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News Breaks
March 4, 2014
09:35 EDTLLY, TEVATeva 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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January 30, 2015
06:30 EDTLLYEli Lilly FY15 EPS guidance does not include 12c potential charge
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06:28 EDTLLYEli Lilly backs FY15 EPS view of $3.10-$3.20, consensus $3.18
Lowers FY15 revenue guidance to $19.5B-$20B from $20.3B-$20.8B, consensus $20.67B.
06:26 EDTLLYEli Lilly reports Q4 EPS 75c, consensus 74c
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January 29, 2015
15:37 EDTLLYNotable companies reporting before tomorrow's open
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13:36 EDTLLYEli Lilly volatility elevated into Q4 and outlook
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13:29 EDTLLYEarnings Preview: Eli Lilly to report Q4 results amid new product launches
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12:00 EDTLLYLeerink biotech analysts hold an analyst/industry conference call
Biotech Analyst Schwartz discusses Biogen Idec BIIB037 and whether 2015 will be the year when Amyloid Beta is finally validated as a disease-modifying target in Alzheimer's Disease on an Analyst/Industry conference call to be held on February 3 at 2 pm.
January 27, 2015
09:10 EDTTEVAGevo announces Supreme Court rules in favor of Gevo
Gevo (GEVO) announced that the U.S. Supreme Court ruled in Gevo's favor and overturned an earlier Federal Circuit Court of Appeals ruling on the interpretation of key patent claims. The result is that Gevo's victory in the Delaware District Court is reinstated, and that the case has been remanded back to the Appeals Court for consideration in light of the new standard of appellate review that was decided in the Teva Pharmaceuticals USA, Inc., v. Sandoz, Inc. case last week. In Teva (TEVA), the Supreme Court ruled that the Appeals Court must apply a more stringent "clear error" standard of review, rather than a "de novo" standard of review. In Gevo's case, the Appeals Court must now apply the "clear error" standard of review and cannot set aside the Delaware District Court's findings of fact in Gevo's favor unless they were clearly erroneous. The Supreme Court's decision effectively reinstates Gevo's victory at the District Court where a final judgment of non-infringement was entered in Gevo's favor following the acknowledgment by Butamax Advanced Biofuels LLC that Gevo does not infringe Butamax's Patent Nos. 7,851,188 and 7,993,889.
January 26, 2015
15:24 EDTTEVATeva confirms U.S. approval of AstraZeneca's Nexium generic
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14:15 EDTTEVATeva unit wins FDA approval for Nexium generic
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January 23, 2015
16:08 EDTTEVATeva volatility elevated, Pfizer approached late last year, Bloomberg says
Teva (TEVA) overall option implied volatility of 25 compares to its 26-week average of 23 according to Track Data, suggesting large price movement into Pfizer (PFE) approach late last year, Bloomberg says.
16:04 EDTTEVATeva rebuffed Pfizer approach late last year, Bloomberg says
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January 21, 2015
10:16 EDTLLYLeerink biopharma analysts hold an analyst/industry conference call
Analyst Fernandez, along with Dr. Paul Gurbel and Dr. Richard Becker, discuss AstraZeneca's PEGASUS trial and the current use of Brilinta and dual antiplatelet therapy for prevention of CV disease and implications of the recently completed DAPT trial on an Analyst/Industry conference call to be held on January 21 at 1:30 pm.
08:38 EDTTEVAMomenta announces Supreme Court decision to remand generic Copaxone back to CAFC
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January 20, 2015
14:37 EDTTEVATeva generic competition to Copaxone pushed out by ruling, says BMO Capital
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12:56 EDTTEVAMylan says continues to believe '808 patent is 'invalid'
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11:29 EDTTEVATeva says Supreme Court reverses circuit court judgment on Copaxone 20 mg/mL
Teva Pharmaceutical announced the U.S. Supreme Court’s decision in Teva Pharmaceuticals USA, Inc. et al. Petitioners v. Sandoz Inc. et al. that reversed the Federal Circuit Court’s judgment of invalidity of Teva’s ‘808 patent for COPAXONE 20 mg/mL. The Supreme Court remanded the case to the Federal Circuit for further review in light of the applicable standard the Supreme Court laid out for appellate review of claim construction. A ruling last year by the U.S. Court of Appeals for the Federal Circuit upheld four Teva patents that expired in May 2014, while invalidating the ‘808 patent that is set to expire on September 1, 2015. “We are encouraged by the U.S. Supreme Court’s Decision and look forward to the Federal Circuit’s review. We will continue to explore all available avenues to protect our intellectual property for COPAXONE 20mg/mL,” said Erez Vigodman, President and CEO of Teva. “There is currently no FDA-approved follow-on version of Teva’s COPAXONE. We are encouraged by the FDA’s willingness to date to have dialogue regarding the complexities of COPAXONE 20 mg/mL and the potential limitations and other unknowns of purported follow-on versions,” added Rob Koremans, MD, President and CEO of Global Specialty Medicines at Teva.
10:45 EDTTEVATeva spikes, retraces, after win in Copaxone patent case
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10:40 EDTTEVAMomenta Pharma sinks after Supreme Court rules on Copaxone
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10:35 EDTTEVATeva rises after patent ruling upheld by Supreme Court
The Supreme Court upheld a lower court ruling related to generic versions of Teva's Copaxone drug. In the ruling, the court wrote that "When reviewing a district court’s resolution of subsidiary factual matters made in the course of its construction of a patent claim, the Federal Circuit must apply a “clear error,” not a de novo, standard of review." Teva shares are up 1.5% to $58.58 in early trading after the ruling. Reference Link
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