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June 11, 2014
17:19 EDTAZN, AMGNAmgen says Phase 2 study of brodalumab met primary endpoint
Amgen (AMGN) and AstraZeneca (AZN) announced that results from a Phase 2 study evaluating brodalumab in 168 patients with psoriatic arthritis were published in The New England Journal of Medicine. These data will also be presented at the 2014 European League Against Rheumatism Annual Congress in Paris on June 14.. Brodalumab is the only investigational treatment in development that binds to the interleukin-17 receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 ligands to the receptor. The IL-17 pathway plays a central role in inducing and promoting inflammatory disease processes. The study showed that treatment with brodalumab significantly improved signs and clinical symptoms associated with the disease, including tender and swollen joints, at 12 weeks as measured by a 20% improvement in the American College of Rheumatology response criteria. The study also showed that many patients continued to improve, and that the improvements were sustained, through the first 52 weeks of the study reported in NEJM. The study achieved its primary endpoint with both doses of brodalumab exhibiting superiority to placebo in ACR20 responses at week 12. These responses continued to improve through 24 weeks and were sustained through the first 52 weeks of the study.1 ACR response criteria are a measure of improvement in tender and swollen joints, as well as patient and physician global assessments of disease activity, pain, disability and inflammatory markers. A 20% improvement from baseline in ACR response rates is known as ACR20, a 50% improvement from baseline is known as ACR50 and a 70% improvement from baseline is known as ACR70.
News For AMGN;AZN From The Last 14 Days
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November 23, 2015
07:59 EDTAZNPerrigo acquires Entocort from AstraZeneca for $380M
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06:00 EDTAZNAstraZeneca sells U.S. Entocort drug rights to Perrigo for $380M
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November 22, 2015
15:03 EDTAMGNMerck reports multiple data sets from Keytruda combination studies
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November 20, 2015
07:31 EDTAZNLabcyte, AstraZeneca partner to develop acoustic liquid handling system
Labcyte announced a partnership with AstraZeneca to develop a state-of-the-art automated pharmaceutical compound management system based on its revolutionary Echo acoustic liquid handling technology. The new system, which will employ storage tubes compatible with acoustic liquid handling, will be deployed at the AstraZeneca MRC UK Centre for Lead Discovery in Cambridge.
06:09 EDTAZNSanofi, AstraZeneca to exchange more than 210,000 compounds
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November 19, 2015
16:06 EDTAMGNAmgen's Kyprolis approved for multuple myeloma by European commission
Amgen announced the European Commission granted marketing authorization for Kyprolis in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. The EC approved Kyprolis based on data from the pivotal Phase 3 ASPIRE trial. The study showed that patients treated with Kyprolis in combination with lenalidomide and dexamethasone had increased median time to progressive disease or death by 8.7 months compared to patients treated with lenalidomide and dexamethasone. Approval from the EC grants a centralized marketing authorization with unified labeling in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area, will take corresponding decisions on the basis of the decision of the EC. Amgen plans to submit data from the Phase 3 ENDEAVOR trial for potential authorization of Kyprolis in combination with dexamethasone in the EU. This data also serves as the basis of the supplemental New Drug Application of Kyprolis in combination with dexamethasone for patients with relapsed multiple myeloma, which has been accepted for priority review by the FDA.
November 18, 2015
16:43 EDTAZNBIND Therapeutics gets $4M milestone payment from AstraZeneca
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08:11 EDTAZNIMS Health forecasts global drug spending to increase 30% by 2020 to $1.4T
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08:02 EDTAZNBIND says AstraZeneca initiates patient dosing in AZD2811 Phase 1 trial
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07:26 EDTAZNZS Pharma downgraded to Neutral from Buy at Citi
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November 17, 2015
07:03 EDTAZNCerulean, AstraZeneca partner to evaluate LYNPARZA, CRLX101 combo
Cerulean (CERU) announced that it has entered into a collaboration with AstraZeneca (AZN) and the National Cancer Institute, part of the National Institutes of Health, to study LYNPARZA and CRLX101. The collaboration will explore the synergistic effects of AstraZeneca's LYNPARZA, a poly ADP ribose polymerase inhibitor, and CRLX101, Cerulean's inhibitor of topoisomerase 1. The NCI will conduct a combination Phase I/IIa trial in the Branch led by Yves Pommier, M.D., Ph.D., Chief of the Developmental Therapeutics Branch.
06:02 EDTAZNAstraZeneca drug to cost over $12K for a month's supply, Reuters reports
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05:37 EDTAZNClovis downgraded to Neutral from Conviction Buy at Goldman
Goldman Sachs analyst Terence Flynn downgraded Clovis Oncology (CLVS) to Neutral from Conviction Buy citing limited visibility on the path to FDA approval following yesterday's update on the company's lung cancer drug Roci. The drug now has a less compelling profile relative to AstraZeneca's (AZN) Tagrisso, Flynn tells investors in a research note. He cut his price target for shares to $23 from $123. Clovis closed yesterday down $66.19, or 70%, to $30.24.
