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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
Check below for free stories on MRK;PFE;GSK;JNJ;BMY;NVS;SHPG;ABT;CELG;SNY the last two weeks.
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April 23, 2014
15:35 EDTCELGNotable companies reporting before tomorrow's open
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13:29 EDTGSK, NVSArray BioPharma: Novartis to honor Array-Novartis agreement with binimetinib
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10:01 EDTGSKOn The Fly: Analyst Upgrade Summary
A.O. Smith (AOS) upgraded at BMO Capital... Agnico-Eagle (AEM) upgraded to Outperform from Sector Perform at RBC Capital... Allergan (AGN) upgraded to Overweight from Neutral at JPMorgan... Cabot Oil & Gas (COG) upgraded to Buy from Hold at Societe Generale... Cree (CREE) upgraded to Buy from Hold at Summit Research... E-Trade (ETFC) upgraded to Outperform from Market Perform at Wells Fargo... Equifax (EFX) upgraded at Credit Suisse... Fluidigm (FLDM) upgraded to Buy from Neutral at Mizuho... GlaxoSmithKline (GSK) upgraded to Buy from Hold at Argus... GulfMark Offshore (GLF) upgraded to Buy from Neutral at Global Hunter... Hanmi Financial (HAFC) upgraded to Outperform from Market Perform at Fig Partners... Illumina (ILMN) upgraded to Buy from Hold at Maxim... Lumber Liquidators (LL) upgraded to Buy from Neutral at Longbow... Medidata Solutions (MDSO) upgraded to Buy from Neutral at B. Riley... Prologis (PLD) upgraded to Buy from Neutral at ISI Group... Sanmina (SANM) upgraded to Buy from Hold at Craig-Hallum... SunPower (SPWR) upgraded to Buy from Hold at Deutsche Bank... TECO Energy (TE) upgraded to Neutral from Sell at UBS... Torchmark (TMK) assumed with a Market Perform from Underperform at Keefe Bruyette... Valeant (VRX) upgraded to Buy from Hold at TD Securities... Vitamin Shoppe (VSI) upgraded at Sterne Agee... Wolseley (WOSYY) upgraded to Outperform from Neutral at Credit Suisse... athenahealth (ATHN) upgraded to Overweight from Equal Weight at Morgan Stanley.
07:41 EDTCELGAlliqua to launch Biovance human amniotic membrane allograft product
Alliqua (ALQA) will launch its Biovance human amniotic membrane allograft product. Biovance was originally developed by, and is currently being manufactured through a supply agreement with, Celgene Cellular Therapeutics, a subsidiary of Celgene (CELG), to assist wound care specialists, physicians and nurses, as well as vascular, plastic and general surgeons, in the treatment of a wide variety of complex, acute, chronic, recalcitrant, full and partial thickness wound types. With the right to develop and market Biovance, Alliqua has entered into one of the fastest-growing areas of wound care, which involves regenerative medicine. Alliqua will commence sales of Biovance immediately following the Symposium via its team of direct sales representatives.
07:37 EDTBMYPeregrine announces investigator-sponsored combination trial with Bristol-Myers
Peregrine Pharmaceuticals (PPHM) announced the opening of an investigator-sponsored trial, or IST, of its investigational immunotherapy bavituximab in combination with Bristol-Myers Squibb's (BMY) ipilimumab, for the treatment of advanced melanoma. Bavituximab is an upstream immune checkpoint inhibitor that targets phosphatidylserine, or PS, a highly immunosuppressive molecule exposed on cells that line tumor blood vessels and tumor cells. Preclinical data in a model of melanoma demonstrate that the combination of a bavituximab equivalent and ipilimumab yield enhanced anti-tumor activity compared to ipilimumab alone. The trial is being conducted at the University of Texas Southwestern Medical Center, Dallas, and led by Arthur E. Frankel, M.D., Associate Professor of Internal Medicine at the Simmons Comprehensive Cancer Center. Bavituximab, Peregrine's lead immuno-oncology candidate, is being evaluated in second-line non-small cell lung cancer, as part of the SUNRISE pivotal Phase III clinical trial.
07:24 EDTGSKGlaxoSmithKline upgraded to Buy from Hold at Argus
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07:00 EDTNVS, SHPG, PFETerrapinn to hold a conference
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06:54 EDTGSK, MRK, SNY, PFECambridge Healthtech Institute to hold a conference
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06:54 EDTPFE, SNY, JNJ, MRKGlobal Technology Community to hold a summit
7th Annual Diabetes Summit is being held in Cambridge, MA on April 23-25.
06:53 EDTJNJ, SNY, PFEFood & Drug Law Institute to hold a conference
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06:16 EDTJNJ, MRK, SNY, GSK, NVS, PFE, BMYPharmaceutical companies narrowing focus, WSJ reports
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05:25 EDTNVSNovartis announces new data confirms efficacy of Gilenya
New analyses of pooled data from the FREEDOMS and FREEDOMS II trials will be presented at the 66th American Academy of Neurology, or AAN, Annual Meeting in Philadelphia, Pennsylvania, and will show the consistent efficacy of Gilenya on four key measures of multiple sclerosis disease activity - reducing relapses, new MRI lesion counts, brain volume loss and disability progression. Demonstrating benefit on these four measures is important in order to improve the course of MS and ultimately address the loss of function experienced by patients with MS. An additional analysis of FREEDOMS and FREEDOMS II will show that significantly more Gilenya-treated patients had brain volume loss rates comparable to people without MS. Given that brain volume loss, measured by MRI, starts early in the disease course and is correlated with long-term disability, a treatment benefit on this measure will be important for patients with MS.
