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Chronological Index of : Clinical News

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  • CLINICAL NEWS: Kite updates KTE-C19 data

    Kite Pharma Inc. (NASDAQ:KITE) gained $4.56 to $54.92 on Thursday after disclosing updated data from multiple trials of KTE-C19 in blood cancer patients who have been treated at NIH's National Cancer Institute. The …

    Published on 1/14/2016
  • CLINICAL NEWS: bluebird sinks after updating LentiGlobin timeline

    bluebird bio Inc. (NASDAQ:BLUE) lost $10.80 (19%) to $44.64, touching a 52-week low of $43.51 in intraday trading Monday after disclosing that it does not plan to provide updated data for LentiGlobin BB305 gene therapy …

    Published on 1/11/2016
  • CLINICAL NEWS: Novartis pauses study of GenVec's gene therapy

    GenVec Inc. (NASDAQ:GNVC) slid $1.02 (59%) to $0.72 on Monday after disclosing in a regulatory filing that partner Novartis AG (NYSE:NVS; SIX:NOVN) notified the biotech on Friday that it would pause enrollment in a …

    Published on 1/11/2016
  • CLINICAL NEWS: Roche reports OS data for PD-L1 mAb in bladder cancer

    Roche (SIX:ROG; OTCQX:RHHBY) reported the first overall survival data from a cohort of patients in the open-label, single-arm Phase II IMvigor 210 trial of atezolizumab (MPDL3280A) to treat locally advanced or …

    Published on 1/8/2016
  • CLINICAL NEWS: Caladrius ends CIRM-funded melanoma trial

    Caladrius Biosciences Inc. (NASDAQ:CLBS) sank $0.36 (34%) to $0.70 on Thursday after announcing plans to discontinue a Phase III study of CLBS20 as monotherapy to treat metastatic melanoma. The company said immune …

    Published on 1/7/2016
  • CLINICAL NEWS: uniQure gains on preliminary hemophilia B data

    uniQure N.V. (NASDAQ:QURE) gained $2.37 (16%) to $17.28 on Thursday after reporting preliminary data from the low-dose cohort of an ongoing Phase I/II trial of AMT-060 to treat hemophilia B. The five-year trial is …

    Published on 1/7/2016
  • CLINICAL NEWS: Clearside's uveitis therapy clears Phase II hurdle

    Clearside Biomedical Inc. (Alpharetta, Ga.) said CLS-TA (CLS-1001) met the primary endpoint in a Phase II study to treat macular edema associated with non-infectious uveitis. The company said CLS-TA significantly …

    Published on 1/5/2016
  • CLINICAL NEWS: Gilead terminates simtuzumab IPF study

    Gilead Sciences Inc. (NASDAQ:GILD) said it stopped a Phase II study of simtuzumab (GS-6624) to treat idiopathic pulmonary fibrosis. Gilead said a DMC recommended that the study be terminated early due to lack of …

    Published on 1/5/2016
  • CLINICAL NEWS: Gilead's TAF non-inferior to Viread in HBV

    Gilead Sciences Inc. (NASDAQ:GILD) said it plans to submit U.S. and EU regulatory filings this quarter for single-agent tenofovir alafenamide (GS-7340) to treat chronic HBV after reporting on Tuesday that the compound …

    Published on 1/5/2016
  • CLINICAL NEWS: Teva, Active Biotech cut laquinimod doses on CV signal

    Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and partner Active Biotech AB (SSE:ACTI) said they halted testing higher doses of laquinimod (SAIK-MS) in two ongoing multiple sclerosis trials due to an imbalance in the …

    Published on 1/4/2016
  • CLINICAL NEWS: Tetra candidate backed by NIH's Blueprint enters clinic

    Tetra Discovery Partners LLC (Grand Rapids, Mich.) began Phase I testing of BPN14770, the first candidate funded by NIH's Blueprint Neurotherapeutics Network (BPN) to reach the clinic. The negative allosteric modulator …

    Published on 12/30/2015
  • CLINICAL NEWS: NEJM: Patient resensitized to Xalkori

    A study published in the New England Journal of Medicine said a patient with metastatic anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer (NSCLC) regained sensitivity to Xalkori crizotinib after …

    Published on 12/28/2015
  • CLINICAL NEWS: pSivida rises on Phase III uveitis data

    pSivida Corp. (NASDAQ:PSDV; ASX:PVA) gained $0.79 (21%) to $4.49 on NASDAQ on Tuesday after its Medidur fluocinolone acetonide intravitreal implant met the primary endpoint in a Phase III study to treat chronic, non-…

