AstraZeneca

Medimmune receives Fast Track designation in the US for MEDI8852 for treatment of patients hospitalised with influenza A

7 Mars 2016 08:03

AstraZeneca today announced that its global biologics research and development arm, MedImmune, has received Fast Track designation from the US Food and Drug Administration (FDA) for its investigational human monoclonal antibody (mAb), MEDI8852, for the treatment of patients hospitalised with Type A strain influenza. The FDA’s Fast Track programme is designed to expedite the development and review

AstraZeneca tecknar avtal med ProStrakan för rätten till Moventig i Europa

1 Mars 2016 09:02

Ltd, för rätten till Moventig (naloxegol) i EU, Island, Norge, Schweiz och Liechtenstein. Moventig är den första orala, perifert verkande my-opioidreceptor-antagonisten (PAMORA) för daglig behandling som är godkänd i Europa för behandling av opioidinducerad förstoppning (OIC) hos vuxna patienter som inte har svarat tillräckligt bra på laxermedel.

AstraZeneca reports top-line result of tremelimumab monotherapy trial in mesothelioma

29 Februari 2016 15:03

Trial didnot meet primaryendpointof improvingoverall survival in challenging to treat mesothelioma patientswith no currently approved treatmentoptions in the second-line setting Tremelimumabremainskeycomponent of Immuno-Oncologycombinationstrategy across multipletumourtypes

AstraZeneca enters licensing agreement with China Medical System Holdings for hypertension medicine

29 Februari 2016 09:00

Agreement for Plendil in China reinforces AstraZeneca’s focus on innovative medicines

ACALABRUTINIB RECOMMENDED FOR ORPHAN DRUG DESIGNATION IN EUROPE FOR THREE INDICATIONS

25 Februari 2016 10:14

AstraZeneca and Acerta Pharma BV, a company in which AstraZeneca has a majority equity investment, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) adopted three positive opinions recommending acalabrutinib (ACP-196) for designation as an orphan medicinal product.

Brilique (ticagrelor) har godkänts i EU för utvidgad behandling av patienter med tidigare hjärtinfarkt

19 Februari 2016 08:08

Godkännande av en ny dos på 60 mg utvidgar den nuvarande indikationen till att även omfatta långsiktig behandling ett år efter tidigare hjärtinfarkt

Zurampic (lesinurad) approved in the European Union for patients with gout

19 Februari 2016 08:03

AstraZeneca today announced that the European Commission (EC) has granted marketing authorisation for ZurampicTM(lesinurad) 200mg in combination with a xanthine oxidase inhibitor (XOI) for the adjunctive treatment of hyperuricemia in adult gout patients (with or without tophi) who have not achieved target serum uric acid (sUA) levels with an adequate dose of an XOI alone.
Zurampic is a selectiv

Durvalumab granted Breakthrough Therapy Designation by US FDA for treatment of patients with PD-L1 positive urothelial bladder cancer

17 Februari 2016 08:03

AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for durvalumab (MEDI4736),

AstraZeneca’s BioVentureHub expanding with leading science

11 Februari 2016 08:00

Two new companies have moved into the BioVentureHub at AstraZeneca Gothenburg, bringing the total to 17 companies and 1 academic group.

AstraZeneca PLC’s resultatrapport för helåret och fjärde kvartalet 2015

4 Februari 2016 08:02

Pascal Soriot, koncernchef, kommenterar resultatet: "Vi stärkte vår forskningsportfölj och levererade ett starkt finansiellt resultat under 2015 samtidigt som vi påbörjade nästa fas av vår strategiska resa. .....

