Feb 19, 2009 (Datamonitor via COMTEX) –
— Cordex Pharma, a developer of new cardiovascular medicines, has submitted to the FDA an amended Phase III protocol for ATPace to be reviewed as a special protocol assessment.
According to Cordex, the amendment addresses written comments recently received from the FDA in response to the company’s initial special protocol assessment (SPA) submission to the FDA in November 2008.
Amir Pelleg, Cordex’s Read the rest of this entry »

In Orlando, a 38-year-old contractor suffers from erectile dysfunction, a side effect of the drug he takes for depression. The anti-ED prescription his doctor gave him doesn’t help. He seeks steroids instead.
And in a town north of Seattle, an eighth-grade boy wants steroids for school sports. If he can get his weight up to 170, he thinks he can make the football team.
Here, from the business records of a Florida wellness center that was closed Read the rest of this entry »

Ltd. said Friday it filed a lawsuit against
’s antibiotic Doryx.
) sells the drug in strengths of 75 mg, 100 mg and 150 mg, with Mayne Pharma International, a subsidy of
) Inc. Last month, Sandoz asked the Food and Drug Administration to approve its generic version for sale.
Bermuda-based Warner Chilcott and Mayne are also suing Mylan Inc., Impax Laboratories Inc. and Mutual Pharmaceutical Co. to prevent them from selling generic versions Read the rest of this entry »

The hospital issued a prepared statement: “We are aware of the lawsuit, however, it is hospital policy not to discuss care rendered to patients due to federal privacy laws.”
Franke was a partner in Hepler, Broom Law Firm in Edwardsville, specializing in health care negligence cases and defending personal injury claims. She also was a former St. Clair County prosecutor. Franke graduated from the Southern Illinois University School of Law in 1982.
Read the rest of this entry »

(Dec 24, 2008)–Trinity Biotech, developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, today announced the filing of its 510k submission with the FDA for its new high throughput coagulation analyzer, the Destiny Max.
Trinity recently obtained CE marking which enables it to sell the Destiny Max in Europe and has now filed its 510k submission with the FDA seeking permission to sell the instrument Read the rest of this entry »

As the cliché goes, there are only two certainties in life: death and taxes. But, they’re intertwined. When you go to the
great beyond, the government generally wants its cut, which is just under half the size of your estate, provided it reaches
a certain size. Yep: The government can be your biggest heir, whether you like it or not.
Every few years, the estate
tax, also known as the death tax, flares Read the rest of this entry »

(KTVI – myFOXstl.com)

 – 
Mariano Favazza is the longtime St. Louis Circuit Clerk. His older brother, Lou works for the Collector of Revenue. They were both big guys, literally, around city hall. By big I mean Mariano weighed 370 pounds. Lou weighed 506 pounds. They are now just shadows of their former selves. The duo has lost more than 400 pounds between them. Mariano now tips the scales at 233. Lou is now at 236. What in Read the rest of this entry »

BIRMINGHAM –Physicians Medical Center Carraway filed for federal bankruptcy protection for the second time in two years Monday and planned to shut down by the end of October.
The century-old hospital, which was purchased by a group of doctors after it filed a bankruptcy petition in 2006, had only 100 or so patients but still employs about 1,000 people. Located near downtown Birmingham, Carraway is licensed for 617 beds.
The hospital quit admitting Read the rest of this entry »

BioVigilant Submits Drug Master Files to U.S. FDA, Accelerating
Regulatory Approval Process for Instantaneous Microbial Detection
Equipment Use
TUCSON, Ariz.–(
BioVigilant Systems, Inc.
),
inventors of
, today announced that the Company has submitted
two Type V Drug Master Files (DMFs) to the U.S. Food and Drug
Administration (FDA) for its
(TM)-A
product line, a family of products used for rapid Read the rest of this entry »

BOSTON, Feb. 10 (Reuters) – OSI Pharmaceuticals Inc said on
Tuesday that Israeli drugmaker Teva Pharmaceuticals Industries
Ltd (
TEVA.TA
TEVA.O
) has submitted an application to the U.S.
Food and Drug Administration to make a generic version of OSI’s
cancer drug Tarceva.
Melville, New York-based OSI said it has 45 days from its
receipt of the notice to commence a patent infringement lawsuit
against Teva, and it said it expects to file within Read the rest of this entry »