Amgen (NASDAQ:AMGN) and Micromet, Inc. (NASDAQ:MITI) today announced that the companies have entered into a definitive merger agreement under which Amgen will acquire Micromet for$11 per share in cash or approximately $1.16 billion. The acquisition includes blinatumomab, a Bispecific T cell Engager (BiTE) antibody in Phase 2 clinical development for acute lymphoblastic leukemia (ALL). Blinatumomab is also in clinical development for the treatment of [...]

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced on Monday that its PDUFA date for ADASUVE, originally set for February 4, 2012, has been delayed until May 4, 2012. The extension was due to a modified Risk Evaluation and Mitigation Strategy (REMS) program, which the FDA deemed was a major amendment and exercised its right to extend the PDUFA date by [...]

Allos Therapeutics, Inc. (NASDAQ: ALTH) today received a negative opinion from the Committee for Medicinal Products for Human Use (CHMP) for the marketing authorisation for the medicinal product Folotyn, intended for the treatment of peripheral T-cell lymphoma. The Company plans to submit a request for re-examination of the CHMP opinion within two weeks. CHMP made the following comments as to [...]

Cell Therapeutics, Inc. (NASDAQ: CTIC) announced that it now expects the Committee for Medicinal Products for Human Use (“CHMP”) to issue an opinion on its Marketing Authorization Application (“MAA”) for Pixuvri in mid-February. It had originally guided of a decision at the end of this week.  The next meeting is scheduled for February 13-16, 2012. It [...]

Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that it is offering to sell shares of its common stock in an underwritten public offering. Anthera Pharmaceuticals, Inc (Nasdaq: ANTH) filed a shelf today allowing it to sell from time to time a combination of stock and warrants up to $100m. This replaces its $75m shelf filed in [...]

ArQule, Inc. (NASDAQ: ARQL) today announced that its Phase 2 trial of tivantinib in patients with hepatocellular carcinoma (HCC) produced statistically significant data in previously treated patients (hazard ratio = 0.64; p-value = 0.04). Complete data from this trial will be released at a peer-reviewed forum later this year. Adverse events were reported at similar rates in the [...]

See individual posts made in the last week for more detail. PDUFA/NDA FILINGS/ADVISORY COMMITTEE NEWS Delcath Systems, Inc. (Nasdaq: DCTH) intends to refile its NDA during 2Q 2012 for the treatment of patients with metastatic melanoma in the liver. Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) - PDUFA date of June 27 set for lorcaserin in patients with obesity. AVEO Pharmaceuticals, Inc. (NASDAQ: [...]

As many of you may be aware BMY offered INHX $26 per share for its acquisition last week.  I posted on twitter a link detailing a SEC filing noting that it had offered $20/share just the previous week only to be informed that it needed to increase its bid as another company was offering more. I have pasted [...]