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Chronological Index of : Clinical News

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  • CLINICAL NEWS: Ascendis announces Phase II results for ACP-001

    Ascendis Pharma A/S (NASDAQ:ASND) announced top-line results from a Phase II study of TransCon Growth Hormone (ACP-001) to treat growth hormone deficiency (GHD). The study's primary endpoints were related to …

    Published on 7/30/2015
  • CLINICAL NEWS: Astellas antifungal misses in Phase III

    Astellas Pharma Inc. (Toyko:4503) released top-line results from the Phase III ACTIVE trial of Cresemba isavuconazonium to treat Candida infection, saying that the broad-spectrum water-soluble azole antifungal missed …

    Published on 7/30/2015
  • CLINICAL NEWS: Sanofi's LixiLan meets in Phase III

    Sanofi (Euronext:SAN; NYSE:SNY) said LixiLan, its fixed-ratio combination of lixisenatide and Lantus insulin glargine, met the primary endpoint of significantly reducing HbA1c over Lantus or lixisenatide alone in the …

    Published on 7/29/2015
  • CLINICAL NEWS: Immunomedics falls on Phase III miss in lupus

    Immunomedics Inc. (NASDAQ:IMMU) sank $1.16 (31%) to $2.55 after partner UCB Group (Euronext:UCB) said epratuzumab missed its primary endpoints in the identical Phase III EMBODY 1 and EMBODY 2 trials to treat systemic …

    Published on 7/28/2015
  • CLINICAL NEWS: Loxo gains after patient responds in LOXO-101 trial

    Loxo Oncology Inc. (NASDAQ:LOXO) gained $4.33 (26%) to $20.91 after Cancer Discovery published a brief describing a response in the first patient in a Phase I trial of LOXO-101 in patients with advanced solid tumors. …

    Published on 7/28/2015
  • CLINICAL NEWS: Bellerophon plummets on BCM data

    Bellerophon Therapeutics Inc. (NASDAQ:BLPH) lost $4.26 (56%) to $3.39 on Monday, bringing its market cap to $43.7 million, after the PRESERVATION I trial of its Bioabsorbable Cardiac Matrix (BCM) device (BL-1040) missed…

    Published on 7/27/2015
  • 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

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