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
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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.
AstraZeneca Update on clinical trials AstraZeneca this morning announced an update on two new treatments, both of which exceeded expectations.
In the first release, AstraZeneca and MedImmune, its global biologics research and development arm, presented the full progression-free survival (PFS) data from a planned interim analysis of the Phase III PACIFIC trial
Results show that Imfinzi (durvalumab) demonstrated a statistically-significant and clinically-meaningful improvement in PFS compared to current standard of care with active surveillance in patients with locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy (CRT)
Results of the Phase III PACIFIC trial show an improvement in PFS of more than 11 months in patients treated with Imfinzi compared to placebo (full details in table below)
In the second release, the company presented the full results of the Phase III FLAURA trial, which support Tagrisso's (osimertinib) clear potential as a new standard of care (SoC) in the 1st-line treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC)
Results of the Phase III FLAURA trial demonstrated a superior, clinically-meaningful PFS advantage with Tagrisso compared with current SoC EGFR-TKIs (erlotinib or gefitinib).
AstraZeneca has announced that a study has shown that Duaklir significantly improves lung function in chronic obstructive pulmonary disease patients while a trial showed that tezepelumab cuts exacerbations in severe asthma. AstraZeneca announced positive top-line results from the phase III AMPLIFY trial for Duaklir (aclidinium bromide/formoterol 400µg/12µg twice-daily), which met its primary endpoints, demonstrating a statistically-significant improvement in lung function in patients with moderate to very severe stable chronic obstructive pulmonary disease (COPD) compared to each individual component (either aclidinium bromide or formoterol). In addition, aclidinium bromide achieved its primary bronchodilation endpoint of demonstrating non-inferiority to tiotropium bromide 18µg once-daily. Dr. Sanjay Sethi, Professor and Chief, Pulmonary, Critical Care and Sleep Medicine at University at Buffalo, The State University of New York, USA and the lead investigator of the trial, said: "These results demonstrate the improvement in lung function achieved by the combination of aclidinium and formoterol compared to single LAMA bronchodilators tiotropium and aclidinium, with comparable safety." AstraZeneca and Amgen Inc announced results from the PATHWAY phase IIb trial of tezepelumab that showed a significant reduction in the annual asthma exacerbation rate compared with placebo in patients with severe, uncontrolled asthma. Tezepelumab is a first-in-class anti-TSLP monoclonal antibody being developed by MedImmune, AstraZeneca's global biologics research and development arm, in collaboration with Amgen. The trial results were published today in the New England Journal of Medicine, and will be followed by an oral presentation on 12 September at the ERS International Congress 2017 in Milan. The PATHWAY trial achieved its primary efficacy endpoint, showing annual asthma exacerbation rate reductions of 61%, 71% and 66% in the tezepelumab arms receiving either 70mg or 210mg every four weeks or 280mg every two weeks, respectively (p<0.001 for all comparisons to placebo). In the trial, tezepelumab was given as an add-on therapy to patients with a history of asthma exacerbations and uncontrolled asthma despite receiving inhaled corticosteroids/long-acting beta-agonists with or without oral corticosteroids and additional asthma controllers. Story provided by StockMarketWire.com
Potential share-moving presentations ahead at key European cancer meeting
Aug. 30, 2017 3:38 PM ET|By: Douglas W. House, SA News Editor
The abstract drop for the European Society for Medical Oncology (ESMO) will launch in less than six hours. The conference will take place September 8-12 in Madrid. Presentations to watch:
AstraZeneca (NYSE:AZN): Top-line data from Phase 3 FLAURA study assessing Tagrisso (osimertinib) in EGFR+ NSCLC patients. Primary endpoint: PFS.
What is expected to boost Keytruda sales even more, is the collaboration between Merck and AstraZeneca (AZN). The two companies entered a strategic oncology collaboration to co-develop AstraZenecas drug Lynparza for a number of cancer types. Lynparza will be developed as monotherapy and in combination trials with other medicines. The drug will also be developed and commercialized in combination with Mercks Keytruda and AstraZenecas Imfinzi. Mercks management had this to say about the collaboration:
In addition, we are very much looking forward to collaborating with AstraZeneca in oncology as announced yesterday. We believe LYNPARZA can be a very important product in different indications over time. And the combination of our proven commercial success in oncology launching KEYTRUDA, with AstraZeneca's strong experience, will enable us together to make this product a tremendous success.
The collaboration gives Merck access to more patients, thus enabling Keytruda to generate more revenue
AstraZeneca's breast cancer drug Faslodex has received approval from the the US Food and Drug Administration. AstraZeneca said the FDA had approved Faslodex (fulvestrant) 500mg as monotherapy for expanded use in women with hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, who have gone through menopause and have not received previous endocrine therapy. It said the FDA approval was based on data from the phase III FALCON trial, which were published in the November 2016 issue of The Lancet. Executive vice-president, head of the oncology business unit, Jamie Freedman, said: "We're pleased that the landmark FALCON trial results demonstrated the efficacy of Faslodex as initial monotherapy treatment for women who are living with HR+ HER2- advanced breast cancer. "This approval, building on more than 15 years of clinical experience, means more patients can have the opportunity to receive Faslodex earlier in the treatment journey." Story provided by StockMarketWire.com
Aug. 24, 2017 4:10 AM ET|By: Yoel Minkoff, SA News Editor
Novartis (NYSE:NVS) has received EU approval for its breast cancer drug Kisqali, boosting its oncology portfolio with a medicine it believes could potentially provide billions of dollars in revenues.
