Pharma News

EMA grant marketing authorisation for Vabomere

  • Posted on: 22 September 2018
  • By: Shalini.Sharma

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Vabomere (meropenem trihydrate/vaborbactam), a new treatment option against the following infections in adults: Complicated urinary tract infection, including pyelonephritis, a sudden and severe infection causing the kidneys to swell and which may permanently damage them; Complicated intra-abdominal infection; Hospital-acquired pneumonia, including ventilator associated pneumonia; Bacteria in the blood associated with any of the infections listed above; Infections due to aerobic Gram-negative organisms in adults with limited treatment options.

EMA committee recommend grant marketing authorisation for Emgality (galcanezumab)

  • Posted on: 22 September 2018
  • By: Shalini.Sharma

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Emgality (galcanezumab), a monoclonal antibody for the prevention of migraine. Emgality belongs to a new class of medicines that work by blocking the activity of calcitonin gene-related peptide (CGRP), a molecule that is involved in migraine attacks.

WHO is developing Benchmark Documents for practice in traditional medicine

  • Posted on: 19 September 2018
  • By: Shalini.Sharma

World Health Organisation is developing Benchmark Documents for practice in Ayurveda, Panckarma and Unani system as part of its global strategy to provide safe, effective and accessible Traditional Medicine to global community. Development of these benchmarks documents is included in the Project Collaboration Agreement (PCA) between WHO and Ministry of AYUSH. WHO Working Group Meetings for three WHO benchmark documents scheduled 17 -19 September, 2018, was inaugurated at Jaipur. The three days programme containing four sessions on each day has been organized by Ministry of AYUSH and coordinated by National Institute of Ayurveda (NIA), Jaipur.

FDA takes important steps to encourage appropriate and rational prescribing of opioids through final approval of new safety measures governing the use of immediate-release opioid analgesic medications

  • Posted on: 19 September 2018
  • By: Shalini.Sharma

U.S. Food and Drug Administration took new steps as part of its broader efforts to address the opioid crisis by approving the final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS). This new plan includes several measures to help better communicate the serious risks about the use of opioid pain medications to patients and health care professionals. This expanded REMS now, for the first time, applies to immediate-release (IR) opioid analgesics intended for use in an outpatient setting.

Health ministry initiate Empanelment of Independent National Monitors

  • Posted on: 18 September 2018
  • By: Shalini.Sharma

The Central government initiated empanelling independent individual and institutional monitors across the country.

The main objective is  to undertake regular monitoring of major national programmes and special monitoring of specific interventions under the NHM, to identify areas for improvement following the review and to provide suggestions for addressing the gaps identified

NIH announce the launch of initiative to accelerate genetic therapies to cure sickle cell disease

  • Posted on: 18 September 2018
  • By: Shalini.Sharma

The National Institutes of Health announced the launch of a new initiative to help speed the development of cures for sickle cell disease, a group of inherited blood disorders affecting at least 100,000 people in the United States and 20 million worldwide. The Cure Sickle Cell Initiative will take advantage of the latest genetic discoveries and technological advances to move the most promising genetic-based curative therapies safely into clinical trials within five to 10 years.

Sun Pharma and SPARC Announce US FDA Approval of XELPROS™

  • Posted on: 14 September 2018
  • By: PharmaTutor News

Sun Pharma Advanced Research Company Ltd. announced U.S. Food and Drug Administration (USFDA) approval for the New Drug Application (NDA) of XELPROSTM (latanoprost ophthalmic emulsion) 0.005% for the reduction of elevated intraocular pressure (IOP, or pressure inside the eye) in patients with open-angle glaucoma or ocular hypertension. This approval is from Sun Pharma’s Halol (Gujarat, India) facility.

FDA is issuing new warning letters to companies marketing kratom with unproven medical claims; and the agency’s ongoing concerns about kratom

  • Posted on: 13 September 2018
  • By: Shalini.Sharma

Epidemics don’t occur overnight. U.S. Food and Drug Administration must remain vigilant and aggressive against trends that threaten to reverse our progress, or substances that have the potential to cause new epidemics of abuse.

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