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Stock Market & Financial Investment News

News For MRK;PFE;GSK;JNJ;BMY;NVS;SHPG;ABT;CELG;SNY From The Last 14 Days
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March 27, 2015
16:23 EDTSHPGOn The Fly: Closing Wrap
Stocks opened slightly higher but were unable to gather any upside momentum. They quickly crossed into negative territory but never really picked up speed to the downside. After the slightly better than expected consumer confidence reading, the averages moved back into positive ground where they spent most of the session hovering near the flat line. Near the close, comments by Fed Chair Janet Yellen that an interest rate hike "may be warranted later this year," lifted the averages into positive territory. ECONOMIC EVENTS: In the U.S., real GDP growth was steady at 2.2% in Q4, falling below consensus forecasts for 2.4% growth. GDP price index grew 0.1% on a linked quarter basis, matching expectations. U.S. consumer sentiment fell to 93.0 against consensus of 92.1. The current conditions index dipped to 105.0 from February's 106.9, while the consumer expectations index dropped to 85.3 from 88.0. COMPANY NEWS: Dow Chemical (DOW) and Olin (OLN) were up 3% and 14%, respectively, after announcing that Dow will separate much of its chlorine value chain and merge the entity with Olin in a $5B deal. Additionally, the companies announced a 20-year arrangement in which Dow will supply Olin with ethylene. Late in the session, the Wall Street Journal reported that Intel (INTC) was in talks to acquire Altera (ALTR), sending both stocks higher by 6% and 28%, respectively. MAJOR MOVERS: Among the notable gainers was Carnival (CCL), which rose over 6% after beating earnings expectations and raising FY15 revenue yield guidance. Also higher was BioMarin (BMRN), jumping 11% after speculation of a Shire (SHPG) takeover deal. Among the noteworthy losers was Southern Cooper (SCCO), which fell nearly 4% after the company cancelled its Tia Maria mining project. Also lower was OvaScience (OVAS), down 10% after Oppenheimer reported pushback from academics during the company's presentation of early Augment data. Opco cautioned, however, that criticism of non-trial data is "inevitable" and JMP Securities called the results encouraging. INDEXES: The Dow rose 34.43, or 0.19%, to 17,712.66, the Nasdaq gained 27.86, or 0.57%, to 4,891.22, and the S&P 500 added 4.87, or 0.24%, to 2,061.02.
15:14 EDTJNJJohnson & Johnson not likely to buy Intuitive Surgical, says BofA/Merrill
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14:04 EDTSNYRegeneron price target raised to $500 from $450 at Argus
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12:36 EDTSHPGOn The Fly: Midday Wrap
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10:29 EDTSHPGBioMarin rises amid takeover speculation, price target raises
The shares of BioMarin (BMRN) are climbing after a blog reported last night that Shire (SHPG) is considering offering to acquire the company. Meanwhile, analysts at UBS and Deutsche raised their price targets for the orphan drug maker, in part due to the possibility of a takeover. WHAT'S NEW: "Well-informed" sources are saying that Shire recently approached BioMarin about a merger deal, Ben Harrington of the blog Betaville reported last night. It's not clear how far the talks have progressed, but Morgan Stanley and Lazard are advising Shire on a deal that could be worth $65B, the blog added. ANALYSTS' TAKE: The recent acquisition of Pharmacyclics (PCYC) by AbbVie (ABBV) shows that drug companies need to acquire products and pipelines, UBS analyst Andrew Peters wrote in a note to investors earlier today. Given its diversified pipeline of orphan products and multi-billion revenue potential, BioMarin is among the most attractive targets in the sector, according to Peters. As a result, the analyst finds it appropriate to assign premiums to drug companies for their strategic value. Additionally, the analyst has become more upbeat on several of BioMarin's pipeline drugs and on its R&D capabilities. He raised his price target on the stock to $136 from $112 and kept a Buy rating on the shares. Also upbeat on the stock was Deutsche Bank analyst Robyn Karnauskas. BioMarin's top four pipeline drugs have 25%-50% chances of succeeding, but not everything in the company's pipeline needs to work for it to obtain an M&A premium, the analyst stated in a note to investors today. She believes that BioMarin can be acquired for $194-$271 per share in the next year, depending on the data from several of its drug candidates. The analyst raised her price target on the name to $140 from $90 and kept a Buy rating on the stock. PRICE ACTION: In early trading, BioMarin jumped 13.5% to $130. PRICE ACTION: In early trading, BioMarin climbed 13.5% to $130.
