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March 4, 2014
09:35 EDTTEVA, LLYTeva 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
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September 29, 2015
08:18 EDTTEVATeva initiated with a Neutral at Nomura
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08:02 EDTTEVAEagle Pharma receives new patent for bendamustine rapid infusion product
Eagle Pharmaceuticals (EGRX) announced that the United States Patent and Trademark Office has granted U.S. Patent No. 9,144,568, which pertains to the use of the bendamustine hydrochloride formulation administered in a 50mL bag within ten minutes. The patent issued today expires on March 15, 2033. This new patent, along with three previously issued Patents, further expands and protects Eagle's bendamustine HCI intellectual property estate. The Prescription Drug User Fee Act goal date for a decision on the NDA by the FDA is December 2015. The NDA requests FDA approval of the rapid infusion bendamustine HCl product for the treatment of patients with chronic lymphocytic leukemia and patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. The NDA for Eagle's rapid infusion bendamustine product is supported by data from a clinical trial completed in November 2014, which demonstrated that the rapid infusion bendamustine HCl product can be administered in ten minutes in a low- volume, 50 mL admixture. The rapid infusion product candidate has received Orphan Drug Designations for both CLL and indolent B-cell NHL, and therefore may be eligible for seven years of exclusivity upon approval. In February 2015, Eagle and Teva Pharmaceutical Industries Ltd. (TEVA) entered into an exclusive license agreement for the rapid infusion bendamustine product. Teva will be responsible for all U.S. commercial activities for the product including promotion and distribution. Eagle has responsibility for obtaining all regulatory approvals, conducting post-approval clinical studies, if required, and initially supplying drug product to Teva.
06:47 EDTLLYEli Lilly and Incyte's baricitinib Phase 3 study met primary objective
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September 28, 2015
19:11 EDTLLYOn The Fly: After Hours Movers
HIGHER: Yahoo (YHOO), up 3.3% after the board authorized Yahoo to continue to pursue the Aabaco spin-off plan... Cheniere Energy (LNG), up 0.67% after Carl Icahn raised his stake in the company to 11.43%... Republic Airways (RJET), up 7.4% after the company was upgraded to Buy from Hold at Deutsche Bank... Exelon (EXC) and Pepco (POM), higher by 1% and 2.4%, respectively, after the DC Mayor's office released a statement confirming discussions of a settlement agreement with the companies. LOWER AFTER EARNINGS: SYNNEX (SNX), down 2.7% after the company reported Q3 results, gave Q4 guidance, and raised its quarterly dividend. ALSO LOWER: Zosano (ZSAN), down 52.5% after it discontinued development of its Daily ZP-PTH treatment for severe osteoporosis and terminated a collaboration agreement with Eli Lilly (LLY)... OvaScience (OVAS), down 15.9% after the company announced it doesn't expect to meet its previous 2015 goal of 1,000 Augment treatment cycles.
16:40 EDTTEVAAllergan to begin reporting Global Generics business as discontinued ops in Q3
Allergan (AGN) intends to begin reporting its Global Generics business as discontinued operations with its third quarter 2015 results. The transaction with Teva (TEVA) is expected to close in the first quarter of 2016.
16:23 EDTTEVAAllergan sees 10% branded revenue growth after divestiture of generics unit
Following the close of the divestiture of the Generics business to Teva (TEVA), New Allergan (AGN) expects to have a powerful financial profile to drive continued long-term growth: 10% branded revenue growth; Non-GAAP gross margins of 77% to 79% with additional long-term expansion anticipated; Non-GAAP SG&A as a percentage of revenue between 21-24%, declining within that range over time; Non-GAAP tax rate of ~15%; Interest expense for New Allergan will be largely dependent on capital deployment decisions following the close of the transaction; Commitment to investment grade ratings. "New Allergan will have strong double-digit revenue growth and will be a development powerhouse stacked with 70 mid-to-late stage R&D projects to address customer and patient needs," said Brent Saunders, CEO and President. "The New Allergan will be lean and nimble with an expanded margin profile driven by leading brands in seven therapeutic categories, a streamlined operating model with one of the most efficient SG&A as a percentage of sales in the industry, a non-GAAP tax rate of approximately 15 percent, and a simplified manufacturing network globally. The continued robust performance of our overall business and strong mid-to-late stage pipeline puts Allergan in a strong position to meet our growth targets for the remainder of the year and over the long-term."
