Proverbs 26 vs 5
30 Apr 2018
EU positive on Tagrisso AstraZeneca said European regulators had adopted a positive opinion of its drug Tagrisso, recommending a change to the terms of its marketing authorisation to include treatment for certain lung cancer conditions. The Committee for Medicinal Products for Human Use of the European Medicines Agency based its recommendation on results from a Phase III FLAURA trial, presented at the European Society of Medical Oncology 2017 Congress and published in the New England Journal of Medicine. 'This positive recommendation acknowledges Tagrisso's potential as a new first-line standard of care for patients with EGFR-mutated NSCLC in Europe,' chief medical officer Sean Bohen said. 'It reflects the strength of the FLAURA data that show Tagrisso delivered a statistically-significant and clinically-meaningful improvement in progression-free survival over the EGFR-TKI comparator arm across all pre-specified patient subgroups, including those with or without central nervous system metastases.' At 1
4pm: (LON:AZN) AstraZeneca PLC share price was +77.5p at 5069.5p Story provided by StockMarketWire.com
Proverbs 26 vs 5
19 Apr 2018
FDA gives Tagrisso 1st line status AstraZeneca said Thursday the US Food and Drug Administration approved its lung cancer treatment Tagrisso for the first-line treatment of patients with metastatic non-small cell lung cancer. The approval comes after the results of the phase III FLAURA trial, showed Tagrisso met the primary endpoint. 'Today's FDA approval of Tagrisso in the 1st-line setting is an exciting milestone for patients and our company. Tagrisso delivered unprecedented medianprogression-free survival data across all pre-specified patient subgroups, including patients with or without CNS metastases, and could prolong the lives of more patients without their tumours growing or spreading,' said Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca. Story provided by StockMarketWire.com
Proverbs 26 vs 5
16 Apr 2018
A good article to read. Follow the link. [link]
Proverbs 26 vs 5
15 Apr 2018
Astra Zeneca reassures investors Astra Zeneca reassures investors: we’ve got blockbuster drugssee:[link]
Proverbs 26 vs 5
09 Apr 2018
'The FDA has granted the moxetumomab pasudotox BLA Priority Review status AstraZeneca's global biologics research arm MedImmune announced Tuesday that the US Food and Drug Administration has accepted the Biologics License Application for moxetumomab pasudotox, a potential new medicine for the treatment of adult patients with hairy cell leukaemia. 'The FDA has granted the moxetumomab pasudotox BLA Priority Review status with a Prescription Drug User Fee Act date set for the third quarter of 2018,' the firm said. Moxetumomab pasudotox is an investigational anti-CD22 recombinant immunotoxin and a potential new medicine for the treatment of adult patients with hairy cell leukaemia who have received at least two prior lines of therapy. Story provided by StockMarketWire.com
gamesinvestor
09 Apr 2018
Woody's bottled it! He's dumped most of the holding in the Equity Income Fund :-In it's place he's done this (mix up these words -- hot pan the frying out the fire into of) :-""""These judgements are always fluid but the opportunity in domestically-exposed companies has become increasingly attractive and the portfolios are evolving to take advantage. This has meant adding further to Lloyds and several housebuilders such as Barratt Developments, Crest Nicholson, Taylor Wimpey and a new position in Bovis. Meanwhile, we have also added to Provident Financial, Babcock International and NewRiver REIT amongst several others.""""Games - LMFAO !!
Proverbs 26 vs 5
03 Apr 2018
FDA Priority Review for AZN new drug The FDA accepts under Priority Review AstraZeneca's (NYSE:AZN) marketing application seeking approval for moxetumomab pasudotox for the treatment of adult patients with hairy cell leukemia (HCL) who have received at least two prior lines of therapy. The agency's action date is in Q3.Orphan Drug-tagged moxetumomab pasudotox is an anti-CD22 recombinant immunotoxin. It consists of an antibody that binds to protein found on B-lymphocytes (CD22) that is fused to a toxin. Once the molecule is internalized by the cancer cell, the toxin leads to cell death by inhibiting protein translation. Specifically, the cell cannot read the information from messenger RNA so it cannot build proteins and dies.
