RESOLVE, ASRM Applaud FDA Changes to Donating Eggs and Embryos

RESOLVE, along with the American Society for Reproductive Medicine (ASRM) and the Society for Assisted Reproductive Technologies (SART), lobbied FDA to make needed changes to these proposed regulations. The new regulations now allow egg and embryo donors to be tested for infectious diseases up to 30 days prior to the use of the donated tissue, and adds an exemption from screening for donors of previously cryopreserved (frozen) embryos, allowing couples who completed infertility treatment to donate their frozen embryos to another infertile couple, even though they did not undergo screening.


Click here for more information: http://www.resolve.org/main/national/media/pressrelease/pr20050526.jsp?name=media&tag=press

Supreme Court of California Oral Arguments for Elisa B and Kristine H.

On May 24, 2005, the California Supreme Court heard oral arguments on two cases that could be pivotal to gay and lesbian rights to parent using assisted reproduction. The issues in Elisa B., and Kristine H. are as follows : (1) May the presumption in Family Code section 7611(d)—that a man is a presumed father if he “receives the child into his home and openly holds the child out as his natural child”—be applied to a birth mother’s same-sex partner when both women made the decision to have a child, received the child into their home and held the child out as their own, and agreed to support the child? (2) Under Johnson v. Calvert (1993) 5 Cal.4th 84, can both same-sex partners be considered the legal parents of children conceived as a result of artificial insemination and born during their domestic partnership? (3) Must a woman who donates ova that are fertilized in vitro and implanted in her domestic partner’s womb, resulting in the birth of a child, file an adoption petition in order to be a parent of the child under Johnson v. Calvert?

For more information about the cases and to hear the oral arguments, click the following link: http://www.courtinfo.ca.gov/courts/supreme/

Holozyme Therapeutics Receives FDA Approval for IVF Enzyme

Halozyme Therapeutics, Inc. (Amex: HTI), a development stage biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Cumulase(TM) for the treatment of oocytes to facilitate certain in vitro fertilization (IVF) procedures. The active pharmaceutical ingredient in Cumulase is the first and only recombinant human hyaluronidase approved in the United States for cumulus removal in the IVF process.

"We are thrilled to receive FDA 510(k) clearance to market our first product in the U.S.," said Jonathan Lim, MD, Halozyme's Chairman and CEO. "This achievement is a key milestone for our company and provides validation of our technology and our team's ability to develop and commercialize products based on recombinant human hyaluronidase."

Cumulase is an ex vivo formulation of rHuPH20 (recombinant human PH20 hyaluronidase) to replace bovine and ovine extracts currently used for the preparation of oocytes prior to IVF during the process of intracytoplasmic sperm injection (ICSI), in which the enzyme is an essential component. The enzyme strips away the hyaluronic acid that surrounds the oocyte, allowing the clinician to then perform ICSI, injecting the sperm into the oocyte. Cumulase provides the IVF specialist with a safer, purer and more reliable alternative to slaughterhouse-derived extracts.

Click here for more information: http://www.halozyme.com/4_0_investor.htm

FDA Donor Regulations Effective May 25, 2005

Beginning May 25, 2005, the U.S. Food and Drug Administration (FDA), has issued new guidelines requiring the screening of donated cord blood, semen, eggs and embryos (as well as other tissues) within seven days before or after the actual donation.

To read the complete article, please click the following link: http://www.surrogacy.com/Articles/news_view.asp?ID=131