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Stock Market & Financial Investment News

News Breaks
June 10, 2014
11:22 EDTACT, AGN, NVSAllergan Latisse patents found invalid by appeals court
The U.S. court of appeals for the federal circuit overturned a lower court ruling related to Allergan's (AGN) patents for Latisse, a treatment for eyelash loss. Several companies, including Actavis (ACT) and Novartis' (NVS) Sandoz unit, appealed a lower court ruling that said they'd infringed Allergan's patents. The appeals court sided with the appealing companies and reversed the district court's findings with respect to the validity of the patents held by Allergan and Duke University. Reference Link
News For AGN;ACT;NVS From The Last 14 Days
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August 28, 2015
09:50 EDTAGNAllergan plans for generic version of Endo's Fortesta blocked, Bloomberg reports
A judge upheld Endo's (ENDP) patents on Fortesta expiring in 2018 and blocked Allergan's (AGN) bid to launch a generic version of the testosterone gel, according to Bloomberg.
05:32 EDTNVSNovartis renews pledge with WHO to end leprosy
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August 25, 2015
15:02 EDTNVSMylan says USPTO institutes IPR of two Copaxone patents
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08:14 EDTAGNAllergan multiple is low, says Leerink
Leerink predicts that Allergan's 2016 EPS will come in at $17-$18. The firm thinks the company has "durable revenue streams," and a "deep pipeline with several potential blockbuster candidates." Leerink adds that the company "has significant capacity for M&A." It keeps a $388 price target and Outperform rating on the shares.
August 24, 2015
13:15 EDTNVSFDA expands use of Novartis' Promacta to include children ages 1 and older
Ligand Pharmaceuticals (LGND) announced that the FDA has approved an expanded use for Promacta, a Novartis (NVS) product, to include children 1 year of age and older with chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Promacta was acquired by Novartis in March from GlaxoSmithKline (GSK). Promacta was discovered as a result of research collaboration between GSK and Ligand Pharmaceuticals and was developed by GSK. The updated label also includes a new oral suspension formulation of Promacta that is designed for younger children who may not be able to swallow tablets. Promacta was approved by the FDA as a tablet formulation in June 2015 for children 6 years of age and older and in 2008 for use in adult patients with the same condition. The label expansion of Promacta was based on data from two double-blind, placebo-controlled trials, including the largest Phase 3 clinical trial in this patient population. Treatment with Promacta significantly increased and sustained platelet counts among pediatric patients with chronic ITP with an insufficient response to prior chronic ITP therapies, and some patients taking concomitant ITP medications were able to reduce or discontinue their use of these medications, primarily corticosteroids. Promacta should be used only in those whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.
12:11 EDTNVSNovartis announces FDA approves expanded use for Promacta
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08:37 EDTAGNAllergan recalls certain lots of REFRESH, FML, Blephamide treatments
Allergan announced that it is conducting a voluntary recall down to consumer level of specific lots of its REFRESH Lacri-Lube 3.5g and 7g for dry eye, REFRESH P.M. 3.5g for dry eye, FML 0.1%, and Blephamide 10%/0.2% sterile topical ophthalmic ointment combining an antibacterial and a corticosteroid, 3.5g. Allergan chose to initiate this recall based on a small number of customer complaints which reported a small black particle at the time of use. Allergan has informed the U.S. Food and Drug Administration of this voluntary recall. Allergan is contacting retailers and wholesalers who have been shipped affected product lots to initiate the recall and is informing them of the steps needed to return affected product.
August 21, 2015
05:25 EDTNVSNovartis acquires all remaining rights to Ofatumumab from GSK
Novartis (NVS) announced that it has entered into an agreement to acquire all remaining rights to Ofatumumab from GlaxoSmithKline (GSK). Ofatumumab, a fully human monoclonal antibody which targets CD20, is being developed for relapsing remitting multiple sclerosis, or RRMS, and other autoimmune indications. Novartis previously acquired the rights to Ofatumumab for oncology indications and it is marketed under the brand name Arzerra. Novartis will be responsible for the worldwide development, regulatory and commercialization activities for Ofatumumab. Under the terms of the agreement, Novartis will make an initial upfront payment of $300M to GSK for the acquisition of the compound and a further payment of $200M payable following the start of a phase III study in MS by Novartis. Upon completion of pre-determined milestones, contingent payments of up to $534M may be made. Novartis will also pay royalties of up to 12% to GSK on any future net sales of Ofatumumab in autoimmune conditions.
