BC Innovations | Nov 6, 2014
Distillery Techniques

Technology: Drug platforms

Approach Summary Licensing status Publication and contact information Drug platforms Liposome-supported peritoneal dialysis for detoxification Rat studies suggest liposome-supported dialysis could be useful for extracting excess metabolites and drugs from the peritoneal cavity. In rats,...
BioCentury | Jul 1, 2013
Finance

2Q Stock Wrap-Up: If it ain't broke

Despite one segment that finished the second quarter in the red, all market cap groups are still up for the year. In 2Q13, the sector was led by large caps, which closed up 4%, marking...
BC Week In Review | Oct 3, 2011
Clinical News

Dianeal regulatory update

EMA's CHMP completed its review of the manufacturing of Dianeal, Extraneal and Nutrineal peritoneal dialysis solutions at Baxter's Castlebar, Ireland, manufacturing plant and concluded that the undetected cracks in equipment allowed the growth of endotoxin-producing...
BC Week In Review | Jan 31, 2011
Clinical News

Extraneal regulatory update

The European Commission requested that CHMP begin a full review of the manufacturing of Dianeal , Extraneal and Nutrineal peritoneal dialysis solutions at Baxter's Castlebar, Ireland, manufacturing plant after the company said it had not solved...
BC Week In Review | Jan 31, 2011
Clinical News

Dianeal regulatory update

The European Commission requested that CHMP begin a full review of the manufacturing of Dianeal, Extraneal and Nutrineal peritoneal dialysis solutions at Baxter's Castlebar, Ireland, manufacturing plant after the company said it had not solved...
BC Week In Review | Jan 10, 2011
Company News

Baxter sales and marketing update

Baxter will replace bags of Dianeal, Extraneal and Nutrineal peritoneal dialysis solutions in the EU as newly produced solutions are made available. The company discovered during routine inspection that two production tanks used at its...
BC Week In Review | May 25, 2009
Clinical News

Extraneal regulatory update

FDA approved a boxed warning to the label of Extraneal peritoneal dialysis solution to warn of dangerous drug-device interaction. The boxed warning states that blood glucose measurement in patients receiving Extraneal must be done with...
BioCentury | Sep 8, 2008
Regulation

Refinement wanted

Refinement wanted As mandated by the FDA Amendments Act of 2007, FDA last week released its first quarterly report on potential signals of risk for marketed drugs. Under FDAAA, the agency must report new safety...
BC Week In Review | Aug 7, 2006
Clinical News

Adept icodextrin regulatory update

FDA approved a PMA for Adept 4% icodextrin as an adjunct to reduce post-operative adhesions in patients undergoing gynecological laparoscopic adhesiolysis. Baxter BioSurgery, which has worldwide marketing rights to Adept, will launch the product in...
BC Week In Review | Jun 5, 2006
Clinical News

Adept icodextrin regulatory update

IOV received an approvable letter for a PMA for Adept to reduce post-operative adhesions in patients undergoing gynecological laparoscopic adhesiolysis. FDA requested an amended label copy for adverse event data and warnings and proposals for...
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