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.
The Indian Health ministry has taken different steps to ease the conductance of clinical trials in India by creating strong regulatory platform for ensuring safety, rights and well beings of the clinical research.
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.
Alkermes plc. initiated second of two core phase 3 studies for ALKS 3831, an investigational, novel, oral atypical antipsychotic drug candidate designed to be a broad-spectrum treatment for schizophrenia.
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.
(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.
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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