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Stock Market & Financial Investment News

News For VVUS;JNJ;AZN;PFE From The Last 14 Days
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October 30, 2014
11:58 EDTAZNSanofi looked to AstraZeneca head regarding Viehbacher, Bloomberg says
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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
07:19 EDTAZNAstraZeneca says FDA approves once-daily XIGDUO XR
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07:15 EDTPFEASCO / ASTRO / IASLC to hold symposium
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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 FDAís Breakthrough Therapy designation and Priority Review programs.
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 EDTAZN, PFEOn 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 Kohlís (KSS), which dropped $3.89, or 6.64%, to $54.66 after the department store operatorís 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.
13:09 EDTJNJOptions with increasing implied volatility
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12:57 EDTAZN, PFEOn The Fly: Midday Wrap
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10:48 EDTPFEPfizer says reviewing options around two businesses
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10:23 EDTPFE, AZNPfizer 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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07:21 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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07:01 EDTPFEPfizer reports Q3 adjusted EPS 57c, consensus 55c
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October 27, 2014
20:54 EDTAZNLeerink's major pharma analyst holds an analyst/industry conference call
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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 EDTAZN, PFEEarnings 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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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.
07:29 EDTJNJ, AZNWorldwide Business Research to hold a conference
ProcureCon Pharma 2014 is being held in Philadelphia on October 27-29.
07:22 EDTAZN, PFEAmerican College of Chest Physicians to hold a conference
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October 24, 2014
08:15 EDTJNJJohnson & Johnson management to meet with JPMorgan
Meetings to be held in Chicago/Kansas City on October 29 hosted by JPMorgan.
06:49 EDTPFE, AZNPfizer 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 EDTPFEGlenview Capital acquires stake in Actavis, Bloomberg reports
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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 companyís current share repurchase program.
08:15 EDTPFEPfizer 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 Pfizerís 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.
05:58 EDTJNJStocks with implied volatility below IV index mean; XLNX JNJ
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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.
07:35 EDTAZNCardiometabolic Health Congress to hold annual meeting
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05:31 EDTJNJJohnson & Johnson announces commitment to speed Ebola vaccine development
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October 21, 2014
07:15 EDTPFE, AZNFDA to hold workshop on breast cancer drug development
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07:06 EDTPFEFierce Biotech to hold a breakfast meeting
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06:10 EDTAZNInovio, MedImmune, UPENN awarded $12.2M collaborative study by DARPA
Inovio Pharmaceuticals (INO) announced the Defense Advanced Research Projects Agency, or DARPA, has awarded $12.2M for a collaborative study that will be conducted by scientists from the Perelman School of Medicine at the University of Pennsylvania; Inovio Pharmaceuticals; and MedImmune, the global biologics research and development arm of AstraZeneca (AZN). The group will develop DNA-based monoclonal antibodies, or mAbs, for infectious disease treatment. DARPA is an agency of the US Department of Defense that creates and supports novel technologies important for national security. Together, the three organizations will develop and assess the DNA mAbs in preclinical studies using technology developed by Penn and licensed by Inovio. The collaboration will focus on three disease areas Ė influenza virus, Pseudomonas aeruginosa and Staphylococcus aureus.
October 20, 2014
12:36 EDTJNJOptions with decreasing implied volatility
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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).
07:47 EDTPFE, AZNPfizer less likely to renew Astra pursuit after Shire deal breakdown, FT says
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07:19 EDTAZNIBC 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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07:14 EDTAZNEuropean College of Neuropsychopharmacology to hold a conference
27th ECNP Congress is being held in Berlin, Germany on October 18-21.
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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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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10:37 EDTJNJOptions with decreasing implied volatility: ATLS JNJ XLNX JNK HYG
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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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