Proverbs 26 vs 5
02 Apr 2018
Diagnostic tool to help identify which patients to treat. The Japanese Ministry of Health, Labor and Welfare approves Myriad Genetics' (NASDAQ:MYGN) BRACAnalysis Diagnostic System as a companion diagnostic with AstraZeneca (NYSE:AZN) and Merck's (NYSE:MRK) PARP inhibitor LYNPARZA (olaparib) for patients with BRCA-mutated metastatic breast cancer.LYNPARZA was approved in Japan in January for certain ovarian cancer patients. The application for breast cancer is under review.Previously: AstraZeneca's Lynparza OK'd in Japan for ovarian cancer; shares up 1% premarket (Jan. 19)
Proverbs 26 vs 5
22 Mar 2018
The EU approves AstraZeneca's (AZN +0.2%) Lokelma (sodium zirconium cyclosilicate), The European Commission approves AstraZeneca's (AZN +0.2%) Lokelma (sodium zirconium cyclosilicate), formerly known as ZS-9, for the treatment of adults with hyperkalemia (elevated blood potassium).The approval is a long-awaited breakthrough from the company's $2.7B takeout of ZS Pharma in 2015.U.S. approval is the next big opportunity. The FDA issued a second CRL a year ago. The third marketing application has yet to be submitted.
Proverbs 26 vs 5
19 Mar 2018
AstraZeneca's Farxiga A Phase 3 clinical trial, DERIVE, assessing AstraZeneca's (AZN -0.1%) FARXIGA (dapagliflozin 10 mg) in patients with type 2 diabetes with moderate renal impairment met the primary and secondary endpoints. The data were presented at the Endocrine Society Annual Meeting in Chicago.Treatment with dapagliflozin, an SGLT2 inhibitor, produced a statistically significant reduction in HbA1C versus placebo (-0.37% vs. -0.03%; p<0.001).It also produced a statistically significant average reduction in body weight (-3.17 kg vs. -1.92 kg; p<0.001), mean fasting glucose from baseline to week 24 (-21.46 mg/dL vs. -4.87 mg/dL; p=0.001) and mean systolic blood pressure from baseline to week 24 (-4.8 mm Hg vs. -1.7 mm Hg; p<0.05).The FDA approved FARXIGA in January 2014.
rabbitears
15 Mar 2018
Re: Oh if only... Maybe they remember back to when Pfizer were willing to offer £55 in 2014, they may be thinking they'll be back or the promise to " raise revenues by more than three quarters over the next decade" may be about to start kicking in.Thanks for the update, appreciated.
Proverbs 26 vs 5
14 Mar 2018
Oh if only... Societe Generale today reaffirms its buy investment rating on AstraZeneca PLC (LON:AZN) and set its price target at 7800p. Story provided by StockMarketWire.com Broker Forecasts data provided by www.sharesmagazine.co.uk
Proverbs 26 vs 5
12 Mar 2018
Mystic Trial Results In Second Half of 2018 AstraZeneca on Monday said it expects to deliver final analysis of its phase III MYSTIC trial of Imfinzi in the second half of 2018 rather than the first half of the year as was previously anticipated. The MYSTIC trial is a randomised, open-label, multi-centre, global Phase III trial of Imfinzi monotherapy or Imfinzi in combination with tremelimumab versus SoC in treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally-advanced or metastatic (Stage IV) 1st-line NSCLC. Imfinzi is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses. Story provided by StockMarketWire.
Proverbs 26 vs 5
05 Mar 2018
EMA accepts AstraZeneca's marketing application for dapagliflozin in T1D The European Medicines Agency (EMA) accepts for review AstraZeneca's (NYSE:AZN) marketing application seeking approval for Forxiga (dapagliflozin) for adjunctive treatment of adults with type 1 diabetes (T1D).If approved, it will be the first selective SGLT-2 inhibitor available in the EU as an oral adjunct to insulin.Forxiga was first approved in Europe in November 2012 for type 2 diabetes.
shovelier
20 Feb 2018
Re: AstraZeneca's Imfinzi secures FDA approv... Now that we’re past the ex dividend date and it’s associated drop in the share price I’d have hoped for a better reaction to this news or am I reading it wrong?
