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Chronological Index of : Clinical News

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  • CLINICAL NEWS: Cara gains on pruritus data

    Cara Therapeutics Inc. (NASDAQ:CARA) gained $3.15 (20%) to $18.99 on Thursday after IV CR845 met the primary endpoint of a Phase II trial to treat uremic pruritus. The long-acting peripheral kappa opioid receptor (OPRK1…

    Published on 7/23/2015
  • CLINICAL NEWS: Lilly study links Amyvid to changes in treatment

    Eli Lilly and Co. (NYSE:LLY) presented data showing that knowledge of amyloid status measured by PET imaging agent Amyvid florbetapir led to changes in the diagnosis and management of patients being evaluated for …

    Published on 7/23/2015
  • CLINICAL NEWS: AZ's selumetinib fails in Phase III uveal melanoma study

    AstraZeneca plc (LSE:AZN; NYSE:AZN) said selumetinib plus dacarbazine missed the primary endpoint of progression-free survival (PFS) in the Phase III SUMIT study to treat metastatic uveal melanoma. The company said full…

    Published on 7/22/2015
  • CLINICAL NEWS: Lilly says solanezumab data suggest disease-modifying effect

    Eli Lilly and Co. (NYSE:LLY) reported results from two Phase III studies and an extension study of solanezumab showing that patients with mild Alzheimer's disease (AD) who started treatment immediately retained a …

    Published on 7/22/2015
  • CLINICAL NEWS: Xoma sinks on Phase III Behcet's data

    Xoma Corp. (NASDAQ:XOMA) lost $3.40 (77%) to $1 after gevokizumab missed the primary endpoint in the Phase III EYEGUARD-B trial to treat Behcet's uveitis. The humanized IgG2 mAb against IL-1 beta failed to show a …

    Published on 7/22/2015
  • CLINICAL NEWS: A*STAR cancer therapy enters Phase I study

    Singapore's Agency for Science, Technology, and Research and Duke-National University of Singapore Graduate Medical School (Duke-NUS) said a Phase I trial began last month of ECT-159, the first publicly-funded drug …

    Published on 7/17/2015
  • CLINICAL NEWS: Recro's Dex-IN meets in Phase II pain study

    Recro Pharma Inc. (NASDAQ:REPH) gained $0.65 to $16.58 after it said Dex-IN met the primary endpoint of a Phase II trial to treat acute pain in patients undergoing bunionectomy.The intranasal formulation of …

    Published on 7/17/2015
  • CLINICAL NEWS: Aerpio combo tops Lucentis alone in DME study

    Aerpio Therapeutics Inc. (Cincinnati, Ohio) said a combination of its AKB-9778 and Lucentis ranibizumab was superior to Lucentis alone in the Phase IIa TIME-2 study to treat diabetic macular edema (DME). The combination…

    Published on 7/15/2015
  • CLINICAL NEWS: Allegro reports Phase II Luminate data in vitreoretinal disease

    Allegro Ophthalmics LLC (San Juan Capistrano, Calif.) said the highest of three Luminate (ALG-1001) doses met the primary endpoint in a Phase II trial to treat vitreomacular traction (VMT) or vitreomacular adhesion (…

    Published on 7/13/2015
  • CLINICAL NEWS: Genentech reports Phase II bladder cancer data

    The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) said atezolizumab (anti-PDL1, MPDL3280A, RG7446) met the primary endpoint of overall response rate in a cohort of patients in the Phase II IMvigor 210 trial to …

    Published on 7/13/2015
  • CLINICAL NEWS: Novo's semaglutide meets Phase III endpoint

    Novo Nordisk A/S (CSE:NVO; NYSE:NV) said once-weekly doses of subcutaneous semaglutide met the primary endpoint in the Phase IIIa SUSTAIN 1 trial to treat Type II diabetes in treatment-naive patients. In the 388-patient…

    Published on 7/10/2015
  • CLINICAL NEWS: Aquinox sinks on Phase II COPD data

    Aquinox Pharmaceuticals Inc. (NASDAQ:AQXP) plummeted $4.42 (67%) to $2.13 on Thursday after AQX-1125 failed in the Phase II FLAGSHIP trial to treat chronic obstructive pulmonary disease in patients with a history of …

    Published on 7/9/2015
  • CLINICAL NEWS: Ultragenyx gains on Phase II hypophosphatemia analysis

    Ultragenyx Pharmaceuticals Inc. (NASDAQ:RARE) added $13.63 (14%) to $112.65 on Thursday after announcing interim results from a dose-finding Phase II study of KRN23 to treat X-linked hypophosphatemia (XLH). Ultragenyx …

