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Stock Market & Financial Investment News

News Breaks
May 30, 2014
09:17 EDTTEVA, PFE, MYLTeva receives favorable court decision regarding generic Celebrex capsules
Teva Pharmaceutical Industries Ltd. (TEVA) announced that the U.S. District Court for the Northern District of West Virginia denied a motion filed by Mylan (MYL) and issued an opinion and order affirming a decision by the FDA under which Teva should receive sole 180-day “first-to-file” exclusivity for generic Celebrex 100, 200 and 400 mg capsules. On April 17, Teva entered into a settlement agreement with Pfizer (PFE) related to Teva’s generic version of Celebrex 50, 100, 200 and 400 mg capsules in the United States. Under the terms of the settlement, Teva may launch its generic versions in December, 2014, or earlier under certain circumstances. Teva has received tentative approval from the U.S. Food and Drug Administration for all strengths. Sales of Celebrex were $2.2B in the U.S. according to IMS data as of December, 2013.
News For TEVA;MYL;PFE From The Last 14 Days
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January 27, 2015
07:16 EDTPFEPfizer drops 2.7% after FY15 outlook miss expectations
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07:07 EDTPFEPfizer sees FY15 adjusted EPS $2.00-$2.10, consensus $2.18
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07:01 EDTPFEPfizer reports Q4 adjusted EPS 54c, consensus 53c
Reports Q4 revenue $13.1B, consensus $12.9B.
January 26, 2015
16:15 EDTPFEPfizer commits to lower price for Prevenar 13 in developing countries
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15:40 EDTPFENotable companies reporting before tomorrow's open
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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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13:29 EDTPFEEarnings Preview: Pfizer set to report Q4 results as generics impact Celebrex
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11:00 EDTMYLMylan expands Hepatitis C licensing agreement with Gilead
Mylan (MYL) announced that its subsidiary Mylan Laboratories Limited is expanding its hepatitis C licensing agreement with Gilead Sciences (GILD) to include the non-exclusive rights to manufacture and distribute the investigational NS5A inhibitor GS-5816 and single tablet regimen of sofosbuvir/GS-5816, once approved, in 91 developing countries. The single tablet regimen is being evaluated in Phase 3 clinical studies for the treatment of all six genotypes of hepatitis C. If approved by regulatory authorities, the sofosbuvir/GS-5816 regimen would become the first all-oral single tablet regimen for all hepatitis C genotypes. A pan-genotypic therapeutic option is particularly important for developing countries, where genotype testing is often unreliable or not readily available. This agreement is in addition to the licensing and technology transfer agreement that Mylan entered into with Gilead in September 2014, which grants Mylan the non-exclusive rights to manufacture and distribute sofosbuvir and ledipasvir/sofosbuvir in 91 developing countries. Mylan also partners with Gilead on expanding access to high quality, affordable antiretrovirals for the treatment of HIV/AIDS in India and other developing countries.
January 23, 2015
16:08 EDTTEVA, PFETeva 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 EDTTEVA, PFETeva rebuffed Pfizer approach late last year, Bloomberg says
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January 22, 2015
11:23 EDTPFEPfizer says CHMP adopted positive opinion on Prevenar 13 expansion
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January 21, 2015
12:30 EDTPFEGlaxoSmithKline 'admired' by Pfizer CEO, FT reports
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08:38 EDTTEVAMomenta announces Supreme Court decision to remand generic Copaxone back to CAFC
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January 20, 2015
14:37 EDTMYL, TEVATeva generic competition to Copaxone pushed out by ruling, says BMO Capital
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12:56 EDTTEVA, MYLMylan 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 EDTTEVA, MYLMomenta 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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