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Stock Market & Financial Investment News

News For PFE;ACT;JNJ;NVS;TEVA;MYL;GNK;BMY;GSK From The Last 14 Days
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October 30, 2014
17:10 EDTBMYOn The Fly: Closing Wrap
Stocks on Wall Street advanced, with a strong move higher from Visa (V) after its earnings report accounting for more than 100 points of the Dow's increase. The Nasdaq, which lagged all day, eventually moved off its lows and closed in positive territory as well. The New York Stock Exchange notified customers of a problem at 1:40 p.m., saying there was a “critical issue” and it was “experiencing issues publishing and receiving trades and quotes.” Ten minutes later, it sent a new alert saying the system was “processing trades and quotes normally.” ECONOMIC EVENTS: In the U.S., GDP grew 3.5% in the third quarter, topping the consensus forecast for 3.1% growth. Initial jobless claims rose 3K to 287K in the week ended October 25, which was narrowly above the 285K consensus estimate. COMPANY NEWS: Shares of credit card networks Visa (V) and MasterCard (MA) are rising after both companies reported stronger than expected results. Visa, which also authorized a new $5B share repurchase program and was upgraded to Outperform from Market Perform at FBR Capital, advanced $21.99, or 10.24%, to $236.65, while MasterCard gained $7.14, or 9.4%, to $83.13... Apple (AAPL) CEO Tim Cook publicly acknowledged in an essay published by Bloomberg Businessweek that he is gay. Cook noted that he feels "if hearing that the CEO of Apple is gay can help someone struggling to come to terms with who he or she is, or bring comfort to anyone who feels alone, or inspire people to insist on their equality, then it’s worth the trade-off with my own privacy." MAJOR MOVERS: Among the notable gainers was Bristol-Myers (BMY), which advanced $4.82, or 8.9%, to $58.98 after the company announced data for a trial of its Opdivo drug in certain lung cancer patients that a doctor involved in the study called "encouraging." Also higher was Omeros (OMER), which rose $4.99, or 43.09%, to $16.57 after the company announced it has received transitional pass-through status for its lead product, Omidria, from the Center for Medicare & Medicaid Services. Among the noteworthy losers was Glu Mobile (GLUU), which fell 92c, or 20.31%, to $3.61 after the game maker reported Q3 EPS that beat consensus but non-GAAP revenue that missed expectations. Also lower were shares of beauty products provider Avon (AVP), which fell 99c, or 9.03%, to $9.97 after its third quarter report. INDEXES: The Dow rose 221.11, or 1.3%, to 17,195.42, the Nasdaq gained 16.91, or 0.37%, to 4,566.14, and the S&P 500 added 12.35, or 0.62%, to 1,994.65.
16:11 EDTMYLMylan raises FY14 EPS view to $3.54-$3.60, consensus $3.49
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16:08 EDTMYLMylan sees Q4 EPS $1.03-$1.09, consensus $1.00
16:08 EDTMYLMylan reports Q3 EPS $1.16, consensus $1.14
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15:30 EDTMYLNotable companies reporting after market close
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15:02 EDTBMYLeerink medical devices analyst holds an analyst/industry conference call
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13:02 EDTBMYBristol-Myers, Lonza expand manufacturing agreement
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12:59 EDTBMYOn The Fly: Midday Wrap
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12:50 EDTMYLMylan launches generic Viramune XR
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10:50 EDTJNJJ&J may face additional payments of $250M on hip claims, Bloomberg says
Johnson & Johnson may have to pay an additional $250M to settle claims over the failure of its ASR hip implants, says Bloomberg. The current claims were excluded from last year's $2.5B settlement, added Bloomberg. Reference Link
10:49 EDTBMYBristol-Myers rallies after CheckMate -063 Opdivo study results
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09:39 EDTACTPerrigo in exclusive talks to buy Omega Pharma, Bloomberg says
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09:18 EDTACTPerrigo in exclusive talks to buy Omega Pharma, Bloomberg says
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09:11 EDTTEVATeva reported great Q3 results, says BMO Capital
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09:06 EDTTEVATeva says assessing M&A opportunities of all sizes
09:04 EDTBMYBristol-Myers announces CheckMate -063 Opdivo study results
Bristol-Myers Squibb announced results from CheckMate -063, a Phase 2 single-arm, open-label study of Opdivo With approximately 11 months of minimum follow up, the objective response rate was 15% as assessed by an independent review committee using RECIST 1.1 criteria and the median duration of response was not reached. The estimated one-year survival rate was 41% and median overall survival was 8.2 months.These data will be presented during the Plenary Session at the 2014 Chicago Multidisciplinary Symposium on Thoracic Oncology on October 31. Bristol-Myers Squibb has proposed the name Opdivo, which, if approved by health authorities, will serve as the trademark for nivolumab.
