Waxman asks Obama to look for alternative pathway for biosimilars
NEW YORK Support for a regulatory pathway for biosimilars has grown rapidly, and even a few branded companies, such as Merck & Co. and Pfizer, have expressed interest. But Rep. Henry Waxman’s, D-Calif., request that the Obama administration look for legal means to let the FDA approve biosimilars before his bill, its companion in the Senate or fellow California Democratic Rep. Anna Eshoo’s competing bill is put to a vote, is a strong signal that biogenerics are going to be a reality in American health care — and sooner rather than later.
The Federal Trade Commission released a report Wednesday concluding that giving the Food and Drug Administration authority to approve biosimilars would be an efficient way to get them to market and lower consumers’ healthcare costs.
Immediately, the Generic Pharmaceutical Association praised the report, while the Biotechnology Industry Organization criticized it, particularly over the assertion that allowing market exclusivity periods of 12 to 14 years would be “too long to promote innovation.”
But the report also drew applause from CVS Caremark, whose EVP specialty pharmacy services, Dave Golding, participated in an FTC roundtable event on the issue last fall. CVS’ support is significant because of its stake – through its Caremark Pharmacy Services division – in the growing specialty pharmacy industry, which relies heavily on biotech drugs. In its 2009 Drug Trend report, pharmacy benefit manager Medco, which operates a significant specialty pharmacy business of its own, noted that a pathway for biosimilars could generate “a significant new wave of cost savings opportunities.”
Natrol launches vitamin supplement
CHATSWORTH, Calif. Natrol on Thursday launched Fish Oil + Vitamin D3, a combination of nutrients for overall health and immunity. The supplement is formulated as a softgel to be taken once daily at an average suggested retail price of $16.99.
The company cited recent scientific studies that have shown vitamin D3 — the vitamin that the body manufactures from sunlight — to be beneficial for aiding overall health, including bone health, immunity support and cellular protection in both men and women, and especially for middle-age and older adults, as the genesis for combining the two ingredients.
Commonly known for their heart health and bone health benefits, fish oil (omega-3 fats) and vitamin D have recently been studied for their cellular activity and abilities to promote breast health, colon health and prostate health, Natrol added. At the cellular level, research shows that omega-3 fats are the building blocks for cellular membranes.
Stayhealthy presents wireless body-fat analyzer; final product to be HealthVault-friendly
BELLEVUE, Wash. Following a two-year clinical study at the University of Southern California, Stayhealthy on Thursday introduced their next generation body composition analysis technology at Microsoft’s Connected Health Conference.
The technology accurately measures body composition in various forms depending on the need – from a home use individual device that will retail for less than $100 to a commercial grade device for physicians, fitness and nutrition professionals.
The devices will be able to upload the data directly into Microsoft HealthVault. “Stayhealthy’s body composition analysis is an example of inexpensive and innovative technology that connects with HealthVault to really make a difference in improving healthcare,” stated David Cerino, general manager of the Consumer Health Solutions Group at Microsoft. “Through our cooperative efforts, we are creating technology that brings together the power of the web, server-based processing and medical grade devices to deliver a revolutionary means of helping people better understand and measure their weight-related health risks.”
“At a time when our nation faces a healthcare crisis driven by excess weight and obesity, we are excited to introduce the Stayhealthy Body
Composition Analysis technology,” stated John Collins, CEO of Stayhealthy. “By providing this technology we hope to help millions of people track their body compositions and make positive adjustments as necessary.”
Stayhealthy’s Body Composition Analysis technology incorporates two elements – a physical data collection device that utilizes bio-impedance technology, and a proprietary server-based algorithm that analyzes the data collected at the device and provides a precise body composition reading via the Internet back to the user’s computer.