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News Breaks
December 3, 2012
11:37 EDTFLDM, OVSC, STEM, PFE, PSTI, LH, CYTX, LLY, NBS, ATHX, ACTCGenetics Policy Institute to host a summit
World Stem Cell Summit is being held in West Palm Beach, Florida on December 3-5 with webcasted presentations to begin on December 3 at 8 am. Webcast Link
News For LLY;PFE;ACTC;CYTX;STEM;ATHX;LH;OVSC;NBS;PSTI;FLDM From The Last 14 Days
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February 20, 2015
10:33 EDTPFEBattleground update: AbbVie named top global pick at Jefferies
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10:31 EDTPFEPfizer announces FDA acceptance of NDA for Rapamune
Pfizer announced that the FDA has accepted for priority review a supplemental New Drug Application for RAPAMUNE for the treatment of lymphangioleiomyomatosis, a rare, progressive lung disease in women of childbearing age that is often fatal. With the Priority Review designation for the sNDA, Pfizer anticipates a decision in June of 2015 based on the anticipated Prescription Drug User Fee Act action date. The sNDA is based on results from the Multicenter International Lymphangioleiomyomatosis Efficacy and Safety of Sirolimus Trial. The MILES Trial included 89 LAM patients with moderate lung impairment who were randomized to receive RAPAMUNE or placebo for 12 months, followed by a 12 month observation period. In the trial, those treated with RAPAMUNE for one year experienced stabilization of lung function as measured by forced expiratory volume in one second.
07:23 EDTPFEAbbVie replaces Pfizer as top global pharma pick at Jefferies
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07:13 EDTLHLabCorp says has temporarily suspended share repurchase program
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07:12 EDTLHLabCorp sees FY15 adjusted EPS $7.35-$7.70, consensus $7.34
Guidance includes accretion of approximately 35c-40c to earnings in 2015 from the acquisition of Covance. The Company expects to have approximately 102 million total weighted-average shares outstanding in 2015, after issuing approximately 15.3 million shares for the Covance transaction. Sees FY15 total revenue growth of approximately 40%-44%, after adjusting for approximately 160 basis points of negative currency impact. Revenue growth in the clinical laboratory business of approximately 3%-5%. Consensus is $6.16B. Revenue growth in the Covance business of approximately 4%-6%, after adjusting for approximately 330 basis points of negative currency impact. Sees FY15 operating cash flow $1.075B-$1.1B, CapEx $325M-$350M, free cash flow $725M-$775M. Free cash flow will be used to pay down debt and for tuck-in acquisitions. The company has temporarily suspended its share repurchase program until it approaches its target leverage ratio of 2.5 times debt to EBITDA. The company expects cost synergies from business optimization, corporate overhead and purchasing and logistics in excess of $100M within three years, with associated one-time costs of approximately $50M. The company expects synergies in 2015 of approximately $35M, with associated one-time costs of approximately $20M. Project LaunchPad will re-engineer the Company’s systems and processes, leverage technological advancements, create a sustainable, more efficient business model, and improve the experience of all stakeholders. The company expects this initiative to drive net savings in excess of $150M over the next three years, with associated one-time costs of approximately $30M. The company expects net savings from this initiative in 2015 of approximately $50M, with associated one-time costs of approximately $15M.
07:09 EDTLHLabCorp reports Q4 adjusted EPS $1.65, consensus $1.63
Reports Q4 revenue $1.51B, consensus $1.5B.
February 19, 2015
18:25 EDTPFEPiper Jaffray biotech analyst to hold analyst/industry conference call
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15:32 EDTLHNotable companies reporting before tomorrow's open
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14:49 EDTPFEWalgreens selected by Pfizer as one of pharmacies to dispense Ibrance
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12:50 EDTPSTIPluristem says NIH study of PLX-R18 statistically significant
Pluristem Therapeutics announced the results of a recently completed trial conducted by the U.S. National Institutes of Health to evaluate PLX-R18 cells to treat bone marrow damaged by exposure to high levels of radiation, such as can occur after a nuclear disaster. Injection of PLX-R18 cells into muscle, as compared to a placebo, resulted in a statistically significant improvement in the recovery of white blood cell, red blood cell, and platelet levels in animals exposed to high levels of radiation, the company said. It added, "The data also suggested that the treatment may potentially be able to shorten time to recovery."