April 22, 2014
19:03 EDTBMY Bristol-Myers and Samsung BioLogics to increase scope of existing agreement
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16:33 EDTNVS, GSKOn The Fly: Closing Wrap
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14:47 EDTBMYOnglyza, Kombiglyze XR get Paragraph IV patent challenges
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12:39 EDTMRK, GSK, JNJ, SHPG, NVSOn The Fly: Midday Wrap
Stocks on Wall Street were higher at midday amid a number of big deals and a much talked about proposed deal in the pharmaceutical industry, as well as another wave of earnings reports. The market opened quietly but on the positive side of the ledger as investors pored over the multitude of quarterly reports issued after the close last night and earlier today. Near noon the market stood near its session highs and is pointing toward its sixth consecutive positive close. ECONOMIC EVENTS: In the U.S., existing home sales slipped 0.2% to a 4.59M rate in March, versus expectation for them to have fallen 1% to a 4.56M rate. The Richmond Fed manufacturing survey for April had a reading of 7, beating the consensus forecast for a reading of 2. COMPANY NEWS: Valeant Pharmaceuticals (VRX) teamed with Bill Ackman's hedge fund Pershing Square to make a hostile takeover offer for Allergan (AGN), sending shares of both companies higher. Allergan confirmed it received the offer of $48.30 in cash and 0.83 shares of Valeant stock for each of its own shares, which it said it will evaluate with the help of its advisers. Analysts' opinion on the fallout varied, with one firm suggesting Allergan could pursue its own takeover of Shire (SHPG) or Jazz Pharmaceuticals (JAZZ) as a defense, and another saying a rival big pharma company, such as Johnson & Johnson (JNJ) or Merck (MRK), could launch a competing bid for Allergan. Shares of Allergan led all gainers on the S&P 500, rising 16%, while Valeant shares gained more than 6%... A number of other big drug makers made news with a string of deals, as Novartis (NVS) and GlaxoSmithKline (GSK) both reshaped their companies via a trio of agreements. Novartis will acquire GSK's oncology products for a $14.5B payment and up to $1.5B contingent future payments, Novartis will sells its Vaccines business, excluding flu, to GSK for $7.1B plus royalties, and the two agreed to tie-up their consumer healthcare businesses through a joint venture. In a separate transaction, Novartis agreed to divest its Animal Health Division to Eli Lilly (LLY) for about $5.4B. MAJOR MOVERS: Among the notable gainers following their earnings reports were streaming video service Netflix (NFLX), which advanced almost 6%, and motorcycle maker Harley-Davidson (HOG), which rose 8%. Companies that slid following their earnings reports included printer maker Lexmark (LXK), which fell over 11%, and Pentair (PNR), which dropped almost 6%. INDEXES: Near midday, the Dow was up 106.77, or 0.65%, to 16,556.02, the Nasdaq was up 45.95, or 1.11%, to 4,167.50, and the S&P 500 was up 11.59, or 0.62%, to 1,883.48.
11:22 EDTJNJ, SHPG, MRKAnalysts think Valeant bid for Allergan could spur higher offer, rival deal
After Valeant Pharmaceuticals (VRX) teamed with hedge fund Pershing Square to make a hostile takeover offer for Allergan (AGN), analysts' opinion on the fallout varied, with one firm suggesting Allergan could pursue its own takeover as a defense and another believing Valeant will be pushed to raise its offer. WHAT'S NEW: Valeant, in partnership with Bill Ackman's Pershing Square, offered to combine with Allergan for $48.30 in cash and 0.83 shares of Valeant stock for each share of Allergan. Allergan has confirmed it received the offer and said that it would evaluate the proposal. ANALYST OPINION: In a note to investors, Wells Fargo stated that it believes that Valeant's low tax rate will enable it to raise its bid. Moreover, one or more big pharmaceutical companies, such as Johnson & Johnson (JNJ) or Merck (MRK), could launch a competing bid for Allergan, added Wells. The firm believes that Allergan could ultimately be purchased for $165 per share. Research firm Jefferies said it expects Allergan's board to oppose Valeant's takeover attempt. The firm suggested that Allergan could seek to fend off Valeant's takeover attempt by acquiring Shire (SHPG) or Jazz Pharmaceuticals (JAZZ). Jefferies kept a Hold rating on Allergan. BMO Capital similarly believes that Valeant will have to overcome significant hurdles in order to complete the deal. The management teams of the two companies have different views and Allergan's business could be damaged by significant cost cutting following the deal, according to the firm. Nonetheless, it kept an Outperform rating on the Botox maker. PRICE ACTION: In mid-morning trading, Allergan rallied 15.5% to $164, Valeant gained 4.4% to $133, Jazz shares rose 6.4% to $147.18 and Shire added 4.8% to $158.62.
