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Chronological Index of : Clinical News

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  • CLINICAL NEWS: Farydak/Kyprolis ORR tops Velcade combo in MM

    Data due to be presented Tuesday at the American Society of Clinical Oncology meeting in Chicago showed a combination of Farydak panobinostat from Novartis AG (NYSE:NVS; SIX:NOVN) and Kyprolis carfilzomib from Amgen Inc…

    Published on 5/29/2015
  • CLINICAL NEWS: Keytruda data show correlation with MMR biomarker

    Merck and Co. Inc. (NYSE:MRK) announced the first clinical results showing a correlation of benefit from treatment with PD-1 inhibitor Keytruda pembrolizumab in patients with DNA mismatch repair (MMR) deficiency. In a …

    Published on 5/29/2015
  • CLINICAL NEWS: Aegerion to prep Japanese lomitapide NDA on new data

    Aegerion Pharmaceuticals Inc. (NASDAQ:AEGR) said lomitapide met the primary endpoint in a Japanese open-label Phase III trial to treat homozygous familial hypercholesterolemia (hoFH).The primary endpoint of the nine-…

    Published on 5/26/2015
  • CLINICAL NEWS: CBMG takes ride on CAR data

    Cellular Biomedicine Group Inc. (NASDAQ:CBMG) gained $4.51 (14%) to $35.64 on news its chimeric antigen receptor (CAR) T cell therapy targeting CD30 led to partial responses in two of seven patients in a Phase I study …

    Published on 5/22/2015
  • CLINICAL NEWS: Otonomy preps for Phase III despite Meniere's miss

    Otonomy Inc. (NASDAQ:OTIC) fell $6.19 (20%) to $24.86 on Friday after its OTO-104 missed the primary endpoint in a Phase IIb study to treat unilateral Meniere's disease. Based on positive trends and secondary endpoint …

    Published on 5/22/2015
  • CLINICAL NEWS: bluebird climbs on first LentiGlobin sickle cell data

    bluebird bio Inc. (NASDAQ:BLUE) climbed $7.23 to $172.94 on Thursday after the company disclosed the first efficacy data for a sickle cell disease (SCD) patient treated with its LentiGlobin BB305 gene therapy. The data …

    Published on 5/21/2015
  • CLINICAL NEWS: Calithera gains on Phase I leukemia data

    Calithera Biosciences Inc. (NASDAQ:CALA) rose $1.17 (11%) to $12.02 on Thursday after it said one patient had a complete response among 15 efficacy-evaluable patients in a Phase I trial of CB-839 to treat relapsed or …

    Published on 5/21/2015
  • CLINICAL NEWS: Sarilumab meets Phase III RA endpoints

    Sanofi (Euronext:SAN; NYSE:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said sarilumab (REGN88, SAR153191), a human mAb against the IL-6 receptor, met both co-primary efficacy endpoints in the Phase III SARIL-…

    Published on 5/21/2015
  • CLINICAL NEWS: Genocea rises on Phase II HSV data

    Genocea Biosciences Inc. (NASDAQ:GNCA) gained $0.94 to $11.59 on Tuesday after it said all six dosing combinations that included lead candidate GEN-003 met the primary endpoint in a Phase II dose optimization trial to …

    Published on 5/20/2015
  • CLINICAL NEWS: Prima posts big gain on CVac's survival trend

    Prima BioMed Ltd. (ASX:PRR; NASDAQ:PBMD) surged $4.31 (269%) to $5.91 on NASDAQ on Wednesday after reporting final subset analyses from a Phase II ovarian cancer trial that missed its primary progression-free survival (…

    Published on 5/20/2015
  • CLINICAL NEWS: Intercept falls on Phase III NASH trial design

    Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) shed $50.48 (16%) to $263.50 on Tuesday after announcing the design of its Phase III REGENERATE trial of obeticholic acid (OCA) to treat non-alcoholic steatohepatitis (NASH).…

    Published on 5/19/2015
  • CLINICAL NEWS: Karyopharm reports Phase II selinexor data

    Karyopharm Therapeutics Inc. (NASDAQ:KPTI) announced preliminary results from two Phase II trials of selinexor (KPT-330), its first-in-class oral selective inhibitor of nuclear export (SINE) protein exportin 1 (XPO1; …

    Published on 5/15/2015
  • CLINICAL NEWS: Pfizer, Merck KGaA report Phase I data for avelumab

