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Stock Market & Financial Investment News

News Breaks
June 25, 2014
05:32 EDTACT, NVS, SHPG, MYLShire says New Jersey court found Vyvanse patents infringed
Shire announces that Judge Stanley Chesler of the U.S. District Court for the District of New Jersey granted Shire's summary judgment motion in a patent infringement lawsuit, holding that certain claims of the patents protecting Vyvanse were both infringed and valid. The ruling prevents the five pharmaceutical manufacturers who have filed Abbreviated New Drug Applications from launching generic versions of Vyvanse until the earlier of either a successful appeal to the U.S. Court of Appeals for the Federal Circuit, or the expiration of these patents in 2023. To appeal successfully, the ANDA Defendants must overturn the court's rulings for each of the 18 patent claims, Shire said. The court's summary judgment ruling concerning Shire's motion included 18 patent claims from four of the FDA Orange Book-listed patents for Vyvanse, which cover Vyvanse's active ingredient, the lisdexamfetamine dimesylate compound, and a method of using lisdexamfetamine dimesylate for the treatment of ADHD. Shire's lawsuit is against the five ANDA defendants that filed ANDAs with the FDA seeking to market generic versions of Vyvanse. The defendants are Actavis (ACT), Amneal Pharmaceuticals, Mylan (MYL), Roxane Laboratories and Novartis' (NVS) Sandoz.
News For SHPG;ACT;MYL;NVS From The Last 14 Days
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January 23, 2015
07:25 EDTNVSNovartis drug Jakavi recommended by CHMP for EU approval
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January 22, 2015
05:57 EDTACTActavis, Valeant raise prospects of more healthcare deals, Financial Times says
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05:27 EDTSHPGShire reports positive response from European DCP for Elvanse Adult
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January 21, 2015
12:35 EDTNVSNovartis confirms FDA approval for Cosentyx
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12:33 EDTNVSFDA approves Novartis psoriasis drug Cosentyx
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12:30 EDTACTGlaxoSmithKline 'admired' by Pfizer CEO, FT reports
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10:26 EDTNVSHigh option volume stocks
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07:22 EDTACTActavis price target raised to $330 from $280 at Deutsche Bank
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January 20, 2015
14:37 EDTMYLTeva generic competition to Copaxone pushed out by ruling, says BMO Capital
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14:06 EDTSHPGCitizens, Keysight identified as long positions by Einhorn
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12:56 EDTMYLMylan says continues to believe '808 patent is 'invalid'
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10:40 EDTMYLMomenta Pharma sinks after Supreme Court rules on Copaxone
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08:10 EDTSHPGShire price target raised to $247 from $228 at Jefferies
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05:34 EDTACTActavis reports positive Phase III results for cariprazine
Gedeon Richter and Actavis announced positive results from a Phase III trial evaluating the efficacy and safety of cariprazine in the prevention of relapse in patients with schizophrenia. There were 101 patients randomized to cariprazine 3 to 9 mg per day and 99 randomized to placebo. The primary efficacy measure was time to first relapse during the double-blind period. There were 25 relapses in the cariprazine group versus 47 relapses in the placebo group. Treatment with cariprazine was associated with a 55% reduction in risk of relapse versus placebo.
January 16, 2015
16:36 EDTSHPGMarket finishes week lower on continued oil, global growth worries
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08:31 EDTNVSGlaxoSmithKline CEO says more IPOs like ViiV could happen, Retuers says
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January 15, 2015
14:31 EDTMYLMylan launches generic Epivir-HBV tablets
Mylan (MYL) announced the U.S. launch of its Lamivudine Tablets, 100 mg, which is the generic version of GlaxoSmithKline's (GSK) Epivir-HBV. Mylan received final approval from the U.S. FDA for its Abbreviated New Drug Application for this product, which is indicated for the treatment of chronic hepatitis B virus infection associated with evidence of hepatitis B viral replication and active liver inflammation. Lamivudine Tablets, 100 mg, had U.S. sales of approximately $18.1M for the 12 months ending September 30, 2014, according to IMS Health. Currently, Mylan has 284 ANDAs pending FDA approval representing $109.1B in annual brand sales, according to IMS Health. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $29.3B in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health.
January 14, 2015
18:18 EDTACTOn The Fly: After Hours Movers
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16:59 EDTACTGalena, Orexo AB receive "Paragraph IV" patent certification notice from Actavis
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11:45 EDTNVSImmunoGen discloses triggering of $5M milestone payment from Novartis
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