Charles Grassley

ALSO NOTED: U.S. hatches $265M regenerative medicine initiative; Merck KGaA budgets €1B for R&D;and much more...

Tue, 22 Apr 2008 06:59:50 -0400

> The U.S. government is creating a $265 million research initiative that will develop new stem cell technology to re-grow the skin, limbs and muscles of soldiers injured in Iraq and Afghanistan. And those advances in turn will be made available to the people burned and maimed in everyday accidents. Report

> With about 40 drug development projects in the pipeline, Germany's Merck KGaA says it will spend about €1 billion on drug research this year. That R&D budget represents about 22 percent of sales and is a big increase on last year's budget of €890 million. Report

> University of Cincinnati researcher Melissa DelBello is getting some added scrutiny after finding herself in Senator Charles Grassley's crosshairs. Report

> Call it the blame game. The U.S. FDA says it's traced contaminated heparin back to 12 companies in China. Chinese officials, however, claim the problem started in the U.S. Report

> To listen to news reports about incoming Biovail CEO Bill Wells, you'd think he was one of the horsemen of the Apocalypse. A director for three years, Wells is set to take over the helm May 1, and analysts say they're expecting him to come in swinging his sword. Report

> A new guerilla marketing campaign for over-the-counter Zyrtec is gaining attention in the blogosphere. Report

> Eye on FDA blogger Mark Senak examines recent goings-on at the FDA will change the agency. Report

And Finally... Companies are using nanotechnology as they pursue genome sequencing for the rock-bottom price of $100. Report

Blog divines new FDA standard on data integrity

Tue, 04 Mar 2008 06:59:56 -0500

Drug developers with questionable data beware. The FDA is taking no prisoners, and handing out no approvals, for developers suffering from data integrity issues. That's the world from In Vivo, which tracked Theravance's removal of data from one study site before a scheduled advisory committee meeting on its antibiotic, televancin. Theravance insisted the data removal had no "material impact" on its filings. But Senator Charles Grassley recently staked out his opposition to resolving any data issues by simply removing the data in question. The FDA canceled the meeting, which In Vivo attributes to Grassley's heated stance, and Theravance was left vowing to commit to working with the FDA.

"Other NDA sponsors would be well advised to pay more attention to all pending data integrity issues for products nearing the review stage," advises the blog. "The agency's division of scientific investigations is clearly emboldened and carrying more weight within FDA from Grassley's attention."

- read the post at In Vivo

ALSO: Theravance shares fell to an all-time low after the company announced plans to review trial sites used to test the therapy. Release | Report

Related Articles:
FDA wants more data on Theravance antibiotic. Report
Theravance trumpets positive results of mid-stage trial. Report
Astellas take a pass on Theravance's drugs. Report

ALSO NOTED: AstraZeneca may shake up R&D with spin-off; Vertex sells stock; and much more...

Tue, 12 Feb 2008 06:59:50 -0500

> AstraZeneca is considering spinning off its GI research institute into a separate company that would go out into the market and hunt for venture capital backing, according to Swedish newspaper reports. The news reports say that the pharma company is looking at spinning off five research projects. Report

> Vertex plans to sell 6 million common shares as well as $250 million in convertible senior subordinated notes due 2013. Report

> Belgium's Innogenetics says it plans to shelve new investments at its therapeutics business Genimmune. Report

> Docs needing blood-thinning drugs may be in a fix. Allergic reactions prompted Baxter to stop making multiple-dose vials of heparin, and the FDA told physicians to stop using them except when absolutely necessary--and then, very carefully. Report

> Finally, someone asked the question we've been wanting to ask ourselves: Even if the Enhance study data remained blinded, could Merck or Schering-Plough have divined its overall sway? Sen. Charles Grassley, who's been shooting out letters to the two companies at the rate of at least two a week, made the query in another round of correspondence yesterday. Report

> Schering-Plough, Sanofi and Teva have announced their earnings. Report

> While they were reporting their earnings, Schering-Plough and Sanofi-Aventis executives both found themselves on a hot seat. Report

> A protein may hold the key to a new vaccine that could effectively target pneumonia, according to Children's Hospital of Pittsburgh of UPMC. Report

> If you can't afford $350,000 to have your genome sequenced, wait awhile. The price is dropping fast. Report

And Finally… The World Health Organization says that without urgent action a billion people will be killed by tobacco this century. Release

ALSO NOTED: Novartis sinks$816.5M into Italian vaccine plant; GSK, Astellas take a pass on Theravance's drugs; and much more...

Fri, 07 Sep 2007 06:59:50 -0400

> Novartis is pledging to sink €600 million ($816.5 million) into new and expanded facilities in Italy. FiercePharma

> GlaxoSmithKline won't exercise its option to license Theravance's Gastrointestinal Motility Dysfunction program, and Astellas Pharma has also decided not to license TD-1792 under the terms of the companies' 2005 agreement. Release

> GTC Biotherapeutics said that the FDA has given ATryn a Fast Track designation entitled to accelerated FDA review for the hereditary antithrombin deficiency indication. Report

> Senator Charles Grassley said he would, and now he has: The Republican introduced a bill Thursday that would require drug and medical device makers to report almost every cent they pay to doctors. FiercePharma

> Prominent British cardiac surgeon Magdi Yacoub says that he believes that scientists will quickly perfect the use of adult stem cells for growing a complete new ventricle for transplant, with human trials coming in three to five years. Report

> Researchers have found that a grape skin extract plays a key role in fighting prostate cancer. Report

And Finally... Merck can now say "Whew!" when the words "class action" are mentioned. Report