> Centocor, a Johnson & Johnson company, said the FDA has issued Complete Response letter for its BLA for ustekinumab. The agency said it wants additional information, including a proposal to manage the risks of the drug. However, the FDA will not require any additional trials of ustekinumab, a biologic which treats treats chronic moderate to severe plaque psoriasis. Release
> ArQule and Daiichi Sankyo have signed a deal to co-develop ARQ 197 in the U.S., Europe, South America and the rest of the world, excluding Japan, China, South Korea and Taiwan, where Kyowa Hakko Kirin rights the drug. ArQule gets $60 million up-front licensing payment. Release
The Company also announced today the expiration of the waiting period under the Hart-Scott-Rodino Anti-Trust Improvements Act of 1976, thereby permitting consummation of the collaboration, including receipt of a $60 million cash up-front licensing payment from Daiichi Sankyo in connection therewith.
> The University of Michigan announced that it will purchase Pfizer's Ann Arbor, MI campus for just $108 million. Report
> CrystalGenomics and CG Pharmaceuticals have announced positive results from a Phase IIa osteoarthritis study of the efficacy and safety of a next-generation NSAID, CG100649. Release
> S*BIO has signed a collaboration agreement with Singapore's Tan Tock Seng Hospital to evaluate the effects of its JAK2 inhibitor, SB1518, on biological samples from patients with myeloproliferative neoplasms. Release
> Celldex Therapeutics and Pfizer say they will amend the ongoing ACT III clinical trial involving the investigational compound, CDX-110. The amendment will convert ACT III to a single-arm Phase II clinical trial in which all patients will receive the study medication, CDX-110, in combination with temozolomide, and will continue to enroll to approximately 60 patients. Report
> Maryland's Neuralstem has filed an IND application with the FDA to begin a clinical trial to treat amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). Neuralstem is planning to treat ALS patients through spinal injections of its stem cells via its patented Human Neural Stem Cell technology. Release
> A U.S. and Swiss biotech company have formed a research collaboration to focus on new therapeutic cancer vaccines. Worcester, MA-based Generex and Switzerland's Pevion Biotech plan to initially concentrate their work on oncogenes over-expressed in breast, ovarian, prostate, stomach and colon cancer, as well as other malignancies. Report
> Schering-Plough's stock took a dive this week after the news spread that sales of its troubled cholesterol drugs dropped significantly in November, after stablizing in October. Report
> Steven Nissen (photo) may be on Big Pharma's short list for the least desirable candidate for FDA Commissioner, but many apparently think its critics like him who should be at the top of the list. Report
> Sun Pharmaceuticals announced today that it has once again extended its tender offer for Taro Pharmaceuticals. Sun wants Taro to comply with an order by the Israeli Supreme Court that the offer remain open until a decision is made on Taro's appeal against Sun's Alkaloida. Report
And Finally... Last week, TheStreet shared their pick for the worst biotech CEO of 2008. This week, it's looking at the other end of the spectrum: Myriad Genetics' CEO Peter Meldrum earns Street writer Adam Feuerstein's vote as the best CEO of 2008. Report