Septmber 2014


The FDA is reopening the comment period for the draft guidance document entitled “Informed Consent Information Sheet.” A notice of availability requesting comments on the draft guidance document appeared in the Federal Register of July 15, 2014. The Agency is reopening the comment period to update comments and to receive any new information. 
Comments will be received through October 27, 2014.
 
Israeli scientists behind scientific breakthrough in protein mapping. In an article published in the Proceedings of the National Academy of Sciences (PNAS), Israeli researchers at the universities of Tel Aviv and Haifa sketch the results of research that has successfully mapped the connections between thousands of common proteins, exposing the evolutionary history of their development. The research is expected to make a major contribution to protein engineering, a broad field applied in wide variety of commercial contexts, including synthetic drug production, consumer product development, and the food industry.
 
Significant rise in number of registered patents, but majority of income from pharmaceuticals. Income from Israeli intellectual property in 2012-2013 totaled NIS 1,881 million but gap still exists between academic achievements and economic application. A survey by the ministry’s National Council for Research and Development found that 1,438 patents were registered – 1,000 of them completely new (not registered before in other countries). The innovations led to the founding of 72 start-up companies here in the past two years.
 
Israeli Breakthrough Takes on Infertility. In an article published in the Proceedings of the National Academy of Sciences (PNAS), researchers at Sheba Medical Center in Tel Hashomer and Tel Aviv University detailed results of a study that could increase the success rates of IVF treatments in women battling infertility. The scientists identified a protein, Interleukin-1, which contributes to the reduction of the number of immature egg cells in a woman's ovarian reserve, and to resultant reduced fertility.
 
Israel's A1 Credit Rating Maintained. In an update to the markets released last month, Moody's Investors Service maintained Israel's A1 sovereign rating and stable outlook. The report noted Israel's resilient growth model and effective governance as underpinning its strong rating. "Key to Israel's economic dynamism is a high-tech export sector that benefits from the country's well-educated, relatively young population, as well as one of the highest levels of per capita investment in research and development. Foreign capital inflows are also substantial, as evidenced by the recent decision of Intel to build its $6 billion new chip plant there."
 
Intel & GOI Arrive at Final Investment Agreement. In the largest single investment by a foreign company in Israel, Intel Corporation will invest $6 billion to upgrade its chip manufacturing facility, following approval of its plan by Israel's finance and economy ministries. In a special incentives package designed to increase the attractiveness of the decision, the GOI will proffer the U.S. chip giant a grant in the amount of $300 million over five years, and will offer the company a drastically reduced corporate tax rate of 5% for a 10-year period. Currently, the company employs close to 10,000 people in Israel, and has exported some $35 billion in goods from the country since first establishing local operations forty years ago. During that time, it has invested $10.8 billion in plants and development centers, and received $1.5 billion in grants from the Israeli government.
 
Israeli Company Contracted to Protect American Public Health. Israeli Atox Bio announced that the U.S. Biomedical Advanced Research and Development Authority (BARDA) has granted it a 4.5 year contract valued at up to $24 million, to continue developing its AB103 medicine for treatment of Necrotizing Soft Tissue Infections (NSTI), a rare but very severe bacterial infection. BARDA is the American governmental agency charged with developing and acquiring vaccines, drugs, and diagnostic tools to protect public health in the face of medical emergencies.