GreenRoc Accelerates their World Class Project to Production as Early as 2028. Watch the full video here.
LONDON (Alliance News) - AstraZeneca PLC on Monday announced positive results from its diabetes drug study and said the US Food & Drug Administration has accepted regulatory submission for cancer drug Lynparza.
Farxiga, the pharmaceutical company's type-2 diabetes drug, was found to significantly reduce hospitalisation for heart failure or cardiovascular death by 17% versus placebo. This figure comes as a result of Astra's DECLARE-TIMI 58 trial of more than 17,000 patients.
Patients taking Farxiga were also found to have fewer major adverse cardiovascular events, but this was not statistically significant.
"These positive results are clinically relevant to the 425 million people worldwide living with diabetes, of whom those with type-2 diabetes have a two-to-five times greater risk of heart failure along with an increased risk of a heart attack or stroke," said AstraZeneca Vice President Elisabeth Bjork.
"Heart failure survival rates are only 50% after five years from diagnosis, which is why these new findings are so important in broadening our understanding of how to go beyond blood glucose so we may better address this serious and often overlooked cardiovascular complication," Jork added.
In a separate announcement, Astra also said that the FDA has accepted a supplemental new drug application for priority review. If granted approval, this would be the fourth indication for Lynparza in the US.
The supplemental application is for the use of Lynparza as a maintenance therapy in newly-diagnosed patients with BRCA-mutated advanced ovarian cancer. BRCA mutations mean that patients are more likely to develop genetic alterations that could lead to cancer.
If approved, Lynparza's use will be expanded to patients who are have responded to platinum-based chemotherapy, which is the standard treatment in patients with this type of cancer.
The application is based on the results of Astra's phase three SOLO-1 trial, which showed statistically significant and clinically meaningful improvement in progression-free survival over placebo. Risk of disease progression or death in patients was reduced by 70%.
At present, Lynparza has approval in more than 60 countries for the treatment of relapsed ovarian cancer and for a particular kind of breast cancer.
Shares in AstraZeneca were up 1.7% at 6,274.00 pence on Monday morning.
Sounds to me that Borgy74 is using spread betting / day trading, though I could very easily be wrong.
Both of these options is highly dangerous if you don't know what you are doing. Most amateurs lose a lot of money. I'm certainly not brave enough to do either.
AstraZeneca (AZN) announces positive results from a Phase 3 clinical trial, HARMONIZE, evaluating hyperkalemia med Lokelma (sodium zirconium cyclosilicate) in patients in Japan, Korea, Taiwan and Russia. The data were presented at Kidney Week in San Diego.
Patients who achieved normal blood potassium levels during the first 48 hours with Lokelma were transitioned to the 28-maintenance phase. Those receiving either 5 mg or 10 mg of Lokelma each day maintained normal blood potassium levels during days 8 - 29, representing statistically significant differences compared to placebo.
Lokelma was approved in Europe in March and in the U.S. two months later.
AstraZeneca obtains positive results from its phase 3 study using Lynparza to treat advanced BRCA mutation ovarian cancer patients.
Patients treated with Lynparza were able to reduce their risk of disease progression or death by 70%.
Lynparza is estimated to generate up to $2 billion in revenue by 2023.
Lynparza is also being explored in combination with Avastin in a phase 3 study known as PAOLA-1 for newly diagnosed ovarian cancer patients regardless of BRCA mutation, with data expected by 2nd half 2019.
The info I have today is:
Gross inflow of funds of £11.75bn rose 12%, while net inflows were up 15%
Retention of client funds continued to remain strong at 96%
Group funds under management are up 11% to £100.6bn since the beginning of the year and 17% over the twelve months
Shares trade on 19.4x consensus 2019 earnings and yield 5.6%.
AstraZeneca and partner Merck said results from their phase 3 clinical trial for their ovarian cancer treatment showed a reduction of disease progression or death by 70%. The Solo-1 Phase III trial was carried out to evaluate the efficacy and safety of the company's ovarian cancer treatment Lynparza as maintenance monotherapy compared with placebo, in newly-diagnosed patients with advanced ovarian cancer who had received platinum-based chemotherapy, AstraZeneca said. Results of the trial confirm the statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) for Lynparza compared to placebo, reducing the risk of disease progression or death by 70% At 41 months of follow-up, the median progression-free survival for patients treated with Lynparza was not reached compared to 13.8 months for patients treated with placebo. But of those who had received Lynparza, 60% remained progression-free at 36 months compared to 27% of women in the placebo arm, the company said. 'There is currently a significant unmet need in the treatment of advanced ovarian cancer because 70% of women relapse within the first three years after their initial treatment. The remarkable results of the SOLO-1 trial, which showed that 60% of women with newly-diagnosed, advanced BRCA-mutated ovarian cancer remained progression-free at three years, highlight the potential of Lynparza as a maintenance therapy in the 1st-line setting,' said Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer. 'Women with ovarian cancer are often diagnosed with advanced disease, which unfortunately is associated with poor long-term survival rates. The newly-diagnosed setting is our best opportunity to achieve a sustained remission, since once a patient's ovarian cancer recurs, it is typically incurable,' said Kathleen Moore, Co-Principal Investigator of the SOLO-1 trial and Associate Director for Clinical Research at the Stephenson Cancer Center at the University of Oklahoma, Oklahoma City. 'The SOLO-1 results demonstrate the potential of Lynparza maintenance therapy earlier in the treatment pathway and reinforce the importance of identifying a patient's BRCA mutation status at the time of diagnosis - these results could change the way we treat women with advanced BRCA-mutated ovarian cancer.' Story provided by StockMarketWire.com
To understand the process see
https://www.phrma.org/advocacy/research-development/clinical-trials
Yes I have bought some more this morning via spreadbet....