10:36 EDTNVSEli Lilly sees Novartis deal as accretive on a cash basis by 2016
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10:00 EDTSHPGOn The Fly: Analyst Initiation Summary
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09:16 EDTGSK, NVSOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Netflix (NFLX), up 8%... Harley-Davidson (HOG), up 7%... PLX Technology (PLXT), up 8%... Illinois Tool (ITW), up 2.3%... Comcast (CMCSA), up 1%... McDonald's (MCD), up 0.6%. ALSO HIGHER: Allergan (AGN), up 17% after Valeant (VRX) confirms proposal to combine with the company for $48.30 and 0.83 shares of stock. Valeant is up 5% following its confirmation of the news that broke last night... GlaxoSmithKline (GSK), up 4.5% after agreeing to sell oncology products for $14.5B to Novartis (NVS) and buy Novartis' Vaccines business, currently excluding its flu business, for $7.1B plus royalties. Novartis shares trading in New York are also up 1% following the deals... Revance Therapeutics (RVNC), up 20% after announcing positive results from RT002 Phase 1/2 study... Facebook (FB), up 2% following upgrade at Credit Suisse. DOWN AFTER EARNINGS: Xerox (XRX), down 4%... Lexmark (LXK), down 4.8%. ALSO LOWER: Allison Transmission (ALSN), down 4% after filing to sell 25M shares for holders... FireEye (FEYE), down 2.9% after filing to sell 13.3M shares of common stock for holders... Bebe stores (BEBE), down 16% after reporting preliminary Q3 losses that were steeper than the consensus estimate.
08:49 EDTGSKGSK, Theravance announce Phase III study of FF/VI in Japan
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08:37 EDTGSKTheravance, GlaxoSmithKline receive Australian approval for Breo Ellipta
GlaxoSmithKline (GSK) and Theravance (THRX) announced that the Therapeutic Goods Administration has approved BREO ELLIPTA for the treatment of patients with asthma or chronic obstructive pulmonary disease, or COPD, in Australia. Two strengths of BREO ELLIPTA have been licensed for the treatment of asthma and one strength has been licensed for the treatment of COPD.
08:08 EDTPFEAstraZeneca Pfizer deal is doable, says Bernstein
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08:03 EDTPFEPfizer says OPT Pivotal #1 and #2 programs meet primary endpoints in study
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07:51 EDTSHPGAllergan could fend off Valeant with acquisition, says Jefferies
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07:50 EDTNVSNovartis CEO Jimenez says bolt-on-buys still could occur, Reuters says
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07:48 EDTGSK, NVSGlaxoSmithKline to host conference call
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07:46 EDTGSK, NVSGlaxo thinks Novartis agreement could mean future disposals, Reuters says
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07:43 EDTSHPGShire initiated with a Buy at Jefferies
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07:41 EDTNVSNovartis to host conference call
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07:40 EDTCELGCelgene weakness has created attractive entry point, says Stifel
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07:16 EDTPFEAstraZeneca cancer pipeline viewed as possible draw for Pfizer, Reuters says
Pfizer (PFE) could come back to make an offer to AstraZeneca (AZN) after its reported $101B takeover approach was declined, since an agreement could benefit the U.S. pharmaceutical company as it aims to improve its cancer pipeline, reported Reuters. Reference Link
07:11 EDTNVSEli Lilly to host conference call
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06:11 EDTMRK, JNJWells says big pharma bidders could emerge for Allergan
Wells Fargo believes Allergan (AGN) wants to remain independent and says the "hurdle to convince the company to sell could be pretty high." Wells thinks Valeant's (VRX) low tax rate gives it room to raise its bid for Allergan, and it sees the potential for one or more big pharma bidders, such as Johnson & Johnson (JNJ) or Merck (MRK), emerging due to Allergan's "attractive eye care and aesthetics portfolio and pipeline." Wells believes a purchase price for Allergan of $50B or $165 per share could be justified.
05:38 EDTNVSEli Lilly acquires Novartis Animal Health for $5.4B in all-cash transaction
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05:35 EDTNVS, GSKNovartis says transactions 'represent a transformation' for the company
The elements of the transaction with GSK (GSK) are inter-conditional and subject to approval by GSK shareholders. The Novartis (NVS) board unanimously believes that the transactions with GSK and the transaction with Lilly (LLY) are in the best interests of Novartis and the Novartis Shareholders as a whole. The transaction with Lilly is expected to close by the end of 1Q15 and the transaction with GSK is expected to close during the first half of 2015. The terms of the divestment of the Vaccines business would maximize the value of its pipeline, including Bexsero. The divestment of Animal Health would recognize the full value of the business. The transactions are expected to improve Novartis' sales and core operating income growth rates, while improving margins. Each of the transactions is projected to be value creating. The company commented, "These transactions represent a transformation for Novartis. We have leading positions in our core businesses in high-growth segments of healthcare. This will enable us to continue to build the world's most respected and successful healthcare company. Our strategic focus on science-based innovation and our global scale position the company well to meet the changes in the healthcare industry for the coming decade and beyond."
