Industry News

Pfizer and GlaxoSmithKline Announce Joint Venture to Create a Premier Global Consumer Healthcare Company

  • Posted on: 21 December 2018
  • By: PharmaTutor News

Pfizer Inc and GlaxoSmithKline plc announced they have entered into an agreement to create a premier global consumer healthcare company with robust iconic brands. The Boards of Directors of both companies have unanimously approved the transaction under which Pfizer will contribute its consumer healthcare business to GlaxoSmithKline’s existing consumer healthcare business. The 2017 global sales for the combined business were approximately $12.7 billion.

FDA new steps to promote innovations in medical devices that help advance patient safety

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

Spurring innovation of medical products so that patients can have access to safe, effective treatments that improve or save lives is a fundamental part of our mission. FDA is taking steps on two additional device programs: finalizing guidance on our existing Breakthrough Device Program and announcing plans for a new Safer Technologies Program (STeP).

FDA efforts to modernize generic drug labels while maintaining the efficiency of generic development

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

Protecting patient safety is at the core of the FDA’s mission. All FDA-approved drugs have benefits and risks which must be weighed and balanced by health care providers and patients when making decisions about medical therapy. Our goal is to ensure that the benefits and risks are clearly articulated in drug labeling. That patients and providers have accurate information. And that the benefits outweigh the risks for the intended patient population.

GHIT Fund Announces New Investments in Vaccines for Dengue and Leishmaniasis, and Drug Screening for Malaria and Tuberculosis

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

The Global Health Innovative Technology (GHIT) Fund announced a total of 520 million yen (US$ 4.6 million) to support four partnerships to develop new lifesaving drugs and vaccines for malaria, tuberculosis, dengue and leishmaniasis. This includes three new projects and one that will receive continued funding.

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.

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