Astrazeneca

- Read more about AstraZeneca receives CRL from US FDA for sodium zirconium cyclosilicate (ZS-9)
AstraZeneca announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for sodium zirconium cyclosilicate (ZS-9), the investigational medicine being developed for the treatment of hyperkalaemia (high potassium level in the blood serum) by ZS Pharma, a wholly-owned subsidiary of AstraZeneca.
- Read more about US FDA grants orphan drug status to selumetinib
AstraZeneca announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for the investigational MEK 1/2 inhibitor, selumetinib (AZD6244, ARRY-142886) for adjuvant treatment of patients with stage III or IV differentiated thyroid cancer (DTC). AstraZeneca acquired exclusive worldwide rights to selumetinib from Array BioPharma Inc. in 2003.
- Read more about AstraZeneca fulfill deal of respiratory business of Takeda Pharma
AstraZeneca has fulfilled the deal of the core respiratory business of Takeda Pharmaceutical Company Limited. The agreement, announced in December 2015. Agreement includes the expansion of rights to roflumilast (marketed as Daliresp in the US and Daxas in other countries), the only approved oral PDE4 inhibitor for the treatment of chronic obstructive pulmonary disease. AstraZeneca marketed Daliresp in the US in the first quarter of 2015.
- Read more about AstraZeneca sold global right of Imdur to China Medical System Holdings
AstraZeneca announced that it has handover global rights of Imdur, outside the US, to China Medical System Holdings Ltd and its associated company, Tibet Rhodiola Pharmaceutical Holding Co. Under the agreement,
- Read more about EMA committee recommends approval of AstraZeneca's CAZ AVI
AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of a new antibiotic, CAZ AVI 2g/0.5g powder.
- Read more about AstraZeneca enters into US licensing agreement with Ironwood Pharmaceuticals for lesinurad
AstraZeneca announced that it has entered into a licensing agreement with Ironwood Pharmaceuticals for the exclusive US rights to Zurampic® (lesinurad). Zurampic was approved by the US Food and Drug Administration (FDA)in December 2015, in combination with a xanthine oxidase inhibitor (XOI), for the treatment of hyperuricemia associated with uncontrolled gout.
- Read more about Bevespi Aerosphere™ approved by the US FDA for patients with COPD
Astrazeneca announced that the US Food and Drug Administration has approved Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
- Read more about AstraZeneca launches integrated genomics approach to transform drug discovery and development
AstraZeneca and its global biologics research and development arm, MedImmune, announced an integrated genomics initiative to transform drug discovery and development across its entire research and development pipeline.
- Read more about AstraZeneca and Eli Lilly and Company announce continuation of pivotal clinical trial for people with early Alzheimer’s disease
AstraZeneca and Eli Lilly and Company announced that AMARANTH, a Phase II/III study of AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for early Alzheimer’s disease, will continue into Phase III of the Phase II/III seamless trial.
- Read more about Astrazeneca pandemic influenza vaccine receives positive CHMP opinion
AstraZeneca and its global biologics research and development arm, MedImmune, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the conditional approval of Pandemic Live Attenuated Influenza Vaccine (P/LAIV). P/LAIV is indicated for the prevention of influenza in an officially declared pandemic in children and adolescents from 12 months to less than 18 years of age.