05:29 EDTNVSNovartis divests Animal Health Division to Eli Lilly for about $5.4B
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05:27 EDTPFEAstraZeneca upgraded to Buy from Neutral at Citigroup
Citigroup upgraded AstraZeneca (AZN) to Buy calling a takeover by Pfizer (PFE) a "high probability event." Citi believes AstraZeneca's oncology pipeline is undervalued at current share levels.
05:26 EDTGSK, NVSNovartis OTC, GSK Consumer Healthcare form joint venture
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05:23 EDTGSK, NVSNovartis divests Vaccines business to GSK for $7.1B
Novartis (NVS) has agreed to divest its Vaccines business to GSK (GSK), currently excluding its flu business, for $7.1B plus royalties. The $7.1B consists of $5.25B upfront and up to $1.8B in milestones. As a part of a value-maximization strategy in the context of the portfolio review, Novartis has initiated a separate sales process for its flu business.
05:20 EDTGSK, NVSNovartis to acquire GSK oncology products for $14.5B
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April 21, 2014
16:40 EDTPFEOn The Fly: Closing Wrap
Stocks on Wall Street were higher for the fifth straight session. Volume remained light on this Monday following Easter, as a number of international markets remained closed. The averages spent time on both sides of the flat-line early in the trading day before settling into a narrow range in positive territory for most of the second half of the session. ECONOMIC EVENTS: In the U.S., the Chicago Fed national activity index fell to 0.20 in March, matching the consensus forecast. The Conference Board's index of leading indicators rose 0.8% in March, beating the consensus forecast for an increase of 0.7%. COMPANY NEWS: Ford (F) is preparing to announce that its Chief Operating Officer, Mike Fields, will take the CEO role at the company following the retirement of current CEO Alan Mulally later this year, according to a report from Bloomberg. Shares of Ford were little changed for the session following the report, losing 2c, or 0.13%, to close at $15.98... U.S.-listed shares of British pharmaceutical company AstraZeneca (AZN) gained $5.61, or 8.84%, to $69.10 after the U.K.'s Sunday Times said Pfizer (PFE) has takeover interest in the company. Analysts had mixed opinions on the report, with Citigroup saying a bid looks "highly probable," while analysts at Bernstein think such a deal would conflict with Pfizer's strategy of getting smaller. Shares of Pfizer rose 61c, or 2.02%, to $30.86 following the report... MAJOR MOVERS: Among the notable gainers was Sarepta Therapeutics (SRPT), up $9.58, or 39.26%, to $33.98 after announcing plans to submit a New Drug Application to the FDA by the end of this year for the approval of eteplirsen for the treatment of Duchenne muscular dystrophy. Also higher was Advanced Micro Devices (AMD), which rose 43c, or 11.65%, to $4.12 after the semiconductor manufacturer reported earnings and revenue that topped expectations after the close on Thursday. Among the noteworthy losers was MoneyGram (MGI), down $2.01, or 13.57%, to $12.80 in its second straight losing session after Wal-Mart (WMT) announced that it was launching its own money transfer service. MoneyGram's slide today comes after the stock dropped by more than 18% on Thursday following Wal-Mart's announcement. Also lower was lululemon (LULU), down $2.64, or 5.11%, to $49.07 after analysts at Sterne Agee said the company's investor day presentation, held on Thursday, did not include a substantive plan to grow same-store sales. INDEXES: The Dow was up 40.71, or 0.25%, to 16,449.25, the Nasdaq was up 26.03, or 0.64%, to 4,121.55, and the S&P 500 was up 7.04, or 0.38%, to 1,871.89.
12:47 EDTPFEOn The Fly: Midday Wrap
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11:33 EDTABT, SNYAward of $16M to Sanofi, Abbott for damages upheld on appeal
The Court of Appeals for the Federal Circuit affirmed a lower court ruling that Glenmark Pharmaceuticals infringed a patent related to the antihypertension drug Tarka that is owned by or exclusively licensed to Sanofi (SNY), Abbott Labs (ABT), and their related companies. In the prior case, Glenmark admitted infringement and the jury awarded $15.2M in lost profits and about $800K in price erosion damages. The appeals court affirmed the district court's jurisdiction in the matter, as well as its judgment and related rulings. Reference Link
11:08 EDTJNJAllergan recent rally due to several factors, says BMO Capital
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10:18 EDTPFEAnalysts differ on chances of Pfizer interest in AstraZeneca
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09:21 EDTPFEOn The Fly: Pre-Market Movers
HIGHER: Sarepta (SRPT), up 54% after announcing plans to to submit NDA for Eteplirsen by year end 2014. Shares of Prosnesa (RNA), another drugmaker working on a competing DMD drug, are up more than 12%... AstraZeneca (AZN), up 6% after the Sunday Times says that Pfizer (PFE) is considering a takeover bid for the company. Pfizer is up 1.2% following the report... Newmont Mining (NEM), up 8% after WSJ says the company and Barrick Gold (ABX) could resume merger talks as soon as today... Cbeyond (CBEY), up 39% after agreeing to be acquired for about $323M by Birch Communications... Momenta Pharma (MNTA), up 10.5% after the Supreme Court rejected Teva's (TEVA) bid to delay generic Copaxone... Nu Skin (NUS), up 5% after saying its China division will resume corporate-hosted business meetings... Micron (MU), up 4% after price target raised at Drexel Hamilton... DOWN AFTER EARNINGS: Acacia Research (ACTG), down 6%... athenahealth (ATHN), down 5.6%.
