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News Breaks
February 4, 2014
08:25 EDTABBV, ABBV, AET, AET, AMGN, AMGN, ESRX, ESRX, HSP, HSP, MNTA, MNTA, PFE, PFEFTC to hold a workshop
The Biologics Workshop explores competition issues involving biologic medicines and follow-on biologics with a focus on the potential impact of state regulations affecting competition. Companies participating include AbbVie, Aetna, Amgen, Express Scripts, Hospira, Momenta Pharmaceuticals and Pfizer at the FTC Washington, D.C. offices on February 4 at 8:30 am. Webcast Link
News For ABBV;AET;AMGN;ESRX;HSP;MNTA;PFE From The Last 14 Days
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October 14, 2014
10:05 EDTABBVAbbVie could cause Hep C price tipping point with aggressive pricing, WSJ says
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October 13, 2014
09:23 EDTABBVAbbVie's Humira for hidradenitis suppurativa meets Phase 3 trial endpoint
AbbVie announced new results from PIONEER II, a pivotal Phase 3 study, demonstrating the effect of Humira in reducing common clinical signs and symptoms in moderate-to-severe hidradenitis suppurativa, specifically the number of abscesses and inflammatory nodules. The results of this study, in combination with previously presented results from PIONEER I, will contribute to worldwide regulatory filings for an expanded use of Humira, which is not currently approved by regulatory authorities for the treatment of HS.
08:01 EDTPFEPfizer announces FDA acceptance of Palbociclib NDA with priority review
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07:39 EDTABBV, ESRXPharmaceutical Care Management Association to hold annual meeting
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07:37 EDTABBVAmerican Society of Anesthesiologists to hold annual meeting
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October 10, 2014
08:06 EDTPFEPfizer presents Staphylococcus aureus vaccine Phase 1, Phase 2 study data
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October 9, 2014
16:21 EDTMNTAMomenta Pharma reports top-line Part A results from necuparanib Phase 1/2 trial
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16:11 EDTAMGNAmgen blinatumomab granted priority review by FDA
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08:28 EDTABBVGilead to be challenged by AbbVie in HCV near-term, says Bernstein
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08:03 EDTAETWellPoint named top Managed Care pick at Jefferies
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October 8, 2014
13:00 EDTHSPHospira recalling one lot of Vancomycin Hydrochloride
The FDA announced that Hospira is initiating a voluntary nationwide user-level recall of one lot of Vancomycin Hydrochloride. The action is because the product may have experienced temperature excursions during shipment to a customer and then was further distributed by the customer, the agency said. It added that there have been no adverse events or complaints reported for the affected lot. Hospira is "undertaking the recall out of an abundance of caution," the FDA said.
10:55 EDTPFELeerink pharmaceuticals analyst holds an analyst/industry conference call
Analysts discuss prospects for drugs that raise HDL cholesterol, effects of CETP mechanism, expectations for REVEAL data and the potential place for CETP inhibitors in a crowded hypersholesterolemia landscape on an Analyst/Industry conference call to be held on October 9 at 11 am.
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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08:09 EDTPFEPfizer presents LP2086 Phase 2 study data
Pfizer announced it will present the results of a Phase 2, randomized study to evaluate co-administration of the company’s investigational meningococcal group B vaccine, bivalent recombinant LP2086, or rLP2086, with a licensed quadrivalent human papillomavirus vaccine at IDWeek 2014. Data demonstrated immune responses to both vaccines were generated after concomitant administration of bivalent rLP2086 and HPV4. Prespecified noninferiority criteria were met for the bivalent rLP2086 antigens studied and three of the four antigens for HPV4. Primary immunogenicity endpoints, measured after the third dose, included geometric mean titers against HPV antigens in Groups 1 and 3 and human complement serum bactericidal assay GMTs against meningococcal group B disease test strains in Groups 1 and 2. Secondary immunogenicity endpoints included the rate of seroconversion to HPV antigens. Safety of bivalent rLP2086 was assessed after concomitant administration with HPV4 or saline. The prespecified noninferiority criteria were met for three of four HPV antigens and both meningococcal group B disease test strains. Seroconversion for all four HPV antigens was achieved by 99% or more of the subjects for the groups that received HPV4 concomitantly with bivalent rLP2086 or with saline. More local reactions occurred following administration of bivalent rLP2086 compared with saline but the incidence of these reactions did not increase with subsequent vaccine administration. The rates of local and systemic reactions were comparable when bivalent rLP2086 was given with HPV4 to bivalent rLP2086 given alone.
07:19 EDTAMGN, PFECBI to hold a conference
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07:18 EDTPFE, ABBVInfectious 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.
October 7, 2014
07:48 EDTPFEU.S. Chamber of Commerce to hold a discussion
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07:06 EDTHSPOmeros, Hospira enter into commercial suply agreement for Omidria
Omeros Corporation (OMER) said in a filing that on October 3, it, Hospira S.p.A. and Hospira Worldwide, Inc. (HSP) entered into a Commercial Supply Agreement, pursuant to which Hospira will act as a non-exclusive supplier of Omeros’ product Omidria for commercial sale in the United States and the European Union. Pursuant to the Supply Agreement, Hospira has agreed to manufacture and supply, and Omeros has agreed to purchase, a minimum percentage of Omeros’ requirements of Omidria for commercial sales and clinical supplies for the development of additional therapeutic indications in the United States. In addition, upon receipt of marketing approval in the EU, Hospira has agreed to manufacture and supply a portion of Omeros’ requirements of Omidria in the EU in an amount to be mutually agreed by the parties within four months of marketing approval in Europe, with there being no minimum purchase and supply requirement in the EU if the parties do not reach agreement during such time period and the agreement is not amended thereafter. The Supply Agreement obligates Omeros to provide to Hospira a rolling, non-binding long-term forecast of Omeros’ estimated required quantities of Omidria. The Supply Agreement has an initial term of five years from the date of first commercial sale of Omidria in any country in the Territory. Upon termination of the Supply Agreement, except in the case of termination for an uncured breach by Hospira, Omeros will be required to purchase all of Hospira’s inventory of Omidria and, if applicable, work in progress and reimburse Hospira for all supplies purchased or ordered based on firm purchase orders or Omeros’ estimates of its requirements of Omidria.
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