August 20, 2015
08:16 EDTAGNAllergan's Botox resubmission for lower limb spasticiy accepted by FDA
Allergan 's resubmission of its Supplemental Biologics License Application for Botox for the treatment of adults with lower limb spasticity in adults has been accepted by the FDA. A six-month review period has been assigned for the sBLA. The Prescription Drug User Fee Act date is expected to be in 1Q16. The resubmission provides additional data from a double-blind, placebo controlled study involving 468 patients with lower limb spasticity. The FDA also approved an increase to the maximum Botox cumulative dose within three months from 360 to 400 units in adults treated for one or more indications.
05:29 EDTNVSNovartis Odomzo gains EU approval for laBCC
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August 18, 2015
09:19 EDTNVSPiper Jaffray biopharma analyst holds an analyst/industry conference call
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August 17, 2015
13:30 EDTNVSOn The Fly: Top stock stories at midday
Stocks began the session deep in negative territory after a disappointing Empire Manufacturing report. The data got the market off to a weak start as optimism over last week's finish began to fade. The averages continued to drift in a narrow range for the opening hour before reversing and capturing the opening losses. Each of the major equity indices is now back in positive territory sporting slight gains across the board. ECONOMIC EVENTS: In the U.S., the Empire State manufacturing index plunged to -14.92 in August after rebounding to 3.86 in July from June's -1.98. The consensus estimate was 4.75, and the surprising drop puts the index at its lowest point since April 2009. The employment component slid to 1.82, while new orders crashed to -15.70. Meanwhile, the U.S. NAHB homebuilder sentiment index rose to 61 in August from 60 in June and and is the highest since November 2005. The single family sales index edged up to 66 versus a revised 65 last month, while the index of prospective buyer traffic improved to 45 versus 43 previously. In Europe, various Eurozone parliaments prepare to vote on Greece's new EUR86B bailout plan this week. COMPANY NEWS: Liberty Interactive (QVCA) announced this morning an agreement to acquire zulily (ZU) for $18.75 per share in a deal valuing the online shopping site at $2.4B, driving zulily shares up more than 47% in intraday trading. The acquisition will be attributed to Liberty's QVC Group tracking stock, though QVC and zulily will be operated as separate consumer facing brands. On a conference call discussing the acquisition, Liberty Interactive executives noted that the "highly efficient" deal will allow Liberty to reach a younger base. MAJOR MOVERS: Among the notable gainers AVEO Oncology (AVEO), which rose roughly 50% after announcing a license agreement with Novartis (NVS) for the development and commercialization of AVEO's AV-380 drug and related antibodies. Also higher was Kite Pharma (KITE), which advanced roughly 5.4% after clarifying that an earlier patient death in its Phase 1/2 KTE-C19 trial for non-Hodgkin's lymphoma was unrelated to Kite's therapy. Additionally, shares of Target (TGT) have gained roughly 10c despite lingering in negative territory early Monday after the company promoted CFO John Mulligan to the newly created role of EVP and COO and appointed Cathy Smith as EVP and CFO. Prior to joining Target, Smith served as EVP and CFO at St. Louis-based Express Scripts (ESRX). Among the noteworthy losers was KKR (KKR), which lost roughly 2.4% after Samson Resources announced a restructuring agreement late Friday, adding that it expects to file for bankruptcy within 30 days. Also lower was Estee Lauder (EL), which declined nearly 6.5% after its quarterly guidance missed analysts' estimates. INDEXES: Near midday, The Dow was up 65.11, or 0.37%, to 17,542.51, the Nasdaq gained 34.73, or 0.69%, to 5,082.96, and the S&P 500 advanced 8.80, or 0.42%, to 2,101.03.
06:01 EDTNVSAVEO Oncology announces license agreement with Novartis
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