08:49 EDTTEVATeva says may pursue generic businesses in emerging markets
Says not ruling out "transformational" transactions. Says open to specialty assets in U.S., Europe.
08:40 EDTTEVATeva says $5.00-$5.10 FY14 EPS guidance is for exclusive Copaxone scenario
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07:15 EDTPFE, BMYASCO / ASTRO / IASLC to hold symposium
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07:06 EDTTEVATeva board authorizes increase in share repurchase program to $3B
The Company announced today that, as authorized by the Board of Directors, it will increase its share repurchase program by $1.7 billion to $3 billion. The program has no time limitations. The Company intends to begin purchasing shares promptly.
07:05 EDTTEVATeva raises FY14 EPS view to $5.00-$5.10 from $4.90-$5.10
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07:05 EDTTEVATeva reports Q3 EPS $1.32, consensus $1.23
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05:49 EDTBMYStocks with implied volatility movement; ARCP BMY
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October 29, 2014
14:46 EDTPFEPfizer confirms FDA acclerated approval for TRUMENBA
Pfizer announced that the U.S. FDA has granted accelerated approval of TRUMENBA for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. Approval of TRUMENBA is based on demonstration of immune response, as measured by serum bactericidal activity against four serogroup B strains representative of prevalent strains in the United States. The effectiveness of TRUMENBA against diverse serogroup B strains has not been confirmed. As part of the accelerated approval process, Pfizer will complete its ongoing studies to confirm the effectiveness of TRUMENBA against diverse serogroup B strains. TRUMENBA was reviewed and approved under the FDA’s Breakthrough Therapy designation and Priority Review programs.
14:29 EDTNVSLannett announces FDA approval of Letrozole tablets
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14:03 EDTPFEFDA approves Trumenba vaccine for serogroup B Meningococcal disease
The FDA announced the approval of Trumenba, the first vaccine licensed in the United States to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. Trumenba was granted breakthrough therapy status, which is intended to expedite the development and review of medical products that address a serious or life-threatening condition. Trumenba is manufactured by Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer.
11:08 EDTJNJOptions with increasing implied volatility: ACHN CZR ARCP HSY JNJ
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10:17 EDTJNJGilead retreats after Hepatitis C drug sales miss expectations
Shares of drug maker Gilead (GILD) are falling after the company last night announced lower than expected third quarter profits and reported sales of its Hepatitis C treatment, Sovaldi, that came in below expectations. WHAT'S NEW: Gilead reported Q3 earnings per share of $1.84, versus analysts' consensus estimate of $1.92. The company's revenue came in slightly above expectations. Gilead said its Sovaldi drug had generated $2.8B of sales last quarter. On average, analysts had expected sales of the drug to come in at $2.93B. Sales of Sovaldi dropped 20% in Q3 versus Q2. However, the company said on its earnings conference call that the launch of its new Hepatitis C treatment, Harvoni, was off to a strong start. ANALYST REACTION: In a note to investors earlier today, Bernstein analyst Geoffrey Porges wrote that Gilead's Q3 revenue and EPS were reduced by one-time events. Its EPS would have easily beaten expectations if the company did not have to pay one-time taxes related to the Affordable Care Act, Porges stated. The lower than expected Sovaldi sales were caused by a variety of factors, including anticipation of the Harvoni launch, the analyst believes. The challenges facing Sovaldi should not affect Harvoni's performance in Q4 and 2015, added Porges, who remains very upbeat on the company's overall Hepatitis C franchise for the near to medium term. He kept a $130 price target and Outperform rating on the shares. Analysts at UBS also remained positive on Gilead, writing that the company had a good quarter with its HIV franchise that resulted in a top-line beat despite the lower than expected Sovaldi sales. The firm said it remains bullish on the Harvoni launch and sees potential upside to estimates. UBS reiterated its Buy rating and $125 price target on Gilead shares. OTHERS TO WATCH: Other pharmaceutical companies offering and developing Hepatitis C treatments include Johnson & Johnson (JNJ) and Abbvie (ABBV). PRICE ACTION: In early trading, Gilead fell 2% to $111.25.
