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News Breaks
December 28, 2012
10:36 EDTMYL, TEVAMylan launches generic Nordette 28 tablets
Mylan (MYL) announced that its partner Famy Care Ltd. has received final approval from the FDA for its Abbreviated New Drug Application for Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg. This product is the generic version of Teva Branded Pharmaceutical Products' (TEVA) Nordette 28 Tablets, which are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. The product will be distributed in the U.S. by Mylan Pharmaceuticals Inc., and the company is shipping product immediately.
News For MYL;TEVA From The Last 14 Days
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September 17, 2014
11:01 EDTTEVA, MYLActavis drops after NY AG seeks to block Alzheimer drug switch
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08:05 EDTTEVAEagle Pharm says Teva requests motion to dismiss Bendamustine lawsuit
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September 16, 2014
11:51 EDTMYLOECD looks to close tax loopholes with new proposals
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07:33 EDTMYLMylan initiates Phase III clinical trials for Advair Diskus and Lantus
Mylan (MYL) announced it is initiating Phase III clinical trials for its generic version of GlaxoSmithKline's (GKS) Advair Diskus and its insulin analog to Sanofi's (SNY) Lantus. In October Mylan will commence a Phase III clinical trial to evaluate the equivalence of its product to Advair Diskus when administered by inhalation in adult asthma patients.
September 15, 2014
06:34 EDTMYLMylan signs agreement with Gilead
Mylan (MYL) announced that its subsidiary Mylan Laboratories Limited has entered into an agreement with Gilead Sciences (GILD), under which Mylan has been licensed the non-exclusive rights to manufacture and distribute sofosbuvir and the investigational single tablet regimen of ledipasvir/sofosbuvir in 91 developing countries. Sofosbuvir is marketed by Gilead under the brand name Sovaldi. The countries within the agreement account for more than 100M people living with hepatitis C globally representing 54% of the total global infected population. Under the licensing agreement, Mylan will receive a technology transfer enabling the company to manufacture low-cost versions of the medicines for developing markets.
September 12, 2014
09:01 EDTTEVATeva to present Copaxone gene expression analysis
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08:06 EDTTEVATeva presents new clinical safety data in RRMS patients treated with Laquinimod
Teva (TEVA) and Active Biotech (ACTI) announced new follow-up data evaluating the clinical safety of laquinimod in patients with relapsing-remitting multiple sclerosis, or RRMS, who were treated with laquinimod in Phase II, Phase III and open-label extension studies for two or more years. The pooled safety analysis of the Phase II LAQ/5063 and the Phase III ALLEGRO and BRAVO extension studies supports findings observed in the core studies where currently identified risks were observed within the first months of laquinimod treatment. In the pooled safety analysis, rates of adverse events, or AEs, and serious AEs were lower in the open-label extensions than in the core studies and less than three percent of patients discontinued treatment due to AEs during these extensions. Additionally, shifts to potentially significant laboratory values were considerably lower in patients exposed to at least two years of laquinimod.
08:03 EDTTEVATeva, Active Biotech present laquinimod follow-up data
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September 11, 2014
09:31 EDTTEVATeva announces new data from Phase IIIb GLACIER study
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03:27 EDTTEVATeva Canada announces launch of generic version of Cipralex
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September 10, 2014
14:25 EDTTEVATeva Canada announces launch of generic version of Cipralex
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07:02 EDTMYLMylan to acquire U.S. rights to Arixtra injection from Aspen
Mylan's subsidiary Mylan Ireland Limited has entered into an agreement to acquire the U.S. commercialization, marketing and intellectual property rights relating to Arixtra Injection and the authorized generic of Arixtra from Aspen Global Incorporated. Arixtra is indicated for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism in patients undergoing hip fracture surgery. Mylan already is selling Arixtra in the U.S. through an interim distribution arrangement with Aspen and Apotex is currently selling the AG of Arixtra, which will be transitioning to Mylan Institutional by year end.
September 9, 2014
06:42 EDTMYLLew expects to make decision on combating inversion deals soon, NY Times reports
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September 8, 2014
12:40 EDTTEVAFTC sues AbbVie over blocking of AndroGel generics
The Federal Trade Commission has filed a complaint in federal district court charging several pharmaceutical companies with "illegally blocking American consumersí access to lower-cost versions of the blockbuster drug AndroGel." The FTC's complaint alleges that AbbVie (ABBV) and its partner Besins Healthcare filed baseless patent infringement lawsuits against potential generic competitors to delay the introduction of lower-priced versions of the testosterone replacement drug AndroGel. While the lawsuits were pending, AbbVie then entered into an anticompetitive pay-for-delay settlement agreement with Teva Pharmaceuticals (TEVA) to further delay generic drug competition, the FTC claims. Reference Link
11:05 EDTMYLOptions with increasing implied volatility
Options with increasing implied volatility: NPSP GILD VNET AVNR GTAT YHOO RHT VRTX SDRL COV MYL
10:04 EDTMYLMylan calls active on activist investor speculation
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09:57 EDTMYLRumor: Mylan moves up on activist investor speculation
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09:27 EDTTEVA, MYLLeerink biotech analyst holds a luncheon meeting with a conference call
Biotech Analyst Schwartz provides an update on key trends and controversies for marketed MS therapies and discusses new data presented at ACTRIMS-ECTRIMS at a Luncheon Meeting with an Analyst/Industry conference call to be held in Boston on September 11 at 12:15 pm.
08:02 EDTTEVATeva completes Reslizumab Phase III program
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07:03 EDTMYLMylan annoucnes court grants summary judgment in favor of company
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