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Stock Market & Financial Investment News

News Breaks
August 22, 2014
16:11 EDTACTActavis confirms generic Neupro patent challenge
Actavis confirmed that it has filed an Abbreviated New Drug Application, or ANDA, with the FDA seeking approval to market Rotigotine Extended-release Transdermal Film, 1 mg/24 hr, 2mg/24 hr, 3 mg/24hr, 4 mg/24 hr, 6mg/24hr, and 8 mg/24 hr. Actavis' ANDA product is a generic version of UCB's Neupro, which is indicated for the treatment of signs and symptoms of idiopathic Parkinson's disease and moderate-to-severe primary Restless Legs Syndrome. UCB and LTS Lohmann Therapie-Systeme AG filed suit against Actavis' subsidiaries on August 21 in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of certain U.S. Patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA for up to 30 months from the date the plaintiffs received notice of Actavis' ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities. Based on available information, Actavis believes it may be a "first applicant" to file an ANDA for the generic version of Neupro and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity. For the 12 months ending June 30, Neupro had total U.S. sales of approximately $85M, according to IMS Health data.
News For ACT From The Last 14 Days
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January 22, 2015
05:57 EDTACTActavis, Valeant raise prospects of more healthcare deals, Financial Times says
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January 21, 2015
12:30 EDTACTGlaxoSmithKline 'admired' by Pfizer CEO, FT reports
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07:22 EDTACTActavis price target raised to $330 from $280 at Deutsche Bank
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January 20, 2015
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 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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January 13, 2015
14:00 EDTACTActavis says Allergan deal could close as early as Q1, as late as Q2
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13:49 EDTACTActavis says sees about $8B in free cash flow in 2016
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13:42 EDTACTActavis targeting 2017 EPS of $25
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13:38 EDTACTActavis sees Q4 adjusted EPS beating consensus by 10%-15%
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08:05 EDTACTActavis launches US generic specialty injectable portfolio
Actavis announced the launch of a portfolio of generic specialty injectable medications to be marketed to hospitals across the United States. Actavis will immediately begin marketing approximately 20 injectable products across a number of therapeutic categories in the U.S. The company hopes to be a leader in Oncology, with nearly a dozen marketed products including generic versions of Gemzar, Taxotere, Campostar and Zometa. Actavis also has an industry leading specialty injectable pipeline, with approximately 20 new filings under review at the U.S. Food and Drug Administration, as well as more than 50 additional projects currently in development.
January 12, 2015
12:45 EDTACTActavis CEO says 'can't speculate on what Pfizer is going to do'
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12:10 EDTACTRBC Capital says Celgene's shares could rise to $200 'over time'
The long-term profit guidance that Celgene (CELG) released today suggests that the stock, currently trading around $115, could reach $200 "over time," RBC Capital wrote in a note to investors today. WHAT'S NEW: After Celgene estimated that its EPS would exceed $12.50, excluding certain items, by 2020, RBC Capital says that the guidance exceeded the firm's previous outlook. RBC added that Celgene's projection increases its confidence in the predictability of the drug maker's performance over the longer term. The firm recommended that investors own Celgene in 2015, noting that the company has the potential to settle its patent case with Actavis (ACT). A settlement would enable investors to focus on Celgene's visible long-term growth and the robust opportunity provided by its drugs in development, RBC stated. Historically, investors have not given Celgene credit for these strengths, the firm stated. PRICE ACTION: In early afternoon trading, Celgene rose 1.5% to $115.35.
09:37 EDTACTSupreme Court rejects Allergan appeal on generic Latisse, Bloomberg reports
08:34 EDTACTActavis expects Q4 non-GAAP EPS to exceed consensus by 10%-15%
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08:09 EDTACTActavis and Allergan announce early termination of HSR waiting period
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08:07 EDTACTActavis, Allergan announce early termination of Hart Scott Rodino waiting period
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