CR News

Adverse effect of Afatinib can reduce with dosage monitoring, says Clinical Trial

  • Posted on: 12 September 2016
  • By: Shalini.Sharma

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 will submit SPA to FDA for phase 3 for treatment of ABSSSI

  • Posted on: 15 February 2016
  • By: admin

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 presents data from phase 3 study for multiple myeloma drug

  • Posted on: 9 December 2015
  • By: Shalini.Sharma

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.

New data demonstrate sustained long-term efficacy of OFEV®* on slowing disease progression and safety in patients with IPF

  • Posted on: 30 September 2015
  • By: PharmaTutor News
  • 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

Clinical study confirm the impact of Fenugreek Seed Extract (Furocyst) in Poly Cystic Ovary Syndrome Patients (PCOS)

  • Posted on: 14 September 2015
  • By: PharmaTutor News

(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.

Investigators have to record audio - video recording of vulnerable subjects in clinical trials

  • Posted on: 1 September 2015
  • By: PharmaTutor News

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.

First interim results from Ebola vaccine efficacy trial suggest vaccine provides high protection against disease

  • Posted on: 4 August 2015
  • By: PharmaTutor News

Tests of the experimental Ebola vaccine VSV-ZEBOV in over 7500 participants in Guinea suggest that the vaccine provides high protection against the disease as early as ten days after vaccination, in adults who have potentially been exposed to the virus by coming in close contact with a recently infected person.

Biocon's CRO arm Syngene seeks approval for IPO, files DRHP; offer allows Biocon to monetize its shareholding in Syngene

  • Posted on: 28 April 2015
  • By: PharmaTutor News

(Business Wire India); Biocon Ltd, Asia's premier biopharmaceuticals company, today announced that its Contract Research subsidiary Syngene International Ltd (“Syngene”) has filed the Draft Red Herring Prospectus (DRHP) with the Securities and Exchange Board of India (SEBI) on April 22, 2015, seeking approval for an Initial Public Offering (IPO). This is an offer for sale (OFS) by Biocon of a part of its shareholding in Syngene. Biocon along with its subsidiary Biocon Research Limited (BRL) currently holds an 84.5% equity stake in Syngene.

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