08:36 EDTSNYAastrom announces definitive agreement to acquire Sanofi's CTRM business
Aastrom Biosciences (ASTM) announced that it has entered into a definitive agreement to acquire Sanofi's (SNY) Cell Therapy and Regenerative Medicine, or CTRM, business for a purchase price of $6.5M, with $4M payable in cash at closing and $2.5M payable in the form of a promissory note. The acquisition is subject to customary closing conditions and is scheduled to close in approximately three weeks. Through the CTRM acquisition, Aastrom is acquiring global commercial rights to three marketed autologous cell therapy products. Aastrom will also acquire global manufacturing and production centers located in the United States and Denmark.
08:32 EDTSNYAastrom announces definitive agreement to acquire Sanofi's CTRM business
08:18 EDTNVSMomenta Pharma rises after high court rejects Copaxone delay bid
Shares of Momenta Pharmaceuticals (MNTA) are higher in pre-market trading after the Supreme Court denied Teva's (TEVA) request to delay the launch of generic forms of its relapsing-remitting multiple sclerosis product, Copaxone. WHAT'S NEW: Teva confirmed on April 19 that the Chief Justice of the United States denied the company's application for an injunction seeking to prevent the launch of a generic version of Copaxone. Teva will continue pursuing its appeal in the Supreme Court and defending its intellectual property for Copaxone, the company said. WHAT'S NOTABLE: Momenta has developed a generic version of Copaxone in partnership with Novartis' (NVS) Sandoz unit. Mylan, which is preparing to launch a generic version of Copaxone as well, said after the ruling: "We are pleased with the Chief Justice's decision, and we look forward to introducing the first generic Copaxone treatment for multiple sclerosis patients in the U.S. at market formation. Mylan remains eligible to receive approval from the U.S. FDA on May 25, 2014." PRICE ACTION: In pre-market trading, Momenta shares are up over 12% to $12.46, while Mylan shares are up more than 3% to $48.48. Teva shares trading in New York are down about 1.7% to $50 in pre-market trading.
07:47 EDTPFEPfizer unlikely to have been interested in AstraZeneca, says Bernstein
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07:21 EDTSNY, JNJ, PFE, MRK, NVS, BMYFDA Pediatric Advisory Committee to hold a meeting
The Committee discusses pediatric-focused safety reviews including MDT's Activa Dystonia Therapy, (BAX's Advate and Tisseel, NVS' Famvir, Tibotec's (JNJ subsidiary) Intelence, UCB Pharma's Keppra, MRK's Maxalt, BAYRY's Natazia, Digestive Care's Pertzye, JNJ's Prezista, BMY's Reyataz, SNY's Sklice, PFE's Torisel, Aptalis' Ultresa, and GILD's Viread in a meeting being held in Bethesda, Maryland on April 21 at 8 am. Webcast Link
07:06 EDTPFEPfizer bid for AstraZeneca 'looks highly probable,' says Citigroup
Citigroup believes Pfizer's (PFE) reported takeover interest in AstraZeneca (AZN) "looks highly probable." Citi thinks a deal would fit Pfizer's strategic goals for immunotherapy and autoimmune disease and would also be financially attractive. The firm expects Pfizer to "aggressively" approach AstraZeneca a second time.
06:47 EDTPFEAstraZeneca volatility elevated, said to have been approached by Pfizer – report
AstraZeneca (AZN) implied volatility is expected is to move on Pfizer (PFE) is said to have approached to propose a $101B takeover, says the Sunday Times. Overall option implied volatility of 20 is above its 26-week average of 18 according to Track Data, suggesting large price movement.
06:40 EDTPFEPfizer volatility flat said to be considering bid for AstraZeneca – report
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April 20, 2014
20:37 EDTPFEPfizer said to be considering GBP60B bid for AstraZeneca, Sunday Times says
Drug giant Pfizer (PFE) is said to have approached AstraZeneca (AZN) to propose a GBP60B takeover of the U.K company, says the Sunday Times. Informal discussions have recently taken place, say sources, but AstraZeneca is believed to be resisting Pfizer’s approach, added the Sunday Times. Reference Link
16:45 EDTPFEBiogen hemophilia drug Alprolix priced similar to older treatments, Reuters says
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April 19, 2014
11:12 EDTBMY, MRKLeerink's pharma and biotech analysts hold an analyst/industry conference call
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April 17, 2014
16:31 EDTJNJFDA alert on laparoscopic morcellation mixed for Hologic, says Piper Jaffray
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15:55 EDTGSKGlaxoSmithKline, Genmab get FDA approval for Arzerra use
GlaxoSmithKline (GSK) and Genmab (GNMSF) announced that the U.S. FDA has approved a Supplemental Biologic License Application for the use of Arzerra, a CD20-directed monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukemia for whom fludarabine-based therapy is considered inappropriate. The FDA approval of the first-line indication is based on results from a Phase III study which demonstrated statistically significant improvement in median progression-free survival in patients who received the combination of ofatumumab and chlorambucil compared to patients who received chlorambucil alone.
