|March 4, 2014|
|09:35 EDT||TEVA, LLY||Teva announces approval of generic to Lilly's Evista |
Teva (TEVA) announces the approval of the generic equivalent to Evista Tablets, in the United States. Teva was first to file, making the product eligible for 180 days of marketing exclusivity, it said. Teva will begin shipping the product within the next 30 days. Evista is marketed by Eli Lilly (LLY) and had annual sales of approximately $824M in the United States, according to IMS data as of December 2013.
News For TEVA;LLY From The Last 14 Days
Check below for free stories on TEVA;LLY the last two weeks.
|September 2, 2014|
|08:02 EDT||TEVA||Teva reports statistically significant results in reslizumab trial|
Teva Pharmaceutical Industries announced that reslizumab, an investigational anti-IL-5 monoclonal antibody, demonstrated clear levels of efficacy in achieving the primary endpoint of reduction in the frequency of clinical asthma exacerbations compared to placebo in two pivotal Phase III studies in patients with inadequately controlled moderate to severe asthma with elevated levels of blood eosinophils. In both trials, reslizumab treatment showed both clinically relevant and statistically significant reductions in the frequency of CAE compared to placebo. Reslizumab has also demonstrated a positive effect on lung function and asthma control in the Phase III program . The combination of an effect on clinically important exacerbations and on improvements and preservation of lung function suggest that reslizumab may be a uniquely differentiated treatment for patients with moderate to severe asthma with elevated levels of blood eosinophils. This initial set of results shows the adverse event profile of reslizumab was comparable to placebo in both trials. The incidence of common AEs was consistent with those seen in a moderate to severe asthma population, the most frequent being upper respiratory tract infections, asthma and headache. Further analyses of additional efficacy and safety data are ongoing. These new data are from two global Phase III 12-month, randomized, double-blind, placebo-controlled, parallel-group studies, evaluating the efficacy and safety of intravenously administered reslizumab once every four weeks, compared to placebo in asthma patients that are inadequately controlled by standard of care therapy.
|August 28, 2014|
|11:22 EDT||TEVA||Mylan ANDA for three times per week generic Copaxone accepted by FDA for filing|
Mylan (MYL) announced that its abbreviated new drug application for a three times per week Glatiramer Acetate Injection 40 mg/mL has been accepted for filing by the U.S. Food and Drug Administration. This product is the generic version of Teva's (TEVA) Copaxone 40 mg/mL, which is indicated for the treatment of patients with relapsing forms of multiple sclerosis. Mylan believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity in the U.S. upon final FDA approval. Copaxone 40 mg/mL had U.S. sales of approximately $411.5M for the 12 months ending June 30, 2014, according to IMS Health.
|07:31 EDT||LLY||Eli Lilly management to meet with Deutsche Bank|
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|07:21 EDT||TEVA||Teva recalls batch of generic Parkinson's drug in U.S., Globes reports|
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|August 27, 2014|
|09:53 EDT||LLY||On The Fly: Analyst Initiation Summary|
Bristol-Myers (BMY) initiated with a Hold at Deutsche Bank... ASML (ASML) initiated with a Hold at Stifel... Akamai (AKAM) initiated with an Outperform at RW Baird... Concur (CNQR) initiated with a Neutral at DA Davidson... CyrusOne (CONE) initiated with a Neutral at Citigroup... Eli Lilly (LLY) initiated with a Buy at Deutsche Bank... Garmin (GRMN) initiated with a Neutral at RW Baird... Merck (MRK) initiated with a Hold at Deutsche Bank... NetSuite (N) initiated with a Buy at DA Davidson... Oracle (ORCL) initiated with a Neutral at DA Davidson... Oxford Industries (OXM) initiated with a Buy at Wunderlich... Pfizer (PFE) initiated with a Buy at Deutsche Bank... ServiceNow (NOW) initiated with a Buy at DA Davidson... Workday (WDAY) initiated with a Neutral at DA Davidson... MannKind (MNKD) initiated with a Buy at Jefferies... STMicroelectronics (STM) initiated with an Underperform at Credit Suisse... Kirkland's (KIRK) initiated with an Outperform at Barrington.
|06:42 EDT||LLY||Eli Lilly initiated with a Buy at Deutsche Bank|
|August 26, 2014|
|09:07 EDT||LLY||Eli Lilly announces Jardiance available in U.S. pharmacies|
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|August 21, 2014|
|15:16 EDT||TEVA||DEA restricts painkiller drug prescriptions to curb abuse, WSJ reports|
The Drug Enforcement Agency, or DEA, will reclassify hydrocodone combination painkiller drugs and place them in the category of medical substances that have the highest potential for harm in an attempt to curb the widespread abuse of the drugs, according to The Wall Street Journal. The rescheduling of the drugs will take effect in 45 days and result in people being able to obtain the drug for only 90 days without obtaining a new prescription. Major manufacturers of these drugs include Teva Pharmaceutical (TEVA), Mallinckrodt (MNK), AbbVie (ABBV), and Actavis (ACT). Reference Link
|07:12 EDT||LLY||Eli Lilly announces results from pivotal UNCOVER studies for ixekizumab |
Eli Lilly announces that its investigational medicine ixekizumab was statistically superior to etanercept and placebo on all skin clearance measures in Phase 3 studies. Patients treated with both dosing regimens of ixekizumab had significantly greater levels of skin clearance compared to placebo and to etanercept at the 12-week endpoint. Skin clearance was measured by standard primary endpoints for psoriasis studies: the Psoriasis Area and Severity Index and the Static Physician Global Assessment. For patients treated with ixekizumab either every four weeks or every two weeks, between 78 to 90 percent of patients achieved at least a 75 percent reduction in PASI score at 12 weeks. Additionally, 31 to 41 percent of these patients achieved PASI 100, or clear skin, at week 12. For comparison, between 5 to 7 percent of patients treated with etanercept in the UNCOVER-2 and 3 studies achieved PASI 100. Adverse events were comparable for patients receiving ixekizumab in the 12-week, randomized control portion across all three studies.