Tap into the findings of the latest Regulatory Affairs Professionals Society Overall Compensation & Scope of Practice Survey, a comprehensive study of the salaries, hiring trends, and other noteworthy data for regulatory professionals in 64 countries around the globe.
Names have not been made public, but two frontrunners have been chosen as contenders for notified bodies under the European Union’s new Medical Device Regulation. Find out who the frontrunners could be, and how timing is playing a critical role in this crucial announcement.
The US Centers for Medicare and Medicaid Services (CMS) say they are seeking to improve medical devices reimbursement procedures as the device industry looks for a policy to help breakthrough devices receive temporary and automatic Medicare and Medicaid coverage. Read more here.
Medtech Insight’s Compliance Corner is back for the final installment of the three-part series on Investigator Horror Stories. Tap into the recollections of top industry insiders for a jaw-dropping look at some of the more outrageous tales from the world of compliance.
At the recent Medidata NEXT London meeting, Medidata Solutions, Inc., explained their new Clinical Cloud solution, part of the new crop of clinical trials and data analysis tools that only a few years ago, seemed like a distant dream. Read how Clinical Cloud and other clinical trials tools are taking data analysis to new heights in this informative article.
Explore the findings of an October 2018 panel discussion of market analysts and market access specialists as they discuss the question: As new cures and treatments for patients develop, how does the conversation shift from delivering market access to products to focusing on patient access to progress?
Immuno-oncology: spurred by the approval of first-generation checkpoint inhibitors in 2014, this important market has continued to grow exponentially, as deals are made not only around checkpoint inhibitors themselves, but also for related molecules and technologies to be used in synergy with them. Examine the origins of this important and growing area in this essential In Vivo report.
As a European wave of Humira biosimilars challenges the best-selling drug in the world, the question of how biosimilars will affect the market, from payers, to practitioners, to patients, comes to the forefront. Examine how biosimilars are poised to change the landscape as focus shifts from whether to adopt their use to how to actually use them effectively.
Immuo-oncology is proving to be that rare animal for investors in pharma, where return on invested capital doesn’t seem necessarily tied to risk, with mature assets returning liquidity similar to those of early assets. Examine transaction trends, investor activity, and the exit landscape for this important area.
“Junk science” is being blamed for a lawsuit filed against Unilever for alleged “micro-tears” caused by their St. Ives Apricot Scrub. The suit, first filed in 2016, may be coming to the end of the road, as Unilever requests a summary judgement in the matter.
Plasticizer Dibutyl phthalate (DBP) is said to have been phased out of use in nail polishes, but a recent study by Harvard public health researchers wonders what is being used to replace the ingredient, and whether it is any safer than DBP.
NGO Women’s Voices for the Earth recently called for a ban of five ingredients used in fragrances for personal-care products. These ingredients were recently removed from the safe food additives list by the FDA, despite the FDA’s claims that they pose no risk to public health. Go deeper into this clash between hazard and risk ideologies in this informative article.
Find out more about the proposed The Safe Cosmetics and Personal Care Products Act 2018. This bill would institute a number of reforms for the industry and establish a new set of guidelines for safety, and is very similar to previous proposals for cosmetics reform submitted by Rep. Jan Schakowsky, D-Ill.
“Almost everyone at Deciem has been involved in a major criminal activity.” So claimed Deciem Inc. founder Brandon Truaxe on an October 8 Instagram post in which he also announced the controversial Estee Lauder Companies-backed startup would be ceasing operations “until further notice.” Find out more here.
Although criticism was leveled at the use of real-world datasets in the US FDA advisory committee review of Shire PLC’s constipation drug Motegrity (prucalopride) with worries raised over its lack of race-related patient information, a European pharmacoepidemiology study allayed concerns regarding its cardiovascular safety.
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