagrisso granted Priority Review
AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for the use of Tagrisso (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity agains
AstraZeneca, along with Acerta Pharma, its haematology research and development centre of excellence, and MedImmune, its global biologics research and development arm, will highlight significant progress in blood cancer research at the 59th 2017 American Society of Hematology (ASH) Annual Meeting & Exhibition in Atlanta, USA
AstraZeneca today announced positive top-line results of the Phase IV ASCENT trial for Tudorza Pressair (aclidinium bromide 400 μg, twice-daily), a long-acting muscarinic antagonist (LAMA), in patients with moderate to very severe chronic obstructive pulmonary disease (COPD), with a history of cardiovascular disease and/or significant cardiovascular risk factors.
AstraZeneca today announced that the European Medicines Agency has accepted a variation to the Marketing Authorisation Application (MAAv) for Tagrisso (osimertinib),
AstraZeneca today announced a strategic joint venture with the Chinese Future Industry Investment Fund (FIIF) to form an equally-owned, stand-alone company in China to discover, develop and commercialise potential new medicines to help meet unmet needs globally, and to bring innovative new medicines to patients in China faster.
AstraZeneca today announced the submission of a supplemental new drug application (sNDA) to Japan’s Pharmaceuticals and Medical Devices Agency for the use of Tagrisso (osimertinib).
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 abemac
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 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, bolagets g
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 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 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
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 MedImmune, its global biologics research and development arm, today announced the expansion of their clinical collaboration with Incyte Corporation.
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.
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
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
Imfinzi granted Priority Review Acceptance follows FDA’s Breakthrough Therapy Designation