Gilead Sciences pills prevent HIV in straight men and women. Alchemia Announces USFDA Approval. Print E-mail
By Staff and Wire Reports   
Wednesday, 13 July 2011 19:37
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 13, 2011.

Gilead Sciences, Inc. (Nasdaq:GILD) pills prevent HIV infection in heterosexual men and women.  Two new studies found that daily pills prevented infection with the AIDS virus in heterosexual men and women in Africa, bringing new hope for someday offering a medical shield against HIV infection.

Earlier this year, another study found the same pills did not prevent the AIDS virus among women in Kenya, Tanzania and South Africa. But researchers now say that study may have been flawed based on the success of the two studies announced Wednesday.  The first of the new studies, run by the CDC, involved more than 1,200 men and women in Botswana. About half got a daily pill, Truvada, an HIV treatment made by Gilead Sciences Inc. The other half got a fake pill.

An analysis of people who were believed to be regularly taking the pills found four of those on Truvada became infected with HIV, compared to 19 on the dummy pill. That means the real drug lowered the risk of infection by roughly 78 percent, researchers said.  The second study was funded by the Bill & Melinda Gates Foundation and run by the University of Washington. It involved more than 4,700 heterosexual couples in Kenya and Uganda. In each couple, one partner had HIV and the other did not. The uninfected were given either daily placebos, Truvada pills, or another Gilead treatment, Viread.

The study found 13 HIV infections among those on Truvada, 18 in those on Viread, and 47 of those on dummy pills. So the medications reduced the risk of HIV infection by 62 percent to 73 percent, the researchers said.  An independent review panel on Sunday said the benefit was clear-cut and stopped giving placebos, instead offering the preventive pills. Essentially, they deemed it unethical to withhold the medications from people who had been on placebo, said Dr. Jared Baeten, the University of Washington researcher who co-chaired the study.

"Our results provide clear evidence that this works in heterosexuals," he said.  In both studies, participants also were offered counseling and free condoms, which may help explain the relatively low overall infection rate.  The studies were to be announced at an AIDS conference in Rome next week. But following the recommendation of the review panel to the University of Washington study, both the CDC and the Washington team made hasty decisions to release the results.

These are the third and fourth widely reported studies of AIDS prevention medications.

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Dr. Reddy's Laboratories Ltd Co., (NYSE: RDY ) and ALCHEMIA LTD., (OTC:AEMAF)  announced that Dr. Reddy's has received final approval of Dr. Reddy's ANDA for Fondaparinux Sodium Injection, a bioequivalent generic version of Arixtra, in the US market on July 11, 2011, by the United States Food & Drug Administration (USFDA).

The approval covers 2.5 mg/0.5 mL, 5.0 mg/0.4 mL, 7.5 mg/0.6 mL and 10 mg/0.8 mL doses of the drug in prefilled color-coded, single-dose syringes with automatic needle safety device. Dr. Reddy's will manufacture fondaparinux under license using a patented process developed by Alchemia.


Also Wednesday:


ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, announced that it has signed an agreement to restructure the outstanding senior convertible promissory note scheduled to mature this year. The amended agreement provides for extension of 50% of the principal amount of the note until September 13, 2012.

BIOLASE Technology, Inc. (NASDAQ: BLTI), the World's leading dental laser manufacturer and distributor, today announced that, based on an unaudited preliminary assessment of its financial performance for the second quarter ended June 30, 2011, the Company expects to report net revenue of approximately $12.0 million, up 104 percent from $5.9 million in the second quarter of 2010 and up 14 percent from $10.6 million in the 2011 first quarter.

China Biologic Products, Inc. (NASDAQ:CBPO) ("China Biologic," or the "Company"), a leading plasma-based biopharmaceutical company in China, today announced that the Company has received oral notification from the Guizhou Provincial Health Department that the Guizhou Provincial Government has suspended the implementation of its recently issued "Plan for Guizhou Provincial Blood Collection Institutional Setting (2011-2014)" (the "Plan").

ChromaDex Corp. (OTC:CDXC)
today announced that Cornell University has granted the natural products company ChromaDex exclusive worldwide rights to a novel manufacturing process for  nicotinamide riboside (NR).

Codexis, Inc. (Nasdaq:CDXS) today announced the company will host a conference call and webcast on Thursday, July 28, 2011 at 4:30 p.m. Eastern Time to discuss its second quarter 2011 financial results for the period ended June 30, 2011.

Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that the U.S. Food and Drug Administration (FDA) has given 510(k) clearance for its new EV1000 clinical monitoring platform.

InspireMD, Inc. (OTC BB: NSPR) ("Inspire" or the "Company"), the developer of the MGuardâ„¢ mesh protective stent system, announced today that Sol J. Barer, a biotechnology industry veteran, and the founder and former Chairman, President, COO and CEO of Celgene, a Nasdaq-Listed Company (NASDAQ:CELG), has joined the Company's Board of Directors.

Ohr Pharmaceutical (OTCBB: OHRP) today announced positive results from two critical animal studies on the recently announced Squalamine eye drop formulation for the treatment of wet-age related macular degeneration ("wet-AMD").

Radient Pharmaceuticals Corporation "the Company" or "Radient" (OTCQX: RXPC) (PINKSHEETS: RXPC), a developer and marketer of In Vitro Diagnostic (IVD) cancer tests, announced today it has issued a Corporate Report.

Mr. Ronald L. Chez, a private investor, filed an amended 13D for RepliGen Corporation (Nasdaq:RGEN) with the SEC.

SMART Modular Technologies (WWH), Inc. (NASDAQ: SMOD) today announced that it has filed with the Securities and Exchange Commission ("SEC"), and will commence mailing of, definitive proxy materials in connection with the previously announced merger under the Agreement and Plan of Merger (the "Merger Agreement") dated as of April 26, 2011, among the Company and affiliates of Silver Lake Partners and Silver Lake Sumeru.



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