There were several unusual occurrences at the end of the week and some we saw over the weekend screenings for items missed during the week.  These will also be among some of the top issues for Monday and Tuesday of this week: It looks like someone made a rather large bet that U.S. Steel (NYSE: X) [...]

Visit StreetInsider.com at http://www.streetinsider.com/news.php?st=p&id=4677590 for the full story.

Northfield Laboratories Inc. said it would close its operations and dispose of its assets after the FDA rejected its blood-substitute product.

We have run a watch list of companies under their own strategic review, and the number of biotech (or grouped with biotech) stocks under this description is just staggering.   We published a full review of this over at BioHealthInvestor.com.  The list includes Biosante Pharmaceuticals, Inc. (NASDAQ: BPAX), Cell Genesys, Inc. (NASDAQ: CEGE), EPIX Pharmaceuticals, Inc. [...]

SUGAR LAND--May 12, 2009--Reported by Annette Kreuger, Industrial Info Resources (Sugar Land, Texas)--In a virtual bloodbath, Northfield Laboratories (NASDAQ:NFLD) (Evanston, Illinois) issued a statement on May 8, announcing "that it has terminated the employment of substantially all of its operational and staff employees at its manufacturing facility in Mount Prospect, Illinois and headquarters in Evanston, Illinois." The action follows the Food and Drug Administration's (FDA) recent rejection of the company's Biologics License Application for PolyHeme, a human hemoglobin-based, oxygen-carrying red blood cell substitute.

Due to the explosive demand for BioPharma companies pending Food and Drug Approval on new and innovative drugs, I will begin focusing on companies which are a few weeks away from their reviews. Taking notice of the recent 3000%, and 1000% over night gains respectively of TTNP and VNDA, the risk versus rewards leans well towards the positive end on these[More...]

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA (...)[More...]

Below is a summary of updates to the BioMedReports.com database of 241 entries included in the FDA and Clinical Trial Calendars. 1.) Vion Pharma (VION.OB): Onrigin (laromustine) Injection (formerly known as Cloretazine or VNP40101M) NDA requesting approval as a single agent for remission induction treatment for patients age 60 and older with de novo poor-risk acute myeloid leukemia (AML). The NDA was filed 2/17/09, accepted by FDA for standard, 10-month review on 4/17/09 with a PDUFA decision (...)[More...]

Below is a summary of companies from the BioMedReports.com FDA Decision Date Calendar which have market caps below $200M, making them ideal candidates for extreme stock price volatility trades as their decision dates become imminent. Dyax Corp. (DYAX) secured a narrow approval from a FDA Advisory Panel in early February (with a 6-5-2 vote) for its Kalbitor (ecallantide or DX-88) BLA with a PDUFA date of 3/23/09, which is designated for priority review in the treatment of acute attacks of hereditary angioedema (HAE is a rare disorder marked by severe swelling which can be fatal if the throat area is involved). The panel debated the need for an effective treatment for this rare, potentially dangerous condition against the 3% higher incidence of allergic reactions (13% versus 10%) in patients taking[More...]

The accompanying table (click to enlarge) includes an updated calendar of 78 expected FDA new product decisions with more detailed comments for each entry. Click here for a link to my previous FDA calendars and the list below highlights companies with pending decisions + market caps below $100M, making them ideal candidates for extreme trading opportunities. <a[More...]

Companies featured in this segment: General Motors Corporation (NYSE:GM), Northfield Laboratories (NASDAQ:NFLD), Mitsui and Company Limited (NASDAQ:MITSY), Alkermes Incorporated (NASDAQ:ALKS), Shire plc (NASDAQ:SHPGY), ImmunoGen Incorporated (NASDAQ:IMGN), Schering-Plough (NYSE:SGP), BioMed Realty Trust Incorporated (NYSE:BMR), Amgen (NASDAQ:AMGN), Genzyme (NASDAQ:GENZ), Murphy Oil Corporation (NYSE:MUR), Centrica plc (OTC:CPYYY), Electric Power Development Company Limited (TYO:9513), and Electricite de France SA (EPA:EDF)

Pete from Optionsmonster calls in from the CBOE to tell MN1 listeners about some unusual options activity on [GGC] also unusual activity on Telik [TELK] Jan 20-30 strike prices. Folks that way out of the money. Waiting on some FDA approval by year end keep this on your radar or join Andrew Coffey live on MN1.com For News you can use. Still Pimping out Ken Fisher’s new book. KLF is going to rock you!!! Also [NFLD] straddle.

The Investor Business Daily ran a full page ad for a company that just did a reverse in November. The ad drops all the buzz words similar to the tons of annoying spam small cap spam you get everyday. ARHHH. What was IBD thinking?*DONT GET FAKED OUT* AIM Markets in London were on the Front page of the WSJ and Dr J joined us Live at 9:15CST. Talked about a straddle on [NFLD] other stocks mentioned were [RBAK] [ACAT][ESCL] and [UTX] join us live in the morning at Mn1.com