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C360 Spine Portfolio Unveiled -NuVasive Advises Launch Represents a Significant Opportunity for Growth As Cervical Spine Procedures Comprise An Approximately $2.6 Bil Segment of the Global Spine Market

"C360 spine portfolio unveiling reflects NuVasive's commitment to deliver innovative technology for the anterior and posterior cervical spine designed to improve the quality of care even in the most established area of spine," said Massimo Calafiore, executive vice president, Global Business Units at NuVasive.

Novel Biosynthetic Tissue Valve 6 Month Clinical Results Reported

Six-month data for 16 patients enrolled across three sites in the United States were presented in a moderated poster session during the American Heart Association Virtual Scientific Sessions from November 13-17, 2020. The poster, P148, is titled, Early Results of a Novel ePTFE-based Pulmonary Valved Conduit in a Pediatric Patient Population.

Retinal-imaging Breakthrough That Can Swiftly Detect Eye Diseases

European researchers are developing a new real-time scanner that will create a full image of a moving eye without any blurring. Teaming up with photonics innovation hub ACTPHAST 4R the scientists at Vrije Universiteit (VU) Amsterdam are progressing their scanner concept to a demonstrator stage to acquire data faster than existing optical imaging technologies.  

Hologic Showcases Products at Virtual RSNA 2020

Company will virtually showcase its extensive portfolio of breast and skeletal health products, including screening, surgical, interventional, ultrasound, and skeletal solutions, at the 106th Scientific Assembly and Annual Meeting of the RSNA from Nov. 29 to Dec. 5.

FDA Provides Guidance to Industry for Detecting and Preventing Nitrosamines in Drugs: Statement from FDA Commissioner Stephen M. Hahn, M.D., and Patrizia Cavazzoni, M.D.

Nitrosamines: Since the outset of our discovery of impurities called nitrosamines in some types of drugs more than two years ago, the U.S. Food and Drug Administration has undertaken a thorough investigation in an effort to protect patients. While nitrosamines are common in water and foods, nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time.

For this reason, the discovery of unexpected nitrosamine impurities in some drug products is a serious concern, and the FDA has been working, in collaboration with regulatory counterparts around the world, to find and remove drugs with unacceptable nitrosamine impurities from the U.S. drug supply. As we do so, we’re also taking proactive efforts to help ensure that in the future, drugs can be free from unsafe levels of these impurities from the start of production.

Ensuring that drugs are safe, effective and high-quality is a critical part of FDA’s mission. In our continued efforts to be transparent and provide guidance to manufacturers on how to detect and prevent unacceptable levels of nitrosamine impurities, today we’re publishing our guidance Control of Nitrosamine Impurities in Human Drugs for immediate implementation. This guidance recommends steps, including a comprehensive risk assessment strategy and other actions that manufacturers can take to reduce or prevent the presence of nitrosamine impurities in their drugs.

There are many reasons why these impurities might appear in some drugs, and consequently many approaches to screening for and preventing the appearance of nitrosamines to help ensure drug quality and safety. The source of these impurities can be related to the drug’s manufacturing process, the materials used in manufacturing, the drugs’ chemical structure, or even the conditions in which drugs are stored or packaged. Under FDA’s oversight, manufacturers are responsible for mitigating these impurities.

The most common nitrosamine impurity, N-nitrosodimethylamine (NDMA), is found at low levels in water and foods, including cured and grilled meats, dairy products and vegetables. The FDA and the international scientific community do not expect NDMA to cause harm when ingested at low levels. However, given the risk that genotoxic substances such as NDMA may increase the risk of cancer if people are exposed to them above certain levels and over long periods of time, manufacturers have recalled drugs with NDMA levels higher than the FDA’s recommended acceptable intake levels. Patients taking medications with potential nitrosamine impurities should not stop taking their medications and should talk with their health care professional about concerns and other treatment options.

We believe that the guidance we’ve issued today will assist manufacturers in preventing unacceptable levels of nitrosamines in drugs. Protecting patients is the FDA’s highest priority, and we will continue to work with manufacturers and our international regulatory partners to investigate and definitively resolve this problem.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Latest Posts

C360 Spine Portfolio Unveiled -NuVasive Advises Launch Represents a Significant Opportunity for Growth As Cervical Spine Procedures Comprise An Approximately $2.6 Bil Segment of the Global Spine Market

"C360 spine portfolio unveiling reflects NuVasive's commitment to deliver innovative technology for the anterior and posterior cervical spine designed to improve the quality of care even in the most established area of spine," said Massimo Calafiore, executive vice president, Global Business Units at NuVasive.

LuminUltra Acquires Source Molecular Corporation – To Expands Testing Capacity Including Range of COVID-19 Offerings

LuminUltra has acquired Source Molecular Corporation, a leader in lab-based testing solutions for microbial source tracking of pathogens including SARS-CoV-2, the virus that causes COVID-19.

MapLight Therapeutics Receives $8.1 Million For Parkinson’s Disease Research

The company will use the funds to undertake a large-scale, systematic investigation of the brain circuits and mechanisms that are responsible for triggering psychiatric symptoms in Parkinson's disease.

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Genetron Health Provides Update on HCCscreen™ for Liver Cancer Early Screening in China

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Research Paper Showing ProtoKinetix AAGP® Enhanced Stem Cell Derived Retina Precursor Cells Restoration of Vision

ProtoKinetix notes the research paper has been submitted to a prestigious journal specializing in tissue regeneration for peer review and editing.

OrganaBio to Expand Its cGMP Cell and Gene Therapy Manufacturing Facility: 19,000 Sq. Ft. Slated to Commence Operations In Q3 2021

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Stoke Therapeutics Announces Proposed Public Offering

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TissueCypher Barrett’s Esophagus Assay Confirm the Ability to Identify Patients at High Risk for Progression to Cancer

TissueCypher Barrett’s Esophagus Assay independent peer-reviewed studies, are authored by Prof. Jacques Bergman and Dr. Nicola Frei (University Medical Center, Amsterdam, the Netherlands).