Industry News

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.

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.

FDA warns StemGenex Biologic Laboratories

  • Posted on: 15 November 2018
  • By: PharmaTutor News

The U.S. Food and Drug Administration has warned StemGenex Biologic Laboratories LLC (StemGenex) of San Diego, Calif; its owner/manager Rita F. Alexander and laboratory and medical director Jenny R. Galloway, M.D. about marketing a purported stem cell product without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could lead to microbial contamination, putting patients at risk.

FDA took new steps to strengthen and modernize inspections for sterile injectable drugs

  • Posted on: 13 November 2018
  • By: PharmaTutor News

Manufacturing inspections are one of the FDA’s most important tools for ensuring the quality of pharmaceutical products used by American patients. Inspections help us to identify manufacturing issues that could pose potential risks to patients, or problems that could contribute to drug shortages, enabling us to engage manufacturers to address and resolve issues.

EMA Working with stakeholders to improve availability of medicines in the EU

  • Posted on: 1 November 2018
  • By: Shalini.Sharma

The task force set up by EMA and the Heads of Medicines Agencies (HMA) on availability of authorised human and veterinary medicines is organising a two-day workshop (8-9 November 2018) at EMA in London to gather stakeholders' perspectives on how to better address potential problems with the supply of medicines and how to avoid shortages of medicines.

US FDA issues final guidance for selection of appropriate Package Type terms for labeling injectable medical products

  • Posted on: 30 October 2018
  • By: Shalini.Sharma

US FDA has issued the final guidance for Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers1 for Human Use.