AstraZeneca PLC Qtrilmet recommended for approval in EU by CHMP

AstraZeneca (LON: AZN) has today 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 Phase III trials …

AstraZeneca new agreement gives them full responsibility for Linzess in China

AstraZeneca plc (LON:AZN) has amended its collaboration agreement with Ironwood Pharmaceuticals, Inc. (Ironwood) in China mainland, China Hong Kong and China Macau for Linzess* (linaclotide), a first-in-class new treatment for patients with irritable bowel syndrome with constipation (IBS-C). IBS-C is characterised by symptoms of abdominal pain and constipation, is a chronic and prevalent functional gastrointestinal disorder in China and there are currently few treatment …

Immupharma plc

Anifrolumab update positive for lupus field – while ImmuPharma’s LupuzorTM could represent a highly successful product

The Life Sciences Division (TLSD), a specialist investment bank to global life sciences companies, today announced an update report on ImmuPharma plc, a pharmaceutical development company listed on AIM of the London Stock Exchange focusing on developing novel medicines with high sales potential in specialist markets with serious unmet need. Summary highlights of the update include: AstraZeneca (LON: AZN) announced …

Astrazeneca’s Tagrisso approved in China

AstraZeneca plc (LON:AZN) today announced that it has received marketing authorisation from China’s National Medical Products Administration for Tagrisso as a 1st-line treatment for adults with locally-advanced or metastatic non-small cell lung cancer whose tumours have the genetic mutations of epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitutions. The approval followed the Priority Review Pathway and is …

Astrazeneca plc

AstraZeneca PLC Brilinta reduced the risk of cardiovascular events

Brilinta reduced the risk of cardiovascular events in patients with coronary artery disease and type-2 diabetes in Phase III THEMIS trial. Additionally, Brilinta showed a more favourable clinical benefit in a prespecified sub-analysis of patients who had undergone a procedure to open a coronary artery AstraZeneca plc (LON: AZN) today announced detailed results from the positive Phase III THEMIS trial …

AstraZeneca PLC “Farxiga so effective in trial”

AstraZeneca plc (LON:AZN) today announced detailed results from the landmark Phase III DAPA-HF trial that showed Farxiga on top of standard of care reduced both the incidence of cardiovascular death and the worsening of heart failure. DAPA-HF is the first outcomes trial with an SGLT2 inhibitor investigating the treatment of heart failure in patients with reduced ejection fraction (HFrEF), with and without type-2 diabetes (T2D). Farxiga is currently approved to treat …

Astrazeneca plc

AstraZeneca PLC Anifrolumab Phase III trial meets primary endpoint

AstraZeneca plc (LON: AZN) today announced that the Phase III TULIP 2 trial for anifrolumab, a potential new medicine for the treatment of systemic lupus erythematosus (SLE), met its primary endpoint, achieving a statistically-significant and clinically-meaningful reduction in disease activity versus placebo, with both arms receiving standard of care. The reduction was measured using the British Isles Lupus Assessment Group …

Astrazeneca plc

AstraZeneca plc Breztri Aerosphere Phase III ETHOS trial met primary endpoint

AstraZeneca plc (LON:AZN) today announced positive results from the Phase III ETHOS trial for triple-combination therapy Breztri Aerosphere, formerly PT010, in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). At the standard budesonide dose, Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate 320/14.4/9.6mcg) demonstrated a statistically-significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies Bevespi Aerosphere (glycopyrronium/formoterol fumarate 14.4/9.6mcg) and PT009 …

AstraZeneca PLC Fasenra granted US Orphan Drug Designation

AstraZeneca plc (LON:AZN) today announced that the US Food and Drug Administration has granted Orphan Drug Designation to Fasenra (benralizumab) for the treatment of eosinophilic oesophagitis (EoE). EoE is a rare, chronic, inflammatory disease that occurs when eosinophils, a type of white blood cell, accumulate in the oesophagus causing injury and inflammation.1 The FDA grants ODD status to medicines and potential new medicines intended for …

Astrazeneca plc

AstraZeneca plc agrees to buy US FDA Priority Review Voucher from Sobi

AstraZeneca plc (LON:AZN) today announced that it has agreed to buy a US Food and Drug Administration Priority Review Voucher for a total cash consideration of $95m from a subsidiary of Swedish Orphan Biovitrum AB. A PRV entitles the holder to FDA priority review of a single New Drug Application or Biologics License Application, which reduces the target review time …