FDA Panel votes against Roche's Avastin breast cancer drug Print E-mail
By Staff and Wire Reports   
Wednesday, 29 June 2011 18:59
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 29, 2011.

Due to a panel of cancer experts ruling against Roche Holding Ltd. (OTC:RHHBY) drug Avastin, for the second time, the U.S. Government has removed its endoresment of the best-selling cancer drug in the world since the panel has ruled it should no longer be used in best cancer patients.

The FDA advisory panel came to the same conclusion it reached less than a year ago which voted that Avastin is ineffective, unsafe and should have its approval for breast cancer revoked.  The drug is approved for multiple cancers and will still be available for breast cancer, though most insurers are expected to drop coverage if it loses FDA approval.  Margaret Hamburg, the FDA Commissioner, will make the final decision.  

Wednesday's vote came after two days of hearings that often resembled a courtroom trial, complete with testimony, cross-examination and a final jury verdict. In a public comment period Tuesday, Avastin patients and their families took the role of witnesses against the FDA.

Immediately after the final vote, patients in the audience erupted in shouts against the FDA and its panelists.  

After more than 14 hours of discussion, panelists ultimately sided with the government, saying that Avastin's ability to slow tumor growth, which is measured through medical imaging scans, has not translated into meaningful benefit for breast cancer patients.

A spokesman for the Abigail Alliance, which advocates for patient access to experimental medicine, said the vote should be overruled.

"This was a kangaroo court," said Steven Walker, the group's co-founder. "There wasn't one dissenting thought up there, let alone one dissenting vote."

If the FDA follows through on the withdrawal, Roche Holding Ltd. (OTC:RHHBY) could lose up to $1 billion in revenue for its best-selling product, which generates over $6 billion per year. Avastin is FDA-approved for various types of colon, lung, kidney and brain cancer, which are not part of the debate. Doctors will still be allowed to prescribe Avastin for breast cancer, though insurers may not pay for it. When administration fees are included, a year's treatment of Avastin can cost $100,000.

Roche's Genentech unit argued the drug should remain available while it conducts more research on which patients benefit most from the injectable drug. The drug is approved for breast cancer that has spread, or metastasized, to other parts of the body. Such cancer is generally considered incurable.


Also Wednesday:


Astro-Med, Inc. (NASDAQ: ALOT) announced today that Albert W. Ondis retired as a director and Chairman of the Board and Chief Executive Officer of Astro-Med, Inc. effective immediately due to illness.

Cephalon, Inc. (Nasdaq:CEPH) is scheduled to release its second quarter 2011 results via PRNewswire after the market close (approximately 4:10 p.m.) on Tuesday, August 2, 2011.

China-Biotics, Inc. (NASDAQ:CHBT), a leading developer, manufacturer, and distributor of probiotics products in China, today announces its intent to voluntarily delist the Company's common stock from the Nasdaq Global Stock Market ("Nasdaq").

Cord Blood America, Inc., (OTC Bulletin Board:CBAI), the umbilical cord blood stem cell preservation company focused on bringing the life saving potential of stem cells to families nationwide and internationally, announced today it has entered into agreement with Horizon Healthcare Services, Inc., headquartered in Newark, New Jersey, to offer the storage of umbilical cord blood to its members.

Inovio Pharmaceuticals, Inc. (NYSE Amex:INO), a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that its therapeutic DNA vaccine for prostate cancer showed remarkable immune responses in monkeys, following similarly strong, antigen-specific and sustainable T cell levels in previously reported data from earlier animal studies.

NHS Health Solutions, Inc. (PINKSHEETS: NHSH), currently doing business as Centacom Corporation ("Centacom" or "Company"), is pleased to offer several updates to its shareholders.

PharmStar Pharmaceuticals, Inc. (PINKSHEETS: PHAR) (the "Company") today announced that it has added an additional line extension product to Aquaprin™ called "AQUAPRIN CHILDREN & TEENAGERS."

PHI Group, Inc. (OTCQB: PHIE) (PINKSHEETS: PHIE) (FRANKFURT: PR7), a company focused on M&A consulting services, real estate development, natural resources, energy and special situations, announced today that its subsidiary Provimex, Inc. has completed its merger with Humex Medical Group, Inc., a California corporation, to engage in stem cell research and therapies in Southeast Asia.

Remedent, Inc., (OTCBB: REMI), an international company specializing in research, development, and manufacturing of oral care and cosmetic products, announced today that it has filed a Form 12b-25, Notification of Late Filing, with the Securities and Exchange Commission with regard to its Form 10-K report for the year ending March 31, 2011.



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