Genzyme’s new osteoarthritis drug received recommendation from Food and Drug Administration panel, giving the company’s shares a boost Wednesday.
Genzyme’s stock was up $2.24, or 3.54%, at $65.50 in at midday.
A five-member FDA panel unanimously recommended approval of a single-injection version of Synvisc, which relieves pain between the joints. A three-injection version of Synvisc has already received approval.
Though the FDA doesn’t have Read the rest of this entry »

debate continues, but  U.S.
(FDA) advisors are recommending the painkiller be pulled from the market.  USA Today reported that following a hearing about the popular pain drug, a FDA panel voted to withdraw the drug in a 14-to-12 vote.
Darvon, known generically as Propoxyphene Hydrochloride, is also prescribed as Darvocet, which contains the active ingredient in Tylenol, reported USA Today.  At issue, is that consumer groups feel the drug does Read the rest of this entry »

(Adds FDA comment, product background, byline)
SILVER SPRING, Md., Dec 10 (Reuters) – A U.S. Food and Drug
Administration advisory panel rejected Acusphere Inc’s (ACUS.O:
,
,
,
)
imaging contrast agent on Wednesday, saying possible risks
outweighed its potential for screening heart patients.
In a 16-1 vote, the FDA’s panel of outside advisers said there
was not consistent data to prove the product worked, and expressed
concern about potential Read the rest of this entry »

GAITHERSBURG, Maryland (Reuters) – Female Health Co’s new, potentially less costly version of its female condom, won crucial backing from a U.S. Food and Drug Administration advisory panel on Thursday.
The FDA panel of outside advisers, in a 15-0 vote, said the company’s data supported FDA approval of the FC2 Female Condom as long as some changes were made to the product’s label.
The company is seeking to market the new version as a method to Read the rest of this entry »

Johnson & Johnson said late Thursday a panel of government advisers recommended that its catheter system be approved for a new use in treating irregular heart rhythms.
A Food and Drug Administration panel of medical device experts unanimously voted in favor of approving the Thermocool family of catheters for the new use, with certain conditions. Panelists said the company should be required to educate physicians on proper use of the device and operate Read the rest of this entry »

THURSDAY, Dec. 11 (HealthDay News) — The safety of four asthma medications will be weighed by a U.S. Food and Drug Administration expert panel as two days of hearings end Thursday.
The controversy over these drugs has been going on for several years, with two FDA officials recently calling for banning the use of these drugs for anyone under 17.
One expert thinks the problem is not with the drugs, but with their misuse.
“This is an over-interpretation Read the rest of this entry »

Shares of Genzyme Corp. jumped Wednesday after advisers to the Food and Drug Administration recommended approval of a new osteoarthritis treatment formula.
The stock gained $1.45, or 2.2 percent, to reach $64.64 in morning trading. Shares have traded between $57.61 and $83.97 over the past 52 weeks.
The Cambridge, Mass.-based company wants the FDA to approve a single-dose version of Synvisc, an injectable drug that relives knee pain by providing Read the rest of this entry »

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This press release contains forward-looking statements within the
meaning of the Safe Harbor Provisions of the Private Securities
Litigation Reform Act of 1995. Such statements are based on the current
expectations and beliefs of ReGen management and are subject to a number
of factors and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements, Read the rest of this entry »

Release date: July 1, 2008
Taipei Taiwan (July 1, 2008)–AAEON, the professional medical product manufacturer, announced the debut of two new medical stations-ONYX-195S and ONYX-175S. These medical stations are equipped with 2 independent isolated RS-232 and are based on the latest Intel Core 2 Duo processor (up to 2.16GHz). The ONYX-195S and ONYX-175S deliver a strong performance improvement over traditional computers used in hospitals. They are Read the rest of this entry »