15:03 EDTGSKFDA grants wider approval for Glaxo's Arzerra in treatment of CLL
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13:50 EDTMRKFDA approves Ragwitek for short ragweed pollen allergies
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11:43 EDTGSKGlaxoSmithKline announces Canadian approval for Incruse Ellipta
GlaxoSmithKline announced that Incruse Ellipta has received market authorization in Canada for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, or COPD, including chronic bronchitis and emphysema. This is the first market authorization granted for this product anywhere in the world, the company noted.
08:38 EDTPFETeva settles patent ligitigation with Pfizer on Celebrex
Teva (TEVA) announced that its subsidiary Teva Pharmaceuticals USA, Inc. has entered into a settlement with Pfizer (PFE) related to Teva’s generic version of Celebrex 50, 100, 200 and 400 mg capsules in the United States. Under the terms of the settlement, Teva may launch its generic versions in December 2014 or earlier under certain circumstances. Teva has received tentative approval from the U.S. Food and Drug Administration for all strengths and believes that it is first-to-file on at least the 100, 200 and 400 mg capsules. Sales of Celebrex were $2.2B in the U.S. according to IMS data as of December, 2013.
08:15 EDTJNJJohnson & Johnson price target raised to $116 from $104 at Argus
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07:20 EDTGSKGlaxoSmithKline opens internal probe of bribery allegations, WSJ says
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April 16, 2014
13:54 EDTABTDanone slips after fresh dairy volume shrinks
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13:51 EDTNVSAlnylam COO critical of big pharma, FierceDrugDelivery reports
After Novartis (NVS) decided to end its RNAi research, Alnylam COO Barry Greene told FierceDrugDelivery that big pharma has "never been able to innovate." Greene attributes the recent sell-off in Alnylam shares to "generally bearish sentiment on Wall Street regarding biotech stocks in particular." Reference Link
11:19 EDTNVSNovartis launches new eye care products facility in Singapore, Nikkei says
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09:35 EDTABTAbbott: We have plenty of cash for M&A activity, not constrained on borrowing
09:15 EDTSNYImpax launches generic Renvela for kidney disease licensed from Sanofi
Impax Laboratories (IPXL) is commencing shipment of authorized generic Renvela 800 mg tablets, through Global Pharmaceuticals, Impax's generics division. Renvela is indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. Under the terms of a settlement agreement, Sanofi (SNY) company Genzyme agreed to grant Impax a license to sell an allotment of a specified number of bottles of an authorized generic version of Renvela tablets commencing on April 16. Impax continues to pursue approval of its pending Abbreviated New Drug Application for generic Renvela with the FDA.
09:15 EDTABTAbbott sees pace of EPS growth and sales to accelerate throughout FY14
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09:14 EDTABTAbbott sees Q2 EPS 50c-52c, consensus 51c
Sees Q2 sales growth in low to mid single digits, consensus $5.54B.
09:13 EDTABTAbbott sees accelerating sales growth in 2H14
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08:34 EDTCELGPiper Jaffray tech and biopharma analysts hold analyst/industry conference call
Technical Analyst Johnson, along with BioPharma Analysts, discuss the recent downturn in the biotech and specialty pharmaceuticals industries on an Analyst/Industry conference call to be held on April 17 at 10 am.
07:49 EDTABTAbbott expects to increase global capacity to meet demand in 2014
Expects three new manufacturing facilities scheduled to come on line in China, India and the U.S. in Q2. Adult Nutrition remains on track to achieve an operating margin ratio of more than 20 percent of sales by 2015.
07:47 EDTABTAbbott completes enrollment in U.S., China, Japan in Absorb regulatory trials
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07:46 EDTABTAbbott backs FY14 adjusted EPS $2.16-$2.26, consensus $2.20
07:46 EDTABTAbbott reports Q1 adjusted EPS 41c, consensus 36c
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07:38 EDTJNJJohnson & Johnson reported very strong Q1 results, says Bernstein
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April 15, 2014
17:38 EDTJNJJohnson & Johnson stock looks attractive, Barron's says
Johnson & Johnson stock looks attractive and there's still time to buy in, Barron's contends in its "Barron's Take" column. The company can still deliver strong returns, the paper adds. Reference Link
16:22 EDTJNJOn The Fly: Closing Wrap
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15:19 EDTABTNotable companies reporting before tomorrow's open
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14:29 EDTGSKGlaxoSmithKline confirms FDA approval for Tanzeum
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14:14 EDTABTEarnings Preview: Abbott's established pharmaceuticals sales in focus
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12:58 EDTJNJOn The Fly: Midday Wrap
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10:23 EDTJNJOptions with decreasing implied volatility: FDO JNJ FAST EPB
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10:14 EDTGSKFDA approves Tanzeum to treat type 2 diabetes
The Food and Drug Administration approved Tanzeum subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. Tanzeum has a Boxed Warning to warn that tumors of the thyroid gland have been observed in rodent studies with some GLP-1 receptor agonists, but that it is unknown whether Tanzeum causes thyroid C-cell tumors, including a type of thyroid cancer called medullary thyroid carcinoma, in humans. Tanzeum should not be used in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2. The FDA approved Tanzeum with a Risk Evaluation and Mitigation Strategy, which consists of a communication plan to inform health care providers about the serious risks associated with Tanzeum. Tanzeum is manufactured by GlaxoSmithKline.