09:59 EDTJNJJohnson & Johnson to collaborate with Google to advance surgical robots
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07:38 EDTSHPGBioMarin price target raised to $140 from $90 at Deutsche Bank
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07:25 EDTPFETeva appears to be weighing transformative deal, says Bernstein
After attending Teva's (TEVA) meeting with investors, Bernstein thinks that the company is considering making a 'transformative' acquisition, although it believes that such a deal may not be imminent. The firm sees Mylan ((MYL) and the generic units of Actavis (ACT), Pfizer (PFE), and possibly Valeant (VRX) as the four logical candidates. It says that Teva can pay $81 per share for Mylan, and that a takeover of Mylan would raise Teva's EPS to about $6.50 in 2017 and $7 in 2018. Bernstein raised its price target on Teva to $69 from $60 and keeps an Outperform rating on the shares.
06:46 EDTJNJContact lens makers, discounters battling over price setting, NY Times says
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05:58 EDTSHPGBioMarin price target raised to $136 from $112 at UBS
UBS analysts Andrew Peters and Matthew Roden raised their price target for BioMarin (BMRN) shares to $136 saying investors "are still well served" to buy the stock despite the recent outperformance and talk of a bubble in the Biotech space. The analysts view BioMarin as among the most attractive takeover targets in biotech. They add the company's 2015 is filled with pipeline catalyst and keep a Buy rating on the name. The target raise at UBS comes after Ben Harrington last night, former M&A and Markets Editor at the Daily Telegraph and current editor of the blog Betaville, said that Shire (SHPG) is weighing a takeover of BioMarin. Shares of the orphan drug maker closed yesterday down 7c to $115.55 and are trading up $8.95 to $124.50 in pre-market trading.
March 26, 2015
19:30 EDTSHPGBioMarin up 4% after blog says Shire weighing takeover
BioMarin (BMRN) is trading up over 4% in the after-hours after Ben Harrington, former M&A and Markets Editor at the Daily Telegraph and current editor of the blog Betaville, said that Shire (SHPG) is weighing a takeover of BioMarin. Reference Link
12:13 EDTCELGCelgene, MorphoSys mutually agree to end MOR202 collaboration
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11:13 EDTSHPG, NVS, GSK, SNYBofA/Merrill European pharma analyst holds an analyst/industry conference call
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10:18 EDTNVSHigh option volume stocks
High option volume stocks: BTX ALL FIVE SGYP SWFT RHT IDCC NVS WGO XBI
09:36 EDTCELGActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL GILD TWTR FB KRFT BIDU TSLA CELG NFLX FCAU
08:31 EDTMRKMerck announces collaboration with American Diabetes Association
Merck announced a collaboration with the American Diabetes Association. The collaboration aims to educate adults with diabetes about their increased risk for potentially serious health problems, including pneumococcal pneumonia, influenza and hepatitis B, making it important for people with Type 1 or Type 2 diabetes to talk to their health care professional about these diseases.
07:30 EDTBMY, PFEDeutsche Bank to hold a conference
Pharma One-on-One Day is being held in Denver, Colorado on March 26.
06:45 EDTCELGBiotech valuation concerns 'misguided,' says Piper Jaffray
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05:29 EDTSNYGenzyme reports Cerdelga data shows effectiveness in treating Gaucher disease
Genzyme, a Sanofi company, announced the publication of results from the ENCORE study exploring Cerdelga as a maintenance therapy suitable for adult patients who had reached pre-specific treatment goals on enzyme replacement therapy, or ERT, in the March 26 online issue of The Lancet. ENCORE is a randomized, multinational, Phase 3, open-label, non-inferiority study designed to determine whether patients with Gaucher disease type 1 who had been stabilized after 3 or more years of ERT infusions would remain stable after switching to Cerdelga, a novel, oral, selective inhibitor of glucosylceramide synthase. Eligible patients were randomized 2:1 to receive either oral Cerdelga or ERT with Cerezyme over a period of 12 months. The composite primary efficacy endpoint was the percentage of patients whose hematologic parameters and organ volumes remained stable, using the following stability criteria established for patients with Gaucher disease type 1 on maintenance therapy with Cerezyme: Hemoglobin concentration that did not decrease more than 1.5 g/dL; Platelet count that did not decrease more than 25%; Spleen volume that did not increase more than 25%; Liver volume that did not increase more than 20%. After 12 months, 85% of patients receiving Cerdelga and 94% of patients receiving Cerezyme met the composite endpoint of stability in all four of these measures. The difference between the two treatments was within the pre-specified margins. The principal secondary endpoints were stability with respect to the individual components of the primary endpoint. At least 93% of Cerdelga patients remained stable with respect to hemoglobin concentration, platelet count, spleen volume, and liver volume after 12 months of treatment. Additional endpoints evaluated bone disease, Gaucher disease severity, quality-of-life and Gaucher-disease associated biomarkers.
