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Stock Market & Financial Investment News

News Breaks
June 17, 2014
08:05 EDTTEVA, MYL, NVS, ACTTeva reaches settlement in NUVIGIL patent case
Teva (TEVA) announced that it has reached settlements with Sandoz (NVS), Actavis (ACT), Lupin and Apotex with respect to U.S. Patent 7,132,570 for Teva’s wakefulness product, NUVIGIL tablets. These settlements dismiss a pending appeal with the United States Court of Appeals for the Federal Circuit of a trial court decision that found the ‘570 patent to be valid and infringed. Teva has reached settlements with each of these companies, granting licenses to allow these parties to market their generic products 180 days after Mylan (MYL), the first generic company to file an abbreviated new drug application for the 50 mg, 150 mg, and 250 mg dosages of NUVIGIL. The settlements allow Actavis to launch generic 100 mg and 200 mg dosages in June 2016, and the others may launch these dosages 180 days after Actavis in the 100 mg and 200 mg dosage forms. Additional terms of the settlements are agreed by the parties to remain undisclosed. Previously, Teva settled its patent infringement litigation regarding the ‘570 patent against Mylan, which allowed Mylan to begin selling generic versions of 50 mg, 150 mg, and 250 mg NUVIGIL® under license beginning in June 2016, or earlier under certain circumstances.
News For TEVA;MYL;NVS;ACT From The Last 14 Days
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August 29, 2014
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 EDTMYL, TEVAMylan 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.
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
16:11 EDTACTActavis confirms generic Neupro patent challenge
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08:02 EDTMYLMylan launches first generic Klor-Con Extended-release tablets
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August 21, 2014
15:16 EDTTEVA, ACTDEA 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
07:55 EDTACTActavis volatility expected to move on Pfizer considering new target report
Actavis (ACT) volatility is expected to move on Pfizer (PFE) considering other overseas alternatives, Bloomberg reports. Overall option implied volatility of 27 is near its 26-week average of 31 according to Track Data, suggesting decreasing price movement.
07:47 EDTACTPfizer looking at new targets, including Actavis, Bloomberg reports
While it weighs another attempt to acquire AstraZeneca (AZN), Pfizer is considering other overseas alternatives, including Actavis (ACT), Bloomberg reports, citing people familiar with the matter. Pfizer prefers to reach a deal with AstraZeneca, and a move on another company is unlikely "anytime soon," Bloomberg adds, citing its sources. Shares of Actavis are rising 3%, or $6.65, to $230.01 in pre-market trading, while AstraZeneca is up 2% to $72.59. Reference Link
07:38 EDTACTSupernus announces paragraph IV Abbreviated NDA filing for Trokendi XR
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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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11:18 EDTACTDepomed announces favorable ruling in Gralise case
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10:32 EDTACTDepomed higher after favorable ruling in Gralise case
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07:26 EDTACTActavis confirms positive results from RECLAIM pivotal Phase III studies
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05:11 EDTTEVA, NVSGamida Cell announces investment, option agreement with Novartis
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