New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News For PFE;BMY;NVS;LLY From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
<< 1 | 2 | 3 | all recent news | >>
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
Subscribe for More Information
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
Subscribe for More Information
12:20 EDTLLYOn The Fly: Midday Wrap
Subscribe for More Information
11:57 EDTNVSNovartis management to meet with Jefferies
Subscribe for More Information
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 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.
07:25 EDTLLYEli Lilly CEO says economic outlook 'won't affect Eli Lilly negatively'
Subscribe for More Information
06:35 EDTLLYEli Lilly backs FY14 EPS view of $2.72-$2.80, consensus $2.75
Sees FY14 revenue $19.4B-$19.8B, consensus $19.77B. Due to the strengthening of the U.S. Dollar, as well as competitive pressures and market dynamics in the U.S. animal health business, the company now anticipates 2014 revenue between $19.4B-$19.8B. Patent expirations have led to a rapid and severe decline in U.S. Cymbalta and U.S. Evista sales. These revenue declines are expected to be partially offset by growth from a portfolio of other products including Humalog, Humulin, Trajenta, Cialis, Forteo and Alimta, as well as the animal health business and new product launches. In addition, strong revenue growth is expected in China, while a weaker Japanese yen will dampen revenue growth in Japan. The company now anticipates gross margin as a percent of revenue will be approximately 74.5% in 2014 driven by recent strengthening of the U.S. Dollar versus the Euro. Gross margin in 2014 is now also expected to benefit from a decision to delay until 2015 the shutdown at one of the company's bulk insulin plants to implement production changes. Total operating expenses in 2014 are still expected to decrease substantially compared to 2013. On a reported basis marketing, selling and administrative expenses are now expected in the range of $6.4B-$6.6B, which includes the Branded Prescription Drug Fee. On a non-GAAP basis, marketing, selling and administrative expenses are now expected to be in the range of $6.3B-$6.5B. Research and development expenses are now expected to be in the range of $4.6B-$4.8B. Other income is now expected to be in the range of $200M-$250M of income.
06:32 EDTLLYEli Lilly reports Q3 EPS 66c, consensus 67c
Reports Q3 revenue $4.88B, consensus $4.83B.
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
17:48 EDTLLYCANDA NK-2 files motion to dismiss patent infringement suit
Subscribe for More Information
16:23 EDTLLYEli Lilly expands collaboration with Zymeworks by up to $375M
Subscribe for More Information
15:37 EDTLLYNotable companies reporting before tomorrow's open
Notable companies reporting before tomorrow's market open, with earnings consensus, include Comcast (CMCSA), consensus 71c; Union Pacific (UNP), consensus $1.52; 3M (MMM), consensus $1.96; AbbVie (ABBV), consensus 77c; Celgene (CELG), consensus 95c; Eli Lilly (LLY), consensus 67c; Occidental Petroleum (OXY), consensus $1.57; Caterpillar (CAT), consensus $1.36; Alexion Pharmaceuticals (ALXN), consensus $1.16; Precision Castparts (PCP), consensus $3.32; Raytheon (RTN), consensus $1.60; American Electric Power (AEP), consensus $1.02; Southwest Airlines (LUV), consensus 53c; Lorillard (LO), consensus 90c; T. Rowe Price (TROW), consensus $1.15; Mead Johnson (MJN), consensus 91c; Zimmer Holdings (ZMH), consensus $1.30; Nucor (NUE), consensus 73c; Nielsen (NLSN), consensus 65c; Prologis (PLD), consensus 46c; Sigma-Aldrich (SIAL), consensus $1.06; Under Armour (UA), consensus 40c; EQT (EQT), consensus 56c; Dr Pepper Snapple (DPS), consensus 88c; Cameron International (CAM), consensus $1.10; Coca-Cola Enterprises (CCE), consensus 89c; Quest Diagnostics (DGX), consensus $1.08; CMS Energy (CMS), consensus 41c; Airgas (ARG), consensus $1.29; PulteGroup (PHM), consensus 36c; Diamond Offshore (DO), consensus 79c; Bemis (BMS), consensus 67c.