    Published on 7/9/2015
  • CLINICAL NEWS: Ironwood, AZ planning Chinese NDA for linaclotide

    Ironwood Pharmaceuticals Inc. (NASDAQ:IRWD) and AstraZeneca plc (LSE:AZN; NYSE:AZN) said linaclotide met the co-primary endpoints in a Phase III trial conducted primarily in China to treat irritable bowel syndrome with …

    Published on 7/8/2015
  • CLINICAL NEWS: Samsung, Merck biosimilar of Humira shows bioequivalence

    Samsung Bioepis Co. Ltd. said SB5, its biosimilar of Humira adalimumab from AbbVie Inc. (NYSE:ABBV), met the primary endpoint of equivalence to its reference product in a Phase III trial to treat moderate to severe …

    Published on 7/8/2015
  • CLINICAL NEWS: Tesaro unblinds data to patient in niraparib trial

    Tesaro Inc. (NASDAQ:TSRO) unblinded a treatment assignment to a single patient in the Phase III NOVA trial of niraparib (MK-4827) to treat ovarian cancer, upon the patient's request. CEO Lonnie Moulder told BioCentury …

    Published on 7/8/2015
  • CLINICAL NEWS: Inhalable gene therapy meets Phase II endpoint in CF

    Data published Thursday in The Lancet Respiratory Medicine from a Phase II study of pGM169/GL67A to treat cystic fibrosis showed that the inhalable gene therapy led to a significant benefit in lung function. The U.K. …

    Published on 7/2/2015
  • CLINICAL NEWS: Xenon tumbles after Phase IIb OA miss

    Xenon Pharmaceuticals Inc. (NASDAQ:XENE) fell $2 (17%) to $9.53 after its topical TV-45070 failed in a Phase IIb trial to treat chronic pain in patients with osteoarthritis of the knee. The company said 4% and 8% …

    Published on 7/1/2015
  • CLINICAL NEWS: Roche's ocrelizumab meets Phase III MS endpoints

    Roche (SIX:ROG; OTCQX:RHHBY) said ocrelizumab met the primary endpoints of reducing annualized relapse rates (ARR) in two identically designed Phase III studies, OPERA I and OPERA II, to treat relapsing multiple …

    Published on 6/30/2015
  • CLINICAL NEWS: Sembragiline misses AD endpoint

    Evotec AG (Xetra:EVT) said sembragiline (RG1577; EVT 302) missed the primary endpoint in a Phase IIb trial to treat moderately severe Alzheimer's disease. In the MAyflOwer RoAD study conducted by Evotec partner Roche (…

    Published on 6/30/2015
  • CLINICAL NEWS: CSL reports Phase III rIX-FP data

    The CSL Behring subsidiary of CSL Ltd. (ASX:CSL) said three open-label Phase III trials of Factor IX-albumin fusion protein (rIX-FP) to treat hemophilia B met their primary endpoints. Data were presented at the …

    Published on 6/25/2015
  • CLINICAL NEWS: Alcobra dips on Fragile X data

    Alcobra Ltd. (NASDAQ:ADHD) lost $1.09 (13%) to $7.30 on Wednesday after it said metadoxine ER missed the primary endpoint in a Phase II trial to treat Fragile X syndrome. The study showed no statistically significant …

    Published on 6/24/2015
  • CLINICAL NEWS: Transition falls after missing AD endpoint

    Transition Therapeutics Inc. (TSX:TTH; NASDAQ:TTHI) plunged C$7.99 (73%) to C$2.92 in Toronto and fell $6.74 (74%) to $2.35 on NASDAQ on Wednesday after scyllo-inositol (ELND005) missed the primary endpoint in a Phase …

    Published on 6/24/2015
  • CLINICAL NEWS: Boehringer's idarucizumab meets in Phase III

    Boehringer Ingelheim GmbH (Ingelheim, Germany) reported interim data from the Phase III RE-VERSE AD trial of idarucizumab to reverse the anticoagulant effects of Pradaxa dabigatran etexilate in patients who have …

    Published on 6/22/2015
  • CLINICAL NEWS: Epizyme gains on tazemetostat data

    Epizyme Inc. (NASDAQ:EPZM) jumped $5.23 (25%) to $25.98 on Monday after it reported data from an ongoing Phase I dose-escalation study of cancer compound tazemetostat (EPZ-6438) that showed objective responses in blood …

    Published on 6/22/2015

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