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Stock Market & Financial Investment News

News Breaks
April 21, 2014
08:18 EDTMNTA, NVS, MYL, TEVAMomenta Pharma rises after high court rejects Copaxone delay bid
Shares of Momenta Pharmaceuticals (MNTA) are higher in pre-market trading after the Supreme Court denied Teva's (TEVA) request to delay the launch of generic forms of its relapsing-remitting multiple sclerosis product, Copaxone. WHAT'S NEW: Teva confirmed on April 19 that the Chief Justice of the United States denied the company's application for an injunction seeking to prevent the launch of a generic version of Copaxone. Teva will continue pursuing its appeal in the Supreme Court and defending its intellectual property for Copaxone, the company said. WHAT'S NOTABLE: Momenta has developed a generic version of Copaxone in partnership with Novartis' (NVS) Sandoz unit. Mylan, which is preparing to launch a generic version of Copaxone as well, said after the ruling: "We are pleased with the Chief Justice's decision, and we look forward to introducing the first generic Copaxone treatment for multiple sclerosis patients in the U.S. at market formation. Mylan remains eligible to receive approval from the U.S. FDA on May 25, 2014." PRICE ACTION: In pre-market trading, Momenta shares are up over 12% to $12.46, while Mylan shares are up more than 3% to $48.48. Teva shares trading in New York are down about 1.7% to $50 in pre-market trading.
News For MNTA;NVS;MYL;TEVA From The Last 14 Days
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August 29, 2014
15:29 EDTMYLMylan receives FDA approval for generic lamivudine, aidovudine
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12:23 EDTNVSNovartis drug data to be presented this weekend
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12:18 EDTNVSOn The Fly: Midday Wrap
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11:07 EDTNVSHigh option volume stocks
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10:51 EDTNVSUnited Therapeutics jumps after court rules generic will infringe
United Therapeutics (UTHR) alleged patent infringement against Sandoz, a unit of Novartis (NVS), related to the latter's filing for approval of a generic version of United Therapeutics' remodulin drug. A New Jersey court ruled today that Sandoz's proposed ANDA product will infringe the claims of UTC's '117 patent, according to a court filing. Following the court ruling, shares of United Therapeutics are up 15% to $105.39 in morning trading.
10:17 EDTNVSInnoPharma announces FDA approval of generic Dacogen
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10:04 EDTNVSNovartis hematopoietic support for ALL patients granted orphan status
Novartis' hematopoietic stem and progenitor cells expanded ex-vivo with a low molecular weight aryl hydrocarbon receptor antagonist was granted orphan designation as a hematopoietic support in patients with acute lymphoblastic leukemia, or ALL, the FDA stated. Reference Link
08:46 EDTNVSNovartis has a conference call hosted by JPMorgan
JPMorgan Analyst Vosser hosts a conference call with CEO Joe Jimenez on September 5 at 8 am.
August 28, 2014
11:22 EDTTEVA, MYLMylan ANDA for three times per week generic Copaxone accepted by FDA for filing
Mylan (MYL) announced that its abbreviated new drug application for a three times per week Glatiramer Acetate Injection 40 mg/mL has been accepted for filing by the U.S. Food and Drug Administration. This product is the generic version of Teva's (TEVA) Copaxone 40 mg/mL, which is indicated for the treatment of patients with relapsing forms of multiple sclerosis. Mylan believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity in the U.S. upon final FDA approval. Copaxone 40 mg/mL had U.S. sales of approximately $411.5M for the 12 months ending June 30, 2014, according to IMS Health.
09:32 EDTMNTAMomenta Pharma announces ANDA for generic Copaxone accepted for review by FDA
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08:40 EDTNVSPositive data on Novartis LCZ696 could raise sales outlook, says Leerink
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07:21 EDTTEVATeva recalls batch of generic Parkinson's drug in U.S., Globes reports
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August 22, 2014
08:02 EDTMYLMylan launches first generic Klor-Con Extended-release tablets
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August 21, 2014
15:16 EDTTEVADEA restricts painkiller drug prescriptions to curb abuse, WSJ reports
The Drug Enforcement Agency, or DEA, will reclassify hydrocodone combination painkiller drugs and place them in the category of medical substances that have the highest potential for harm in an attempt to curb the widespread abuse of the drugs, according to The Wall Street Journal. The rescheduling of the drugs will take effect in 45 days and result in people being able to obtain the drug for only 90 days without obtaining a new prescription. Major manufacturers of these drugs include Teva Pharmaceutical (TEVA), Mallinckrodt (MNK), AbbVie (ABBV), and Actavis (ACT). Reference Link
August 20, 2014
12:06 EDTNVSNovartis treatment for pigmented villonodular synovitis gets orphan designation
According to a post on the FDA's website, Novartis' recombinant human monoclonal antibody of the IgG1 kappa class against human macrophage colony-stimulating factor received orphan designation. Reference Link
11:44 EDTMYLMylan completes second bidding round for GSK prescription portfolio, WSJ says
Mylan (MYL), TPG Capital, Advent International, KKR (KKR), Warburg Pincus and a few Indian prescription manufacturers have completed the second round of bidding for GlaxoSmith Kline's (GSK) portfolio of mature medications, according to The Wall Street Journal, citing people familiar with the sales process. GSK noted that it aims to sell a portfolio of drug brands in the U.S. and EU with yearly sales of approximately $1.66B. Reference Link
11:33 EDTMYLMylan into second round of bidding for GSK drug portfolio, WSJ reports
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05:17 EDTNVSNovartis provides drug candidate compounds to TB Alliance
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August 19, 2014
11:44 EDTMYLMylan launches generic Precedex Injection
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05:11 EDTTEVA, NVSGamida Cell announces investment, option agreement with Novartis
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