> Polish drugmakers Polpharma and Bioton are working on a potential merger, with a study on the possible deal due by Dec. 15. Report
> U.S. prescriptions for the antivirals Tamiflu, Relenza and two other drugs used to fight pandemic flu grew by 6 percent week-over-week to 587,960 in the week ending Oct. 30. Report
> Some contrast agents used with magnetic resonance imaging scans appear to carry a higher risk of a potentially fatal skin disease than others, FDA reviewers said in documents released yesterday. Report
> Lohmann Therapie-Systems got the FDA nod for Qutenza, a medicated skin patch that relieves the pain of post-herpetic neuralgia, a serious complication that can occur after a bout with shingles. Release
> FDA warned Abbott Laboratories about poor manufacturing standards at a molecular diagnostics plant. Report
> India's Wockhardt has launched in the U.S. its generic version of Cardene, nicardipine injections used to treat blood pressure. Report
> Pfizer submitted pediatric study data on its cholesterol drug Lipitor to the European Medicines Agency as part of the requirement for an additional six months of market exclusivity for the drug. Release
> More than half of Britons being offered vaccination against pandemic H1N1 flu are turning it down because they fear side-effects or think the virus is too mild to bother. Report
Biotech News
> AstraZeneca rolled out a new set of promising data for Brilinta this morning, demonstrating that the drug works faster than Plavix while its effects fade more quickly--exactly what researchers were hoping to see. The new mid-stage data helps AZ build a case that Brilinta, if approved, can be superior to an industry standard that earns $9 billion a year. Report
> The FDA has accepted NicOx's application for its anti-inflammatory naproxcinod, setting the stage for the potential 2010 launch of a likely blockbuster while attracting significant financial support from the French government, which is contributing to a $149 million fundraising effort. Report
> Vivus' experimental therapy for erectile dysfunction hit its endpoints in a Phase III trial, leaving the developer on track for a 2011 FDA filing and igniting a rally for shares that are now up 61 percent this year. Report
> Faced with the fallout from a failed trial of its lead therapy, BioXell is following a familiar path taken by a lineup of European developers, agreeing to a buyout offer and joining forces with a stronger player. Italy's Cosmo Pharmaceuticals has struck a deal to buy BioXell for $41 million in cash, shares and options. Report
> Qiagen has bet big on the future of molecular diagnostics, and it still has plenty of powder left to fire up a string of new deals. In an interview with Bloomberg, Qiagen CFO Roland Sackers says the biotech company plans to tap its $1 billion in reserves to pay for new acquisitions in a market that has seen prices slide significantly. Report
> Peter Thompson, Trubion Pharmaceuticals' president, CEO, chairman of the board and co-founder, has retired. Steven Gillis, former lead director of Trubion's board, has been appointed executive chairman of the board and acting president. Report
Pharma Manufacturing News
> British security software company Sophos says it has intercepted hundreds of millions of fake pharmaceutical spam advertisements this year and found the originating Internet sites, many claiming to sell such antivirals as Tamiflu. Report
> Last Friday--the 13th--the FDA sent Genzyme (GENZ) a complete response letter regarding the company's application to market Pompe disease treatment Lumizyme. Tucked into that letter was a condition: satisfactory resolution of deficiencies at the Allston Landing manufacturing plant prior to approval. Report
> Cambridge, MA-based biotech Alnylam says that its genetics expertise in drug development also may be useful in biologics manufacturing. In a company update to investors last week, management described how the company's core technology platform--a process of gene silencing in plant and animal cells called RNA interference, or RNAi--provides a manufacturing approach that may create manufacturing business opportunities to supplement the company's development work. Report
> As most business travelers will agree, trip reports become much harder to complete once the traveler gets back to the office. So too with warning letters for regulatory inspectors when they return from the subject facility. Report
And Finally... Doctors around the country are medicating their patients with nature to prevent (or treat) health problems ranging from heart disease to attention deficit disorder. Report