08:31 EDTPFEPfizer publishes PRISTIQ clinical study
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October 28, 2014
17:01 EDTPFEOn The Fly: Closing Wrap
Stocks on Wall Street opened in positive territory despite two disappointing economic data points and a mixed report from social media giant Twitter (TWTR). The market moved in a narrow range for the opening half hour of trading but gained upside momentum following a much better than expected consumer confidence reading. The market continued to tack on points throughout the afternoon and closed at its highs, led by the Nasdaq, which gained 1.75% for the session. ECONOMIC EVENTS: In the U.S., durable goods orders fell 1.3% in September, significantly undershooting expectations for them to have rise 0.7% in the month. The S&P Case-Shiller home price report showed prices were lower on a seasonally adjusted basis in the month of August compared to the prior month. A reading of consumer confidence surged to a seven-year high of 94.5 in October from a revised 89.0 final reading for September. The Richmond Fed's manufacturing index rose 6 points to 20 in October, beating expectations for it to have pulled back to 10. COMPANY NEWS: Twitter (TWTR) sunk $4.78, or 9.84%, to $43.78 after the social media company reported in-line profit and higher than expected Q3 revenue, but also reported a slowdown in user growth and provided weaker than expected Q4 guidance. Following last night's report, the stock was downgraded at RBC Capital, Nomura and Bank of America Merill Lynch to "Hold" or equivalent ratings, while Stifel lowered its rating on Twitter shares to Sell from Hold... Shares of Pfizer (PFE) edged up 6c, or 0.21%, to $29.09 after the pharmaceutical giant reported third quarter adjusted earnings per share and revenue that were a bit better than expected and narrowed its fiscal year profit outlook. Of note, Pfizer said during its earnings conference call that while proposed rule changes have made "inversions" more difficult, that meaningful value from inversion deals can still exists on a "case-by-case" basis. Shares of AstraZeneca (AZN), which was previously a target of Pfizer, gained 67c, or 0.95%, to $71.43 following Pfizer's comments. MAJOR MOVERS: Among the notable gainers following their earnings reports were Whirlpool (WHR), which advanced $10.66, or 6.77%, to $168.06, Cummins (CMI), which gained $9.22, or 6.81%, to $144.59, and Cliffs Natural (CLF), which jumped $2.05, or 22.19%, to $11.29. Among the noteworthy losers was Kohl’s (KSS), which dropped $3.89, or 6.64%, to $54.66 after the department store operator’s outlook for third quarter same store sales and fiscal 2014 profit missed expectations. Also lower were shares of Coach (COH), which fell $2.15, or 5.95%, to $34.00 after the luxury handbag and accessory maker reported sales declined 9% on a constant currency basis in its first quarter. INDEXES: The Dow rose 187.81, or 1.12%, to 17,005.75, the Nasdaq advanced 78.36, or 1.75%, to 4,564.29, and the S&P 500 gained 23.42, or 1.19%, to 1,985.05.
14:10 EDTGSKGlaxoSmithKline liquidates passive stake in Amicus Therapeutics
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13:09 EDTJNJOptions with increasing implied volatility
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12:57 EDTPFEOn The Fly: Midday Wrap
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10:48 EDTPFEPfizer says reviewing options around two businesses
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10:23 EDTPFEPfizer says still looking at deals based on strategic fit
Pfizer (PFE) said during its earnings conference call that uncertainty around future tax actions remain a concern, but that the company is still looking for M&A opportunities. Pfizer says proposed rule changes have made "inversions" more difficult, but that meaningful value from inversion deals can still exists on a "case-by-case" basis. Shares of AstraZeneca (AZN), which was previously a target of Pfizer, are up 1.3% to $71.69 as Pfizer's earnings conference call continues.
