AMAG Pharma (AMAG) more than doubled on word that the FDA accepted its complete response for a NDA of iron-deficiency anemia drug ferumoxytol in patients with chronic kidney disease and will issue a final ruling before year-end. The news is a major relief for AMAG as no new clinical trials were required and the quick decision deadline before year-end is encouraging for the approval prospects of ferumoxytol.
A trio of companies expect FDA decisions for abuse-resistant pain drugs before year-end, including Pain The
Over the long holiday weekend, I had a chance to do some much needed reading. Given my vocation, sometimes I like to read articles that have little to do with the markets or finance as a way of recharging my batteries.
Of course, even when I partake in this guilty pleasure, there really is no way to truly escape. Somehow every story has a link or relationship to investing that I can utilize in my stock-picking mission.
This weekend, it was an article critical of a Shape magazine cover featuring a bikini-clad F
The accompanying table [click to enlarge] includes an updated calendar of 73 expected FDA decision dates. Click here for my previous articles and FDA calendars , including several companies with expected decisions before year-end expected to have major stock price impacts, but keep in mind the backlog of delayed decisions that is building means that none of the dates are certain to produce final decisions.
Genzyme (GENZ) could hear back from the FDA as early as Monday for approval of Myozyme at the 2,000L
The accompanying table includes an updated calendar of FDA decisions expected to occur within the next three months. Most recently, the FDA continued its tough stance toward new antibiotic approvals and issued a complete response letter for ceftobiprole to Johnson & Johnson (JNJ) and its Swiss partner, Basilea Pharma ( Switzerland: BSLN ) – sending the latter down sharply to new lows on Wednesday with a sharp rebound of 30% by the end of the week, but still down by about 43% in the last year.
The accompanying table includes an updated calendar of FDA decisions expected to occur within the next three months. Most recently, the FDA continued its tough stance toward new antibiotic approvals and issued a complete response letter for ceftobiprole to Johnson & Johnson (JNJ) and its Swiss partner, Basilea Pharma ( Switzerland: BSLN ) – sending the latter down sharply to new lows on Wednesday with a sharp rebound of 30% by the end of the week, but still down by about 43% in the last year.
The accompanying table [click to enlarge or download] presents the top five rated companies with market caps of at least $250M from each of the 10 new healthcare indexes developed by ETF Innovators [ETFI] from a database of about 500 companies worldwide. The ETFI Global Healthcare Sector PerformIdex consists of 50 top rated companies on an equal weight basis from each of the 10 new healthcare indexes as an alternative strategy to existing health composite ETFs with highly correlated returns and over-weight exposure to th
The accompanying table [click to enlarge or download] includes an updated calendar of 75 expected FDA decision dates as part of the ETF Innovators [ETFI] New Drug Regulatory Catalyst Index, which includes a full slate of expected action before year-end outlined in my previous article. The last few days have been busy for antibiotics at the agency, resulting in sharply lower stock prices for Targanta Therapeutics (TARG) and Theravance (THRX).
An FDA panel voted against Targanta's oritavancin, which has an upcomin
The accompanying table [click to enlarge or download] includes an updated calendar of 75 expected FDA decision dates, which includes a full slate of expected action before year-end outline in my previous article. The last few days have been busy for antibiotics at the agency, resulting in sharply lower stock prices for Targanta Therapeutics (TARG) and Theravance (THRX).
An FDA panel voted against Targanta's oritavancin, which has an upcoming decision in early December and sent shares crashing from 8 bucks be
Yesterday, in response to Chasing Value: ISRG is falling and I'm buying I received the following comment from Beltway Greg, "You're a brave dude. Why? I've watched this stock for awhile and I worry about possible entry by other folks into the market."
Brave perhaps, even foolish on occasion, but I still think this is the time to be selectively buying equities.
The accompanying table presents the top six rated companies with market caps of at least $250 million (USD) from each of the eight ETFI healthcare indexes (which include a database of about 320 companies) as equally-weighted components in the ETFI Global Healthcare Sector PerformIdex of 48 companies.
"Johnson & Johnson as well as FPL Group are two strong positions in companies that have suffered a few 'hiccups' during this historic panic selling, but are likely to survive and prosper in the next year.
"First, Johnson & Johnson, the health care and pharmaceutical giant, beat expectations in its most recent earnings report. The company's earnings jumped 30% to $3.3
The accompanying table presents an analysis and statistics for the 28 healthcare ETFs listed at the Yahoo! Finance ETF Center. As a group, the healthcare ETFs outpaced the overall market in the past year by more than 10%, posting an average loss of 26.5% compared to a loss of 37.4% for the S&P 500 SPDR ETF (SPY). The best performing healthcare ETF was the Biotech HOLDRs (BBH), thanks to a buyout bid for top holding Genetech (DNA) and solid earnings results this year for the number two position, Amgen (AMGN).
The accompanying table [click to enlarge image] presents an updated calendar of expected FDA decision dates, including a new NDA filing by Johnson & Johnson (JNJ) for Comfyde and recent approval for Barr Pharma's (BRL) low-dose birth control pill Lo-Seasonique. Teva Pharma (TEVA) has closed a deal with Barr's unsecured credit holders in an effort to close its proposed $7.5B acquisition by year-end, which will expand Teva's generic drug business and also add to its line-up of brand name medications through Barr's
The accompanying table [click to enlarge image] presents an updated calendar of expected FDA decision dates, including a new NDA filing by Johnson & Johnson (JNJ) for Comfyde and recent approval for Barr Pharma's (BRL) low-dose birth control pill Lo-Seasonique. Teva Pharma (TEVA) has closed a deal with Barr's unsecured credit holders in an effort to close its proposed $7.5B acquisition by year-end, which will expand Teva's generic drug business and also add to its line-up of brand name medications through Barr's strong presenc
The accompanying table presents my 60 defensive growth stock picks at the recently launched online investing site Inner8.com , which I wrote about yesterday. My picks are focused on healthcare and consumer staples, along with some cash rich tech companies such as Microsoft (MSFT). My picks include companies across the entire spectrum of market cap and risk in the biotech industry, ranging from top performers such as Amgen (AMGN) and Celgene (CELG) to small and micro-cap picks such as Discovery Labs (DSCO),
Johnson & Johnson vs 3M
- I have been waiting and waiting for JNJ to drop but its really dissapointing seeing such a steady stock..on the other hand is 3M who is JNJ's competito