Pharma Business - September 24, 2019
AstraZeneca’s Qtrilmet recommended for approval in EU by CHMP for the treatment of type-2 diabetes
The company has announced that Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) modified-release tablets have been recommended for marketing authorisation in the European Union for the treatment of adults with type-2 diabetes (T2D). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on data from five […]
Pharma Business - September 16, 2019
Fast Track designation for AstraZeneca’s Farxiga
TheUS Food and Drug Administration (FDA) has granted Fast Track designation for the development of Farxiga (dapagliflozin) to reduce the risk of cardiovascular (CV) death, or the worsening of heart failure, in adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF). “Heart failure affects approximately 64 million people worldwide, and […]
Clinical Trials - September 10, 2019
New results from AstraZeneca’s Imfinzi trial
The company has presented detailed results from the Phase III CASPIAN trial, showing Imfinzi (durvalumab) significantly improved overall survival (OS) in patients with previously-untreated extensive-stage small cell lung cancer (SCLC). Imfinzi in combination with four cycles of standard-of-care (SoC) chemotherapy (etoposide with either cisplatin or carboplatin) demonstrated a statistically-significant and clinically-meaningful improvement in OS vs. SoC […]
Pharma Business - September 4, 2019
AstraZeneca’s Tagrisso approved in China as a 1st-line treatment for EGFR-mutated non-small cell lung cancer
The company has received marketing authorisation from China’s National Medical Products Administration (NMPA) for Tagrisso (osimertinib) as a 1st-line treatment for adults with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have the genetic mutations of epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitutions. The approval followed the […]
Drug Development Pharma - August 28, 2019
FDA grants Fast Track designation for AstraZeneca’s Farxiga
The US Food and Drug Administration (FDA) has granted Fast Track designation for the development of Farxiga (dapagliflozin) to delay the progression of renal failure and prevent cardiovascular (CV) and renal death in patients with chronic kidney disease (CKD). The FDA’s Fast Track programme is designed to accelerate the development and review of new medicines […]
Agreement - August 22, 2019
Sobi sells Priority Review Voucher to AstraZeneca
Swedish Orphan Biovitrum has entered into an agreement to sell a US Food and Drug Administration (FDA) Priority Review Voucher (PRV) to AstraZeneca for a total cash consideration of USD 95 million. A PRV entitles the holder to FDA priority review of a single New Drug Application or Biologics License Application, which reduces the target […]
