Industry News

NIH to fund HIV care and prevention research in vulnerable southern U.S. communities

  • Posted on: 14 December 2018
  • By: Shalini.Sharma

The National Institute of Allergy and Infectious Diseases will fund a series of collaborations with medical research institutions in the southern United States to test new ways of implementing HIV treatment and prevention tools in counties with some of the highest rates of new HIV cases nationwide. The U.S. South overall has the highest rates of new HIV diagnoses, people living with HIV, and HIV-related deaths of any U.S. region.

Tanzania is first African country to reach an important milestone in the regulation of medicines: WHO

  • Posted on: 14 December 2018
  • By: Shalini.Sharma

Tanzania is the first confirmed country in Africa to achieve a well-functioning, regulatory system for medical products according to the World Health Organization (WHO).  This means that the Tanzania Food and Drug authority (TFDA) has made considerable improvements in recent years in ensuring medicines in the healthcare system are of good quality, safe and produce the intended health benefit.

FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications

  • Posted on: 14 December 2018
  • By: Shalini.Sharma

The U.S. Food and Drug Administration  released a  warning letter  issued to Zhejiang Huahai Pharmaceutical Co. Ltd. (ZHP), in Linhai, Taizhou Zhejiang China, the manufacturer of the active pharmaceutical ingredient (API) found in valsartan that is the subject of an ongoing FDA investigation into probable cancer-causing impurities in certain commonly prescribed heart medicines. The letter outlines several manufacturing violations at ZHP’s Chuannan facility, including impurity control, change control and cross contamination from one manufacturing process line to another. The warning letter is another step forward in the ongoing investigation. The agency is still looking into the root cause of the impurity.

Myriad Validates Polygenic Score to Predict Breast Cancer Risk in Women of Hispanic Ancestry Who Test Negative for Hereditary Cancer Mutations

  • Posted on: 8 December 2018
  • By: Shalini.Sharma

Myriad Genetics, Inc a leader in molecular diagnostics and personalized medicine, today announced results from an important study to validate the polygenic component of a forthcoming riskScore™ test for Hispanic women who test negative for a hereditary cancer mutation with the myRisk® Hereditary Cancer test.  The results are being presented at the 2018 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas.

FDA’s new strategic framework to advance use of real-world evidence to support development of drugs and biologics

  • Posted on: 7 December 2018
  • By: Shalini.Sharma

The health care system is integrating more effective ways to leverage electronic tools to gather and use vast amounts of health-related data. These tools offer new opportunities to use data collected during the routine care of patients to advance medical care. Leveraging such data – typically called real-world data (RWD) - to improve regulatory decisions is a key strategic priority for the FDA. Today, the FDA is announcing our new 2019 strategic Framework for how we’ll continue to advance these opportunities.

Health benefits far outweigh the costs of meeting climate change goals: WHO

  • Posted on: 6 December 2018
  • By: Shalini.Sharma

Meeting the goals of the Paris Agreement could save about a million lives a year worldwide by 2050 through reductions in air pollution alone. The latest estimates from leading experts also indicate that the value of health gains from climate action would be approximately double the cost of mitigation policies at global level, and the benefit-to-cost ratio is even higher in countries such as China and India.

FDA approves an oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor

  • Posted on: 27 November 2018
  • By: Shalini.Sharma

The U.S. Food and Drug Administration  granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker).

Democratic Republic of the Congo begins first-ever multi-drug Ebola trial: WHO

  • Posted on: 27 November 2018
  • By: Shalini.Sharma

The Ministry of Health of the Democratic Republic of the Congo (DRC)  announced that a randomized control trial has begun to evaluate the effectiveness and safety of drugs used in the treatment of Ebola patients. The trial is the first-ever multi drug trial for an Ebola treatment. It will form part of a multi-outbreak, multi-country study that was agreed to by partners under a World Health Organization (WHO) initiative.

EMA and USFDA Workshop on how to better support medicine developers in the generation and preparation of quality data packages for PRIME and Breakthrough Therapy applications

  • Posted on: 25 November 2018
  • By: Shalini.Sharma

EMA and the US Food and Drug Administration (FDA) are organising a workshop on 26 November 2018 to discuss how regulators can better guide and support medicine developers in generating quality and manufacturing data packages in the context of development support programmes, such as the PRIority MEdicines scheme (PRIME) in the EU and Breakthrough Therapy designation programme in the US. The goal is to help patients to benefit as early as possible from these therapies that target serious or life-threatening diseases or unmet medical needs.

India's first chatbot for patients launched by Lupin

  • Posted on: 25 November 2018
  • By: Shalini.Sharma

Lupin announced the launch of a chatbot named ‘ANYA’ specially designed to provide medically verified information for health-related queries. ANYA is the first bot of its kind to be launched in India for disease awareness. It’s a made in India for India initiative aimed at answering patient queries related to ailments.

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