> Genmab says it got positive top-line results from a mid-stage study of Arzerra in combination with cyclophosphamide, doxorubicin, vincristine and prednisone in front line follicular non-Hodgkin's lymphoma. Release
> The FDA has accepted Labopharm's response to its letter on the antidepressant Trazodone and set February 11 as its new PDUFA date. The agency failed to approve the therapy after it inspected a manufacturing facility in Italy. Release | Story
> France's BioAlliance Pharma says it's ready for a sit-down with drug regulators now that a late-stage trial of acyclovir Lauread has delivered positive, preliminary data on oro-facial herpes. "These data show that acyclovir Lauriad brings a strong clinical benefit to patients both in preventing and treating recurrent oro-facial herpes. This trial provides a good basis for a constructive dialog with the regulatory authorities. These results strongly validate the Mucoadhesive Buccal Tablet concept based on early targeted treatment", said Dominique Costantini, president and CEO of BioAlliance Pharma. Release
> Novelos Therapeutics will reap $9 million in a private placement with Purdue Pharma. Report
> ISTA Pharmaceuticals says it's ready to file for approval of its once-per-day eye therapy Xibrom QD after a late-stage study demonstrated that the eye drops were significantly better than a placebo in reducing eye inflammation 15 days after cataract surgery. ISTA acquired U.S. marketing rights for Xibrom in 2002 and launched the product in the U.S. in 2005. Release
> Bio-Matrix Scientific Group and its subsidiary Entest BioMedical have finalized a definitive agreement with Therinject LLC for the development of a new immuno-therapeutic cancer vaccine. Release
Pharma News
> Biogen Idec has won a grace period from the U.S. court hearing its fight with Tysabri partner Elan. Report
> Another victory for Pfizer in the U.K. The National Institute for Health and Clinical Excellence once again decided against three kidney cancer drugs, leaving Pfizer's Sutent as the only cutting-edge treatment on the National Health Service formulary. Left out in the cold are Roche's Avastin, Bayer's Nexavar and Wyeth's Torisel. Report
> We're one step closer to pre-Plavix screening. A new study tagged a common gene variation that predicts patients' response to the blockbuster anti-clotting drug sold by Bristol-Myers Squibb and Sanofi-Aventis. Report
> Amgen has dodged a potential Aranesp bullet. A new study dubbed "TREAT" showed that while the anemia drug didn't improve the heart health of patients with chronic kidney disease, it didn't hurt, either. Report
Manufacturing News
> Time spent gathering and analyzing data from multiple sources is the biggest challenge facing both small/medium and large drug makers, say respondents to a recent survey. In addition, more than 60 percent of 538 manufacturing professional respondents report "moderate" or "significant" variability in their manufacturing processes. Report
> It's been a good summer for drug theft. Mylan subsidiary Dey announced last Wednesday the theft of two lots of its Albuterol sulfate inhalation unit-dose vials. GlaxoSmithKline announced Monday that two lots of Advair Diskus medication were stolen earlier this month from the company's distribution facility near Richmond, VA, while awaiting shipment to retail pharmacies. Report
> Attempting to bust the oft-frustrating venture-funded biotech business model, University of Pittsburgh Medical Center CEO Jeffrey Romoff testified before congress last week, proposing a public/private model for vaccine production. Report
And Finally... Healthcare workers around the world will be at the front of the line for a new swine flu vaccine this fall. But many may not want it. More than half of the healthcare workers in Hong Kong say they plan to shun the jab. Report