07:35 EDTPFEDURECT price target liowered to $1.50 from $2.50 at Stifel
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07:31 EDTNVSThe FDA to hold a workshop
First Annual Neonatal Scientific Workshop, "Roadmap for Applying Regulatory Science to Neonates" is being held at FDA Silver Spring, Maryland offices on October 28-29 at 8:30 am. Webcast Link
07:21 EDTJNJCBI to hold a conference
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07:06 EDTPFEPfizer reports Q3 GEP sales down 6% operationally, GIP sales down 4%
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07:05 EDTPFEPfizer narrows FY14 adjused EPS view to $2.23-$2.27 from $2.20-$2.30
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07:04 EDTBMYBristol-Myers enters agreement to acquire F-star Alpha, rights to FS102
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07:03 EDTBMYBristol-Myers enters agreement to acquire F-star Alpha, rights to FS102
07:01 EDTPFEPfizer reports Q3 adjusted EPS 57c, consensus 55c
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05:35 EDTNVSNovartis confirms FY14 revenue view of growth at a low to mid-single digit rate
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05:31 EDTNVSNovartis reports Q3 core EPS $1.37, consensus $1.29
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04:58 EDTMYLThe Medicines Co. wins favorable judgement in Angiomax patent litigation
The Medicines Company (MDCO) announced the U.S. District Court for the Northern District of Illinois in The Medicines Company v. Mylan, Inc. entered judgment in favor of The Medicines Company on all issues concerning U.S. Patent No. 7,582,727. Following a June 2014 trial, Judge Amy St. Eve found all of the asserted claims are infringed by Mylan’s (MYL) Abbreviated New Drug Application, or ANDA. The same claims were also found to be valid and enforceable. Mylan’s ANDA seeks FDA approval to commercially manufacture, use or sell a generic version of The Medicines Company’s Angiomax drug product before the expiration of the ’727 patent. The ruling prevents Mylan from obtaining FDA approval of its generic bivalirudin and launching its ANDA product until the earlier of a successful appeal or expiration of the ’727 patent in 2028. To appeal successfully, Mylan must overturn the Court’s rulings on each of the asserted claims.
October 27, 2014
20:54 EDTBMYLeerink's major pharma analyst holds an analyst/industry conference call
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18:34 EDTMYLMedicines Co. wins patent suit against Mylan, Bloomberg reports
The Medicines Co. (MDCO) has won a patent suit against Mylan (MYL), Bloomberg reports. A U.S. district court found that Mylan infringed the Medicines Co. patent for its blood-clot-inhibiting drug Angiomax. Shares of Medicines Co. are up 11.5% to $24.76 following the report. Reference Link
16:36 EDTPFEOn The Fly: Closing Wrap
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15:36 EDTPFENotable companies reporting before tomorrow's open
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15:18 EDTPFE, ACTEarnings Preview: Pfizer looks to new products to offset generic competition
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12:46 EDTPFEPfizer October weekly volatility elevated into Q3 and outlook
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12:44 EDTMYLStocks with call strike movement; CELG MYL
Celgene (CELG) April 115 call option implied volatility increased 4% to 30, Mylan (MYL) April 60 call option implied volatility increased 3% to 29 according to IVolatility.
10:36 EDTACTAllergan delivers earnings beat, says willing to consider higher Valeant bid
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08:25 EDTNVSCSL to acquire Novartis' influenza vaccine business
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08:15 EDTPFEPain Therapeutics to regain full rights to REMOXY
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08:08 EDTPFEDURECT reports Pfizer to discontinue agreement with Pain Therapeutics
DURECT (DRRX) reported today that Pfizer (PFE) announced that it has notified Pain Therapeutics (PTIE) that Pfizer has decided to discontinue its agreement to develop and commercialize REMOXY Extended-Release Capsules CII, an investigational extended-release oral formulation of oxycodone. Pfizer will return all rights, including responsibility for regulatory activities, to Pain Therapeutics. As a result, Pain Therapeutics has the rights to develop and commercialize REMOXY on its own or with an alternative licensee. Pain Therapeutics had the rights to develop and commercialize this product candidate under a license from DURECT.
08:02 EDTPFEPfizer to discontinue agreement on REMOXY ER capsules CII
Pfizer Inc. (PFE) has notified Pain Therapeutics, Inc. (PTIE) that it has decided to discontinue its agreement to develop and commercialize REMOXY Extended-Release Capsules CII, an investigational extended-release oral formulation of oxycodone. Pfizer will return all rights, including responsibility for regulatory activities, to Pain Therapeutics, Inc. Pfizer has concluded an internal review of the top-line results of five recently completed clinical studies required to address the Complete Response Letter received in June 2011 from the U.S. Food and Drug Administration (FDA). Pfizer and Pain Therapeutics, Inc. will work together for an orderly transition of REMOXY to Pain Therapeutics, Inc. Pfizer will continue ongoing activities under the agreement for the next six months until the scheduled termination date. Pfizer supports the appropriate use of opioid pain medications, and believes that abuse-deterrent products are important to help address the growing public health problem of opioid abuse in the U.S.
07:33 EDTGSKFDA and CDC to hold a meeting
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07:29 EDTGSK, NVS, JNJWorldwide Business Research to hold a conference
ProcureCon Pharma 2014 is being held in Philadelphia on October 27-29.