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Using a spread is dangerous.
To all other readers don't do it unless you really understand that your losses could be huge.
I have BHP Bilton, S32, Shell and Chevron amongst my holdings.
As I wrote 25% of my portfolio in in Pharma and Biotech. Overall the portfolio is comfortably up but there are a few horrid red patches.
As I wrote I would continue to monitor before I jumped in. (down 1.5p at the close today I see.
One possible source for ideas is to have a look at what Neil Woodford has in his biotech folios. He obligingly puts them on the web. I'd also say do have a look at IBT.
As Always DYOR. and if it seems too good to be true then it probably isn't.
Be warned! This is high risk. IMHO it would be unwise to put more than 5% of your investable pot into this company prior to the human trials.
Trials are exactly that and in Pharma most fail, as Neil Woodford found with Prothenahttps://www.onenewspage.com/n/Business/1zj7iv9ru3/Woodford-backed-Prothena-collapses-as-it-scraps-development.htm
You have many posts credited to you name. Are you generally an experienced investor and just new to Biotech?
What I am saying will not be popular on this board. I have followed the company for many years but (thankfully) never invested. I will continue to monitor but I won't be investing any time soon.
Good luck and above all DYOR.
Oh if only I new that about any company.
I am not giving advice but I would/will wait to see if there are any concrete developments before I investing. If it's positive you may miss out on some profits but if it is going to be as big as others posting here are convinced it will be there will still be lots to be had.
Here is the summary of the last 5 years performance:
https://uk.advfn.com/stock-market/london/avacta-AVCT/share-price-history
It also depends on how much you have to risk.
About 25% of my portfolio is in Pharma and Biotech. Most of it directly into shares but some into International Biotechnology Trust - (IBT) and pays a 4% dividend.
My outlook is to get rich slowly but get rich
AstraZeneca confirmed Monday it had agreed to sell the commercial rights in Europe for its hypertension and heart failure treatment to Cheplapharm for $200m. Under the terms of the agreement, AstraZeneca had received a payment of $200m from Cheplapharm for hypertension and heart failure treatment Atacand and Atacand Plus. A time-bound payment of $10m as well as sales-contingent milestones would also be payable, AstraZeneca said. AstraZeneca said it would continue to manufacture and supply Atacand and Atacand Plus under a supply agreement and continue to commercialise the medicines in all markets where it still held the rights. Story provided by StockMarketWire.com
The Tory party will largely take the political blame
(Unfairly as it was a cross party issue) if there is
an economic hit.
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No not unfairly. This is an unnecessary crisis created by the Conservative lunatic right.
They will pay the price in coming elections and be out of power for a generation just as they were over the repeal of the Corn Laws.
Glaxosmithkline said its ViiV Healthcare joint venture had submitted a marketing authorisation application to the European Medicines Agency for a single-tablet, two-drug regimen for the treatment of HIV. The submission was based on studies that included more than 1400 infected adults, the results of which were presented at the 2018 International AIDS Society meeting in July. A new drug application to the US FDA was planned for the single tablet regimen for October. Other global regulatory submissions of dolutegravir and lamivudine as a single-tablet, two-drug regimen were anticipated in the coming months. At 1:09pm: (LON:GSK) GlaxoSmithKline PLC share price was -9.7p at 1485.9p Story provided by StockMarketWire.com
Sep. 13, 2018 2:17 PM ET|About: AstraZeneca Group plc (AZN)|By: Douglas W. House, SA News Editor
The FDA approves AstraZeneca's (AZN -1.1%) Lumoxiti (moxetumomab pasudotox-tdfk) injection for the treatment of adult patients with relapsed/refractory hairy cell leukemia (HCL) who have received at least two prior lines of systemic therapies, including a purine nucleoside analog.
Orphan Drug-tagged Lumoxiti 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.