Pharma is ready for recession; FDA considers updates to Plavix label;

> Pharma's 2008 pain could be its 2009 gain, as cost-cutting, layoffs and other restructuring measures pay off in this economic downturn. Report 

> Amid studies showing the anticlotting drug Plavix may not be effective for 30 percent of cardiac patients, federal regulators are considering updating the drug's label to include data on genetic factors that could interfere with the medicine. Report

> Daiichi Sankyo is set to book an accounting loss of more than 300 billion yen ($3.3 billion) in the April-to-December period to reflect the declining share price of newly acquired Indian subsidiary Ranbaxy Laboratories, according to a report in the Monday morning edition of the Nikkei newspaper. Report

> Bristol-Myers Squibb has denied claims it is making a further 10 percent reduction to its work force, and said any new reported cuts are still part of the same cost saving plan it announced a year ago. Report

> Pfizer is joining with two Boston hospitals to test whether computerized patient records can be used in helping federal regulators detect dangerous drug side effects. Report

> A Journal of Clinical Oncology study demonstrates that adding Erbitux to standard oxaliplatin-based chemotherapy works better than chemo alone in previously untreated patients with metastatic colorectal cancer whose tumors are of the KRAS wild type. Release

> PDL BioPharma and Alexion Pharmaceuticals settled a patent dispute over the blood disorder drug Soliris, in a cash for rights exchange. Release

> Bernstein Research analyst Dr. Aaron Gal expects that Teva Pharmaceutical industries' Azilect drug for Parkinson's will peak at $450 million in sales rather than the $1 billion that Teva said it expects. Report

> Federal regulators are recalling a surgical device made by Advanced Medical Optics after receiving reports the product caused inflammation in patients' eyes. Report

> Watson Pharmaceuticals received final approval from the FDA for a generic version of the contraceptive Mircette. Release

> The FDA has approved the first new advanced prostate cancer treatment in four years. Degarelix--made by Ferring Pharmaceuticals--is an injectable gonadotropin-releasing hormone (GnRH) receptor antagonist. Report

> King Pharmaceuticals annnounced the successful completion of the tender offer for Alpharma for $37.00 per share in cash. Release

> The FDA has decided that Salix Pharmaceuticals will have to run another "adequate and well-controlled clinical trial" before it can approve the company's ulcerative colitis tablet balsalazide. Report

> Novartis is forking over $20 million up front to license AlphaVax's investigational Cytomegalovirus (CMV) vaccine program. Report

> Lexington, MA-based Synta Pharmaceuticals and Roche have signed a licensing deal for preclinical anti-inflammatory compound, according to an SEC filing. Synta gets $25 million up front and up to $1 billion in milestone payments if the drug makes it to market. Report

> Unable to pay rent at its Bothell, WA headquarters, stem cell company CellCyte Genetics announced that it will shut down operations. Report

> The U.K.'s Biocompatibles International has forged a €302.3 million ($422.6 million) licensing agreement with AstraZeneca covering its preclinical glucagon-like peptide (GLP-1) analogue for diabetes and obesity. Report

> The Massachusetts Biotech Council is in hot water again. The state's Ethics Commission fined President Robert Coughlin $10,000 for secretly negotiating for the job while using his influence as the governor's economic development aide to craft a $1 billion subsidy program for the industry. Report

> California's stem cell agency is making contingency plans to raise fresh funds as a global financial meltdown threatens to dry up its stream of bond revenue. The San Francisco Business Times reports that the California Institute for Regenerative Medicine will consider a private placement with philanthropic groups. Report

> Takeda says it is facing an eight-month delay before it gets an FDA decision on its new diabetes drug. The drug company says that the agency has set a decision date of June 26, 2009 for alogliptin, a DPP-4 inhibitor. The FDA said it missed the initial October 27 deadline due to "internal resource constraints." Report

And Finally... Administering antibiotics as a preventive measure to patients in intensive care units increases their chances of survival, a new study finds. Report

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