09:16 EDTJNJOn The Fly: Pre-market Movers
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09:11 EDTJNJJohnson & Johnson says has implemented some cost reductions in MD&D sector
Says has implemented some cost reductions, combined some businesses in the Medical Devices & Diagnostics sector to better compete in the current marketplace.
08:56 EDTJNJJohnson & Johnson sees FY net interest expense $400M-$500M
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08:23 EDTBMY, GSK, MRKLeerink's pharma and biotech analysts hold an analyst/industry conference call
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08:19 EDTBMY, MRKLeerink's pharma and biotech analysts hold an analyst/industry conference call
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08:19 EDTJNJJohnson & Johnson sees deal to sell K-Y brand to Reckitt closing mid-year
Sees sees deal to sell K-Y brand to Reckitt Benckiser (RBGPF) closing mid-year. Says offer from Carlyle Group (CG) to acquire Ortho-Clinical Diagnostics expected to close mid-year. Comments from slides that will be presented on the Q1 earnings conference call.
08:06 EDTGSKProsonix, Mylan enter licensing deal for generic version of Flixotide, Flovent
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08:04 EDTPFEWuXi PharmaTech names Steve Yang as COO and Executive VP
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07:49 EDTJNJJohnson & Johnson reports Q1 Domestic sales up 2.2%; Intl sales up 4.5%
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07:47 EDTJNJJohnson & Johnson raises FY14 EPS to $5.80-$5.90, consensus $5.83
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07:46 EDTJNJJohnson & Johnson reports Q1 adjusted EPS $1.54, consensus $1.48
Reports Q1 revenue $18.1B, consensus $18.0B
07:35 EDTNVSAlnylam outlook not affected by Novartis decision, says JMP Securities
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07:22 EDTNVS, SHPGNovartis to Shire said to mull offers for ThromboGenics, Bloomberg says
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06:36 EDTNVSRanbaxy inspection failures add $900M to heart drug costs, Bloomberg says
A gap in U.S. patent law has kept cheap copies of Novartis' (NVS) heart drug Diovan off the market for 18 months, which has cost U.S. consumers and insurers as much as $900M in possible savings, reported Bloomberg. Ranbaxy (RBXLY) is the only company permitted to sell a generic version of Diovan, and hasn’t been able to manufacture and market them after four factories it runs in India failed U.S. inspections. Reference Link
06:32 EDTSNY, MRK, GSK, JNJ, NVS, BMY, PFEPatients paying much more for specialty drugs, NY Times says
The amount that patients with certain diseases must pay for specialty drugs has increased significantly, a research firm reported, according to The New York Times. Meanwhile, consumers' use of health care increased in 2013 for the firm time in three years, the newspaper quoted the firm, the IMS Institute for Healthcare Informatics, as saying. Publicly traded drug makers include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Publicly traded health insurers include AMERIGROUP (AGP), Aetna (AET), Centene (CNC), Cigna (CI), Health Net (HNT), Healthspring (HS), Humana (HUM), Molina Healthcare (MOH), UnitedHealth (UNH), WellCare (WCG) and WellPoint (WLP).Reference Link
April 14, 2014
18:00 EDTMRKU.S. FDA approves Merck's GRASTEK
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15:17 EDTJNJNotable companies reporting before tomorrow's open
Notable companies reporting before tomorrow's market open, with earnings consensus, include Johnson & Johnson (JNJ), consensus $1.48; Coca-Cola (KO), consensus 44c; Charles Schwab (SCHW), consensus 22c; Northern Trust (NTRS), consensus 78c; Comerica (CMA), consensus 72c; Westamerica (WABC), consensus 58c; Comverse (CNSI), consensus 49c; Pep Boys (PBY), consensus 5c.
14:42 EDTNVSAlnylam slips after Novartis reportedly cuts back RNAi development
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13:25 EDTJNJEarnings Preview: J&J looking for another strong performance in pharmaceuticals
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11:48 EDTNVSNovartis significantly reducing RNAi development efforts, FierceBiotech says
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10:02 EDTJNJOn The Fly: Analyst Downgrade Summary
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09:05 EDTPFEGlycoMimetics presents GMI-1070 data
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09:05 EDTABTAbbott announces FDA clearance for test to diagnose diabetes
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08:15 EDTBMYBristol-Myers submits NDA for Reyataz-cobicistat combo for HIV-1
Bristol-Myers Squibb (BMY) announced the submission of a new drug application, or NDA, on April 4 to the FDA for a fixed-dose combination of atazanavir sulfate, a protease inhibitor marketed as Reyataz, and cobicistat, an investigational pharmacokinetic enhancer, or boosting agent, that can increase the level of certain HIV-1 medicines in the blood and make them more effective. Bristol-Myers Squibb is seeking approval of the fixed-dose combination tablet for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. If approved, atazanavir sulfate and cobicistat could offer patients living with HIV-1 a single tablet that eliminates the need to take a boosting agent in a separate tablet. Cobicistat is being developed by Gilead Sciences (GILD). Under the terms of a previously announced agreement, Bristol-Myers Squibb and its affiliates are responsible for the formulation, manufacturing, registration, distribution and commercialization of the atazanavir sulfate and cobicistat fixed-dose combination product worldwide. Gilead retains sole rights for the manufacture, development and commercialization of cobicistat as a stand-alone product and for use in combination with other agents.
