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News Breaks
May 9, 2014
16:02 EDTAMGN, AZNAmgen, AstraZeneca reports brodalumab study met primary, secondary endpoints
Amgen (AMGN) and AstraZeneca (AZN) announced that the Phase 3 AMAGINE-1 study evaluating brodalumab in patients with moderate-to-severe plaque psoriasis met all primary and secondary endpoints for both evaluated doses. 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. Primary endpoints were patients achieving at least a 75% improvement from baseline in disease severity at week 12, as measured by the Psoriasis Area Severity Index, and patients achieving clear or almost clear skin at week 12 according to the static Physician Global Assessment.
News For AMGN;AZN From The Last 14 Days
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September 15, 2014
16:40 EDTAMGNAmgen trial finds Prolia treatment enables non-osteoporotic T-scores
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16:05 EDTAMGNAmgen says romosozumab treatment increases bone mineral density
Amgen and UCB announced results from several exploratory analyses of the Phase 2 study evaluating romosozumab in postmenopausal women with low bone mineral density, BMD. Romosozumab is an investigational bone-forming agent that is designed to work by inhibiting the protein sclerostin, thereby increasing bone formation and decreasing bone breakdown. These data were presented at the American Society for Bone and Mineral Research, ASBMR, 2014 Annual Meeting in Houston, Sept. 12-15. "Fractures or broken bones due to osteoporosis are very common and often have a life altering impact on an older woman and her family," said Michael McClung, M.D., director of the Oregon Osteoporosis Center. "It is encouraging to see that treatment with romosozumab for a second year provided additional increases in bone mineral density beyond what was seen during the first 12 months of treatment." "Despite continuing progress in the management and treatment of patients with osteoporosis, there remains a considerable need for new therapeutic approaches for individual patients," said Professor Dr. Iris Loew-Friedrich, chief medical officer and executive vice president, UCB. "Investigational studies to date suggest that the bone building capacity of romosozumab may show promise as a new treatment option to manage this serious disease. We look forward to reporting the results of the romosozumab Phase 3 program in 2016."
07:27 EDTAZNPfizer acquisition could drive shares higher, says JPMorgan
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07:21 EDTAMGNHeart Failure Society of America to hold annual meeting
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05:12 EDTAMGNAmgen presents analyses of Phase 3 ivabradine data for treatment of chronic HF
Amgen announced data from the Phase 3 Systolic Heart failure treatment with the If inhibitor ivabradine Trial, or SHIFT, study evaluating ivabradine in patients with chronic heart failure, or HF, were presented at the 18th Annual Scientific Meeting of the Heart Failure Society of America, or HFSA, in Las Vegas. A post-hoc analysis from the SHIFT study confirmed low systolic blood pressure, or SBP, is associated with poor outcomes in chronic HF, and that ivabradine reduced the primary composite endpoint of cardiovascular death or hospitalization for worsening HF in this subgroup with low baseline SBP. Safety was similar across the three SBP groups. Results were published in the July 2014 issue of the European Journal of Heart Failure. Sean E. Harper, M.D., executive vice president of Research and Development at Amgen said, "Despite standard of care, chronic heart failure remains a disabling condition with a poor prognosis for patients at risk for hospitalization. Analyses from the pivotal SHIFT study complement the main trial findings that form the basis of our U.S. submission package for ivabradine. We recently received a priority review designation for ivabradine from the FDA and are working with the agency to potentially bring this important treatment option to certain patients with chronic heart failure in the U.S. as soon as possible."
September 14, 2014
13:39 EDTAMGNFurther gains in Amgen could be subdued, Barron's says
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September 12, 2014
10:32 EDTAZNPfizer CEO says company still open to inversion deal, FT says
Pfizer (PFE) CEO Ian Read said U.S. rhetoric against tax inversions has been "political theater" ahead of midterm elections and made clear that his company is still open to a potential tax-saving acquisition, according to Financial Times, which added Read's comment about not being “held hostage” over price would likely be read as a signal the company might look elsewhere after being rebuffed by AstraZeneca (AZN). The Fly notes that Bloomberg previously reported, citing people familiar with the matter, that Pfizer is looking at targets other than AstraZeneca, including Actavis (ACT). Shares of Actavis trading in New York are up 2% this morning. Reference Link
07:14 EDTAMGNAmerican Society for Bone & Mineral Research holds annual meeting
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September 10, 2014
15:21 EDTAZNAstraZeneca has a conference call hosted by JPMorgan
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September 8, 2014
14:13 EDTAZNConnecticut AG tells FDA to speed up generic Nexium
A news release from the Connecticut Attorney General George Jepsen, dated September 4, says: In comments to a Citizen Petition filed with the FDA, Attorney General George Jepsen called on the federal agency to expeditiously end several years of delays preventing the sale of a generic form of the drug esomeprazole magnesium , esomeprazole, currently marketed under the brand name Nexium. Nexium is the second highest-selling pharmaceutical drug in the United States, and delays in approving generic versions have cost consumers and government healthcare payers billions of dollars. In his comments, Attorney General Jepsen alleges that an agreement between drug manufacturers Ranbaxy (RBXLY) and AstraZeneca Pharmaceuticals (AZN), Nexium’s brand-name manufacturer, has prevented other drug-makers from launching a generic version of the drug, ultimately harming all consumers by artificially inflating prices. Ranbaxy was first-to-file with the FDA for approval of a generic form of Nexium. AstraZeneca sued Ranbaxy for patent infringement, and the dispute was settled by an agreement that provided financial incentives for Ranbaxy to delay entry of its generic into the consumer market. Reference Link
07:15 EDTAMGNIBC Life Sciences to hold a conference
10th Annual Cell Line Development & Engineering Conference to be held in Berkeley, California on September 8-10.
07:02 EDTAZNAstraZeneca announces availability of Bydureon pen 2mg
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06:49 EDTAMGNAmgen shares to trend higher, price target to $150 at RBC Capital
RBC expects shares of Amgen to trend higher due to evolving sentiment around the 2015 pipeline and low multiple. Some investors want a break-up of the company to increase shareholder value but the analyst does not expect it to occur given the concentrated portfolio, tax reasons, and a commercial infrastructure that can not be split off. Shares are Outperform rated with a $150 price target, raised from $135.
September 4, 2014
17:15 EDTAZNAstraZeneca granted orphan status for EFGR non-small cell lung cancer treatment
The FDA posted on its website that AstraZeneca has been granted orphan status for its treatment of epidermal growth factor receptor, or EFGR, mutation-positive non-small cell lung cancer. Reference Link
07:23 EDTAZNAstraZeneca called for inversion clamp down as part of defense, WSJ says
Amid its defense against an unsolicited takeover bid from rival Pfizer (PFE), AstraZeneca (AZN) hired advisers with close ties to the Obama administration, who made calls to senior administration officials urging a clamp down on tax inversions, said The Wall Street Journal, citing people familiar with the previously undisclosed calls. Reference Link
September 3, 2014
05:44 EDTAZNTeva announces positive judgement in patent case against AstraZeneca
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September 2, 2014
08:21 EDTAMGNAmgen submitts MAA to EMA for evolocumab
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08:20 EDTAMGNAmgen submits application to EMA for talimogene laherparepvec
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08:01 EDTAMGNAmgen price target raised to $153 from $140 at Leerink
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06:45 EDTAZNAstraZeneca volatility elevated
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