AstraZeneca said Monday it had submitted a new drug application to Japan's Pharmaceuticals and Medical Devices Agency for its oral adjunct treatment to insulin in adults with type-1 diabetes. The application was based on Phase III data from the DEPICT - Dapagliflozin Evaluation in Patients with Inadequately Controlled Type 1 Diabetes - clinical programme for Forxiga in type-1 diabetes and a dedicated trial in Japanese patients. The application for Forxiga, which provided the added benefits of blood pressure reductions and weight loss in adult patients with type-2 diabetes, comes after regulatory submission for the drug was accepted in Europe earlier this year, the firm said Story provided by StockMarketWire.com
AstraZeneca announced Monday the US Food and Drug Administration had approved its hyperkalaemia drug, a serious condition associated with elevated levels in the blood. The US Food and Drug Administration's approval of Lokelma, an oral potassium-removing agent, was supported by data from three double-blind, placebo-controlled trials and two open-label trials showing the drug helped to normalise potassium levels. 'The consequences of hyperkalaemia can be very serious and it's reassuring for treating physicians that Lokelmahas demonstrated lowering of potassium levels in patients with chronic kidney disease, heart failure, diabetes and those taking RAAS inhibitors,' said Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca. 'This FDA approval represents an exciting milestone, as it stands to deliver a rapid, effective and generally well-tolerated treatment option to patients suffering from hyperkalaemia in the US,' said Steven Fishbane, MD, Professor, Donald and Barbara Zucker School of Medicine at Hofstra Northwell, New York. Story provided by StockMarketWire.com
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 1:04pm: (LON:AZN) AstraZeneca PLC share price was +77.5p at 5069.5p Story provided by StockMarketWire.com
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
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
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.""""
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.
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)
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).
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.
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
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.
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.
AstraZeneca and MedImmune, its global biologics research and development arm, said Monday that the US Food and Drug Administration (FDA) approved Imfinzi for the treatment of Stage III unresectable non-small cell lung cancer. Imfinzi (durvalumab) 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. The approval of Imfinzi was based on the positive PFS data from the Phase III PACIFIC trial. Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca, said: 'The approval of Imfinzi in this earlier stage of non-small cell lung cancer is a truly meaningful milestone for patients who, until now, had no FDA-approved treatment options following chemoradiation therapy.' 'Globally, approximately 30% of patients with NSCLC present with Stage III disease and we are excited to launch the first immunotherapy into this setting.' Story provided by StockMarketWire.com
Edited highlights below - all sounds solid enough. Looks like AZN is still Citi's "preferred name" in the secor globally, though I would be more neutral at the current SP...
"Despite the strong quarter and above consensus revenue guidance, 2018 Core EPS guidance may disappoint some investors. We anticipated the increase in SG&A associated with the launch of several new drugs in our recent report ... but it appears we may have under-appreciated the near-term negative impact on gross margin, associated with launch of biologics Imfinzi and Fasenra, on top of LOE for mature products. Despite this, we view the revenue outlook as key however. Profitability from both COGS and OPEX will follow, assuming revenue meets or exceeds our expectations.
We underline our confidence in AZNs c.20% LT Core EPS CAGR outlook (ex externalisation revenues) given the breadth and depth of its small and large molecule pipeline. It remains our global preferred name in the sector. We prefer BUY-rated Bayer in EU. We prefer BUY-rated LLY, BMY and MRK among the US majors.
What's New? AZN reported a strong quarter with notable beats in diabetes (Onglyza, Farxiga), respiratory and Tagrisso leading to a 5% revenue beat. The 62% EPS beat versus consensus for the quarter reflected the contribution from lower R&D (post MRK deal) and a significant contribution from other operating income. AZN reported Core EPS of $1.30 compared with Citi 4Q estimate of $1.17. Guidance for 2018 revenue is slightly ahead of consensus, but the mid-point of EPS guidance ($3.35) is 4% below consensus expectations.
Implications Market should overlook near-term margin pressure in 2018, and focus on new products revenue opportunities.."
The announced tie up between Syndax pharma and ANZ has pushed Syndax up 10% today.
This could be the breakthrough in cancer treatment, injecting the tumour with a combination of the ANZ and Syndax drugs, which kills off the tumour and activates the immune system to kill off all secondary tumours as well.
