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Stock Market & Financial Investment News

News For LLY;PFE;ACTC;CYTX;STEM;ATHX;LH;OVSC;NBS;PSTI;FLDM From The Last 14 Days
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October 30, 2014
16:50 EDTNBSNeoStem reports Q3 revenue $4.1M, consensus $4.76M
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16:04 EDTFLDMFluidigm narrows FY14 revenue guidance to $114M-$117M from $112M-$118M
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16:02 EDTFLDMFluidigm reports Q3 EPS (49c), consensus (47c)
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07:15 EDTLLY, PFEASCO / 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.
14:36 EDTLLYEli Lilly sees Q4 $90M charge, $55M related to Boehringer Ingelheim pact
Eli Lilly stated in a filing that n October the company and Boehringer Ingelheim agreed upon certain changes to the operational structure of their diabetes collaboration. Under the revised agreement the companies will continue their co-promotion work in 17 countries, representing over 90% of the collaborationís anticipated market opportunity. In the other countries, the companies will exclusively commercialize the respective molecules they brought to the collaboration. The modifications become effective on December 31, 2014, and will change the financial terms related to the modified countries; however, the financial impact resulting from the revised terms of the agreement in these countries is not anticipated to be material. As a result of these changes, in Q4, Lilly expects to record a gain of approximately $90M related to the transfer of its license rights to co-promote Trajenta and Jardiance in these countries, as well as a charge of approximately $55M related to the transfer to us of Boehringer Ingelheim's rights to co-promote its new insulin glargine product in countries where it is not yet approved, which will be recorded as acquired IPR&D expense.
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.
08:46 EDTLLYEli Lilly management to meet with Guggenheim
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08:45 EDTLLYEli Lilly management to meet with Leerink
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08:31 EDTPFEPfizer publishes PRISTIQ clinical study
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08:11 EDTLLYboehringer Ingelheim and Eli Lilly changing operational structure of alliance
Boehringer Ingelheim and Eli Lilly are changing the operational and financial structure of their diabetes alliance in certain countries. Under the revised agreement, 17 countries representing more than 90% of the alliance's anticipated market opportunity will continue their co-promotion work. In all other countries, the companies will exclusively commercialize the respective molecules they brought to the alliance. The changes will be implemented starting January 1, 2015. The scope of the alliance will remain unchanged in the following 17 countries: United States, Germany, Italy, Spain, France, United Kingdom, Republic of Ireland, Portugal, Canada, Japan, China, Australia, New Zealand, South Korea, Taiwan, Brazil, and Mexico. Under a revised agreement, Boehringer Ingelheim and Lilly will exclusively commercialize the respective molecules they brought to the alliance in all other countries under revised financial terms that will include an upfront payment and ongoing payments paid to Lilly in lieu of commission payments in those markets. Lilly plans to communicate the impact to its 2014 financial guidance in its third quarter Form 10-Q report to the U.S. Securities and Exchange Commission.
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 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.
16:11 EDTACTCAdvanced Cell Technology files $100M mixed securities shelf
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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07:06 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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06:57 EDTLHLabCorp sees FY14 revenue growth 3%, consensus $5.93B
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06:49 EDTLHLabCorp sees FY14 adjusted EPS $6.70-$6.80, consensus $6.73
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06:48 EDTLHLabCorp reports Q3 adjusted EPS $1.80, consensus $1.75
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October 27, 2014
19:48 EDTLLYEli Lilly responds to ruling in Takeda case
Eli Lilly (LLY) issued the following statement in response to a judge's ruling that the punitive damages awarded in the case of Terrence Allen, et al. v. Takeda Pharmaceuticals (TKPYY) be reduced. The judge reduced the punitive damages from $3B for Lilly and $6B for Takeda to $9.2M for Lilly and $27.6M for Takeda. Plaintiffs also were awarded $1.27M in compensatory damages. The allocation of liability was 75% Takeda, 25% Lilly. "While we have empathy for the plaintiff, we believe the evidence did not support his claims," said Mike Harrington, senior VP and general counsel, Lilly. "We will continue working vigorously to overturn the verdict."
18:45 EDTLLYTakeda Pharmaceutical Co. Ltd. reponds to ruling in diabetes drug case
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17:31 EDTLLYEli Lilly, Takeda have Actos award cut to $36.8M from $9B, Bloomberg reports
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16:36 EDTPFEOn The Fly: Closing Wrap
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15:36 EDTPFE, LHNotable companies reporting before tomorrow's open
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15:18 EDTPFEEarnings 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.
07:22 EDTPFEAmerican College of Chest Physicians to hold a conference
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07:20 EDTSTEMAmerican Association of Blood Banks to hold annual meeting
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06:28 EDTLLYVirbac 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 Commissionís review of Eli Lillyís 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 Virbacís 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.
