California Governor Jerry Brown has vetoed a bill that would have limited the use of biosimilar pharmaceuticals in the state. Governor Brown explained that the legislation was premature, as the FDA hasn't yet set the rules governing such drugs. Biosimilars are not called generics, as it's difficult to prove that they're exactly the same as the biologic original. The campaign to limit the use of biosimilars has been led by Amgen and Genentech. So far, 10 states have blocked such efforts this year, including Illinois and Texas .. Read more

Right Site Asia, an industrial real estate specialist, estimated that there are more than 1 ,000 biotech industrial parks across the country. Most of these parks are small and spread around the country; the largest and most successful are in major urban centers. An informal list of what might be the 10 largest, most successful and best known of these parks includes the following ..... Click here to access the list

"We designed the recent studies with input and guidance from the FDA, and both achieved their primary efficacy endpoints and safety objectives," said  Alfred Mann (photo right), Chairman and Chief Executive Officer of MannKind Corporation. "I am very proud of our team for completing an extensive submission on a very ambitious schedule. We will continue to work with the FDA to bring AFREZZA to market for the millions of diabetes patients in the United States who might benefit from this novel product." ... Read press release

The Aliso Viejo-based Inceptus Medical, LLC, a medical device company incubator, announced today that it has completed a $4.7M Series A financing for its first new company, Inari Medical Inc. The financing will provide the resources to develop and commercialize innovative devices for the interventional treatment of cardiovascular disease ...Read more

The Monrovia-based Xencor was founded in 1997 and is led by Chief Executive Bassil Dahiyat (photo right). It recorded $9 million in collaboration revenue for the 12 months ended June 30. Corporate partners include Amgen Inc., Pfizer Inc. and Boehringer Ingelheim. The company said net proceeds from the offering will pay for mid-stage clinical study for an autoimmune treatment and an early-stage study of an asthma therapy. Amgen has licensed an option to commercialize the autoimmune drug if trial results pan out  ...

Amgen to apply the Emerville-based KineMed's mass spectrometric Dynamic Proteomics platform to the study of brain protein homeostasis linked to neuro-degenerative diseases. KineMed's biomarker platform will allow Amgen to track synthesis and clearance rates of pathogenic proteins in the brain that drive neurodegeneration ... Read more   

The FDA's Sept. 19 letter to the company reflects alleged violations found during an inspection of Medtronic's Northridge, CA, manufacturing facility from Feb. 11 through April 12, 2013. Regulators spotted a number of quality system violations. Among the issues for which they cited Medtronic: not having a viable system that enables correction and prevention of manufacturing problems .... Read more