07:22 EDTPFE, GSK, TEVAAmerican College of Chest Physicians to hold a conference
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06:28 EDTNVSVirbac acquires veterinary assets from Eli Lilly in U.S.
Virbac announces that it has entered into an agreement with Eli Lilly (LLY) to acquire "major" U.S. veterinary products currently marketed by Novartis (NVS) Animal Health. Eli Lilly has agreed to divest these U.S. assets in connection with the U.S. Federal Trade Commission’s review of Eli Lilly’s pending acquisition of Novartis Animal Health worldwide. Under the terms of this agreement, Virbac would acquire a combination of titles and rights for the U.S. on trademarks, marketing authorizations, patents, know-how, customer lists and other assets, related to two parasiticides for dogs including Sentinel Flavor Tabs and Sentinel Spectrum, currently marketed in the U.S. by Novartis Animal Health. In the U.S., Sentinel Flavor tabs and Sentinel Spectrum are expected to reach total revenues of approximately $90M-$100M in 2014. Adding these brands and commercial franchise to the current Virbac portfolio of products offered to veterinary clinics and pet owners in the U.S. will strengthen Virbac’s presence and penetration in the U.S. companion animal veterinary market and leverage its growth potential. The completion of this transaction is subject to approval by the Federal Trade Commission, which Virbac expects may be received in the near future. It is also conditioned on the closing of the acquisition of Novartis Animal Health by Eli Lilly and should occur shortly thereafter.
October 24, 2014
16:02 EDTBMYOptions Update; October 24, 2014
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13:31 EDTGSKEbola vaccine testing could begin in December, NY Times says
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11:15 EDTBMYBristol-Myers says has capacity for large deal
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10:42 EDTBMYBristol-Myers sees coming in closer to high end of FY14 EPS guidance
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10:10 EDTBMYBristol-Myers to host conference call
Conference call to review data presented at the Chicago Multidisciplinary Symposium on Thoracic Oncology (CMSTO) will be held on October 31 at 2:30 pm. Webcast Link
08:15 EDTJNJJohnson & Johnson management to meet with JPMorgan
Meetings to be held in Chicago/Kansas City on October 29 hosted by JPMorgan.
07:35 EDTBMYBristol-Myers reports Q3 Eliquis revenue $216M
Reports Q3 Baraclude revenue $325M, Sprycel revenue $385M, Yervoy revenue $350M. Reports Q3 Abilify revenue $449M, Orencia revenue $444M.
07:33 EDTBMYBristol-Myers confirms FY14 adjusted EPS view $1.70-$1.80, consensus $1.78
Cuts FY14 GAAP EPS view to $1.15-$1.25 from $1.50-$1.60. Both GAAP and non-GAAP guidance assume current exchange rates and that the R&D tax credit will be extended by Congress in 2014. Sees FY14 worldwide revenue $15.2B-$15.8B, consensus $15.58B. Also sees: Full-year gross margin as a percentage of revenues between 75% and 76%. Advertising and promotion expense decreasing in the mid-teen-digit range. Marketing, sales and administrative expenses decreasing in the mid-single-digit range. Research and development expenses growing in the mid-single-digit range. An effective tax rate of 19% - 20%.
07:31 EDTBMYBristol-Myers reports Q3 adjusted EPS 45c, consensus 42c
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06:49 EDTPFEPfizer repurchase could squash AstraZeneca bid goal, Reuters says
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06:32 EDTJNJJohnson & Johnson found 'not liable' in all-metal hip implant suit, WSJ reports
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October 23, 2014
18:52 EDTPFEOn The Fly: After Hours Movers
UP AFTER EARNINGS: Rubicon Project (RUBI), up 19.2%... KLA-Tencor (KLAC), up 15.8%... Gigamon (GIMO), up 13.5%... Maxwell (MXWL), up 11.3%... Qlik Technologies (QLIK), up 9.8%... NetSuite (N), up 5.5%... Microsoft (MSFT), up 3.3%... Juniper Networks (JNPR), reverses in after-hours trading and is up 1.4% after reporting third quarter results and announcing a $1.1B increase to the company's share repurchase authorization. ALSO HIGHER: Vitae Pharmaceuticals (VTAE), up 38.6% following positive top-line results from two Phase 1 clinical trials of BI1181181/VTP-37948... Pfizer (PFE), up 1.8% after announcing a new $11B share repurchase program. DOWN AFTER EARNINGS: Amazon.com (AMZN), down 10.7%... Synaptics(SYNA), down 12.7%... Pandora (P), down 6.8%... Lattice Semiconductor (LSCC), down 5.6%... Maxim Integrated (MXIM), down 5.8%. ALSO LOWER: DryShips (DRYS), down 16.5% after filing an automatic common stock shelf... NPS Pharmaceuticals (NPSP), down 7.9% following PDUFA date for Natpara extended three months to January 24... GoPro (GPRO), down 2.8% after being initiated with an Underperform at Oppenheimer.