March 25, 2015
12:17 EDTSNYSanofi Pasteur announces FDA approval of Quadracel DTaP-IPV vaccine
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07:29 EDTJNJLeerink to hold booth tours
Leerink Booth Tours at AAOS 2015 will be held in Las Vegas on March 25-26.
07:28 EDTMRKOptions expected to be active
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March 24, 2015
19:40 EDTMRKOn The Fly: After Hours Movers
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17:02 EDTMRKMerck announces new $10B share repurchase program
Merck announced that its board of directors has authorized additional purchases of up to $10B of Merck’s common stock for its treasury. The treasury stock purchase has no time limit and will be made over time in open-market transactions, block transactions on or off an exchange, or in privately negotiated transactions. With this announcement, the company’s total outstanding share repurchase authorization is now approximately $11.7B, which includes approximately $1.7B in authorized repurchases remaining under the program previously announced on May 1, 2013. Merck continues to expect average diluted shares outstanding will be approximately 2.86B in 2015.
17:00 EDTMRKMerck announces new $10B share repurchase program
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16:00 EDTMRKOptions Update; March 24, 2015
iPath S&P 500 VIX Short-Term Futures down 10c to 25.14 Option volume leaders: AAPL TSLA TWTR GILD FB AMAT GOOG C MRK GILD according to Track Data.
13:24 EDTJNJContact lens manufacturers accused of price-fixing, Bloomberg says
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11:05 EDTNVSNovartis granted orphan status for medulloblastoma treatment
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08:31 EDTMRKMerck: Phase 3 KEYNOTE-006 study met co-primary endpoints, will be stopped early
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08:02 EDTBMYBristol-Myers acquires exclusive license from Novo Nordisk for research program
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07:45 EDTPFE, JNJ, GSKFDA Pediatric Advisory Committee holds a meeting
The Committee discusses pediatric-focused safety reviews, as mandated by the FDA Safety and Innovation Act (FDASIA) for Eli Lilly's Cymbalta, Pfizer's Quillivant XR and Revatio, Johnson & Johnson's Risperdal, GlaxoSmithKline's Advair, HFA Altabax Ointment and Fluarix Quadrivalent, Supernus Pharmaceuticals' Oxtellar XR, Teva Pharmaceutical's Qnasl and Roche's Invirase. The Committee will also discuss the safety ongoing propriety of the humanitarian device exemption for the Medtronic Activa Dystonia Therapy and for the Liposorber LA-15 System in a meeting being held in Silver Spring, Maryland on March 24 at 8 am. Webcast Link
07:26 EDTCELGCelgene drug competitor will need additional studies, says UBS
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March 23, 2015
16:01 EDTCELGOptions Update; March 23, 2015
iPath S&P 500 VIX Short-Term Futures down 48c to 25.24 Option volume leaders: AAPL TSLA TWTR GILD CELG FB TSLA AMZN TEVA PBR according to Track Data.
11:32 EDTCELGStocks with call strike movement; GILD CELG
Gilead (GILD) August 115 call option implied volatility increased 5% to 27, Celgene (CELG) July 140 call option implied volatility increased 3% to 28 according to IVolatility.
