Starting this year, the US Centers for Medicare and Medicaid Services (CMS) has instituted a new system for Common Procedural Terminology codes, which are used to bill Medicare for molecular diagnostics tests. Test 1 tests include most of the tests already in use. Tier 2 consists of low-volume, esoteric test divided among nine levels. Pricing […]
Drug approvals by the US FDA’s Center for Drug Evaluation and Research reached a 15-year high last year, growing 33% to 39 new drugs, and consisting of 33 new molecular entities, up from 24 in 2011, and 6 new biological entities, the same as a year ago. Twenty of the drugs were first in-class agents. […]
Global investments in clean energy declined 11% last year to $268.7 billion. Countries where investments showed the fastest growth included China, the largest investor, where they increased 20% to $67.7 billion; and Japan, where they jumped 75% to $16.3 billion (excluding R&D). US, German and Brazilian investments plunged 32%, 27% and 32% to $44.2 billion, […]
US R&D grew 1.8% to $414.0 billion in 2011, according to preliminary estimates. But, in constant dollars, the amount, as in the previous two years, is below 2008 levels. Also, as in 2010, R&D grew slower than GDP in 2011. Business funded 60% of US R&D activities in 2011, a 0.1% increase, and performed 69%, […]
The US FDA released proposals earlier this month for two new food safety rules as part of the Food Safety Modernization Act. The first rule, “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food,” would require firms handling food to have written plans identifying hazards and how to address them, […]
The US Congress passed legislation in early January temporarily delaying automatic federal budget cuts until March 1. It is estimated that the fiscal 2013 cuts would have eliminated 2,500 NIH grants and 1,500 NSF grants. However, research funding remains vulnerable. The new agreement only lowers the required cuts for fiscal 2013 from $361 billion to […]
According to a new estimate by the UK’s Office of Health Economics based on 2002 and 2003 confidential CMRI surveys, the average R&D cost of a medicine is $1.5 billion (in 2011 prices). The four primary variables affecting the cost are out-of-pocket costs, success rates, development times and cost of capital. The cost of capital […]
This month, the EPA released final amendments to clean air standards for industrial boilers and certain incinerators, as well as a new definition of nonhazardous secondary materials. Of the 1.5 million boilers in the US, less than 1% will need to meet numerical emission limits, which differ among the different subcategories of boilers, and 13% […]
Global R&D spending is forecast to increase 1.8% to $1,496.4 billion in 2013, measured in purchase powered parity, down from 5.2% growth. R&D expenditures in the life sciences, chemicals and energy sectors are expected to increase 4.2%, 0.6% and 1.6% to account for 13%, 3% and 1% of worldwide R&D spending, respectively. R&D spending is […]
US biotech revenues grew 4.9% last year to $53.8 billion, compared to 6.5% in 2010, according to Novel Health Strategies. By biologics class, monoclonal antibodies (mAbs) remained the largest, with sales rising 10.1% to around $20.3 billion. Ten of the 36 FDA-approved mAbs accounted for 86% of sales. The fastest growing major class was hormones, […]
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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.

