May 2012

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FDA is amending the regulations to expand the scope of clinical investigator disqualification.  Under this rulemaking, when the Commissioner of Food and Drugs determines that an investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA.
 
The FDA has issue an update to the Human Subject Protection (HSP)/Bioresearch Monitoring (BIMO) Initiative Accomplishments Report. The report highlights FDA's significant accomplishments and initiatives relating to the conduct of clinical trials from September 2010 through the present.

Orbimed Closes $222M Fund for VC Opportunities in Israel. US healthcare investment management firm OrbiMed has announced the closing of its first investment fund dedicated to life science venture capital opportunities in Israel. The $222 million fund, which will be called the OrbiMed Israel Partners Limited Partnership, includes an investment of approximately $40M provided by the Israeli government.
 
Israeli biomed companies raised more than quarter of the total amount raised during the first quarter of 2012, according to survey conducted by KPMG and IVC-Online towards the ILSI-Biomed conference. Israeli medical equipment companies raised 71 million dollars; the higher amount among the life science sector (Hebrew)
 
Increase of 20% in demand for employees working in checmistry areas in the biomed industry (Hebrew)

Report: Orphan drug market on the rise. GBI Research, a pharmaceutical market expert, has released its report "Orphan Disease Therapeutics Market to 2018: Improved Understanding of Rare Diseases' Heterogeneity and Novel New Clinical Trial Designs to Foster Innovation,” which provides insights into the orphan disease therapeutics market until 2018.
 
The ILSI-Biomed 2012 Conference will be held May 21-23, 2012 in Tel-Aviv. This is the leading international conference covering the fast-growing field of innovation in the biomedical, health care and life sciences industries, where industry and academia join hands to learn about the latest and future developments, explore opportunities for new business ventures, meet up with old colleagues and make new contacts.