11:09 EDTPFEPfizer hits best level in over decade after Jefferies adds to list of best ideas
The shares of Pfizer (PFE) are rising after an analyst wrote that the company's shares are poised to rise significantly over the next one to two years. Additionally, the company announced that it would resume developing its painkiller, tanezumab, in partnership with Eli Lilly (LLY). ANALYST OUTLOOK: Pfizer's breast cancer drug for postmenopausal women, Ibrance, has had one of the best launches of any oncology drug ever, Jefferies analyst Jeffrey Holdford wrote in a note to investors today. A survey of U.S. oncologists conducted by the firm shows that the doctors expect the drug to be used on about 50% of patients needing first line hormonal therapy within one year, while the drug will be used as an off-label treatment in all lines of therapy, the analyst wrote. The drug will generate revenue of $5.5B in 2020, versus the consensus outlook of $3.3B, Holford estimated. Meanwhile, the drug maker's Global Established Pharmaceutical, or GEP, business' revenue and profits should top consensus estimates by14% by 2018, according to the analyst. Pfizer could generate value through accretive M&A activity and by separating the GEP unit by 2017, Holdford stated. He raised his price target on the name to $45 from $42, kept a buy rating on the shares, and added the stock to the firm's Franchise Picks list, which encompasses its best ideas. WHAT'S NOTABLE: Pfizer announced that, in partnership with Eli Lilly, it would resume its Phase 3 clinical program for tanezumab. The announcement was made after the FDA removed a partial clinical hold on the drug, Pfizer noted. As a result of its decision, Pfizer expects to receive a $200M payment, in accordance with the companies' agreement, Pfizer stated. PRICE ACTION: In mid-morning trading, Pfizer climbed 2.4% to $35.08. The stock has not traded at a price per share this high since 2004.
11:01 EDTPFEPfizer rallies to fresh 52-week high, levels to watch
Shares are up over 2.8% at time of writing to $35.14, just below the new 52-week high at $35.26 which is now initial resistance. Next resistance above is at $35.89 and then at $36.63. Support is at $34.89.
09:45 EDTSHPG, NVS, GSK, SNY, MRKUBS to hold a field trip
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09:37 EDTPFE, SHPG, CELGActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL AUY SLB PFE MCP CELG VRTX SHPG GILD LOGI TSLA TASR NFLX SCTY WFM
09:03 EDTJNJ, NVSLeerink analysts hold a meeting with a conference call hookup
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09:03 EDTABTFiserv says Abbott employee credit union expands partnership
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08:06 EDTPFEPfizer, Eli Lilly to resume Phase 3 chronic pain program for Tanezumab
Pfizer (PFE) and Eli Lilly and Company (LLY) announced that they are preparing to resume the Phase 3 clinical program for tanezumab. As a result, Pfizer expects to receive a $200M upfront payment from Lilly in accordance with their collaboration agreement. This announcement follows a decision by the U.S. FDA to lift the partial clinical hold on the tanezumab development program after a review of a robust body of nonclinical data characterizing the sympathetic nervous system response to tanezumab. The data were submitted to the FDA in February. In the prior clinical studies of more than 11,000 patients, tanezumab demonstrated clinically meaningful efficacy vs. placebo and other select commonly used pain medicines. A partial clinical hold has been in place for tanezumab and all other anti-nerve growth factor antibodies since December 2012 due to adverse changes in the sympathetic nervous system of mature animals. Studies in terminal cancer pain were allowed to proceed.
08:05 EDTPFEPfizer, Eli Lilly to resume Phase 3 chronic pain program for Tanezumab
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07:36 EDTSHPG, GSK, PFEPfizer 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.
07:17 EDTMRKAmerican Academy of Dermatology to hold annual meeting
73rd Annual Meeting of AAD is being held in San Francisco on March 20-24.
05:55 EDTCELGStocks with implied volatility movement; AMZN CELG
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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
13:04 EDTCELGCelgene reports results from long-term efficacy,safety analyses of Otezla trials
Celgene announced that results from long-term efficacy and safety analyses of the ESTEEM phase III clinical trial program of Otezla were presented at the 73rd Annual Meeting of the American Academy of Dermatology. OTEZLA is the company’s oral, selective inhibitor of phosphodiesterase 4 approved for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and for the treatment of adults with active psoriatic arthritis. In ESTEEM 1 and 2, patients were randomized to treatment with OTEZLA 30 mg twice daily or placebo for the first 16 weeks. At week 16, patients either continued on OTEZLA or were switched from placebo to OTEZLA 30 mg twice daily through week 32. Patients initially randomized to OTEZLA who achieved a Psoriasis Area and Severity Index-75 response or PASI-50 response at week 32 were then re-randomized to either OTEZLA 30 mg twice daily or placebo. Celgene said improvements in the severity of preexisting nail, scalp and palmoplantar psoriasis achieved at week 16 were maintained in OTEZLA responders through week 52 in ESTEEM 2; OTEZLA improved the severity of palmoplantar psoriasis at week 16 in a subset of patients across three trials; Long-term safety profile for up to 104 weeks in ESTEEM 1 was consistent with previously reported data from OTEZLA clinical trial programs, with no new safety signals and no clinically meaningful changes in laboratory values.
