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Biomedtracker
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.
Pharma Consulting
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.
Scrip
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
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
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
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
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
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
Biomedtracker
15 Aug 2018
What's on the horizon for pharma in 2018? Find out with Biomedtracker's Early 2018 Outlook Report extract. Download free extracts from this essential report, which investigates the catalysts expected to occur in the first part of the year for 21 different drugs.
Biomedtracker
15 Aug 2018
Download an extract of the data-rich resource: Biomedtracker’s Q3 2018 Outlook Report. This latest installment in Biomedtracker’s ongoing quarterly reports contains expected drug catalyst predictions, important clinical and regulatory milestones, and Large Impact catalysts for the upcoming quarter.
Meddevicetracker
14 Aug 2018
In this report, we cover catalysts from 10 devices expected to occur in Q3 2018. These include important regulatory milestones and trial data across the cardiovascular, neurology, and endocrine (including diabetes) spaces. Additionally, at the end of this report we have included a list of Large Impact catalysts through Q3 2018.
Scrip
By Mandy Jackson 14 Aug 2018
Perrigo previously saw value in keeping its prescription pharmaceuticals in-house, but now says it will sell off or spin out the topical generics to focus on its over-the-counter brands. Questions remain about whether the company's generics portfolio is valuable enough to stand alone or attract a buyer.
Scrip
By Jules Quartly 14 Aug 2018
The market debuts of BeiGene and Ascletis on the new Hong Kong Stock Exchange’s Biotech section could further encourage other Chinese biotech companies as they seek to draw in a wider pool of investors and focus on the promising domestic sector.
Pink Sheet
By Bridget Silverman 14 Aug 2018
Differences in eligibility and evidentiary criteria between the US FDA's two expedited regulatory programs are reflected in a new guide; metrics to date suggest comparable success rates for designation requests under the two programs. Our infographics aid in understanding the programs.
Topic FDA
In Vivo
By William Looney 13 Aug 2018
The 16 million survivors of cancer in the US today form a restless constituency with its own disparate set of interests – and by sheer weight of numbers is beginning to direct changes to medical practice that pose both risks and opportunity for biopharma.
Topic Cancer
Medtech Insight
20 Aug 2018
Pink Sheet
19 Aug 2018
Pink Sheet
17 Aug 2018
Pink Sheet
17 Aug 2018
Scrip
17 Aug 2018
Scrip
17 Aug 2018
Pink Sheet
17 Aug 2018
Scrip
17 Aug 2018
Scrip
17 Aug 2018
Scrip
17 Aug 2018
Scrip
17 Aug 2018
Scrip
17 Aug 2018
Medtech Insight
17 Aug 2018
Pink Sheet
17 Aug 2018
Medtech Insight
17 Aug 2018
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