Lonza news Tolvaptan identified as a treatment for autosomal dominant polycystic kidney disease

A phase 3 trial studying the effects of tolvaptan has found that the drug slowed the rate of decline in kidney function in patients with polycystic kidney disease… A phase 3 trial studying the effects of tolvaptan has found that the drug slowed the rate of decline in kidney function in patients with the most […]

Testing GxP system that is FDA-compliant

Process validation is the method of using data from stages ranging from the process design stage to production, to ensure that the process that is being used can deliver consistently high-quality products. Companies that come under the life sciences must comply with GxP regulations to ensure that their processes meet the regulatory guidelines to be […]

GMP and Regulatory Expectations for Early IND Products

 What the FDA’s recent guidance documents covering GMP requirements for Phase I products have done is to significantly reduce a few of the complexities that early phase products are typically against. These guidance documents are in addition to those that cover the CMC sections for IND submissions at Phase I. These new guidelines appear to […]

Video of father comforting newborn son receiving his first vaccines goes viral

On October 26, first-time father Antwon Lee took his two-month-old son Debias King to get his first vaccinations. Lee, 29, said he was very nervous for the appointment, telling People Magazine that he “felt kind of scared a little bit,” as he knew the child was “going to go through some pain.” Before the visit, […]

The science of Sad: understanding the causes of ‘winter depression’

For many of us in the UK, the annual ritual of putting the clocks back for daylight saving time can be accompanied by a distinct feeling of winter blues as autumn well and truly beds in. This might be felt as a lack of energy, reduced enjoyment in activities and a need for more sleep […]

The use of Applied Statistics for FDA Process Validation

The use of Applied Statistics for FDA Process Validation is considered a matter of very high importance in the pharmaceutical industry. The FDA’s guidance for the industry, which it called “Process Validation: General Principles and Practices”, was set up in 2011. This guideline sets the framework for Process Validation in the pharmaceutical industry. The FDA […]

Professionals Involved in The FDA’s Tougher Import Rules for 2017

Of late, the FDA and the Customs and Border Patrol Service (CBP) have become increasingly agile, smart, sophisticated and demanding when it comes to the submission of information and adherence to government procedures from importing firms. The FDA and the CBP can delay, detain or refuse shipments of firms do not properly execute an import […]

A step towards better health care

  Today, we live in an era of customization. Increasingly, customers can modify a product’s appearance, features, or content according to their unique needs or desires. Often, even the news we see in our newsfeeds is customized based off our preferences. Why, then, are so many aspects of the health care industry still one-size-fits-all? As […]

Flu vaccine: NHS patients wanted to test ‘universal’ jab

Researchers are seeking about 500 NHS patients to try out a new “universal” vaccine against seasonal flu. The experimental vaccine works differently from the one currently available, which has to be remade each year based on a “best guess” of what type of flu is likely to be about. The new jab targets part of […]

Program for parents improves ADHD behaviors in young children

A program that focuses on strengthening parenting skills also improves symptoms of Attention Deficit/Hyperactivity Disorder (ADHD) in 3-8 year-olds, according to researchers at the at the University of North Carolina at Chapel Hill. FPG scientists completed a rigorous review of evidence that demonstrated the effectiveness of the “Incredible Years Basic Parent Program.” “Prior research already […]