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Stock Market & Financial Investment News

News Breaks
March 21, 2014
13:16 EDTNVS, GSKGlaxo gets injunction against Novartis division over asthma drug, WSJ reports
GlaxoSmithKline (GSK) has obtained a preliminary injunction to prevent Novartis' (NVS) generic-drug division Sandoz from selling its AirFluSal Forspiro inhaler, a rival to Glaxo's Advair inhaler, in Germany due to its purple color, according to the Wall Street Journal. Glaxo is working to hold onto the sales of its $9B Advair treatment, which lost patent protection in most of Europe last year. Reference Link
News For GSK;NVS From The Last 14 Days
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March 23, 2015
09:45 EDTNVS, GSKUBS to hold a field trip
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09:03 EDTNVSLeerink analysts hold a meeting with a conference call hookup
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07:36 EDTGSKPfizer should rise 'significantly' over next two years, says Jefferies
Jefferies analyst Jeffrey Holford told investors this morning that he expects shares of Pfizer (PFE) to appreciate "significantly" over the next two years. A survey of U.S. oncologists indicated the company's Ibrance drug will be used in 50% of first line hormonal therapy within one year, with off-label use in all lines of therapy including adjuvant, Holford noted. He thinks peak sales of the drug could top $13B, which is well above consensus. In addition, the analyst views Pfizer's Global Established Pharmaceutical business as being underappreciated by the market. Potential value creating options for the pharmaceutical giant include spinning off its GEP unit by 2017 and accretive acquisitions, with possible takeover targets being Shire (SHPG), Actavis (ACT), AstraZeneca (AZN) and GlaxoSmithKline (GSK), in the eyes of Holford. He added the stock to the firm's Franchise Picks list, which encompasses its best ideas. He also raised his price target for Pfizer to $45 from $42. The stock closed Friday up 10c to $34.25.
March 22, 2015
15:17 EDTGSKGSK looks to conclude negotiations with U.K. on vaccine cost, Bloomberg says
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March 20, 2015
12:41 EDTGSKOn The Fly: Midday Wrap
Stocks began the day sharply higher and have continued to tack on gains throughout the morning. The market’s move put the Nasdaq back above 5,000 and the S&P above 2,100. The market is undergoing quadruple witching, which occurs 4 times per year and typically is accompanied by high volume and volatility. ECONOMIC EVENTS: In the U.S., the economic calendar was quiet. The Baker Hughes U.S. rig count, which has been closely watched in recent months amid the protracted slide in oil prices, is expected at 1:00 pm EDT. The count of U.S. rigs stood at 1125 at the end of last week. In Europe, reports indicate German Chancellor Angela Merkel said Greece has agreed to send a list of overhauled reforms to European officials within days. COMPANY NEWS: Shares of Nike (NKE) advanced 4% following its Q3 earnings beat. Credit Suisse raised Nike's price target to $106 following the report, saying Nike's underlying futures growth remains in double-digits and preliminary FY16 guidance suggests management has been effective in managing currency headwinds... The shares of Biogen (BIIB) rallied 8% after the company reported results for an early stage study of its Alzheimer's drug, BIIB-037. The company announced that the three milligram, six milligram, and ten milligram dose versions of its Alzheimer's treatment, aducanumab, had reduced the amount of amyloid plaque in the brains of Alzheimer's patients taking the drug by statistically significant amounts compared with those taking placebos. The cognitive decline of patients taking BIIB-037 was also significantly less than that of patients who were taking placebos, the company reported. MAJOR MOVERS: Among the notable gainers was Prothena (PRTA), which surged 30% after announcing results from a Phase 1 single ascending dose study of its potential treatment of Parkinson's disease. Also higher was Darden Restaurants (DRI), which gained 4% after the owner of the Olive Garden and Long Horn restaurant chains reported earnings that beat expectations. Among the noteworthy losers was China's Youku Tudou (YOKU), which dropped 9% and was downgraded to Sell at Deutsche Bank after the company reported mixed Q4 results. Also lower was Theravance (THRX), which fell 7% after the company and partner GlaxoSmithKline (GSK) announced that an FDA advisory committee voted that the efficacy data for their Breo Ellipta inhaler provides substantial evidence of a clinically meaningful benefit in adults, however it voted against approval for the proposed indication in 12-17 year olds. INDEXES: Near midday, the Dow was up 189.04, or 1.05%, to 18,148.07, the Nasdaq was up 40.24, or 0.81%, to 5,032.62, and the S&P 500 was up 19.54, or 0.94%, to 2,108.81.
12:33 EDTNVSNovartis says CLEAR Phase IIb study met primary endpoint
Novartis announced results from the CLEAR study demonstrating that Cosentyx is significantly superior to Stelara, a widely used biologic, in achieving clear or almost clear skin for psoriasis patients. The detailed findings were presented in a late-breaking research session at the 73rd Annual Meeting of the American Academy of Dermatology in San Francisco, USA. Cosentyx -- at a dose of 300 mg -- is the first and only interleukin-17A inhibitor approved to treat adult patients with moderate-to-severe plaque psoriasis. In this Phase IIIb study, Cosentyx met the primary endpoint of showing superiority to Stelara as assessed by the Psoriasis Area Severity Index 90 response, known as clear to almost clear skin at Week 16. PASI 90 is considered an important measure of treatment success by the European Medicines Agency and an optimal treatment goal for patients. In addition, completely clear skin at Week 16 was achieved by significantly more patients treated with Cosentyx than those receiving Stelara. In addition, Cosentyx demonstrated rapid onset of action and greater efficacy at all time points in the study up to Week 16, with 50% of Cosentyx patients achieving PASI 75 as early as Week 4 compared to Stelara. The CLEAR study follows the pivotal Phase III FIXTURE study, which showed Cosentyx was superior to Enbrel.
