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March 19, 2013
05:55 EDTLLY, LLY, LLY, DNA, DNA, DNA, BMY, BMY, BMY, PFE, PFE, PFE, RHHBY, RHHBY, RHHBY, BIIB, BIIB, BIIB, JAZZ, JAZZ, JAZZ, SNY, SNY, SNY, GILD, GILD, GILD, CORT, CORT, CORT, HZNP, HZNP, HZNPDrug Information Association to host a forum
Medical & Scientific Communications 2013 Annual Forum is being held in Chandler, Arizona on March 19-21.
News For LLY;CORT;GILD;SNY;JAZZ;BIIB;RHHBY;PFE;BMY;DNA;HZNP From The Last 14 Days
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March 18, 2015
17:09 EDTPFEPfizer CAPiTA published in New England Journal of Medicine
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13:05 EDTJAZZJazz Pharmaceuticals management to meet with Piper Jaffray
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12:48 EDTBIIB, LLY, RHHBYFly Watch: Biogen predicted to report strong Alzheimer's data this Friday
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09:32 EDTSNYMannKind faces cash shortfall if $100M debt not settled, TheStreet says
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07:46 EDTRHHBY, LLYLilly Roche would have upbeat read through from strong BIIB data, says Bernstein
Bernstein notes that the data for Biogen's (BIIB) Alzheimer's treatment, due to be released on Friday, is widely expected to be positive. The firm thinks that positive data would boost the outlook for similar Alzheimer's drugs being developed by Eli Lilly (LLY) and Roche (RHHBY), since consensus estimates for those drugs are low. The firm keeps Outperform ratings on Eli Lilly and Roche.
07:34 EDTBIIBBiogen should report strong Alzheimer's data, says RBC Capital
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March 17, 2015
10:00 EDTSNYOn The Fly: Analyst Upgrade Summary
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08:13 EDTRHHBYCelldex announces clinical trial collaboration with Roche
Celldex Therapeutics (CLDX) announced that it has entered into a clinical trial collaboration with Roche (RHHBY) to evaluate the safety, tolerability and preliminary efficacy of varlilumab, Celldex's CD27 targeting investigational antibody, and MPDL3280A, Roche's investigational cancer immunotherapy in a Phase 1/2 study in renal cell carcinoma. Varlilumab and MPDL3280A are part of a new class of investigational medicines known as cancer immunotherapies that are designed to harness the body's own immune system to fight cancer through separate yet complementary mechanisms of action that may enable the activation of T cells, restoring their ability to effectively detect and attack tumor cells. Preclinical data suggest the combination of these two mechanisms are synergistic and may enhance anti-tumor immune response compared to either agent alone. In Celldex's Phase 1 study of varlilumab in multiple solid tumors, promising signs of clinical activity in patients with refractory renal cell carcinoma were observed, including a durable partial response that has continued to decrease in tumor volume over time and prolonged stable disease. Under the terms of this agreement, Roche will provide study drug and Celldex will be responsible for conducting and funding the study, which is expected to begin in 2015.
08:02 EDTSNYSanofi says Shantha will provide up to 37M doses of Shan5
Sanofi Pasteur, the vaccines division of Sanofi, announced that its affiliate Shantha Biotechnics of Hyderabad, India has delivered the first 400,000 doses of its pediatric pentavalent vaccine Shan5 to support the immunization of children in the cities of Gwalior and Jabalpur, both in the state of Madhya Pradesh, India. In December 2014, following a two-year international tender, Shantha was awarded to supply global health organizations with a total of 37M doses of Shan5 in 2015 and 2016, in a ten-dose vial presentation. This tender provides the basis upon which purchase orders will be made for specific vaccine deliveries throughout the period, the company said.
07:43 EDTSNYSanofi upgraded to Outperform on abating concerns at Leerink
Leerink upgraded Sanofi to Outperform from Market Perform saying key concerns around the lack of a CEO, Toujeo positioning and guidance are either resolved or largely factored into expectations. The firm believes the company's currency risk is hedged over time and that its multibillion dollar PCSK9 and dupilumab therapy assumptions have further upside potential. It raised its price target for shares to EUR 106 from EUR 85.