13:49 EDTLLYEarnings Preview: Lilly looks to rebound from recent patent expirations
Eli Lilly and Company (LLY) is scheduled to report third quarter earnings before the market open on Thursday, October 23 with a conference call scheduled for 9:00 am ET. Lilly is a global pharmaceutical manufacturer that also has an animal health business segment. EXPECTATIONS: Analysts are looking for earnings per share of 67c on revenue of $4.83B, according to First Call. The consensus range for EPS is 60c-77c on revenue of $4.75B-$4.92B. LAST QUARTER: Eli Lilly reported second quarter EPS of 68c, which beat consensus estimates, on revenue of $4.94B against estimates of $4.9B. Lilly reaffirmed its FY14 EPS and revenue view at the time. The company said it sees FY14 EPS of $2.72-$2.80 on revenue of $19.4B-$20.0B, against consensus estimates of $2.78 and $19.93B respectively. Lilly's CEO John Lechleiter commented on the quarter, "Lilly's second-quarter results reflect a substantial decline in revenue and earnings resulting from recent patent expirations. At the same time, new product approvals and impending launches give us great confidence that Lilly is poised for growth in the years ahead. We have stayed the course with our innovation-based strategy, replenishing and advancing our pipeline. We remain firm in our commitment to sustain and accelerate a flow of important new medicines that make life better for people around the world." STREET RESEARCH: In late August, Deutsche Bank initiated coverage of the name with a Buy rating and a $71 price target. PRICE ACTION: Lilly shares are relatively flat since the company's last earnings report on July 24, and they are trading up fractionally to $64.95 in midday trading ahead of tomorrow's earnings release.
07:44 EDTNVSGlaxoSmithKline 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.
07:35 EDTLLYCardiometabolic Health Congress to hold annual meeting
Subscribe for More Information
October 21, 2014
08:32 EDTLLYFDA accepted NDA for empagliflozin plus
Subscribe for More Information
07:15 EDTNVS, PFE, LLY, BMYFDA to hold workshop on breast cancer drug development
Subscribe for More Information
07:06 EDTPFEFierce Biotech to hold a breakfast meeting
Subscribe for More Information
October 20, 2014
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.
07:47 EDTPFEPfizer less likely to renew Astra pursuit after Shire deal breakdown, FT says
Subscribe for More Information
07:26 EDTNVSFDA Dermatologic & Ophthalmic Drugs Advisory Committee to hold a meeting
Subscribe for More Information
07:19 EDTBMYIBC Life Sciences to hold a conference
Subscribe for More Information
07:15 EDTPFEAmerican Academy of Child & Adolescent Psychiatry to hold annual meeting
Subscribe for More Information
07:12 EDTPFECongress of Neurological Surgeons to hold annual meeting
Subscribe for More Information
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
Subscribe for More Information
October 17, 2014
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
Subscribe for More Information
14:50 EDTNVSBARDA asks labs to ramp up Zmapp production, Reuters says
Subscribe for More Information
10:51 EDTLLYOptions with increasing implied volatility
Options with increasing implied volatility: COV DISH HLT QEP GREK BKW BYI LLY DTV TIBX
October 16, 2014
14:36 EDTLLYLilly to close Guayama facility, will take 16c charge in Q4
Eli Lilly announced plans to conclude production and pursue a sale of one of its three manufacturing plants in Puerto Rico. The manufacturing site, located in Guayama, Puerto Rico, will remain in operation until the end of 2015. All of the approximately 100 full-time non-contracted employees currently working in Guayama will be offered employment at Lilly's Carolina, Puerto Rico, location. As a result of this action, the company expects to record a charge of approximately $170M or approximately 16c per share, after tax, in Q414. While Lilly will initiate efforts to sell the Guayama site, the company will continue to invest in two manufacturing plants at Carolina. In November 2013, Lilly announced a $200M investment to increase capacity in its Carolina-based insulin active ingredient manufacturing plant. In July, Lilly announced an additional $40M in investments to increase capabilities at its Carolina-based drug product site as part of a rebalancing of Lilly's oral solid dosage network.
10:01 EDTBMYOn The Fly: Analyst Upgrade Summary
Subscribe for More Information
08:42 EDTBMYBristol-Myers upgraded at BMO Capital
Subscribe for More Information
08:38 EDTPFEBaxter expects divestiture of vaccines business to Pfizer to close in Q4
Subscribe for More Information
08:08 EDTPFEActavis confirms generic Quillivant XR patent challenge
Subscribe for More Information
07:28 EDTPFEFDA to hold a joint advisory committee meeting on Chantix
Subscribe for More Information
06:16 EDTBMYBristol-Myers upgraded to Outperform from Market Perform at BMO Capital
October 15, 2014
17:03 EDTNVSNovartis announces CTL019 data demonstrating efficacy in certain ALL patients
Novartis and the University of Pennsylvania's Perelman School of Medicine announced preliminary results from two pilot clinical trials published in The New England Journal of Medicine, or NEJM, evaluating the efficacy and safety of CTL019 in patients with relapsed/refractory acute lymphoblastic leukemia, or r/r ALL. The studies, conducted by Penn, demonstrated that 27 of 30 pediatric and adult patients, or 90%, experienced complete remissions with the investigational chimeric antigen receptor, or CAR, therapy CTL019. Largest published cohort to date for CTL019, which served as the basis for recent Breakthrough Therapy designation from the FDA. Sustained remissions of up to two years in r/r ALL patients with six-month event-free survival of 67% and overall survival of 78%.
