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1043 Total results for product and free and sample content found

Biomedtracker

Clinical Trials Industry Report

By KNect365 17 Aug 2018

Clinical trials are continually evolving, particularly in light of increasing pressures from new technologies and other disruptors. Trends ranging from artificial intelligence (AI) and mHealth to patient-centricity are challenging the industry to innovate against the backdrop of looming regulatory changes and shifting competitor landscapes resulting from M&A activity. In order to explore these trends, KNect365 Life Sciences recently conducted one of the biggest surveys of its kind across clinical trial professionals from within pharma, CROs, sites, service providers, academia and patient groups across the world to look beyond the hype.

Topic Clinical trials Clinical trial optimization

Pharma Consulting

Changing the future of data

17 Aug 2018

With fewer successful drug launches in the market and expiring patents, competitive intelligence and commercial R&D decision makers are hard-pressed to make sound forecasting and planning decisions based on highly reliable data analysis. That’s a big challenge because, even with access to big data from many sources, the tasks associated with collecting, organizing and mapping data sets is time-consuming, costly and labour-intensive. As result, decision making takes longer and innovation suffers.

Topic Business strategies Company analysis

Scrip

Amicus' Oral Fabry Drug Priced To Compete Against Traditional ERT

By Jessica Merrill 17 Aug 2018

FDA approved Galafold under accelerated approval, paving the way for the launch of the first oral therapy to treat a subset of patients with the rare condition Fabry disease. Amicus priced Galafold at $315,000 per year.

Topic FDA

Scrip

Sensyne Health CEO Drayson Says IPO Will See AI Group To Profitability

By Sten Stovall 17 Aug 2018

Flush with IPO funding, AI-focused healthcare technology group Sensyne Health will now ready additional products and find three more NHS trust partnerships. CEO Lord Drayson spoke to Scrip.

Topic Research Business strategies

Medtech Insight

QSR Author Kim Trautman Predicts What A Mash-Up Of FDA's Quality System Regulation And ISO 13485 Might Look Like

By Shawn M. Schmitt 17 Aug 2018

US FDA will face high hurdles as it works to write a new rule that would merge the agency's Quality System Regulation with international quality systems standard ISO 13485. That's according to Kim Trautman, a longtime industry insider who wrote the QSR in the early to mid-1990s. "It’s a clear heavy lift from a regulatory policy perspective" that could take as long as five years to complete, she says. In the meantime, Trautman offers some insight into what device-makers might see in a new hybrid quality systems regulation from FDA. She addresses everything from corrective and preventive action (CAPA) to labeling, and complaint handling to risk management – and more.

Topic FDA

Medtech Insight

Pre-Certs, Test Groups And More: US FDA Outlines Possible New Dx Paradigm

By Sue Darcey 17 Aug 2018

The agency has responded to a draft diagnostics reform bill in Congress with proposed reforms that diverge some ways from the proposed legislation, but stick with the underlying goal of completely remaking how lab tests, including test kits and lab-developed tests, are regulated. The agency has put forward a proposal to establish a pre-certification process for test developers, divide most tests into high- or low-risk categories (but exempt many from pre-market review) and remove the concept of substantial equivalence.

Topic FDA

Rose Sheet

GC3 Announces Preservative Challenge Winners

By Ryan Nelson 17 Aug 2018

Avisco, a biotech startup focused on the antimicrobial properties of the Inula viscosa plant, and IMD Natural Solutions, whose INS Glycolipid mushroom extract purportedly is “up to 80 times more effective than traditional preservatives,” are among winners named Aug. 6 by GC3.

Topic BioPharmaceutical

In Vivo

True Innovation In Women's Health Hindered Because Conditions Are Not Fatal

By Lucie Ellis 17 Aug 2018

Drug developers and financiers discuss the biggest challenges delaying novel R&D in diseases effecting only women and how poor awareness of the debilitating symptoms that come with some conditions has led to a lack of emphasis on innovative research.

Topic Drug approval Drug review

Medtech Insight

Pharma Intelligence Announces the Finalists for the First Annual Medtech Insight Awards

16 Aug 2018

LONDON – AUGUST 13, 2018 – Informa Pharma Intelligence today announces the finalists for the 2018 Medtech Insight Awards. The diverse group of finalists were chosen by a highly respected independent panel of experts from across the sector.

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