13:03 EDTPFEPfizer says oral tofacitinib meets primary endpoint in Phase 3 trials
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13:01 EDTCELGCelgene announces positive Phase III study results evaluating Otezla
Celgene announced that results from its ongoing phase III LIBERATE trial evaluating Otezla, the company’s oral, selective inhibitor of phosphodiesterase 4, in patients with moderate to severe plaque psoriasis. The LIBERATE study evaluated the clinical efficacy and safety of either oral OTEZLA 30 mg twice daily or weekly subcutaneous etanercept 50 mg compared with placebo at week 16 in 250 patients who had no prior exposure to a biological therapy. It also examined the relative safety of a switch from etanercept to OTEZLA after week 16. At week 16, patients receiving OTEZLA 30 mg twice daily demonstrated statistically significant and clinically meaningful improvement when compared with placebo, as measured by the Psoriasis Area and Severity Index-75 response. At week 16, statistical significance was also achieved for patients receiving weekly injections of etanercept 50 mg when compared with placebo. A post-hoc analysis revealed no significant difference between OTEZLA and etanercept in PASI-75 at week 16. LIBERATE was not designed or powered to directly compare OTEZLA to etanercept.
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.
10:51 EDTCELGStocks with call strike movement; DAL CELG
Delta Air Lines (DAL) September 57.5 call option implied volatility decreased 1% to 34, Celgene (CELG) July 145 call option implied volatility increased 3% to 28 according to IVolatility.
10:00 EDTSHPGOn The Fly: Analyst Upgrade Summary
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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.
09:45 EDTCELGActive equity options trading on open
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09:41 EDTSHPGBernstein global specialty pharma analyst holds analyst/industry conference call
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08:12 EDTSHPGShire upgraded to Outperform from Market Perform at Bernstein
Bernstein upgraded Shire as the firm thinks that the stock's risk/reward ratio is positive following several new developments. Among these developments are the firm's belief that the company's orphan drug strategy looks increasingly strong, while the risks to the company's Vyvanse and mesalamines drugs look to have moderated and the company has several near-term, 2015 catalysts. Target $295.
07:55 EDTBMY, PFEAstraZeneca seen as potential target again if oncology drugs lag, Bloomberg says
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07:41 EDTMRK, PFE, NVS, CELGAmerican Academy of Dermatology to hold annual meeting
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06:26 EDTCELGCelgene price target raised to $144 from $135 at Piper Jaffray
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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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11:00 EDTPFEPfizer participates in a conference call with Bernstein
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09:37 EDTCELGActive equity options trading on open
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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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07:09 EDTSNYSanofi reports top-line results for Lyxumia for cardiovascular safety
Sanofi announced top-line results of the Phase IIIb ELIXA cardiovascular outcomes study, which compared lixisenatide to placebo in a high-risk population of adults with type 2 diabetes evaluating cardiovascular safety. The study showed that lixisenatide was non-inferior, although not superior, to placebo for cardiovascular safety. The results will be included in the U.S. New Drug Application of lixisenatide, which is on track to be resubmitted to the FDA in Q3. Lixisenatide is not approved in the U.S.