    Published on 12/22/2015
  • CLINICAL NEWS: Baxalta, Momenta biosimilar Humira meets endpoints

    Baxalta Inc. (NYSE:BXLT) and Momenta Pharmaceuticals Inc. (NASDAQ:MNTA) said M923, their proposed biosimilar of Humira adalimumab, met the primary endpoint in a head-to-head pharmacokinetic study. The partners said they…

    Published on 12/21/2015
  • CLINICAL NEWS: Bionor reports latent HIV reservoir reductions

    Bionor Pharma ASA (OSE:BIONOR) said its Vacc-4x in combination with cancer drug Istodax romidepsin significantly reduced latent HIV reservoirs among patients in Part B of the Danish Phase I/II REDUC trial. Viral load …

    Published on 12/21/2015
  • CLINICAL NEWS: UC Davis delays KaloBios trial on Shkreli news

    University of California Davis postponed the start of a Phase I trial of lenzilumab (KB003) from KaloBios Pharmaceuticals Inc. (NASDAQ:KBIO) to treat chronic myelomonocytic leukemia (CMML). In a statement, the …

    Published on 12/21/2015
  • CLINICAL NEWS: Monotherapy prospects slip for AZ's durvalumab

    AstraZeneca plc (LSE:AZN; NYSE:AZN) said data from the Phase II ATLANTIC trial of durvalumab (MEDI4736) are "unlikely" to support a regulatory submission of the PD-L1 inhibitor as monotherapy to treat advanced non-small…

    Published on 12/18/2015
  • CLINICAL NEWS: Novo: semaglutide superior to Januvia

    Novo Nordisk A/S (CSE:NVO; NYSE:NVO) said once-weekly 0.5 mg and 1.0 mg doses of subcutaneous semaglutide (NN9535) were superior to once-daily Januvia sitagliptin from Merck & Co. Inc. (NYSE:MRK) in reducing baseline …

    Published on 12/17/2015
  • CLINICAL NEWS: Advaxis climbs after FDA lifts clinical hold

    Advaxis Inc. (NASDAQ:ADXS) gained $2.62 (32%) to $10.92 on Wednesday after FDA lifted a clinical hold on INDs for cancer products axalimogene filolisbac (ADXS11-001), ADXS-PSA, and ADXS-HER2. The hold affected nine …

    Published on 12/16/2015
  • CLINICAL NEWS: Array gains after binimetinib meets in Phase III

    Array BioPharma Inc. (NASDAQ:ARRY) jumped $0.79 to $4.62 after lead candidate binimetinib (MEK162) led to an improvement in progression-free survival (PFS) over dacarbazine in the Phase III NEMO trial to treat …

    Published on 12/16/2015
  • CLINICAL NEWS: GSK's sirukumab headed for RA submission

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said it plans to submit regulatory applications next year for sirukumab (CNTO 136) to treat rheumatoid arthritis. The company said the human IgG1 kappa mAb against IL-6 produced "…

    Published on 12/16/2015
  • CLINICAL NEWS: Atara looks to pipeline after Phase II failure

    Atara Biotherapeutics Inc. (NASDAQ:ATRA) plans to focus its efforts on a pipeline of four clinical oncology and immunotherapy candidates after PINTA 745 missed the primary endpoint of a Phase II trial to treat protein …

    Published on 12/15/2015
  • CLINICAL NEWS: Cancer Research UK, OHSU to study early detection

    Cancer Research UK (London, U.K.) partnered with the Knight Cancer Institute at Oregon Health & Science University to support early cancer detection research. The partners plan to hold a conference next year that will …

    Published on 12/15/2015
  • CLINICAL NEWS: Puma slips on new neratinib data

    Puma Biotechnology Inc. (NYSE:PBY) shed $4.28 to $67.94 on Friday after presenting data showing neratinib (PB272) led to a modest three-year disease-free survival (DFS) benefit as an adjuvant treatment for HER-2 …

    Published on 12/11/2015
  • CLINICAL NEWS: Roche's PD-L1 mAb produces responses in TNBC

    Roche (SIX:ROG; OTCQX:RHHBY) reported a 70.8% objective response rate (ORR) in a Phase Ib study of atezolizumab (MPDL3280A) to treat triple-negative breast cancer. The human mAb against PD-L1 produced responses in both …

    Published on 12/11/2015

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