09:47 EDTGSKGlaxoSmithKline, Theravance launch Revlar Ellipta in Italy
In a regulatory filing, GlaxoSmithKline (GSK) and Theravance (THRX) announced the launch of Revlar Ellipta in Italy following the recent approval by the Italian regulatory authorities in December 2014. Relvar is a fixed dose combination of the inhaled corticosteroid fluticasone furoate and the long-acting beta2-agonist vilanterol. The components will be administered using the Ellipta, a dry powder inhaler. In Italy, the product is indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product is appropriate; and for the symptomatic treatment of adults with Chronic Obstructive Pulmonary Disease with a FEV1<70% predicted normal post-bronchodilator with an exacerbation history despite regular bronchodilator therapy.
07:41 EDTNVSAmerican Academy of Dermatology to hold annual meeting
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March 19, 2015
18:14 EDTGSKGlaxoSmithKline, Theravance announce FDA panel outcome on Breo Ellipta
GlaxoSmithKline (GSK) and Theravance (THRX) announced the outcome of the joint meeting of the Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee of the United States FDA regarding the supplemental New Drug Application for Breo Ellipta as a once-daily inhaled treatment for asthma in patients aged 12 years and older. The FDA Advisory Committee voted that the efficacy and safety data for FF/VI 100/25 mcg and 200/25 mcg once daily in asthma support approval in adults 18 years of age and older (16 for, 4 against). The Committee voted that the efficacy data provides substantial evidence of a clinically meaningful benefit in adults (18 for, 2 against) and that the safety in this population has been adequately demonstrated (17 for, 3 against). The Committee voted against approval for the proposed indication in 12-17 year olds (2 for, 18 against). The Committee voted that the efficacy data was not sufficient to demonstrate the benefit (4 for, 16 against) and the safety (1 for, 19 against) has not been adequately demonstrated in this sub-population. The Committee recommended that a large LABA safety trial with FF/VI should be required in adults (13 yes, 7 no) and in 12-17 year olds (17 yes, 2 no and 1 no-vote), similar to the ongoing LABA safety trials being conducted as an FDA Post-Marketing Requirement by each of the manufacturers of LABA containing asthma treatments. FDA Advisory Committees provide non-binding recommendations for consideration by the FDA. Based on these opinions and the data presented, the FDA will make its final decision on approval, which is expected on April 30.
15:55 EDTNVSAmgen injunction bid for Neupogen biosimilar denied, Reuters reports
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15:13 EDTNVSAmgen denied preliminary injunction for biologics against Novartis, Reuters says
15:12 EDTGSKFDA panel says Breo lacks efficacy data in children with asthma, Bloomberg says
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07:26 EDTGSKFDA to hold a joint advisory committee meeting
The Pulmonary-Allergy Drugs Advisory Committee and the Drug Safety & Risk Management Advisory Committee discuss the supplemental New Drug Application (sNDA) 204275-S001, for fluticasone furoate and vilanterol dry powder for inhalation (with the brand name of BREO® ELLIPTA®), sponsored by Glaxo Group Limited (d/b/a GSK) for the once-daily treatment for asthma in patients aged 12 years and older in a meeting being held in Gaithersburg, Maryland on March 19 at 8 am. Webcast Link
07:10 EDTGSKTheravance announces trading in common stock halted as FDA meets on sNDA
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March 17, 2015
12:51 EDTNVSNovartis hit with $100M gender discrimination lawsuit, Reuters reports
A proposed class action lawsuit against Novartis claims the drug maker routinely denied female employees equal pay and promotional opportunities, reports Reuters. The $110M lawsuit filed on Tuesday says Novartis' Alcon Laboratories maintains a "boy's club atmosphere" that is hostile to women and bars them from leadership positions. Reference Link
07:07 EDTGSKVeeva says selected by GlaxoSmithKline for multichannel CRM
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07:06 EDTGSKVeeva selected by GSK as global multichannel CRM partner
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05:32 EDTNVSIncyte announces Novartis receives EC approval for Jakavi
Incyte (INCY) announced that Novartis (NVS) received approval from the European Commission for Jakavi for the treatment of adult patients with polycythemia vera, or PV, who are resistant to or intolerant of hydroxyurea. Jakavi is the first targeted treatment approved by the European Commission for these patients. Under the Incyte-Novartis Collaboration and License Agreement signed in 2009, Novartis received exclusive development and commercialization rights to ruxolitinib outside of the United States for all hematologic and oncologic indications, and sells ruxolitinib under the name Jakavi. Ruxolitinib is marketed by Incyte in the United States as Jakafi. Jakafi is approved by the FDA for treatment of people with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi is also indicated for treatment of people with intermediate or high-risk myelofibrosis, or MF, including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.
05:30 EDTNVSNovartis receives EU approval for Jakavi in polycythemia vera
Novartis announced that the European Commission has approved Jakavi for the treatment of adult patients with polycythemia vera, or PV, who are resistant to or intolerant of hydroxyurea. Jakavi is the first targeted treatment approved by the European Commission for these patients. Jakavi is the only JAK 1/2 inhibitor available to treat PV and is also currently approved in more than 80 countries to treat myelofibrosis.
March 16, 2015
07:32 EDTGSKEmergent BioSolutions signs agreements with GSK, Oxford University, NIAID
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