05:30 EDTSNYSanofi reports lixisenatide was non-inferior, though not superior to placebo
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March 18, 2015
17:09 EDTPFEPfizer CAPiTA published in New England Journal of Medicine
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17:07 EDTCELGCelgene GED-0301 Phase II data published in New England Journal of Medicine
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09:32 EDTSNYMannKind faces cash shortfall if $100M debt not settled, TheStreet says
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08:03 EDTSHPGTherapeuticsMD names Angus Russell, J. Martin Carroll as directors
TherapeuticsMD (TXMD) announced the appointment of two biopharmaceutical senior executives, Angus C. Russell and J. Martin Carroll, as independent members of its board of directors, and that Randall S. Stanicky has stepped down from the board of directors. Angus C. Russell served as CEO of Shire PLC (SHPG) from June 2008 until April 2013. J. Martin Carroll served as president and CEO of Boehringer Ingelheim Corp. U.S. from 2003 until 2011.
07:22 EDTSHPGShire looking for 'transformational' deal, Betaville blog says
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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
10:00 EDTSNYOn The Fly: Analyst Upgrade Summary
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08:02 EDTSNYSanofi says Shantha will provide up to 37M doses of Shan5
Sanofi Pasteur, the vaccines division of Sanofi, announced that its affiliate Shantha Biotechnics of Hyderabad, India has delivered the first 400,000 doses of its pediatric pentavalent vaccine Shan5 to support the immunization of children in the cities of Gwalior and Jabalpur, both in the state of Madhya Pradesh, India. In December 2014, following a two-year international tender, Shantha was awarded to supply global health organizations with a total of 37M doses of Shan5 in 2015 and 2016, in a ten-dose vial presentation. This tender provides the basis upon which purchase orders will be made for specific vaccine deliveries throughout the period, the company said.
07:43 EDTSNYSanofi upgraded to Outperform on abating concerns at Leerink
Leerink upgraded Sanofi to Outperform from Market Perform saying key concerns around the lack of a CEO, Toujeo positioning and guidance are either resolved or largely factored into expectations. The firm believes the company's currency risk is hedged over time and that its multibillion dollar PCSK9 and dupilumab therapy assumptions have further upside potential. It raised its price target for shares to EUR 106 from EUR 85.
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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05:40 EDTSNYSanofi upgraded to Outperform from Market Perform at Leerink
05:35 EDTJNJJohnson & Johnson to invest $10M in UK government fund to fight dementia
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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
15:33 EDTMRKMerck says study shows VYTORIN reduced CV events more than simvastatin alone
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15:04 EDTJNJPharmacyclics says committee recommends unblinding after primary endpoint met
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08:23 EDTSNYPCSK9 data continues to impress, says Leerink
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07:32 EDTGSKEmergent BioSolutions signs agreements with GSK, Oxford University, NIAID
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07:16 EDTSNYRegeneron Sanofi dupilumab drug can generate $6B+ in revenue, says Bernstein
Bernstein believes that dupilumab, a drug made by Regeneron and Sanofi, has shown strong efficacy in patients with severe atopic dermatitis. The firm notes that the drug is currently in pivotal trials involving patients with severe levels of other common diseases. The firm thinks the drug can generate $1.5B of revenue by 2018 and $3.8B by 2020. Bernstein keeps a $500 price target and Outperform rating on Regeneron.
06:40 EDTPFE, SNYPCSK9 studies show potential improvement in heart health, WSJ says
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March 15, 2015
14:16 EDTABTAbbott announces 'favorable' data from MitraClip study
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13:04 EDTSNYSanofi, Regeneron announce publication of results of ODYSSEY long term trial
Sanofi (SNY) and Regeneron Pharmaceuticals (REGN) today announced that 18-month results of a Phase 3 trial of Praluent, alirocumab, an investigational therapy, involving 2,341 high risk patients with hypercholesterolemia were published online in The New England Journal of Medicine. In the ODYSSEY LONG TERM trial, Praluent 150 mg every two weeks reduced low-density lipoprotein cholesterol by an additional 62% at week 24 when compared to placebo, the primary efficacy endpoint of the study, with consistent LDL-C lowering maintained over 78 weeks."These results demonstrated the durable efficacy for Praluent when added to maximally-tolerated statin therapy and further reinforce its generally consistent safety profile," said Jennifer Robinson, M.D., M.P.H., Director of the Prevention Intervention Center, Professor, Departments of Epidemiology & Medicine, College of Public Health at the University of Iowa. "Additionally, the post hoc analysis of major cardiovascular events represents an important finding for Praluent -- we look forward to results from the ongoing ODYSSEY OUTCOMES trial, which is prospectively evaluating the potential of Praluent to reduce cardiovascular events."
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