18:18 EDTPFE, ACTGlenview Capital acquires stake in Actavis, Bloomberg reports
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16:21 EDTGSKFive Prime announces expansion of respiratory disease research collaboration
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16:17 EDTPFEPfizer announces new $11B share repurchase program
The board of directors also authorized a new $11B share repurchase program to be utilized over time. This new program is in addition to the $1.3B of authorization remaining under the company’s current share repurchase program.
15:39 EDTBMYNotable companies reporting before tomorrow's open
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11:57 EDTNVSNovartis management to meet with Jefferies
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10:01 EDTGSKOn The Fly: Analyst Upgrade Summary
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08:15 EDTPFE, MYLPfizer wins SUTENT patent case In Delaware District Court
Pfizer (PFE) announced today that the U.S. District Court for the District of Delaware upheld its basic patent and the L-malate salt patent covering SUTENT capsules. This decision, which is subject to appeal, affirms Pfizer’s right to exclusively provide sunitinib malate as SUTENT to patients through the term of the patent, which expires in 2021. Pfizer filed suit in June 2010 after Mylan (MYL) applied to the U.S. Food and Drug Administration to market a generic version of SUTENT prior to the expiration of the patents covering sunitinib malate and its uses. After a four-day trial, the Court agreed that Mylan infringed the valid patents covering SUTENT.
08:10 EDTACTActavis confirms appeals court upholds Lo Loestrin Fe patent
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06:22 EDTMYLMylan, Abbott enter into amendment, still see deal closing in 1Q15
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05:58 EDTJNJStocks with implied volatility below IV index mean; XLNX JNJ
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05:27 EDTGSKGlaxoSmithKline upgraded to Overweight from Equal Weight at Barclays
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05:21 EDTNVSNovartis AIN457 meets primary endpoint in two Phase III studies in AS
Novartis announced that AIN457 met primary and key secondary endpoints in two pivotal Phase III studies, MEASURE 1 and MEASURE 2, in patients with ankylosing spondylitis, or AS. Key endpoints included improvements in signs and symptoms of the disease versus placebo and associated improvements in physical function and quality of life. Secukinumab is an investigational medicine that works by stopping the action of interleukin- 17A, a protein that is central to the development of inflammatory diseases, including AS. MEASURE 1 and MEASURE 2 enrolled a combined total of approximately 600 patients. Detailed results of the studies will be presented at an upcoming medical congress. Joint regulatory applications for secukinumab in AS and PsA are planned for 2015. This follows the secukinumab global regulatory applications for moderate- to-severe plaque psoriasis which were filed in October 2013 with regulatory decisions anticipated in late 2014 or early 2015.
October 22, 2014
17:50 EDTJNJBavarian Nordic announces expanded collaboration with Janssen on MVA-BN
Bavarian Nordic A/S announced that it has agreed with Crucell Holland B.V., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), to expand the collaboration announced earlier to include evaluation of Bavarian Nordic's proprietary vaccine platform technology, MVA-BN, for additional undisclosed disease targets. Bavarian Nordic and Janssen will collaborate on the evaluation of MVA-BN for three additional infectious disease targets. Janssen is granted the exclusive option to collaborate on one or more of the targets, following scientific evaluation of MVA-BN-based vaccine candidates, which will be developed by Bavarian Nordic.
14:43 EDTGSKTheravance drops after partner announces restructuring, posts abstracts
Shares of Theravance, (THRX) a biopharmaceutical company that has economic ties to GlaxoSmithKline (GSK), are lower in afternoon trading after Glaxo reported restructuring plans. Additionally, Theravance disclosed last night that GSK is scheduled to present data from Phase 3 studies at an upcoming medical conference. CHEST 2014 in Austin, Texas, to be held from October 25-30. WHAT'S NEW: Earlier today, GlaxoSmithKline announced it intends to refocus its global pharmaceuticals business and cost base following the divestment of its oncology products and the changed dynamics now faced in the U.S. respiratory market. Theravance has strategic alliances with GlaxoSmithKline in respiratory products. Also, Theravance disclosed last night that Glaxo is scheduled to present data from Phase 3 studies at CHEST 2014, which is being held from October 25-30. Umeclidinium/Vilanterol, a once-daily combination treatment comprising two bronchodilators in Theravance's ELLIPTA inhaler, and Fluticasone Furoate/Vilanterol, a once-daily combination of a LABA and inhaled corticosteroid, have been developed under a collaboration pact between Glaxo and Theravance. Abstracts of the planned oral presentations can be found in the CHEST Journal, Theravance noted in its filing. PRICE ACTION: In afternoon trading, shares of Theravance fell 10.25% to $16.73.