09:22 EDTLHLabCorp completes acquisition of Covance
LabCorp (LH) announced the completion of its acquisition of Covance (CVD), following its entry into a definitive purchase agreement on November 2, 2014. At closing, the purchase consideration was valued at $107.19 per Covance share, consisting of $75.76 in cash and 0.2686 LabCorp shares for each Covance share, or an equity value of approximately $6.2B and an enterprise value of approximately $5.7B. The closing of the transaction follows the receipt of all necessary regulatory requirements and approval of the transaction by Covance shareholders on February 18. With the closing of the transaction, Covance common stock will cease trading and will no longer be listed on the NYSE.
09:09 EDTFLDMLeerink's life science tools analyst holds an analyst/industry conference call
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08:04 EDTLLYEli Lilly extends Evacetrapib Phase 3 trial by six months
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07:12 EDTPFEWharton Health Care Club to hold a conference
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February 18, 2015
09:27 EDTLHCovance stockholders approve acquisition by LabCorp
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09:10 EDTPSTIOn The Fly: Pre-market Movers
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05:17 EDTPSTIPluristem Therapeutics reports 'significant' findings in NIH trial of PLX-R18
Pluristem Therapeutics announced the positive results of a recently completed trial conducted by the U.S. National Institutes of Health, or NIH, to evaluate PLX-R18 cells to treat bone marrow damaged by exposure to high levels of radiation, such as can occur after a nuclear disaster. Injection of PLX-R18 cells into muscle, as compared to a placebo, resulted in a statistically significant improvement in the recovery of white blood cell, red blood cell, and platelet levels in animals exposed to high levels of radiation. The data also suggested that the treatment may potentially be able to shorten time to recovery. High levels of radiation can destroy the body's ability to produce these three blood lineages, and rapidly regaining that capacity is a key factor in surviving the hematologic component of acute radiation syndrome, or ARS, a condition caused by high-dose irradiation that can involve severe, sometimes lethal damage to the bone marrow as well as other physiologic systems and organs. The objective of this latest trial was to investigate the mechanism of action behind the significant improvement in survival in irradiated mice treated with PLX-R18 that was demonstrated in the NIH's first efficacy study. The results of the current study indicate that intramuscular administration exerts a systemic healing effect on bone marrow, lending further support to the concept that Pluristem's cells work systemically via secretion of therapeutic proteins, although the cells themselves remain in the muscle into which they were initially injected. While additional animal trials are needed prior to FDA approval of PLX-R18 for use in ARS, no human trials would be required because product development is conducted under the FDA's Animal Rule.
February 17, 2015
15:36 EDTPFETianyin JCM plans for FDA certification process
Tianyin Pharmaceutical (TPI) updated on the business and development at its Jiangchuan Macrolide Facility, or JCM, active pharmaceutical ingredients operation. In addition to JCM's certification at India, along with other international clients located at Bangladesh, Philippines and Iran on import status, TPI plans for FDA certification process at its JCM facility in order to service international clients such as Pfizer's (PFE) and their subsidiaries in China, the company said. "This is expected to translate to further demand for JCM's macrolide API business in both the domestic and international markets," Tianyin stated.
10:01 EDTPFECVS says PCSK9 inhibitors could cost system $150B annually
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08:03 EDTCYTXCytori Therapeutics begins enrollment in Phase II ACT-OA trial
Cytori Therapeutics announced that the first patient has been treated in its FDA approved trial assessing the effect of Cytori Cell Therapy for osteoarthritis of the knee. The patient was treated by Dr. Peter Hanson, Medical Director of Orthopedic Surgery at Sharp Grossmont Hospital. ACT-OA is a Phase II FDA approved randomized, double-blind, placebo controlled trial in 90 patients evaluating the efficacy and safety of Cytori’s autologous adipose derived therapy ECCO-50 (Cytori’s therapeutic under study). The trial tests both a low dose and a high dose vs. placebo and will be conducted over 48 weeks. The randomization will be 1:1:1 between the control, low dose and high dose groups. The primary end point will be pain on walking as measured by the Knee Injury and Osteoarthritis Outcome Score at 12 weeks. Secondary endpoints assessed will include pain, joint function, magnetic resonance imaging and adverse events.
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