PHARMACY

Genentech loses key patent protection

BY Drew Buono

SAN FRANCISCO The U.S. Patent and Trademark Office has rejected the validity of a key patent of Genentech that involves the method of producing antibodies and antibody fragments, a crucial step in the manufacture of biotechnology drugs, according to Reuters.

The company said the patent, known as the Cabilly patent, remains valid and enforceable through the appeals process, which it anticipates could take one to two years, or longer. If not revoked, the patent would run until 2018.

Genentech, which also receives revenue under licensing agreements covering other companies’ medicines that utilize the technology, said it would file a response to the action and, if necessary, appeal the decision to the Board of Appeals within the Patent Office.

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FDA to closer scrutinize consumer drug advertisements

BY Drew Buono

WASHINGTON The Food and Drug Administration’s current budget for reviewing consumer drug advertisements is larger this year than the previous five years combined, according to USA TODAY.

The FDA received $6.1 million for the current fiscal year to check the fairness and accuracy of consumer drug ads. That’s up from $2.2 million the previous year and $1 million the year before.

The FDA says it plans to hire more people so it can review more ads. It has 13 workers devoted to policing direct-to-consumer ad materials, six of which are primary reviewers. Last year, the FDA received 12,616 drug ad materials.

The FDA has been so overwhelmed by drug industry ad materials that only a “small portion” is reviewed, the Government Accountability Office said in a 2006 report. The FDA often didn’t declare consumer ads false or misleading until after ad campaigns were over, the GAO said.

President Bush’s proposed 2009 budget calls for $14 million from user fees to fund 27 FDA positions devoted to the consumer-ad-review program. In exchange, the FDA would review TV drug ads within 45 days of getting them from drugmakers — which is faster than many reviews occur now — and before the ads are seen by millions of viewers.

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BY Drew Buono

HOUSTON The Professional Compounding Centers of America has named John Herr its recipient of the Dr. M. George Webber Compounding Pharmacist of the Year, an award that is presented annually to an independent pharmacist who has demonstrated service excellence to patients, healthcare providers and pharmacy colleagues.

L. David Sparks, PCCA’s president/chief executive officer, presented the award to Herr during the company’s International Seminar held in Houston in January 2008. “This year, we recognize a pharmacist who has become one of our profession’s most respected compounders,” Sparks declared. “His colleagues appreciate his generosity and willingness to share and network with them. His pharmacy staff respects his dedication to compounding, compassion for patients and concern for their own well being as his employees. His patients and prescribers appreciate his ability to solve specific medication needs in a high-quality manner.”

Herr has been a registered pharmacist for more than 20 years, and has been an owner of Town & Country Pharmacy since 1999. He is the recipient of several recognition awards for his outstanding service in his practice of the art and science of pharmacy compounding, including the New Jersey Hospice and Palliative Care Organization’s 1998 Hospice Team Award for outstanding leadership as a Hospice Pharmacist.

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