II Editor
08 Nov 2017
NEW ARTICLE: How I am preparing for a stockmarket correction "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 £100,000 invested in equities, and much ..."[link]
II Editor
03 Nov 2017
NEW ARTICLE: Have Neil Woodford and these three other star managers lost their Midas touch? "Thirty years ago, the notion of robots replacing humans was the vision of dystopian science fiction. However, huge technological advances since then mean that 'intelligent' systems now pose a threat to many occupations - including fund managers, ..."[link]
Proverbs 26 vs 5
31 Oct 2017
New drug approval by FDA 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.Previously: AstraZeneca completes $4B Acerta Pharma transaction (Feb. 2, 2016)
Proverbs 26 vs 5
09 Oct 2017
EU approval in the pipeline 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.Durvalumab is a PD-L1 inhibitor.Shares are up a fraction premarket.
Proverbs 26 vs 5
09 Oct 2017
AZN cancer drug granted breakthrough therapy designation 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
nick2name
21 Sep 2017
Re: quiet up another 10+%
Proverbs 26 vs 5
14 Sep 2017
Bydureon Trial Results 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.
Hawk Eye32
11 Sep 2017
Re: Update on clinical trials Neil Woodford, will be pleased and those invested in his funds!!
Proverbs 26 vs 5
11 Sep 2017
Update on clinical trials 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).
Proverbs 26 vs 5
07 Sep 2017
Positive drug trial reported. 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
Proverbs 26 vs 5
30 Aug 2017
Madrid oncology conference Potential share-moving presentations ahead at key European cancer meetingAug. 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.Details of Flaura trial in earlier post.
Proverbs 26 vs 5
30 Aug 2017
AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLAURA)[link]
Proverbs 26 vs 5
30 Aug 2017
Merck /Astrazeneca oncology collaboration 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 AstraZeneca’s 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 Merck’s Keytruda and AstraZeneca’s Imfinzi. Merck’s 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 revenu
Proverbs 26 vs 5
29 Aug 2017
FDA approval for Faslodex 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
Proverbs 26 vs 5
24 Aug 2017
Drugmaker news roundup 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.