11:59 EDTMYLStocks with call strike movement; MYL AMZN
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09:21 EDTGSKOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Dow Chemical (DOW), up 3.7%... iRobot (IRBT), up 12%... Six Flags (SIX), up 13%... GlaxoSmithKline (GSK), up 2%... Broadcom (BRCM), up 7%... Boston Scientific (BSX), up 4.3%... Abbott (ABT), up 1.8%... Yahoo! (YHOO), up 6%. ALSO HIGHER: Blue Earth (BBLU), up 26.4% after CEO says statements in Seeking Alpha blog are "false and misleading."... GW Pharmaceuticals (GWPH), up 5.4% after Epidiolex receives orphan designation from EMA. DOWN AFTER EARNINGS: 3D Systems (DDD), down 15%... Biogen (BIIB), down 7%... Lumber Liquidators (LL), down 13.4%... Norfolk Southern (NSC), down 3%... Angie's List (ANGI), down 8.8%. ALSO LOWER: Nanosphere (NSPH), down 33% after filing secondary, reporting preliminary Q3 revenue... Himax Technologies (HIMX), down 16% after announcing that Google (GOOG) will not exercise an additional investment option in the company... Cree (CREE), down 10.5%, downgraded at DA Davidson and Canaccord following the company's Q1 earnings results... Ocwen Financial (OCN), down 7% after downgraded to Hold at Evercore, downgraded to Neutral at BofA Merrill Lynch... VMware (VMW), down 7.8%, downgraded at Nomura and Raymond James following the company's Q3 results.
09:16 EDTMYLAbbott sees Q4 reported sales growth in high single digits
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08:38 EDTACTActavis signs option to acquire Rhythm Health
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07:49 EDTGSKGlaxoSmithKline sees FY14 dividend to rise 3% to 80p, 2015 dividend flat
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07:48 EDTGSKGlaxoSmithKline announces restructuring program for pharmaceuticals business
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07:46 EDTGSKGlaxoSmithKline to explore IPO of minority shareholding in ViiV Healthcare
Glaxo announced "further significant steps" within its Pharmaceuticals business to realize value for shareholders and deliver improved operational performance. Glaxo stated: "Five years ago, we created ViiV Healthcare, a new standalone global business focused on development of treatments for HIV. This has been a highly innovative and successful venture with our equity partners Pfizer and Shionogi. The business has made very significant progress in both R&D and commercial execution, culminating in the recent successful launches of Tivicay and Triumeq. We believe now is the right time to explore the potential for an IPO of a minority shareholding in this business. This will provide greater visibility of the intrinsic value we see in its currently marketed assets and future pipeline and also enhance potential future strategic flexibility."
07:44 EDTGSK, NVSGlaxoSmithKline backs FY14 view for core EPS 'broadly similar' to FY13
GlaxoSmithKline (GSK) continues to expect full year 2014 core EPS to be broadly similar to 2013 at CER and on ex-divestment basis. Glaxo says its proposed 3-part transaction with Novartis (NVS) is on track for completion in 1H15.
07:42 EDTGSKGlaxoSmithKline reports Q3 core EPS 27.9p, up 5% CER ex-divestments
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06:41 EDTGSKWHO fast-tracking testing of two Ebola vaccines, Guardian reports
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05:31 EDTJNJJohnson & Johnson announces commitment to speed Ebola vaccine development
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October 21, 2014
11:04 EDTGSKGlaxoSmithKline receives orphan status for dabrafenib
The FDA granted GlaxoSmithKline orphan status for dabrafenib, its possible treatment of patients with BRAF mutation positive non-small cell lung cancer.