05:26 EDTPSTIPluristem PLX-RAD cells to be studied at Case Western Reserve University
Pluristem Therapeutics announced that researchers at Case Western Reserve University will conduct a preclinical study of the Company's PLacental expanded-RAD, or PLX-RAD, cells. The study will evaluate whether PLX-RAD cells increase the success rate of human umbilical cord blood transplantation. Umbilical cord blood cells are transplanted to replace a patient's unhealthy bone marrow cells. When successful, a transplant can treat bone marrow failure, which can result from immune system disorders, genetic diseases, and leukemia treatment. When cord blood cells are administered to a patient, they travel to the bone marrow and produce healthy white and red blood cells and platelets after the patient's own abnormal cells have been eliminated. Sometimes, however, the cord blood cells fail to take hold and the transplant fails. The study at Case Western Reserve will research the feasibility of using PLX-RAD cells to help the cord blood to engraft more effectively, resulting in higher rates of successful transplantation and treatment. PLX-RAD cells are also being studied by the U.S. National Institutes of Health, NIH, for the treatment of acute radiation syndrome, or ARS, which involves bone marrow failure after exposure to high levels of radiation, as can happen after a nuclear catastrophe.
October 24, 2014
10:11 EDTACTCAdvanced Cell Technology management to meet with Jefferies
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06:49 EDTPFEPfizer repurchase could squash AstraZeneca bid goal, Reuters says
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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.
12:20 EDTLLYOn The Fly: Midday Wrap
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09:04 EDTCYTXOn The Fly: Pre-market Movers
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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.
07:25 EDTLLYEli Lilly CEO says economic outlook 'won't affect Eli Lilly negatively'
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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.
October 22, 2014
18:19 EDTCYTXCytori Therapeutics receives FDA approval to resume ATHENA trial enrollment
Cytori Therapeutics has received notification from the FDA that Cytori has provided additional information sufficient to support continuation of enrollment in its ATHENA cardiovascular trials. The FDA has agreed that the submitted data and protocol amendments support the fact that there are no subject protection concerns that preclude continuation of the trials. The ATHENA trials have enrolled a total of 31 patients thus far but enrollment was stopped last May by the company based on meeting the trialsí internal stopping rules related to potential cerebrovascular events affecting both cell and placebo treated patients. Based on consultation with the FDA, Cytori initiated a thorough safety review consisting of evaluating each adverse event in all of its previous and ongoing cardiovascular trials and conducted additional testing of its product and cellular output. In addition, Cytori implemented several protocol changes to enhance the safety of the trial procedures for patients. The FDA response to Cytoriís submission was received on October 22.
17:48 EDTLLYCANDA NK-2 files motion to dismiss patent infringement suit
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16:23 EDTLLYEli Lilly expands collaboration with Zymeworks by up to $375M
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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.
11:34 EDTFLDMLeerink's life science tools analyst holds an analyst/industry conference call
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07:35 EDTLLYCardiometabolic Health Congress to hold annual meeting
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October 21, 2014
08:32 EDTLLYFDA accepted NDA for empagliflozin plus
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07:15 EDTPFE, LLYFDA 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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05:09 EDTPSTIPluristem moves to large-scale manufacturing after second product line completed
Pluristem Therapeutics announced that it has completed development of its second major product line, and can now begin manufacturing the cells on a large-scale at its state-of-the art facility in order to meet demand for anticipated studies in a range of hematologic conditions. This second cell product candidate, called PLX-RAD, was created using Pluristem's proprietary three dimensional cell expansion technology platform. The company's first product, PLX-PAD, is already in clinical trials for the treatment of peripheral artery disease, muscle injury and pulmonary arterial hypertension. Pluristem's development plan for the PLX-RAD cells considers numerous potential clinical indications such as: enhancement of engraftment of transplanted hematopoietic stem cells for the treatment of bone marrow deficiency, which can result from immune system disorders, genetic diseases, and treatment of leukemia and other blood cancers; treatment of bone marrow deficiency in patients who have undergone chemotherapy; treatment of acute radiation syndrome, or ARS in conjunction with the U.S. National Institutes of Health's National Institute of Allergy and Infectious Diseases.
October 20, 2014
09:04 EDTACTCAdvanced Cell Technology names LeRoux Jooste as CCO
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08:45 EDTLHLabCorp launches HIV GenoSure Archive
Laboratory Corporation of America Holdings and Monogram Biosciences, Inc., part of the LabCorp Specialty Testing Group, today announced the launch of HIV GenoSure Archive, the first laboratory test to help optimize antiretroviral drug regimens in virally suppressed HIV patients. GenoSure Archive was developed using the Next Generation Sequencing platform.
07:47 EDTPFEPfizer less likely to renew Astra pursuit after Shire deal breakdown, FT says
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07:19 EDTPSTIIBC 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 EDTPFE, FLDMAmerican Society of Human Genetics to hold annual meeting
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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
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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.
08:38 EDTPFEBaxter expects divestiture of vaccines business to Pfizer to close in Q4
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08:08 EDTPFEActavis confirms generic Quillivant XR patent challenge
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07:28 EDTPFEFDA to hold a joint advisory committee meeting on Chantix
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