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  • Novartis Cosentyx shows improvement in hidradenitis suppurativa in trials

    Novartis announced the results from two pivotal, Phase III studies, in which Cosentyx (secukinumab) demonstrated rapid and sustained relief from the common clinical signs and symptoms of moderate-to-severe hidradenitis suppurativa (HS) with a favorable safety profile.

    The data were presented as a late-breaking abstract at the 31st European Academy of Dermatology and Venereology (EADV) Congress.

  • Zydus initiates Phase IV clinical trial for Desidustat

    Zydus Lifesciences initiates Phase IV clinical trial for Desidustat in patients with Chronic Kidney Disease (CKD) induced anemia.

    Desidustat sold under a brand name Oxemia which is a prescription drug approved in India for patients with Chronic Kidney Disease (CKD) induced anemia, and can be taken only under the advice and guidance of a Nephrologist or an internal medicine specialist.

  • Results from a new post-hoc analysis of two large phase III trials (LUX-Lung 3 and LUX-Lung 6) assessing the impact of dose adjustments for Giotrif (afatinib) in patients with advanced non-small cell lung cancer (NSCLC) were published in Annals of Oncology. The analysis suggests specific dose reductions, as described in SmPC / prescribing information, led to decreases in the incidence and severity of treatment-related adverse events (AEs) in afatinib-treated patients without any apparent compromise in efficacy.

  • Cellceutix Corporation will be submitting a Special Protocol Assessment (SPA) request for phase 3 clinical research of its novel single-dose antibiotic, Brilacidin, for the treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI) caused by Gram-positive bacteria. The Company anticipates submission of the SPA request to the U.S. Food and Drug Administration (FDA) within two weeks.

  • Takeda Pharmaceutical Company Limited announced results from the TOURMALINE-MM1 trial presented at the 57th Annual Meeting and Exposition of the American Society of Hematology (ASH), showing that treatment with NINLARO® (ixazomib) capsules is effective in extending progression free survival (PFS) with a manageable tolerability profile in patients with relapsed and/or refractory multiple myeloma. The TOURMALINE-MM1 trial is an international, randomized, double-blind, placebo-controlled Phase 3 clinical trial designed to evaluate once-weekly oral ixazomib plus lenalidomide and dexamethasone compared to placebo plus lenalidomide and dexamethasone.

    • Interim analysis of INPULSIS®-ON study shows: Beneficial effect of OFEV®* on slowing disease progression was maintained and the change from baseline in FVC was consistent over 2 years
    • Long-term treatment with OFEV®* had a manageable safety and tolerability profile (mean exposure of 2.4 years, maximum exposure of more than 3 years)
    • Commonly used concomitant medications, such as anti-acids or systemic steroids, do not influence the beneficial effect of OFEV®* on slowing disease progression
  • (Business Wire India); A clinical study conducted on 50 women in the age group of 18-45 years showed significant results in the treatment of polycystic ovary syndrome with the use of Fenugreek seed extract (Furocyst). The average BMI of the study population was 23.88 and had adequate hepatic, renal and haematological functions. At the time of enrolment, most of the patients had prolonged menstrual cycle (81%) and a few had irregular cycle (10%). Rest of the patients (10%) had primary infertilities.

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  • Government makes new rule for clinical trial after consultation with the Drugs Technical Advisory Board that an audio - video recording of vulnerable subjects in clinical trials of New Chemical Entity or New Molecular Entity including procedure of providing information to the subject and his understanding on such consent, shall be maintained by the investigator for record.

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