07:15 EDTPFE, NVS, BMYFDA to hold workshop on breast cancer drug development
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07:06 EDTPFE, GSKFierce Biotech to hold a breakfast meeting
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06:44 EDTACTActavis among bidders for Omega Pharma, Bloomberg reports
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October 20, 2014
18:51 EDTACTOn The Fly: After Hours Movers
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15:09 EDTNVSNovartis reports FDA advisory committee recommends approval of secukinumab
Novartis announced the Dermatologic and Ophthalmic Drugs Advisory Committee to the FDA voted unanimously to support the approval of AIN457, or secukinumab, a selective interleukin-17A inhibitor, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. A Biologics License Application for secukinumab is currently under FDA review with an anticipated action date in early 2015.
12:36 EDTJNJOptions with decreasing implied volatility
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09:09 EDTGSKEMA encourages applications for orphan designation for Ebola treatments
The European Medicines Agency encourages developers of treatments or vaccines against Ebola to apply for orphan designation. Applications for orphan designation of Ebola medicines will be treated as a priority and EMA has committed to fast-tracking their evaluation, the regulator announced. Drug companies that are working on experimental Ebola vaccines and treatments include Tekmira (TKMR), Sarepta (SRPT), BioCryst (BCRX), Chimerix (CMRX), NewLink Genetics (NLNK) and GlaxoSmithKline (GSK).
08:14 EDTJNJPharmacyclics files supplmeental NDA for Imbruvica for macroglobulinemia
Pharmacyclics (PCYC) announced that it has submitted a supplemental New Drug Application to the FDA based on data from a Phase 2 study evaluating the use of IMBRUVICA in patients with Waldenstrom's macroglobulinemia. IMBRUVICA, which received FDA Breakthrough Therapy Designation in February 2013 for patients with WM, is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech (JNJ).
08:04 EDTMYLGerman fund pressured to sell Mylan stake over drug used in executions, FT says
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07:47 EDTPFEPfizer less likely to renew Astra pursuit after Shire deal breakdown, FT says
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07:26 EDTNVSFDA Dermatologic & Ophthalmic Drugs Advisory Committee to hold a meeting
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07:20 EDTMYLInternational Continence Society to hold annual meeting
ICS Annual Meeting 2014 is being held in Rio de Janeiro, Brazil on October 20-24.
07:19 EDTGSK, BMYIBC Life Sciences to hold a conference
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07:15 EDTPFEAmerican Academy of Child & Adolescent Psychiatry to hold annual meeting
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07:12 EDTPFECongress of Neurological Surgeons to hold annual meeting
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07:11 EDTPFEAmerican Society for Reproductive Medicine to hold annual meeting
2014 Annual Meeting of ASRM is being held in Honolulu on October 18-22.
07:10 EDTPFEAmerican Society of Human Genetics to hold annual meeting
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06:28 EDTACT, TEVAAllergan price target raised to $210 from $190 at Citigroup
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October 17, 2014
16:55 EDTJNJStocks end volatile week lower amid oil price plunge
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16:41 EDTPFEPfizer confirms FDA labeling approval for EMBEDA capsules
Pfizer announced that the FDA has approved an updated label for EMBEDA extended-release capsules, for oral use to include abuse-deterrence studies. The updated label states that EMBEDA has properties that are expected to reduce abuse via the oral and intranasal routes when crushed. However, abuse of EMBEDA by these routes is still possible. The updated label also includes data from a human abuse potential study of intravenous, or IV, morphine and naltrexone to simulate crushed EMBEDA. However, it is unknown whether the results with simulated crushed EMBEDA predict a reduction in abuse by the IV route until additional postmarketing data are available. EMBEDA is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Pfizer expects EMBEDA will be available in the U.S. in early 2015.
16:30 EDTPFEFDA approves new labeling from Embeda extended-release capsules
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14:50 EDTGSK, NVSBARDA asks labs to ramp up Zmapp production, Reuters says
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11:17 EDTGSKGSK says Ebola vaccine too late for current epidemic, BBC reports
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10:37 EDTJNJOptions with decreasing implied volatility: ATLS JNJ XLNX JNK HYG
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09:47 EDTACTValeant will not raise Allergan bid ahead of record date, CNBC reports
Valeant (VRX) will not raise its hostile takeover bid for Allergan (AGN) ahead of the record date for the vote, CNBC's David Faber reports. Allergan (AGN) is not currently in takeover talks with Actavis (ACT), Faber added.
09:45 EDTACTAllergan not in deal talks with Actavis, CNBC reports
08:57 EDTJNJPharmacyclics price target raised to $188 from $185 at Roth Capital
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08:51 EDTJNJPharmacyclics announces European approval for Imbruvica
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08:02 EDTJNJCovidien granted preliminary injunction against Ethicon's Harmonic ACE+7
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