15:00 EDTPFEShire-Allergan, AbbVie-Pfizer deals possible if merger scrapped, Bloomberg says
Subscribe for More Information
09:57 EDTBMYLeerink biotech analysts hold an analyst/industry conference call
Subscribe for More Information
October 14, 2014
11:23 EDTPFE, BMY, NVSBIND Therapeutics and The Conference Forum hold a conference
Subscribe for More Information
07:15 EDTLLYBiotech Industry Organization to hold a summit
Subscribe for More Information
October 13, 2014
08:05 EDTBMYBristol-Myers, Pharmacyclics, Janssen announce clinical collaboration
Bristol-Myers Squibb Company (BMY), Pharmacyclics, Inc. (PCYC), and Janssen Research & Development, LLC (JNJ) announced today they have entered into a clinical trial collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor OPDIVO in combination with IMBRUVICA, an oral Bruton's tyrosine kinase inhibitor co-developed and co-marketed by Pharmacyclics and Janssen. The Phase 1/2 study will focus on evaluating the safety and anti-tumor activity of combining OPDIVO and IMBRUVICA as a potential treatment option for patients with non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, follicular lymphoma and chronic lymphocytic leukemia. Bristol-Myers Squibb has proposed the name OPDIVO, which if approved by health authorities, will serve as the trademark for the investigational drug, nivolumab. OPDIVO is part of a new class of cancer treatments known as immunotherapies, which are designed to harness the body’s own immune system in fighting cancer by targeting distinct regulatory components of the immune system. Each agent has individually shown activity against hematologic malignancies in clinical trials; pre-clinical evidence suggests OPDIVO and IMBRUVICA may have the potential for additive treatment effects in patients with hematologic malignancies. The study will be conducted by Janssen. Additional details of the collaboration were not disclosed.
08:01 EDTPFEPfizer announces FDA acceptance of Palbociclib NDA with priority review
Subscribe for More Information
07:13 EDTBMYBioFlorida to hold a conference
Subscribe for More Information
October 10, 2014
10:03 EDTLLYEli Lilly olaratumab granted orphan designation as soft tissue sarcoma treatment
Subscribe for More Information
10:03 EDTBMYBristol-Myers receives orphan status for melanoma treatment
Subscribe for More Information
08:19 EDTBMYMedivir announces Janssen initiates enrolment in phase II IMPACT study
Subscribe for More Information
08:06 EDTPFEPfizer presents Staphylococcus aureus vaccine Phase 1, Phase 2 study data
Subscribe for More Information
05:13 EDTNVSNovartis reports new analyses of AIN457 Phase III data show consistent efficacy
Novartis announced that new analyses of AIN457 Phase III studies showed that treatment with secukinumab 300 mg resulted in higher rates of clear to almost clear skin at Week 12 versus placebo, regardless of patients' psoriasis disease severity. Secukinumab's new mode of action stops interleukin-17A, which plays a central role in the development of psoriasis. In the analyses, the majority of patients across two disease severity subgroups, including those with severe psoriasis, experienced complete clear to almost clear skin measured as 100 or 90% reduction of respective baseline PASI, or Psoriasis Area and Severity Index. Skin clearance was sustained through one year of treatment. This is important as historically, psoriasis patients' disease severity at the start of treatment has been shown to negatively impact their response to other therapies. Disease severity subgroups were PASI less than or equal to 20 and PASI greater than 20. PASI measures redness, scaling and thickness of psoriatic plaques and the impact in regions of the body. These findings reconfirm the significantly better responses seen in the published FIXTURE study, where secukinumab showed superiority to Enbrel, a standard of care anti-TNF medication.
<< 1 | 2 | 3 | all recent news | >>

Sign up for a free trial to see the rest of the stories you've been missing.
I agree to the theflyonthewall.com disclaimer & terms of use