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       Sector: Healthcare  >  Industry: Biotechnology & Drugs
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Upcoming FDA Advisory Panel Meetings Graphic_rating_buy DNA
Mikerun
73%
 -13.25%
in 246 days

A trio of diabetes drug candidates are affected by a tougher stance at the FDA for this class of drugs, which is focused on cardiovascular risks such as heart attack and stroke. Two of the drugs will be reviewed at early April FDA advisory panel meeting while a third will likely require additional clinical trials.

http://www.biomedreports.com/fda-calendar.html

<> In December the FDA issued a new guidance document that recommended more stringent clinical trials for diabetes drugs to better assess heart attack and stroke risks. In a change that was effective immediately,...
By  Mike Havrilla   (+1.04%  risk: conservative)  03/09/09 Comment


FDA Decision Calendar: Pain Drug Delays Likely Graphic_rating_buy DNA
Mikerun
73%
 +11.70%
in 27 days
(closed on 03/09/09)
FDA Decision Calendar: Pain Drug Delays Likely
By Mike Havrilla on 2/9/09
ETF Innovators
 
The tables at my website link below include an updated calendar of 86 expected FDA new product decisions and 89 pending clinical trial result estimates + pending FDA re-submissions or new submissions for regulatory approval. Click here for a link to my previous calendars.
 
 
New FDA Decision Calendar Entries:
 
<> 1.) Biogen Idec (BIIB) and Genentech (DNA) have a PDUFA...
By  Mike Havrilla   (+1.04%  risk: conservative)  02/10/09 Comment


Calendar of 163 FDA Decisions and Clinical Trials Graphic_rating_buy DNA
Mikerun
73%
 +0.68%
in 20 days
(closed on 02/10/09)
The tables at my web link below include an updated calendar of 80 expected FDA new product decisions and 83 pending clinical trial result estimates + pending FDA re-submissions. Click here for a link to my previous FDA calendars and the below is a summary of new entries and updates on the calendars.
 
 
<> 1.) Genentech (DNA) expects to report results in mid-April in its Avastin colon cancer adjuvant trial, in addition to pending FDA decisions to expand product labels for Avastin in relaps...
By  Mike Havrilla   (+1.04%  risk: conservative)  01/21/09 1 comment


Buyout Binge Begins for Bio-Pharma, Diagnostics Graphic_rating_buy DNA
Mikerun
73%
 -5.50%
in 11 days
(closed on 01/21/09)

Buyout Binge Begins for Bio-Pharma, Diagnostics

<>
<>
<> With news late Friday that Roche (RHHBY) is prepared to up its bid for complete control of Genentech (DNA) to $95 from a previous offer of $89 per share and a $41M ($1.50 per share) all-stock takeover offer by Sequenom (SQNM) for EXACT Sciences (EXAS); 2009 is off to a strong start for M&A activity in the bio-pharma and diagnostic space.

Larger and well funded bio-pharma and diagnostic companies are opportunistically looking to expand their product offerings, pipeline prospects, patent portfolios, ...
By  Mike Havrilla   (+1.04%  risk: conservative)  01/10/09 Comment


A More Focused Highly Defensive Index Graphic_rating_buy DNA
Mikerun
73%
 +20.78%
in 37 days
(closed on 01/10/09)

A More Focused Highly Defensive Index

<>
The accompanying table [click to enlarge] includes an updated version of the ETF Innovators [ETFI] ETFI Highly Defensive PerformIdex of 36 companies based in the U.S., Canada, and Europe with market caps over $10B, which are the leaders by market cap in their defensive industry groups. This update includes a 10% reduction in the number of companies with an equal distribution of 12 each from consumer staples and healthcare, with the remaining 12 companies chosen from a variety of defensive industry groups.

(A) Mass Merch...
By  Mike Havrilla   (+1.04%  risk: conservative)  12/03/08 Comment




From the Blogosphere

Google: Art Levinson Leaves Board
N/A

Google (GOOG) this morning announced that former Genentech (DNA) CEO Arthur Levinson has resigned as a director effective immediately. Levinson remains a member of the Apple (AAPL) board; recall that the FTC earlier this year launched a probe of the close ties between the Google and Apple boards. Google CEO Eric Schmidt resigned from the Apple board in August.

The company did not provide a reason for the resignation.
By  Eric Savitz (Barron's)    10/12/09 Comment


Immunogen (IMGN): Investing in antibody technology

Filed under: Newsletters, Genentech Inc (DNA), Stocks to Buy

"How does one go about investing in the antibody space?" asks biotech specialist John McCamant. In The Medical Technology Stock Letter, he eyes Immunogen (NASDAQ: IMGN), and offers an in-depth report for biotech-savvy readers.

"As background, T-DM1 is a second generation Herceptin that may even exceed the original in sales because the armed antibody has been more potent to date by showing effectiveness in mBC patients who have failed either Herceptin or Tykerb.

<>"The company will continue to benefit from Genetech's extensive antibody ...
By  Steven Halpern   (+4.82%  risk: moderate)  07/14/09 Comment


OSI Pharmaceutical Gets a Boost from Cancer Drug

By Jon "DRJ" Najarian

<>OSI ChartLung Cancer Drug Advances

OSI Pharmaceutical (OSIP) and Roche subsidiary Genentech (DNA) announced that a pivotal Phase III study of Tarceva met a key secondary endpoint of extending overall survival in patients with advanced lung cancer who received the drug immediately after initial chemotherapy. A statistically significant improvement in overall survival was seen in this final analysis of the total patient population. OSIP and Genentech will present during the 13th World Conference on Lung Cancer to be held July 31 to Aug. 4 in San Francisco. OSIP closed at $28.44 Fri...
By  trackseekingalpha   (-13.57%  risk: aggressive)  07/13/09 Comment


Comparing Medicine’s Effectiveness…and Cost
N/A

Two important reports today offer early hints of the potential impact of a $1.1 billion federal program to compare the medical benefit and the cost-effectiveness of surgeries, medicines and medical devices. The reports — by the Institute of Medicine and the Federal Coordinating Council for Comparative Effectiveness Research – suggest priorities for spending $700 million of the research funds set aside under the American Recovery and Reinvestment Act of 2009.

<>The reports don’t name particular products or companies, but many of the suggested projects would scrutinize expensive produ<><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><>< /><>< /><>< /><>< /><>< />< />...
By  Eric Savitz (Barron's)    07/01/09 Comment


Are Tech Companies Colluding To Hold Down Salaries?
N/A

The Justice Department reportedly is investigating whether some of the largest U.S. tech companies have violated antitrust laws by negotiating the recruiting and hiring of each other’s employees. If true, the implication would be that compensation of some of the industry most talented employees is being artificially reduced by the companies for whom they toil.

<>The probe, first reported by the Washington Post, and followed up by the New York Times, apparenrtly is focused on the activities of many of the Valley’s biggest companies. The Post story said Justice is focused on Google (GOOG), <>Y...
By  Eric Savitz (Barron's)    06/03/09 Comment



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