November 16, 2015
16:05 EDTAMGNAmgen to present eight IMLYGIC abstracts
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16:00 EDTAZNDiplomat Pharmacy to dispense TAGRISSO
Diplomat Pharmacy (DPLO) announced that it will offer TAGRISSO (osimertinib), recently approved by the U.S. Food and Drug Administration as an oral therapy for a specific type of metastatic non-small cell lung cancer. TAGRISSO is distributed by AstraZeneca (AZN).
14:07 EDTAZNClovis plunges after lung cancer drug response rate misses expectations
Shares of Clovis Oncology (CLVS) plunged more than 70% after the drugmaker reported new details regarding its cancer drug candidate rociletinib, with new, confirmed data showing an unexpected drop in effectiveness. SURPRISING DRUG RESULTS: Clovis announced this morning new details regarding its rociletinib drug, which is being studied for the treatment of non-small cell lung cancer. According to the company, the Food and Drug Administration is now requesting additional clinical data on the drug, with a renewed focus on so-called confirmed treatment responses. Clovis explained that previous applications submitted to the FDA -- as well as early data on the drug publicized at medical conferences and elsewhere -- contained some immature and unconfirmed results. Perhaps most notably, the company disclosed that "as the efficacy data have matured, the number of patients with an unconfirmed response who converted to a confirmed response was lower than expected," with the current confirmed response rate for rociletinib now standing at 28% for the 500mg dose and 34% for the 625mg group. The primary driver of the low conversion to confirmed responses was due to ineffective tumor shrinkage as well as general disease progression, including brain metastasis, said the company. APPROVAL DELAY: In the wake of this morning's update, Piper Jaffray's Charles Duncan cut his price target on Clovis shares to $28 from $92 while reiterating a Neutral rating. Duncan explained that Clovis had previously reported a 54%-60% unconfirmed response rate for rociletinib, a significant change from today's confirmed numbers. The analyst had previously speculated that rociletinib might further differentiate itself in the market by demonstrating a meaningful impact on brain metastasis, but Monday's commentary from Clovis seems to specifically downplay that possibility. Though the new data "may still ultimately be approvable," Duncan envisions an approval delay of three to six months given what was revealed, and he pushed anticipated first U.S. sales of the drug to the fourth quarter of 2016 while cutting his expected second-line market penetration to just 25% from 45%. RETHINKING CLOVIS: Goldman Sachs analyst Terence Flynn said he views the news as a "significant setback" for rociletinib, especially given that the updated responses rates come in below that of Tagrisso, AstraZeneca's (AZN) recently-approved rival treatment option. As a result, Flynn put his Conviction Buy rating and $123 price target on Clovis "under review." IMMUNOGEN PRESSURED: Weighing in on the news, RBC's Simos Simeonidis speculated that Monday's selloff in ImmunoGen (IMGN) shares could be related to the Clovis update, as investors may be drawing a parallel between the company's IMGN853 and rociletinib. IMGN853 saw a similar drop in efficacy when adjusting data for confirmed responses, but the drug looks outright potent when limiting results to just key patient groups, the analyst contended. Though IMGN853 will still have to prove itself in larger trials, Simeonidis nevertheless sees the current weakness in ImmunoGen as a buying opportunity. PRICE ACTION: Shares of Clovis have dived more than $71, or 71.5%, to $28.35 in afternoon trading, while ImmunoGen has fallen 7% to $11.62. AstraZeneca, meanwhile, is up better than 4%.
10:27 EDTAZNGoldman puts Conviction Buy-rated Clovis under review
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10:23 EDTAZNClovis price target cut to $28 from $92 at Piper Jaffray
Piper Jaffray analyst Charles Duncan cut his price target for shares of Clovis Oncology (CLVS) to $28 from $92 after the company announced that rociletinib efficacy data matured and the number of patients with a confirmed response is lower than expected. The updated response rate may still ultimately be approvable, but it further hinders rociletinib's competitive positioning compared to AstraZeneca's (AZN) Targrisso, Duncan tells investors in a research note. The analyst pushed back his first rociletinib sales estimate to Q4 of 2016 and lowered the drug's peak penetration of the second line market from 25% to 45%. He reiterates a Neutral rating on Clovis. The stock is down 67%, or $66.93, to $32.50 in morning trading.
08:32 EDTAZNClovis reopens, down 64% after FDA requests added data for rociletinib
AstraZeneca (AZN), which is at work on a drug similar to rociletinib, is up 2.5% in pre-market trading.
05:57 EDTAZNAstraZeneca urges UK for antibiotics investment shake-up, Financial Time says
AstraZeneca has urged the U.K. government to develop a new model for incentivizing investment in antibiotics, reports the Financial Times. In a letter to the Financial Times, the company said it has joined other "leading voices" in the life sciences sectory to implore Britain to go ahead with a new system rather than waiting for an international agreement. The company said a new payment model was needed that would reward companies' investments but without encouraging the over-use of antibiotics. Reference Link
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