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Biotech takes issue with move to limit reimbursement.

Active Care Network and biotech partners aim to increase patient compliance.

Drug makers find it hard to recoup development costs, report finds.

Restasis goes against the grain of Rx-to-OTC switching.

June 2007 CE

It's not FDA's job to make doctors and patients take more responsibility for using drugs wisely. But whose job is it? Really, whose?

Cell Genesys knows something about building successful biotech companies. In fact, its chairman and CEO, Stephen Sherwin, MD, a Genentech alum, has built at least three, if you count Cell Genesys spinouts Abgenix and Ceregene. Through a strategy of M&A and licensing programs-plus betting on the right technology at the right time-Cell Genesys has been able to raise enough capital to gamble on what Sherwin believes could be the future's most promising therapies, including gene activation, immunotherapy, and oncolytic virus therapy.

The danger is that effectiveness studies could be used to limit coverage to low-cost products and that additional research requirements for sponsors could be costly

Medicare Part D's infamous donut hole-the gap in coverage where subscribers have to shell out full drug costs-sparked a national debate long before the first poor, frail, creaky (or so you imagine) senior citizen stumbled into it. Critics of Part D-mostly Democrats, plus advocates ranging from AARP to the Gray Panthers-argue that government price negotiations, which the legislation bans, would lead to savings that could close the gap. Part D backers-mostly Republicans and PhRMA-counter with "Don't fix it if it ain't broke," pointing to surveys showing that as many as 80 percent of the 23 million subscribers are pleased with the program after just the first year. Plus, they say, Part D's so-called consumer-driven design controls costs, which, in fact, came in lower than projected.

With fewer feet on the street because of downsizing at many drug firms, sales reps and managers need to work smarter-and that means working with information that's both accurate and up to date

A week and a day after the nation?s leading medical journal announced that Avandia poses a much higher heart attack risk than either its maker, GlaxoSmithKline, or FDA had previously reported, the media dustup has come nowhere near peaking. Meantime, analysts are already revising?downward?the damage to GSK?s blockbuster anti-diabetes drug in the face of what appears to be a rush to switch on the part of doctors and patients.

In an effort to clamp down on corruption, China sentenced its former top drug regulator to death on Tuesday.

Provenge setback not deterring others in the field.

Schwarz's Neupro is company's first new chemical entity launched in US.

High settlement could suggest frustration with pharma's marketing tactics.

'Very hostile' FDA panel recommends tighter prescribing guidelines.

Companies are poised to speed up investments in electronic data capture.

Senate report suggests drug makers have too much influence on CME content.

Allergan launches celebrity campaign for Botox and Juvederm.

PE Ad Readership Study

Activist protests steal thunder from Abbott's shareholder meeting.

Pricey merger adds expertise in vaccines, biologics.

May 2007 CE

The top 50 pharmaceutical companies, ranked by prescription pharmaceutical drug sales, plus rankings of top products, R&D spend, and more.

The lights were hot, the cameras were flashing, and the B-list celebrities were out in full force for the New York premiere of InnerState, an hour-long documentary following the lives of three individuals who are using biologic drugs to combat different diseases.

Pharma industry alliances are increasingly critical to success. They are gaining on R&D in terms of importance, especially since many companies are falling short in their internal pipelines and need to look outside for promising compounds. Today, nearly two-thirds of the top 20 pharma and biotech companies have established alliance-management functions. These usually cover deals in the discovery, development, and marketing space.

The reauthorization of the Prescription Drug User Fee Act (PDUFA) comes but once every five years. Set to expire September 30-and with congressional Democrats riding high and consumer confidence in drug safety at record lows-the deal by which pharma pays FDA to review its products is in for a long hot summer of debate.

The push is on to establish an approval pathway for generic versions of biotech therapies. The Hatch-Waxman Act of 1984 established a process whereby generic-drug manufacturers could obtain approval for a product based on the innovator company's data. But Hatch-Waxman doesn't apply to biologics regulated by the Public Health Service Act, and generics makers-as well as some Big Pharma companies and small biotech firms-want Congress to give the Food and Drug Administration authority to set up a similar process for these products as well.

Back in 2003, Roche resolved a long-standing lawsuit with Igen International by acquiring the company. As part of the deal, Roche acquired a perpetual license to use the Igen technology that gave rise to the lawsuit-electrochemiluminescence (ECL)-in certain applications. Igen's ECL patents, meanwhile, were assigned to a new publicly held spin-off company focusing on biosecurity testing, clinical point-of-care products, and vaccines. In March, Roche announced that it was acquiring the spin-off, Maryland-based BioVeris, for $21.50 per share, or a total of about $600 million.