    Pfizer Inc. (NYSE:PFE) and Merck KGaA (Xetra:MRK) announced interim data from Phase I trials of anti-PD-L1 antibody avelumab (MSB0010718C) in patients with ovarian cancer, non-small cell lung cancer (NSCLC) and gastric …

    Published on 5/15/2015
  • CLINICAL NEWS: Xtandi benefit larger in certain TNBC patients

    Data from a Phase II trial of Xtandi enzalutamide from Astellas Pharma Inc. (Tokyo:4503) and Medivation Inc. (NASDAQ:MDVN) to treat triple-negative breast cancer (TNBC) showed a stronger clinical benefit in patients …

    Published on 5/15/2015
  • CLINICAL NEWS: AZ's PD-L1 shows efficacy in NSCLC, melanoma

    Abstracts released in advance of the American Society of Clinical Oncology (ASCO) meeting featured data from multiple studies of MEDI4736 from AstraZeneca plc (LSE:AZN; NYSE:AZN), including efficacy data in studies to …

    Published on 5/14/2015
  • CLINICAL NEWS: Genentech reveals survival data for MPDL3280A in NSCLC

    The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) announced interim results from the Phase II POPLAR study comparing anti-PD-L1 antibody MPDL3280A with docetaxel in squamous and non-squamous non-small cell lung …

    Published on 5/14/2015
  • CLINICAL NEWS: New Keytruda data show responses in diverse tumor types

    Abstracts released ahead of the American Society of Clinical Oncology (ASCO) meeting featured the first data from several studies of Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK), including the first data from…

    Published on 5/14/2015
  • CLINICAL NEWS: Bavarian Nordic smallpox vaccine meets in two trials

    Bavarian Nordic A/S (CSE:BAVA) gained DKK13.50 to DKK327 on Wednesday after two formulations of its Imvamune smallpox vaccine met the primary endpoints in clinical trials. In a Phase III study, three separate lots of a …

    Published on 5/13/2015
  • CLINICAL NEWS: New Opdivo data show survival benefit in NSCLC

    Abstracts released ahead of the American Society of Clinical Oncology (ASCO) meeting featured data from several studies of Opdivo nivolumab from Bristol-Myers Squibb Co. (NYSE:BMY), including overall survival data from …

    Published on 5/13/2015
  • CLINICAL NEWS: Puma down on Phase III neratinib data

    Puma Biotechnology Inc. (NYSE:PBYI) sank $44.72 (21%) to $165 in after-hours trading Wednesday after an abstract released ahead of the American Society of Clinical Oncology meeting revealed details from the Phase III …

    Published on 5/13/2015
  • CLINICAL NEWS: Takeda discontinues alisertib trial

    Takeda Pharmaceutical Co Ltd. (Tokyo:4502) discontinued a Phase III trial of alisertib (MLN8237) to treat relapsed or refractory peripheral T cell lymphoma (PTCL). Takeda said an interim analysis showed the trial was …

    Published on 5/13/2015
  • CLINICAL NEWS: Pain gains on Remoxy, pipeline updates

    Pain Therapeutics Inc. (NASDAQ:PTIE) jumped $0.68 (35%) to $2.62 on Tuesday after the company gave a corporate update and said it would resubmit an NDA in 1Q16 for Remoxy, its high viscosity capsule formation of …

    Published on 5/12/2015
  • CLINICAL NEWS: Ardelyx falls on CKD trial miss

    Ardelyx Inc. (NASDAQ:ARDX) lost $2.61 (24%) to $8.30 on Wednesday after its tenapanor (AZD1722) missed the primary endpoint in a Phase IIa trial to treat chronic kidney disease (CKD) stage 3 in patients with Type II …

    Published on 5/6/2015
  • CLINICAL NEWS: PTC falls on SMA trial suspension

    PTC Therapeutics Inc. (NASDAQ:PTCT) lost $7.71 (13%) to $53.13 on Tuesday after it said partner Roche (SIX:ROG; OTCQX:RHHBY) had suspended the Phase II MOONFISH trial of RG7800 to treat spinal muscular atrophy (SMA). In…

    Published on 5/5/2015
  • CLINICAL NEWS: Acceleron releases luspatercept MDS results

    Acceleron Pharma Inc. (NASDAQ:XLRN) announced preliminary results from a 44-patient, open-label Phase II dose-escalation trial of luspatercept (ACE-536) to treat lower risk myelodysplastic syndromes (MDS). In a high-…

    Published on 5/4/2015

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