Pharma News

FDA efforts to reduce animal testing through a study aimed at eliminating the use of dogs in certain trials

  • Posted on: 20 November 2018
  • By: Shalini.Sharma

The U.S. Food and Drug Administration is committed to animal welfare in research by reducing, replacing and/or refining the use of animals in research, whenever possible.

The aim is this: by doing a single study to help establish a non-animal based model, it can potentially replace much of the need to use dogs in future trials with new informatics tools. The  goal is to do one single study involving a small number of dogs—where the dogs will only be subject to minimally invasive blood sampling, and adopted as pets at the completion of the short trial—to eliminate the need for the use of dogs in certain types of future studies, some where they might have been euthanized.

FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot

  • Posted on: 20 November 2018
  • By: Shalini.Sharma

The U.S. Food and Drug Administration expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly.

Cliantha Research holds Respiratory Symposium

  • Posted on: 20 November 2018
  • By: PharmaTutor News

Respiratory Clinical Development is becoming more and more challenging due to several reasons. There is a specific need for exchanging clinical, regulatory and bio-analytical science amongst the stakeholders in clinical development. Fulfilling this, Cliantha Research Limited organized a Respiratory Symposium on 17th November at Hotel Taj Santacruz, Mumbai. The symposium featured an array of immersive experiences of Respiratory Clinical Research by globally distinguished experts. About 125 industry experts attended this unique symposium, including senior delegates from Pharma, Life-science and Clinical Research industry as well as leading pulmonologists from all corners of India.

CHMP recommends first oral-only treatment for sleeping sickness

  • Posted on: 17 November 2018
  • By: Shalini.Sharma

EMA’s human medicines committee (CHMP) has adopted a positive opinion for Fexinidazole Winthrop (fexinidazole), the first oral-only medicine (tablets) for the treatment of human African trypanosomiasis (HAT), commonly known as sleeping sickness, due to Trypanosoma brucei gambiense.

This is the tenth medicine recommended by EMA under Article 58, a mechanism that allows the CHMP to assess and give opinions on medicines that are intended for use in countries outside the European Union.

Results from 2018 National Youth Tobacco Survey show dramatic increase in e-cigarette use among youth over past year: FDA

  • Posted on: 17 November 2018
  • By: Shalini.Sharma

U.S. Food and Drug Administration and U.S. Centers for Disease Control and Prevention (CDC) released new findings from the National Youth Tobacco Survey (NYTS) showing that more than 3.6 million middle and high school students were current (past 30 day) e-cigarette users in 2018, a dramatic increase of more than 1.5 million students since last year. The sharp rise in e-cigarette use has resulted in an increase in overall youth tobacco product use, reversing a decline seen in recent years, and is prompting a series of steps by the FDA to curb youth use trends.

Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics : EMA

  • Posted on: 17 November 2018
  • By: Shalini.Sharma

EMA has reviewed serious, disabling and potentially permanent side effects with quinolone and fluoroquinolone antibiotics given by mouth, injection or inhalation. The review incorporated the views of patients, healthcare professionals and academics presented at EMA’s public hearing on fluoroquinolone and quinolone antibiotics in June 2018.

MoU signed on India-UK Cancer Research Initiative for Affordable Approaches to Cancer

  • Posted on: 16 November 2018
  • By: Shalini.Sharma

A Memorandum of Understanding (MoU) for the partnership between Department of Biotechnology and Cancer Research UK for the India-UK India-UK Cancer Research Initiative was signed today in New Delhi.The India-UK Cancer Research Initiative is a collaborative 5-year bilateral research initiative by the Department of Biotechnology, Ministry of Science & Technology, India and Cancer Research UK (CRUK) that will focus on affordable approaches to cancer. Both CRUK and DBT will invest £5m each in this 5-year pilot, and seek further investment from other potential funding partners.

Health Ministry has taken up several focused and targeted schemes for addressing nutrition challenges in the country: J P Nadda

  • Posted on: 16 November 2018
  • By: Shalini.Sharma

The Health Ministry has taken up several focused and targeted schemes for addressing nutrition challenges in the country in a convergence mode with the other Ministries.We have focussed on Immunisation, detection and supplementation.  This was stated by Shri J P Nadda, Union Minister for Health and Family Welfare at the 3rd meeting of the “National Council on India’s Nutrition Challanges” in presence of Smt Maneka Sanjay Gandhi, Minister of Women and Child Development.

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