TAGRISSO™ (osimertinib) har godkänts i EU som den första behandlingen för patienter med EGFR T790M mutationspositiv metastaserad icke-småcellig lungcancer

3 Februari 2016 12:29

Det första nya läkemedlet som godkänts inom ramen för Europeiska kommissionens accelererade process Godkännandet baseras på studier som visar på en objektiv responsfrekvens av 66 % och en progressionsfri överlevnad med en median på 9,7 månader. Tumörprov eller blodprov kan fastställa vilka patienter som sannolikt kan dra nytta av osimertinib

Tagrisso™ (osimertinib) approved in EU as first-in-class treatment for patients with EGFR T790m mutation-positive metastatic non-small cell lung cancer

3 Februari 2016 08:04

TAGRISSO™ is the first new medicine to be approved under the European Commission’s expedited process
Approval based on studies showing objective response rate of 66% and median progression-free survival of 9.7 months
Tumour sample or blood test can determine patients likely to benefit from osimertinib
AstraZeneca today announced that the European Commission (EC) has granted conditional m

Lynparza™ (olaparib) granted breakthrough therapy designation by US FDA for treatment of BRCA1/2 or ATM gene mutated metastatic Castration Resistant Prostate Cancer

28 Januari 2016 08:03

AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for the oral poly ADP-ribose polymerase (PARP) inhibitor Lynparza™ (olaparib),

AstraZeneca and Incyte announce new lung cancer clinical trial collaboration

11 Januari 2016 13:03

AstraZeneca and Incyte Corporation today announced a new collaboration to evaluate the efficacy and safety of Incyte’s Janus-associated kinase (JAK) 1 inhibitor, INCB39110, in combination with AstraZeneca’s next generation epidermal growth factor receptor (EGFR) inhibitor, Tagrisso® (osimertinib). The combination will be assessed as a second line treatment for patients with EGFR mutation-positive

AstraZeneca and Moderna Therapeutics announce new collaboration to co-develop and co-commercialise Immuno-Oncology mRNA Therapeutics™

11 Januari 2016 13:01

Moderna to lead preclinical development; AstraZeneca to lead clinical development; Moderna to co-commercialise and share profits on resulting products in the US
AstraZeneca, along with its global biologics research and development arm, MedImmune, and Moderna Therapeutics today announced a new collaboration to discover, co-develop and co-commercialise messenger RNA (mRNA) therapeutic candidates

ZURAMPIC® (lesinurad) approved by US FDA for patients with gout

23 December 2015 08:01

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved ZURAMPIC®(lesinurad) 200mg tablets in combination with a xanthine oxidase inhibitor (XOI) for the treatment of hyperuricemia associated with gout

TAGRISSO™ (OSIMERTINIB) , LESINURAD OCH BRILIQUE (TICAGRELOR) FÅR POSITIVT UTLÅTANDE FRÅN CHMP I EU

18 December 2015 15:43

AstraZeneca meddelar idag att den europeiska läkemedelsmyndigheten EMA:s rådgivande kommitté CHMP ger positivt besked och rekommenderar godkännande av TAGRISSO™ (AZD9291, osimertinib) och lesinurad, samt ny indikation för BRILIQUE (ticagrelor) 60mg för behandling av patienter som har en historia av hjärtinfarkt och hög risk att få en ytterligare aterotrombotisk händelse.

Durvalumab ATLANTIC trial supports clinical activity and AstraZeneca’s overall immuno-oncology strategy

18 December 2015 08:03

Durvalumab demonstrated clinical activity and durable responses in 3rd-line or later stage NSCLC patients; full data to be presented at a scientific congress in 2016

AstraZeneca enhances long term growth through oncology investment in Acerta Pharma

17 December 2015 08:02

Transaction includes late-stage, potential best-in-class irreversible small molecule BTK inhibitor, acalabrutinib Opportunity for first regulatory submissions in haematological malignancies in 2016

AstraZeneca continues strategic investment in China to accelerate delivery of innovative biologics and targeted medicines

16 December 2015 08:34

Strategic alliance with WuXi AppTec to develop next-generation biologics in China New small molecule development facility; new global hub for Pharmaceutical Development

Ämnen: Industri, tillverkning