09:35 EDTLLYEli Lilly and Sanofi reach settlement agreement in glargine litigation
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09:33 EDTLLYSanofi reaches patent settlement with Eli Lilly on Lantus
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08:04 EDTLLYEli Lilly announces study of Cyramza in combination met primary end
A Phase II study of Eli Lilly's CYRAMZA in combination with docetaxel met its primary endpoint, demonstrating a statistically significant increase in progression-free survival (PFS) for patients with locally advanced or metastatic urothelial carcinoma who failed prior platinum-based therapy. Bladder cancer accounts for the vast majority of all urothelial carcinoma. Final results of the Phase II trial were presented at the European Cancer Congress (ECC2015) in Vienna, Austria on September 27. Based on these findings, Lilly recently initiated a Phase III trial called RANGE, which has begun to enroll patients. The three-arm trial evaluated 140 patients with advanced carcinoma of the urothelial tract who, after a first-line platinum-based chemotherapy regimen, had relapsed up to one year following the initial treatment. Patients were randomized to receive either a combination of ramucirumab and docetaxel, docetaxel alone (n=45), or a combination of icrucumab and docetaxel. Treatment continued until disease progression or toxicity levels resulted in an interruption of treatment with one or more of the study medicines.
07:52 EDTTEVAIIR Holdings to hold a conference
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07:46 EDTTEVAUBS to hold a field trip
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07:38 EDTLLYBox to hold a user conference
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07:27 EDTLLYFDA and the Parental Drug Association to co-host a conference
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05:26 EDTTEVATeva announces approval of Copaxone in Japan
Teva announced the approval by the Japanese Ministry of Health, Labour and Welfare of once-daily COPAXONE 20mg injection for the prevention of relapse of multiple sclerosis . The product will be commercialized in Japan by Takeda Pharmaceutical Company Limited. In Japan, glatiramer acetate was developed as an Unapproved New Drug by Teva Pharmaceutical K.K., a wholly owned subsidiary of Teva, at the request of the MHLW. In March, 2013, Takeda and Teva signed an agreement in which Teva granted Takeda the right to commercialize COPAXONE in Japan. The Japanese approval for COPAXONE is based on the safety and efficacy results of an open-label, 52-week clinical trial conducted by Teva Pharmaceutical K.K. in patients with relapsing-remitting multiple sclerosis in Japan as well as the pivotal trial data sets used for approvals in other countries.
September 27, 2015
16:53 EDTTEVATeva reports Phase 3 data on reslizumab for asthma exacerbations
Teva Pharmaceutical presented results from a post hoc analysis of two pivotal Phase 3 clinical trials showing that treatment with reslizumab reduced clinical asthma exacerbations by 75% versus placebo in a subgroup of patients with late onset asthma with elevated blood eosinophils, who were inadequately controlled on inhaled corticosteroids. Reslizumab is a humanized anti-interleukin-5 monoclonal antibody. Results were pooled from two Phase 3 clinical trials that investigated reslizumab IV 3mg/kg in patients who had at least one asthma exacerbation within the previous year. In the subgroup with late onset asthma, reslizumab showed a 75% reduction in asthma exacerbations and improvement in lung function as measured by forced expiratory volume in one second. In the overall pooled patient population, asthma exacerbations were reduced by 54%, and in the subgroup of subjects diagnosed with asthma at less than 40 years of age, exacerbations were reduced by 42%. Common adverse events in the reslizumab treatment group were comparable to placebo.
September 25, 2015
09:02 EDTTEVATeva acquires Gecko Health Innovations, terms not disclosed
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08:37 EDTTEVAAntares Pharma could benefit from drug pricing controversy, says Oppenheimer
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07:22 EDTTEVA, LLYEuropean Society for Medical Oncology to hold a conference
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September 24, 2015
07:26 EDTTEVATeva stock performance can improve into year-end, says Deutsche Bank
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07:12 EDTTEVATeva added to short-term buy list at Deutsche Bank
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