Wal-Mart Lands In Middle of Diabetic Product Recall (COV, WMT)
Covidien, Ltd. NYSE: COV) and the FDA have notified patients and healthcare professionals of a product recall which has been sold to diabetics. Wal-Mart Stores Inc. (NYSE: WMT) gets to find itself at yet another controversy, yet it isn’t really Wal-Mart’s fault on the surface.
This recall is covering the ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles used by insulin-dependent diabetes. These syringes were sold only by Wal-Mart or Sam’s Club pharmacies under the ReliOn name.
The mislabeled syringe may result in patients receiving an overdose of as much as 2.5 times the intended dose, with serious health consequences, low blood sugar, and even death. The recall applies only to lot number 813900. The product was distributed from Aug. 1, 2008 until Oct. 8, 2008, and includes 471,000 individual syringes in 4,710 boxes.
If you need to read more, here is the official notice.
Jon C. Ogg
November 6, 2008
BioHealth Morning Daily, Wednesday, October 1, 2008
Cepheid Inc. (NASDAQ: CPHD) received FDA clearance for the first on-demand diagnostic test for life threatening MRSA and staphylococcus aureus from patient positive blood cultures. No shares have traded yet.
Emergent Biosolutions, Inc. (NYSE: EBS) announced that the U.S. government will purchase an additional 14.5 million doses of BioThrax as part of the anthrax shield under a new contract valued at up to $404 million. Its market cap is $390 million and its 2007 revenues were $182.9 million in total.
Johnson & Johnson (NYSE: JNJ) won a rather large judgment after a U.S. District Court in Delaware entered a final judgment including accrued interest, which comes to approximately $1.2 billion in favor of J&J’s Cordis unit. It won this against Medtronic (MDT) and Boston Scientific (BSX) in cases involving the original balloon expandable stent patent.
Universal Health (NYSE: UHS) is among some hospital downgrades by UBS this morning. It seems that the hospital sector is not immune from a rapidly weakening economy. Its rating was cut to Neutral from Buy. FULL HOSPITAL DOWNGRADE LIST.
Jon Ogg
October 1, 2008
Something Brewing At Dendreon? (DNDN)
We just noticed a large options volume alert over at Volume Spike today, and it is one that biotech investors may care about quite a bit more because of the timing. We have witnessed a flurry of trading in Dendreon Corp. (NASDAQ: DNDN) November stock options activity today.
We have seen what would represent more than 2 million shares in a risk reversal trade, although it could be called a myriad of terms depending upon your sophistication in trading. Frankly, most would call it a synthetic straddle.
As far as our calendar is concerned, we didn’t have any major event risk scheduled on the calendar until 2009.
After looking around there is actually some data coming out as soon as October, but the biggest data is still out into next year. This is probably simple to explain. Either someone put on a massive belief trade or they are hedging a large position of stock.
Jon C. Ogg
July 31, 2008
Forget ImClone, Cadence Pharma Is Today’s Biotech Winner (CADX, IMCL)
You’ve already seen and read all over the web about Carl Icahn receiving a letter from Bristol-Myers that the company is offering $60.00 to acquire Imclone Systems Inc. (NASDAQ: IMCL). There is a stock moving far more than ImClone, yet it is no buyout.
Cadence Pharmaceuticals, Inc. (NASDAQ: CADX) has received written guidance from the FDA noting that one post-operative pain trial and one fever trial are sufficient to meet the pivotal clinical trial requirements for its New Drug Application for Acetavance
This pertains to the company’s intravenous formulation of acetaminophen to treat acute pain and fever in adults and children. Both studies have already been completed with positive outcomes and it is not required to initiate any additional clinical trials of Acetavance for its NDA submission.
What is crucial here is that teh company is pre-revenue stage and has only been spending cash on R&D. Cadence is up 75% in early trading at $11.28, which is actually styill not a new high.
52-Week range: $4.84 to $15.70
Avg. Volume: 115,000 shares
Market Cap: $433 million (after huge gains)
Options: N/A
Jon Ogg
July 31, 2008
Biotech Implosion: Vanda Pharmaceuticals (VNDA)
Vanda Pharmaceuticals, Inc. (NASDAQ: VNDA) is seeing a major implosion this morning. The company has disclosed that it received a dreaded FDA not-approvable letter on its iloperidone. This was its late-stage schizoprenia candidate as well. The drug candidate is apparently too close to other drugs already on the market and the FDA said more safety data would be required to consider another application.
Vanda shares are down 59% at $1.35, which has gone from the good to the bad to the ugly. Its prior 52-week trading range was $2.70 to $19.62. Its current market cap after the drop is about $36 million. While that is well under its cash levels on the books, it will burn through much cash to fulfill its FDA obligations to proceed.
This one isn’t a biotech zombie yet, but you’d never know it if you just looked at its stock chart.
Jon Ogg
July 28, 2008
When Drug Firms Add ex-FDA Chiefs to Payrolls
GlaxoSmithkline (NYSE: GSK) has appointed Dan Troy as Senior Vice President and General Counsel for the company with an effective hire date of September 2, 2008.
Normally a general counsel hiring doesn’t mean much, but this one is a headline grabber if you believe that drug companies have to have a good clear line into the FDA. Mr. Troy was formerly Chief Counsel for the US Food and Drug Administration, where he served as a primary liaison to the White House and the US Department of Health and Human Services.
He led an office of attorneys who reviewed and approved all major regulations, and oversaw the legislative implications of many of the most important issues facing the pharmaceutical industry. Some issues were the reform of the Hatch-Waxman Act and subsequent legislative ratification, and his office also approved and managed all agency litigation and established new procedures for the FDA legal team to follow in preparing and then litigating high-profile cases.
We usually call this “bringing in the former enemy.”
Jon Ogg
July 22, 2008