Using biomarkers from patients’ tumors in clinical trials may not be as reliable as genetic variation in determining who will benefit most from particular drug treatments. For example, the protein levels detected in a test may differ based the part of a tumor from which a biopsy was obtained and the extent of a cancer’s […]
The US FDA has finalized its 2012 drafts on biosimilarity with three guidance documents. The first guidance presents the approach for sponsors to obtain evidence showing biosimilarity and by the FDA in reviewing applications for biosimilars. It also provides some clarifications in its recommendations. It encourages frequent consultation with the FDA during the early stages […]
More than 60 authors from the academic and industrial sectors have published a science and technology road map in the journal Nanoscale for graphene, related to 2-D crystals, other 2-D materials and hybrids. The authors are members of the Graphene Flagship, an international research initiative formed to take graphene from labs and into European society […]
Germantown, MD and Hilden, Germany 3/16/15; Cambridge, MA 3/16/15—QIAGEN has acquired certain technology and other assets from AdnaGen, a subsidiary of Alere, including the CE-IVD marked products AdnaTest Breast Cancer and AdnaTest Prostate Cancer. Terms were not disclosed. The technology enables enrichment and molecular analysis of circulating tumor cells from blood samples. QIAGEN will exclusively […]
Aubagne, France 4/17/15; Glasgow, UK 4/17/15—Biopharmaceutical industry provider Sartorius Stedim Biotech has acquired BioOutsource for an undisclosed amount. BioOutsource provides contract testing services for monitoring the safety and quality of biologic drugs and vaccines, specializing in services for biosimilars. Based in Glasgow, Scotland, BioOutsource’s 12-month revenues totaled around €9 million ($12 million = €0.75 = […]
With the completed acquisition of Life Technologies (see IBO 2/15/14) in 2014, Thermo Fisher Scientific further solidified its number one position among IBO’s list of the top 30 analytical and life science instrument, aftermarket and lab product companies. All sales and sales growth figures in this article are based on IBO’s calculations of companies’ revenues […]
This month, the FDA approved the first biosimilar drug in the US—Novartis’s Zarxio. An approximate copy of Amgen’s biologic drug Neupogen for increasing the white-blood-cell counts of cancer patients, Zarxio’s approval for all of Neupogen’s uses leads the way for competition and lower prices for biologics in the US. With the FDA now authorized to […]
At Pittcon, IBO took the opportunity to talk to executives at four of the analytical-instrument and laboratory-product industry’s largest companies, PerkinElmer, Shimadzu Scientific Instruments (SSI) (the US-based division of Japan’s Shimadzu), Thermo Fisher Scientific and Waters, to discuss challenges and opportunities for both their businesses and the instrument industry in general. Asked about challenges this […]
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IBO (Instrument Business Outlook) is a twice-monthly newsletter aimed at providing decision-makers with the latest and most complete information available on the life science and analytical instrument industry, and lab product markets. IBO delivers the latest curated industry news, information and trends, as well as SDi data and analysis to deliver the maximum in industry insight with a minimum time investment for executives and investors.
