Should the FDA relax approval standards for biotech therapies?
Posted by Angel Gonzalez at 4:49 PM
Have biotech advances in cancer therapies evolved beyond the regulators' ability to handle them quickly?
Patients and biotech companies are simmering in frustration at the U.S. Food Administration's rejection of drugs they consider promising. A Wall Street Journal story published Thursday says these groups would like the FDA to allow products that fail to achieve their stated target, but are later discovered to be effective in certain groups among the people tested. That flexibility could save lives of terminally ill patients, they say.
The FDA argues that it's better to be safe than sorry, and that selecting successful sub-groups after the fact is bad science.
Some patient groups are taking an openly confrontational approach. We wrote Tuesday that CareToLive, a group representing prostate-cancer patients, is suing the FDA for rebuffing Provenge, Seattle-based Dendreon's lead therapy. The patient advocates say the refusal is the result of political rivalries within the agency, and is foiling some patients' last hope.
The push by such advocates, however, coincides with a nationwide call for more strict FDA supervision in the wake of drug safety scandals.
Federal court thwarts D.C. pharmaceutical price controls
Posted by Angel Gonzalez at 3:37 PM
A federal court thwarted the District of Columbia's efforts to put a lid on medicine prices on constitutional grounds -- earning the applause of the biotech industry.
The United States Court of Appeal for the Federal Circuit upheld a lower court's ruling that found D.C.'s Prescription Drug Excessive Pricing Act of 2005 breached the goals established by patent laws.
The law sought to keep drugs from costing more than 30 percent above what they cost in other developed countries. It also required companies to reveal their invention costs to the authorities.
Supporters said the measure was necessary to counter skyrocketing pharmaceutical costs. Opponents argued that the law would stifle innovation.
The ruling marks a victory for the biotech industry, currently assailed by a legislative effort to pave the way for generics of genetically-engineered therapies.
The Biotechnology Industry Organization commended the court for its decision.
"This law, like other price control measures, would not have had the intended effect of increasing patient access to drugs," said BIO president Jim Greenwood in a statement.
Grand Theft Auto IV delayed until 2008
Posted by Benjamin J. Romano at 2:13 PM
This could put a damper on the holiday video game season: "Grand Theft Auto IV," one of the most-anticipated games of the year, will not be released until sometime in early 2008, according to publisher Take Two Interactive Software.
The game's release is being moved from the company's fiscal fourth quarter, which ends Oct. 31, to the second quarter of its 2008 fiscal year, which ends April 30, 2008, "due to additional development time required to complete the title," according to a statement on the Take Two's investor relations Web site.
The game was to be released for Sony's PlayStation 3 and Microsoft's Xbox 360 simultaneously.
That apparently complicated development.
"Certain elements of development proved to be more time-intensive than expected, especially given the commitment for a simultaneous release on two very different platforms," Take-Two Chairman Strauss Zelnick said in a statement.
"GTA IV," the next installment of the controversial and wildly popular game that features car jacking and hooker-shooting, was going to be one of a triumvirate of titles to drive Microsoft's Xbox 360 during the all-important holiday season, the other two being "Madden NFL '08" and Microsoft's exclusive "Halo 3" title.
Update: It appears the schedule for the Xbox 360-exclusive "GTA IV" episodic content remains unchanged by this. According to the statement, the episodic content, which will be available via download from Xbox Live, is still in the 2008 line up, where it always has been.
Could this delay help Microsoft when "GTA IV" is ultimately released? The first installment of the episodic content was due in March 2008, according to comments from Take-Two CFO Lainie Goldstein during the company's June 11, 2007 conference call. Goldstein also acknowledged that Take-Two will be paid in two $25 million chunks for the two exclusive installments of episodic content -- for a total, eye-popping price tag of $50 million (a figure that has not been confirmed by Microsoft).
If the first episode of Xbox 360-exclusive content is released in March 2008 -- it's hard to imagine it coming before the game itself -- that would put it within weeks of the release of the game itself.
WSA names new board members
Posted by Tricia Duryee at 1:51 PM
The WSA, the state's technology trade organization, said today that it has named five new members to its board.
Ron Craswell, engineering director, Google : Craswell, one of the leaders at Google's Kirkland office, oversees a number of Google projects, including parts of Google Maps, Webmaster Tools and Google Pack. He previously was vice president of engineering for Seattle-based M:Metrics.
Carla Stratfold, senior vice president of RealNetwork's program integration office: Stratfold joined RealNetworks in 2001 to work in sales. Before that, she was at Oracle.
Keith Smith, CEO, Zango : Smith, who co-founded Zango in 1999, has worked in technology development, financial services and entrepreneurial concerns.
James Sun, CEO, president and founder, Zoodango : Sun was runner-up on the NBC show "The Apprentice" this year. He started out by running an investment trading company during his college years. Before creating Zoodango, he worked as a management consultant at Deloitte Consulting.
Jennifer Shettleroe, vice president of engineering, Attachmate:
Shettleroe joined Attachmate in 1995, holding key leadership positions in product development, information technology, technical support and corporate training. She has a 20-year career in software development and delivery.
WSA board has 35 members. Along with President and CEO Ken Myer, the board drives the direction of the organization.
Clearwire turns on three more cities
Posted by Tricia Duryee at 1:37 PM
Clearwire said today it started providing its wireless broadband service in Dayton, Ohio.
On Wednesday, the Kirkland company, which is building out a national network, said it launched service in Syracuse, N.Y. and Corpus Christi, Texas.
Recently, the company agreed to partner with Sprint Nextel to speed up the deployment of WiMax by splitting up the towns and cities that the two companies will cover.
Onvia saves $$ by moving
Posted by Tricia Duryee at 1:17 PM
In 2002, we wrote about how unused office space was draining the bottom lines of tech companies in the region.
The companies either had secured extra space to accommodate their growth, which never came, or laid off employees, creating a glut.
In that story, we reported that Onvia, an online government-contracting service, lost $5.2 million at its two Seattle buildings (about 100,000 square feet).
Today, the company seems to have finally rid itself of its excess space.
Onvia said it plans to move its headquarters to downtown Seattle in January 2008 from its office near South Lake Union. Simultaneously, Onvia also agreed with its landlord and a third party to terminate Onvia's obligations under its current office lease at no additional cost.
What's more, as a result of these transactions, Onvia's cash flow will improve by about $2.4 million and its operating expenses will decrease by about $700,000 over a 28 month period starting January 2008.
In July, Onvia provided a $538,000 security deposit on the new lease, and upon termination of its existing lease, Onvia's $3.5 million security deposit on its current space will be returned.
Executives are feeling good about the move.
"The net result of the two transactions will be to increase our future cash balance, cash flow and earnings," said Mike Pickett, Onvia's chairman and chief executive. "In addition, the new lease will provide Onvia with additional space to handle our future growth needs."
More data center lookers in Grant County
Posted by Benjamin J. Romano at 11:51 AM
Terry Brewer, executive director of the Grant County Economic Development Council, wrote in response to today's story on the data center boom in Quincy, that his organization has "responded to requests for information from more than a dozen clients and consultants representing clients who are researching sites for data centers."
And, of course, the interest is stretching beyond just Quincy, or just Grant County. Moses Lake, Wenatchee and The Dalles, Ore., are all benefiting from the same trend.