06:40 EDTGSKGlaxoSmithKline paid bribes to Polish doctors to promote Seretide, BBC says
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06:08 EDTMRKMerck volatility elevated into Q1 and outlook
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05:56 EDTJNJJohnson & Johnson downgraded to Hold from Buy at Jefferies
Jefferies downgraded its rating on Johnson & Johnson (JNJ) to Hold citing the recent outperformance of shares. The firm keeps a $105 price target for the stock.
April 11, 2014
18:44 EDTJNJJ&J halting development of Botox competitor, WSJ says
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09:03 EDTCELGCelgene shares can unlock big value, says RBC Capital
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07:19 EDTPFEAcura Pharma to host conference call
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07:06 EDTSNYVIVUS announces avanafil clinical data presentation
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05:22 EDTMRKMerck says Hepatitis C combination therapy shows antiviral activity
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April 10, 2014
17:44 EDTMRKMerck stock could return 20%, Barron's says
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11:42 EDTGSKReport claims Tamiflu, Relenza do little to prevent the spread of flu
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10:05 EDTCELGCelgene CEO Hugin says 'excited' about guidance for the year
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09:37 EDTMRKActive equity options trading on open
Active equity options trading on open according to Track Data: SIRI RAD AAPL AMZN AA FB TSLA MRK CVX C
09:21 EDTMRKOn The Fly: Pre-market Movers
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08:34 EDTABTAbbott completes enrollment of Absorb clinical trials in U.S., Japan and China
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08:10 EDTCELGCelgene likely to prevail in patent case, says Stifel
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08:03 EDTMRKXencor Merck receives milestone payment from Merck for using XmAb antibody
Xencor (XNCR) announced that the company has received a milestone payment from Merck (MRK), through a subsidiary, triggered by the initiation of a Phase 1 clinical trial for an undisclosed biologic drug candidate that uses Xencor's XmAb antibody engineering intellectual property. Under the terms of the agreement signed in June 2013, Xencor granted Merck a non-exclusive license to certain Xencor patents for use in an undisclosed product, as well as an option to license the same intellectual property for future products. Xencor received an upfront payment and continues to receive annual maintenance fees. Xencor is also eligible to receive milestone payments associated with the successful development of Merck product candidates, as well as royalties on sales of any potential products that may result from this agreement.
07:33 EDTCELGCelgene antibody could open door for new area of focus, says Wells Fargo
Wells Fargo believes that Celgene is developing an anti-CD47 antibody that could enable the company to enter the immune-oncology space and pivot into biologics. The firm views the stock as undervalued, and believes that Celgene has many viable opportunities that could enable the stock to rise over the long-term. The firm keeps an Outperform rating on the shares and identifies it as a top pick.
07:04 EDTBMYBristol-Myers presents Phase III data on all-oral Daclatasvir and Asunaprevir
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06:17 EDTPFEAcura Pharma announces return of product rights from Pfizer
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05:27 EDTMRKMerck announces data from C-WORTHy study
Merck announced additional data from the ongoing C-WORTHy study, a multi-arm Phase 2 clinical trial evaluating the efficacy and safety of a once-daily, all-oral regimen combining MK-5172, an investigational hepatitis C virus, or HCV, NS3/4A protease inhibitor, and MK-8742, an investigational HCV NS5A replication complex inhibitor, among patients with chronic HCV Genotype 1 infection, or GT1. In an interim analysis of treatment-naïve, non-cirrhotic patients administered a 12-week regimen of MK-5172/MK-8742, with and without ribavirin, or RBV, a sustained viral response, or SVR, was observed in 98% of patients administered MK-5172/MK-8742 alone and 94% in those administered MK-5172/MK-8742 plus RBV.
April 9, 2014
12:12 EDTCELGMarkman documents appear to favor Celgene, The Street says
Public documents for the pre-trial Markman hearing appear to favor Celgene over Natco, the generic drugmaker challenging some of Celgene's Revlimid patents, The Street's Adam Feuerstein reports. Shares of Celgene are up 5% to $145.33 in mid-day trading. Reference Link
11:43 EDTABT, BMY, MRKGilead defended by analysts after recent pullback
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07:23 EDTJNJ, BMY, MRKEuropean Association for the Study of the Liver to hold annual meeting
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07:09 EDTNVS, SNY, MRKReckitt Benckiser may be frontrunner for Merck unit, Bloomberg reports
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07:09 EDTJNJJohnson & Johnson outlook positive into Q1 results, says Bernstein
Bernstein expects Johnson & Johnson's Q1 EPS to come in slightly above the consensus estimate, with strength in pharmaceuticals more than offsetting lackluster Medical Devices & Diagnostics growth, according to the firm. Bernstein keeps an Outperform rating on the stock.
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