90% of mice were cured with only one treatment, and all the rest were cured with a second treatment. That is all mice were cured! Pretty impressive, and not too expensive.
I believe the ANZ drug is already approved for human use and the Syndax drug is undergoing human trials.
The US Food and Drug Administration has accepted AstraZeneca's regulatory submission for Tagrisso for the treatment of patients with metastatic non-small cell lung cancer. AstraZeneca said the FDA had accepted a supplemental new drug application for the use of Tagrisso (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases, in the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have EGFR mutations (exon 19 deletions or exon 21 (L858R) substitution mutations). The FDA has granted Tagrisso Priority Review status and previously granted Breakthrough Therapy Designation in the first-line treatment of patients with metastatic EGFR mutation-positive (EGFRm) NSCLC. AstraZeneca said the submission acceptance was based on data from the Phase III FLAURA trial, in which Tagrisso significantly improved progression-free survival (PFS) compared to current first-line EGFR-TKIs, erlotinib or gefitinib, in previously-untreated patients with locally-advanced or metastatic EGFRm NSCLC. Story provided by StockMarketWire.com
AstraZeneca has submitted a supplemental new drug application for its lung cancer drug Tagrisso to Japan's Pharmaceuticals and Medical Devices Agency. AstraZenecahas submitted the sNDA for the use of Tagrisso (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases, for the first-line treatment of patients with inoperable or recurrent EGFR mutation-positive (EGFRm) non-small cell lung cancer (NSCLC). The Japan sNDA is based on data from the phase III FLAURA trial, in which Tagrisso significantly improved progression-free survival (PFS) compared to current 1st-line EGFR-TKIs, erlotinib or gefitinib, in previously-untreated patients with locally-advanced or metastatic EGFRm NSCLC. Story provided by StockMarketWire.com
"When Equilibrium's Mike Deverell built our Long-Term Growth portfolio in the spring, he was cautious about the stockmarket. Holly Black reports on what's changed since.With only around half of his notional Â£100,000 invested in equities, and much ..."
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The FDA grants accelerated approval for AstraZeneca's (AZN +0.9%) BTK inhibitor Calquence (acalabrutinib) for the treatment of adult patients with mantle cell lymphoma who have received at least one prior line of therapy.
The company obtained the rights to the drug via its majority stake in Dutch biotech Acerta Pharma in 2016.
The European Medicines Agency accepts for review AstraZeneca's (NYSE:AZN) marketing application seeking approval for Imfinzi (durvalumab) for the treatment of patients with locally advanced (Stage III) unresectable non-small cell lung cancer (NSCLC) that has not progressed following platinum-based chemo.
Stage III NSCLC represents about 1/3 of NSCLC cases.
AstraZeneca has announced that the US Food and Drug Administration has granted breakthrough therapy designation for Tagrisso (osimertinib) for the first-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). Executive vice-president, global medicines development and chief medical officer at AstraZeneca,Sean Bohen, said: 'The breakthrough therapy designation acknowledges not only Tagrisso's potential as a 1st-line standard of care in advanced EGFR mutation-positive NSCLC, but also the significant need for improved clinical outcomes in this disease. 'The results of the FLAURA trial have the potential to redefine clinical expectations and offer new hope for patients who currently have a poor prognosis.' Story provided by StockMarketWire.com
Results from a large-scale Phase 3 clinical trial, EXSCEL, assessing the cardiovascular risk of AstraZeneca's (AZN +0.1%) BYDUREON (exenatide extended-release) in type 2 diabetics showed similarity to placebo. The data were presented at European Association for the Study of Diabetes (EASD) Annual Meeting in Lisbon and simultaneously published online in the New England Journal of Medicine.
Patients who received once-weekly BYDUREON did not experience more major adverse cardiac events (MACE) than those receiving placebo (non-inferiority).
The incidence of CV events was actually lower in the treatment arm (11.4% vs. 12.5%) but the difference was not statistically valid (p=0.061). Patients in the exenatide arm had 14% less risk of death from all causes (hazard ratio = 0.86).
BYDUREON is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The company is working with regulatory authorities to include the data in the drug's label.
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