Roche (OTCQX:RHHBY) has been granted a priority review by the FDA for emicizumab, expediting the examination process for its haemophilia drug.
Meanwhile, results from a clinical trial have shown that Astrazeneca's (NYSE:AZN) blood-thinner Brilinta reduces cardiovascular mortality risks by 29% in patients with a history of heart problems.
What the author doesn't comment on is that the share price movement for Hikma's generics competitors (TEVA and Mylan) exactly shadows that of Hikma. This movement is directly related to the generics market and not just a function of short selling.
BTW the correct spelling is Boehringer Ingleheim.
"Has a plunge in LSE:HIK:Hikma Pharmaceuticals gone too far, accentuated by short selling? And, hence, is the @GB:MCX:FTSE 250 stock due at least some technical rebound?Or, like a (less savage) drop at @GB:UKX:FTSE 100-listed LSE:SHP:Shire, is it ..."
AZ-Merck's Lynparza gets US approval for ovarian cancer and Merck & Co have announced that Lynparza has received additional and broad approval in the US for ovarian cancer. The said the US Food and Drug Administration (FDA) had granted approval for the PARP inhibitor, Lynparza (olaparib), as follows: - New use of Lynparza as a maintenance treatment for recurrent, epithelial ovarian, fallopian tube or primary peritoneal adult cancer who are in response to platinum-based chemotherapy, regardless of BRCA status; - New use of Lynparza tablets (2 tablets twice daily) as opposed to capsules (8 capsules twice daily); - Lynparza tablets also now indicated (conversion from the current accelerated approval) for the use in patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy. AstraZeneca executive vice-president, global medicines development and chief medical officer, Sean Bohen, said: "Physicians have almost three years of clinical experience with Lynparza on the market and we are now pleased to bring this important medicine, in a new tablet formulation, to a broader group of women. "Today's approvals validate more than 10 years of dedicated research behind Lynparza, the world's first PARP inhibitor, which now provides oncologists with the greater flexibility for use in terms of treatment settings. "It builds on our recently-announced collaboration with Merck, which aims to further increase the number of treatment options available to patients." Story provided by StockMarketWire.com
The US Food and Drug Administration on Thursday expanded the use of Lynparza, sold by AstraZeneca and Merck, to include ongoing treatment of patients with recurrent ovarian cancer who have responded to platinum-based chemotherapy.
The agency also approved a new two-tablet regimen for the drug, regardless of whether patients test positive for BRCA genetic mutations associated with high risk for the cancer.
The drug was previously approved for treating advanced ovarian cancer in women who had stopped responding to at least three earlier rounds of chemotherapy.
"Meanwhile I shall be digging deeper into a company in which I have long been interested but have always thought was too expensive (sound familiar?)"
LK - Indeed expensive, and possibly still is.
Another company where debt is growing faster than income.
It's was borrowing £200M 3 years ago and now £414M and the profit has risen. - growth of over 100%.
During that time operating income grew 16% for a close to 19% revenue hike.
A P/E of 22+ and an erratic growth record?
Could be good but doesn't look like it could be a stellar return, unless there are some hidden gems in their basket.
"With no change in the top six rankings over the month of July, Money Observer Rated FUND:LSX3:Fund Fundsmith Equity was once again the most popular fund with clients of our sister website Interactive Investor. With over half of its assets in US ..."
"Woody would be pretty foolish to write such an article given he is a large shareholder (or more accurately his fundholders) of IMB."
Spot on, m8! I don't expect Terry to be doing a Twinkle any time soon, but Woody seems to be crashing and burning alarmingly regularly these days though, to be fair, he did get out from under with BAT in rather a timely fashion given how long he's been in love with their gaspers.
"It's not so much that AZN could pull some rabbits out of a hat and increase ROCE, it's the underhand reporting, or more accurately "not reporting" that he is aiming his arguments at here"
I agree with the thrust of this. The nuances of accounting however are something we have to live with. I find EBITDA a really silly measure, but it's widely used, legal and tolerated. Accounting shenanigans is a pet-subject of Terry Smith since he published "Accounting for Growth" years ago. Woodford's analysis of AZN having a pipeline of profitable prospects does give one hope, albeit "prospects" are just that until the revenue hits the bottom line.
I was feeling pleased that I was not in AZN and had sold GSK higher up and because I like the macro story for pharma, not least because I would not be here typing this without their products, I thought maybe I can now buy one or the other. Sadly not, another look at their accounts and the "adjustments" and the valuation and I have to side with the much smarter Terry, LKH and Games in what they are saying and hunt for other places to park my spondulicks.
I am a fan of Terry, I disagree with him here though. The fact that AZN's ROCE is currently low doesn't mean it's going to remain so. Tesco, is self evidently, a completely different business with far lower barriers to entry and far higher fixed capital requirements than AZN. I'm not exactly Bullish on AZN but it does, IMHO, justify a 2% of my Pot-punt. I'll also be keeping-the-faith with Glaxo and Smith & Nephew!!
Woodford could, quite easily, of written a similar piece last week proclaiming the-end for the Tobacco stocks that Terry Smith enthusiastically holds!!
I've read Terry's FT article comparin' AZN with Tesco, and it seems to me that the boy's 100% right. AZN was quite wrong to exclude restructuring, exceptional legal costs, and intangible asset amortisation from core earnings back whenever it was (it was 2007).
The slump in ROCE since 2006 is especially telling [do you see what I did there?], and makes me happy that I've sold out 100% from AZN.
I suspect that Terry wrote his piece largely in order to stick the knife in Woodentop and, if he did, he's succeeded big time, so far as I'm concerned.
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