Industry News

Nicox announces U.S. FDA Acceptance of Investigational New Drug Application for NCX 4251 Phase 2 Trial in Blepharitis

  • Posted on: 30 January 2019
  • By: PharmaTutor News

Nicox SA an international ophthalmology company, announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Company's Investigational New Drug (IND) application for NCX 4251, a novel patented ophthalmic suspension of fluticasone propionate nanocrystals, being developed as the first targeted topical treatment of the eyelid margin for patients with acute exacerbations of blepharitis.  The IND was submitted to the U.S. FDA in December 2018 ahead of the target of the first quarter of 2019.

Investigational monoclonal antibody to treat Ebola is safe in adults : NIH

  • Posted on: 30 January 2019
  • By: Shalini.Sharma

The investigational Ebola treatment mAb114 is safe, well-tolerated, and easy to administer, according to findings from an early-stage clinical trial published in The Lancet. Eighteen healthy adults received the monoclonal antibody as part of a Phase 1 clinical trial that began in May 2018 at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland. The National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC), part of NIH, developed the investigational treatment and conducted and sponsored the clinical trial.

No new patients should start treatment with Lartruvo after study shows cancer medicine does not prolong life: EMA

  • Posted on: 25 January 2019
  • By: Shalini.Sharma

Preliminary results from the ANNOUNCE study show that Lartruvo (olaratumab) in combination with doxorubicin is not more effective at prolonging the lives of patients with soft tissue cancer than doxorubicin alone.

The Global Commission on the Future of Work calls for fundamental changes in health at work: WHO

  • Posted on: 25 January 2019
  • By: Shalini.Sharma

The ILO Global Commission on the Future of Work calls for fundamental changes in the way we work in the new wave of globalization, rapid technological development, demographic transition and climate change, according to its report Work for a Brighter Future published today. The report examines how to achieve a better future of work for all at a time of unprecedented change and exceptional challenges in the world of work.

ISPE Good Practice Guide: Technology Transfer 3rd Edition Released

  • Posted on: 22 January 2019
  • By: Shalini.Sharma

The International Society for Pharmaceutical Engineering (ISPE) ISPE announced the release of their latest Guide, ISPE Good Practice Guide: Technology Transfer 3rd Edition. This Guide provides industry good practices for successful and efficient execution of technology transfer projects.

Indian firms recall drugs in US market

  • Posted on: 22 January 2019
  • By: Shalini.Sharma

INDIAN DRUG majors Lupin, Sun Pharma and Glenmark Pharmaceuticals are recalling various drugs from the US market for a variety of reasons.

New Findings Reveal Surprising Role of the Cerebellum in Reward and Social Behaviors: NIH

  • Posted on: 18 January 2019
  • By: Shalini.Sharma

A new study in rodents has shown that the brain’s cerebellum—known to play a role in motor coordination—also helps control the brain’s reward circuitry. Researchers found a direct neural connection from the cerebellum to the ventral tegmental area (VTA) of the brain, which is an area long known to been involved in reward processing and encoding. These findings, published in Science, demonstrate for the first time that the brain’s cerebellum plays a role in controlling reward and social preference behavior, and sheds new light on the brain circuits critical to the affective and social dysfunction seen across multiple psychiatric disorders. The research was funded by the National Institute of Mental Health (NIMH), part of the National Institutes of Health.

FICCI welcomes government's move to accord 'industry status' to hospitals

  • Posted on: 17 January 2019
  • By: Shalini.Sharma

The Federation of Indian Chambers of Commerce and Industry (FICCI) has welcomed the Government's announcement of according 'industry status' to private hospitals, along with support for land acquisition, clearances and funding, to boost expansion of healthcare infrastructure in tier 2 and 3 cities.

FDA approves first generic version of Sabril to help treat seizures in adults and pediatric patients with epilepsy

  • Posted on: 17 January 2019
  • By: Shalini.Sharma

The U.S. Food and Drug Administration approved the first generic version of Sabril (vigabatrin) 500 mg tablets for treating complex partial seizures, also called focal seizures, as an adjunctive therapy (given with another primary treatment) in patients 10 years and older who have responded inadequately to several alternative (refractory) treatments.

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