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News Breaks
March 7, 2014
14:18 EDTREGN, SNY, AMGN, PFE, NVS, RHHBYConcerns with PCSK9 class not seen with Regeneron drug, says Citigroup
Citigroup said its talks with Regeneron (REGN) indicate that the issues the FDA has noted with PCSK9 drugs have not arisen in the ongoing Phase 3 studies of Regeneron and Sanofi's (SNY) Alirocumab. Citi suspects the events described in filings by Regeneron and Sanofi might have been seen with PCSK9 inhibitors being developed by Amgen (AMGN), Pfizer (PFE), Novartis (NVS) or Roche (RHHBY). Citi also notes that neurocognitive side effects are known to be caused by statins and it is unclear whether the effects were seen with PCSK9 inhibitors when used alone or when combined with statins.
News For REGN;SNY;AMGN;PFE;NVS;RHHBY From The Last 14 Days
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September 15, 2014
07:21 EDTNVS, AMGNHeart 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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13:32 EDTPFEPfizer shares look cheap, Barron's says
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September 12, 2014
10:32 EDTPFEPfizer 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
10:04 EDTSNYSanofi unit granted orphan status for treatment of Gaucher disease
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07:14 EDTAMGNAmerican Society for Bone & Mineral Research holds annual meeting
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05:18 EDTNVSNovartis announces new data confirms high efficacy of Gilenya in achieving NEDA
Novartis announced new analyses presented at the Joint ACTRIMS-ECTRIMS Meeting in Boston, USA, which confirmed the high efficacy of Gilenya in achieving 'no evidence of disease activity', or NEDA, in people with relapsing-remitting multiple sclerosis, or RRMS, across four key disease measures - relapses, MRI lesions, brain shrinkage and disability progression. Specifically, patients taking Gilenya had a more than four-times greater likelihood of achieving NEDA across these four key measures. NEDA is currently defined as having no relapses, MRI lesions and disability progression. These new analyses from the phase III FREEDOMS and FREEDOMS II trials reinforce the value of including brain shrinkage to the definition of NEDA. The inclusion of brain shrinkage into the NEDA definition would allow physicians to obtain a more complete assessment of a patient's disease, including the underlying damage in MS.
September 11, 2014
05:27 EDTSNYGenzyme announces positive interim results from Lemtrada extension study
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September 10, 2014
13:04 EDTRHHBYRoche unit receives orphan status for lung cancer mutation drug
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07:09 EDTSNYAmericas Committee for Treatment & Research in MS to hold a meeting
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05:17 EDTNVSNovartis Gilenya data confirms reducing brain shrinkage matter for MS patients
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September 9, 2014
07:55 EDTNVSOphthotech earlier than expected Novartis payment positive, says Oppenheimer
After Ophthotech (OPHT) received a $50M Phase 3 enrollment payment from Novartis (NVS) earlier than expected, Oppenheimer thinks the payment highlights an underappreciated stock driver for Opthotech, and demonstrates that recent suggestions of Phase 3 enrollment timelines possibly slipping are unwarranted. The firm believes the company is executing well on the Fovista Phase 3 program and keeps an Outperform rating on the stock.
September 8, 2014
14:16 EDTSNYSanofi announces FDA approval of Menactra vaccine
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09:27 EDTNVSLeerink biotech analyst holds a luncheon meeting with a conference call
Biotech Analyst Schwartz provides an update on key trends and controversies for marketed MS therapies and discusses new data presented at ACTRIMS-ECTRIMS at a Luncheon Meeting with an Analyst/Industry conference call to be held in Boston on September 11 at 12:15 pm.
08:38 EDTNVSMerus Labs acquires Sintrom from Novartis
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07:33 EDTNVSOphthotech achieves $50M milestone under ex-agreement with Novartis for Fovista
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07:15 EDTPFE, RHHBY, AMGN, REGNIBC Life Sciences to hold a conference
10th Annual Cell Line Development & Engineering Conference to be held in Berkeley, California on September 8-10.
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 7, 2014
17:15 EDTNVSNovartis presents new data on once-daily Ultibro Breezhaler
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