06:31 EDTGILDStudies find Gilead's hepatitis C drugs cost effective, Reuters says
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05:40 EDTSNYSanofi upgraded to Outperform from Market Perform at Leerink
March 16, 2015
16:00 EDTGILDOptions Update; March 16, 2015
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08:23 EDTSNYPCSK9 data continues to impress, says Leerink
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07:27 EDTLLYBiodel BIOD-961 Phase 1 clinical trial meets primary efficacy endpoint
Biodel (BIOD) announced positive preliminary results from Study 6-101, a Phase 1 clinical trial comparing Biodel's lyophilized glucagon formulation BIOD-961, designed for use in a proprietary Glucagon Emergency Management, or GEM, auto-reconstitution device, to Eli Lilly's (LLY) Glucagon Emergency Rescue Kit and Novo Nordisk's GlucaGen HypoKit, which are marketed for the treatment of severe hypoglycemia. Study 6-101 was a randomized, single-center, double blind, six-period cross over study in 15 healthy volunteers who received each glucagon administered subcutaneously, or SC, and intramuscularly, or IM, in a randomized treatment sequence. The objectives of the study were to compare the pharmacokinetic, or PK, profiles, the pharmacodynamic, or PD, glucose, responses, and the PK/PD relationships of IM and SC dosing, as well as to assess safety profiles of the three test glucagons. Study 6-101 was a Phase 1 randomized, single-center, double blind, six-period cross over study designed to evaluate the PK and PD profiles of BIOD-961 compared to marketed glucagon formulations manufactured by Eli Lilly and Novo Nordisk. BIOD-961 is a lyophilized glucagon formulation designed for use in the GEM auto-reconstitution device. On six separate dosing days, each subject received 1 mg of one of the test glucagons delivered either SC or IM. Fifteen normal, healthy subjects were randomized into the study and ten completed all dosings. The objectives of the study were to compare the PK profiles, the PD responses, and the PK/PD relationships of IM and SC dosing, as well as to assess safety profiles of the three test glucagons. These data will facilitate selection of an appropriate marketed glucagon to use as a comparator in the planned pivotal study, in which the primary efficacy endpoint for approval is to demonstrate PK and PD bioequivalence of BIOD-961 to one of the marketed comparators.
07:16 EDTSNYRegeneron Sanofi dupilumab drug can generate $6B+ in revenue, says Bernstein
Bernstein believes that dupilumab, a drug made by Regeneron and Sanofi, has shown strong efficacy in patients with severe atopic dermatitis. The firm notes that the drug is currently in pivotal trials involving patients with severe levels of other common diseases. The firm thinks the drug can generate $1.5B of revenue by 2018 and $3.8B by 2020. Bernstein keeps a $500 price target and Outperform rating on Regeneron.
06:40 EDTSNY, PFEPCSK9 studies show potential improvement in heart health, WSJ says
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March 15, 2015
13:04 EDTSNYSanofi, Regeneron announce publication of results of ODYSSEY long term trial
Sanofi (SNY) and Regeneron Pharmaceuticals (REGN) today announced that 18-month results of a Phase 3 trial of Praluent, alirocumab, an investigational therapy, involving 2,341 high risk patients with hypercholesterolemia were published online in The New England Journal of Medicine. In the ODYSSEY LONG TERM trial, Praluent 150 mg every two weeks reduced low-density lipoprotein cholesterol by an additional 62% at week 24 when compared to placebo, the primary efficacy endpoint of the study, with consistent LDL-C lowering maintained over 78 weeks."These results demonstrated the durable efficacy for Praluent when added to maximally-tolerated statin therapy and further reinforce its generally consistent safety profile," said Jennifer Robinson, M.D., M.P.H., Director of the Prevention Intervention Center, Professor, Departments of Epidemiology & Medicine, College of Public Health at the University of Iowa. "Additionally, the post hoc analysis of major cardiovascular events represents an important finding for Praluent -- we look forward to results from the ongoing ODYSSEY OUTCOMES trial, which is prospectively evaluating the potential of Praluent to reduce cardiovascular events."
March 13, 2015
10:37 EDTSNYSanofi says NHS England de-lists cabazitaxel, aflibercept
Sanofi announcd that NHS England has confirmed that it is de-listing both cabazitaxel and aflibercept from the Cancer Drugs Fund, so that neither of these medicines will be available to new patients in England on the NHS. It added, "However regarding cabazitaxel NHS England have agreed to engage in talks to explore immediate ways of maintaining access to patients until it is reviewed by NICE." Tarja Stenvall, General Manager for Sanofi in the UK, commented, "We are hugely disappointed that cabazitaxel and aflibercept have been cut from the CDF and that new patients in England will no longer have access to these crucial cancer treatments. However NHS England remains in dialogue with Sanofi to explore immediate ways of maintaining access to patients for cabazitaxel until the outcome of any NICE review. Our concern is for patients who should continue to have access to cabazitaxel until a longer term solution is reached and who may feel confused and uncertain until this happens."
08:35 EDTBIIBBiogen shares have additional room to run, says JPMorgan
JPMorgan says it would remain a buyer of Biogen ahead of the interim Phase 1b BIIB037 Alzheimer's update on March 20. It believes investors still incorporate a low probability of success for the asset. JPMorgan believes shares have additional upside potential despite the 20% rally year-to-date and keeps an Overweight rating on Biogen with a $420 price target.
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