PHARMACY

Roche signs agreements with pair of diagnostic companies for Hepatits C analyses

BY Allison Cerra

ZURICH, Switzerland Roche Holdings said it has signed licensing and settlement agreements with two diagnostic companies for Hepatitis C virus analyses, according to reports.

Ortho-Clinical Diagnostic and Novartis Vaccines & Diagnostics have granted Roche a license for their antigen-antibody reaction methodology. Financial terms of the deal were not disclosed.

The agreement further includes cross-licensing of patents owned by Roche Diagnosticsand the three companies also agreed to settle all current litigation related to the licensed patents.

Ortho is owned by Johnson & Johnson.

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Cephalon submits application to FDA for supplemental uses of Fentora

BY Drew Buono

FRAZER, Pa. Cephalon has submitted a supplemental application to the Food and Drug Administration to market its cancer drug Fentora as a “breakthrough pain” drug that would treat chronic pain conditions that could include lower back and neuropathic pain, according to the Philadelphia Business Journal.

Breakthrough pain is characterized as pain that is rapid on its onset and moderate-to-severe in intensity and relatively short in duration. If the application is approved, Fentora would also be indicated for breakthrough pain in chronic pain conditions experienced by opiod-tolerant patients.

In September, the FDA and Cephalon issued warnings to patients and doctors alerting them of the potential fatal risk factors associated with improper use of Fentora in such cases as patients using them to treat migraines or other types of short-term pain. Cephalon is also working with the FDA to update the package insert of the drug to include revised patient selection criteria and dosing instructions.

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Reverse-payment bill held up in Congress by pharmaceutical lobbying

BY Drew Buono

WASHINGTON Legislation aimed at speeding up the availability of cheaper generic drugs has stalled in Congress due to major lobbying by the drug industry, according to the Associated Press.

The Senate bill would ban most reverse payments, which occur when a brand-name company pays a generic manufacturer to delay the introduction of a drug.

An Associated Press review of lobbying reports, from July 1, 2006, through June 30, 2007, found that $38.8 million was spent by at least a dozen generic and brand-name companies and their trade associations on issues including the Senate legislation.

More than half of those expenses were piled up by the Pharmaceutical Research & Manufacturers of America, which represents brand-name drug companies. PhRMA spent $19.5 million in the 12-month period ended June 30 on in-house lobbying expenses, an increase of about $3 million over the previous 12-month period.

And the Generic Pharmaceutical Association reported lobbying expenses of around $420,000 for the first six months of this year. The remaining $19 million was spent by a variety of drug companies, including Bayer, Schering-Plough, Pfizer and Teva Pharmaceuticals.

“Lobbyists have a lot of influence in Washington,” said the bill’s sponsor, Sen. Herb Kohl, D-Wis., who chairs the Senate Judiciary subcommittee on antitrust, competition policy and consumer rights. “If we can just get this to a vote, it will be pretty hard for people to vote against it. A vote against this is a vote against consumers.”

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