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News Breaks
May 3, 2013
08:00 EDTAMGN, AMGN, SNY, SNY, GENZ, GENZ, TEVA, TEVAFDA to hold a joint committee meeting
Joint Meeting of the Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee is being held to discuss the safety and efficacy of currently approved leukocyte growth factors (LGFs) as potential treatments for radiation-induced myelosuppression associated with a radiological/nuclear incident. The meeting will be held at FDA Silver Spring, Maryland offices on May 3 at 8 am. Webcast Link
News For AMGN;SNY;GENZ;TEVA From The Last 14 Days
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October 14, 2014
11:23 EDTTEVA, SNY, AMGNBIND Therapeutics and The Conference Forum hold a conference
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11:19 EDTTEVATeva upgraded to Buy from Hold at Standpoint Research
09:00 EDTSNYSanofi rotavirus vaccine enters Phase III trials in India
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08:08 EDTSNYRegulus Therapeutics to present new preclinical data on multiple programs
Regulus Therapeutics (RGLS) announced that it will present new preclinical data on multiple programs and an overview of its clinical portfolio at the 10th Annual Oligonucleotide Therapeutics Society meeting being held October 12-October 15 at the Hilton San Diego Resort and Spa. In a poster titled "Anti-Diabetic Activity of miR-103/107 Anti-miRs", Regulus scientists will present preclinical data further demonstrating the potential benefit of a microRNA therapeutic for the treatment of metabolic disorders. In a poster titled "Inhibition of miR-21 with RG-012 Improves Renal Function and Survival in Multiple Strains of Col4A3 Deficient Mice", Regulus scientists, in collaboration with its strategic alliance partner Sanofi (SNY), will present new preclinical data demonstrating that weekly subcutaneous delivery of RG-012 has shown to provide both glomerular and tubule protection in the kidneys of Col4A3 deficient mice in an Alport syndrome model.
October 9, 2014
16:11 EDTTEVAAlexza reports 32,278 Adasuve units shipped to Teva in Q3
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16:11 EDTAMGNAmgen blinatumomab granted priority review by FDA
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October 8, 2014
10:20 EDTAMGNAmgen biosimilar franchise underappreciated, says Piper Jaffray
After Amgen announced positive Phase 3 results for its biosimilar Humira in psoriasis, Piper Jaffray said it believes that Amgen's overall pipeline is underappreciated since the company's biosimilar franchise is generally not included in consensus estimates. The firm views Amgen as a top large cap picks and reiterate its Overweight rating on the stock.
09:16 EDTAMGNAmgen's ABP 501 for psoriasis shows positive Phase 3 results
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08:05 EDTTEVATeva initiates NDA submission to FDA for CEP-33237
Teva Pharmaceutical announced the initiation of a rolling New Drug Application submission to the U.S. Food and Drug Administration for hydrocodone bitartrate extended-release tablets designed with Teva’s proprietary technology providing potential abuse-deterrent properties CEP-33237 as allowed for fast track designated products. Teva expects to complete the NDA submission by the end of 2014. Teva also announced positive results from a nasal Human Abuse Liability study which supports the NDA. The nasal HAL study found that in nondependent, recreational opioid users, abuse potential for crushed intranasal CEP-33237 was significantly lower than intranasal immediate-release hydrocodone. Teva has now completed positive HAL studies in the two most common routes of hydrocodone abuse, oral and intranasal. CEP-33237 demonstrated a safety profile in the Phase III study that is consistent with the known safety profile of hydrocodone and other opioid analgesic therapies. Adverse events reported in 5% or more of hydrocodone-treated patients during either the titration or double-blind treatment periods included nausea, constipation, vomiting, headache, somnolence and dizziness.
07:19 EDTAMGNCBI to hold a conference
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07:18 EDTSNYInfectious Diseases Society of America to hold a conference
ID Week 2014 is being held in Philadelphia on October 8-12.
07:11 EDTAMGNEuropean Academy of Dermatology and Venereology to hold a conference
23rd EADV Congress is being held in Amsterdam, The Netherlands on October 8-12.
06:47 EDTTEVALawmakers may push for new regulations on generic drug makers, NY Times says
After the prices of some generic drugs soared more than 1,000% over the last year, two influential members of Congress are probing the sector and threatening to look to impose new regulations on it, according to The New York Times. Generic drug makers include Teva (TEVA), Mylan (MYL), Actavis (ACT), and Lannett (LCI).Reference Link
October 7, 2014
07:54 EDTSNYSanofi says alerted U.S. authorities about allegations of impropriety, WSJ says
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October 6, 2014
11:58 EDTTEVATeva simplifaction plans expected but positive, says BMO Capital
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09:25 EDTSNYOn The Fly: Pre-market Movers
HIGHER: HP (HPQ), up 5% after confirming plans to separate into two companies... CareFusion (CFN), up 24% after Becton Dickinson (BDX) agreed to acquire the company for $58 per share in $12.2B deal. Becton Dickinson shares are up 7% following the news... Chimerix (CMRX), up 7% after announcing announced that brincidofovir has been provided for potential use in patients with Ebola Virus Disease... Conn's (CONN), up 6.5% after announcing that it is exploring strategic alternatives... TASER (TASR), up 5% after announces multiple orders of TASER Smart Weapons... Tableau (DATA), up 3.5% after upgraded at Morgan Stanley... Splunk (SPLK), up 3.9% after upgraded at Morgan Stanley... Unilife (UNIS), up 52% after signing a 15-year commercial supply agreement with Sanofi (SNY). LOWER: RadioShack (RSH), down 5% after confirming definitive agreements to restructure debt... Alcobra (ADHD), down 43% after announcing results from Phase III study of MDX in adult ADHD... Sunesis (SNSS), down 71% after announcing Phase 3 VALOR trial did not meet primary endpoint... H&R Block Bank (HRB), down 5% after deal with BofI (BOFI) not expected to get regulatory approval this year. Tekmira (TKMR), down 8% after downgraded at Leerink.
08:32 EDTTEVATeva identifies 14 pipeline projects for discontinuation or divestment
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08:32 EDTTEVATeva announces results of strategic review of core specialty therapeutic areas
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08:02 EDTSNYUnilife signs 15-year commercial supply agreement with Sanofi
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07:19 EDTSNY, AMGNLeerink healthcare analysts hold an analyst/industry conference call
Healthcare Analysts discuss PCSK9 antibodies and evaluate the commercial potential and unmet need on an Analyst/Industry conference call. Relevant companies Amgen, Sanofi and Regeneron may be discussed on the Analyst/Industry conference call being held on October 6 at 11 am.
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