FDA Issues Approvable Letter for Paliperidone ER for the Treatment of Schizophrenia (RedNova)
TITUSVILLE, N.J., Sept. 29 /PRNewswire-FirstCall/ -- Johnson & Johnson Pharmaceutical Research & Development (JJPRD), L.L.C. announced that it has received an approvable letter from the U.S.

Lilly Announces FDA Requirement of Additional Clinical Trial Before Ruboxistaurin Could Be Approved for Treatment of (RedNova)
INDIANAPOLIS, Sept. 29 /PRNewswire-FirstCall/ -- Eli Lilly and Company today announced that it is weighing options for the further development of ruboxistaurin mesylate in light of a request by the Food and Drug Administration (FDA) for an additional, three-year, Phase 3 clinical trial.

FDA Issues Approvable Letter To Ortec For Use Of Cryopreserved OrCel(R) In Epidermolysis Bullosa Patients' Hand (Medical News Today)
Ortec International, Inc.(OTC Bulletin Board: OTCI), a company focused on advancing regenerative medicine through the development of cellular technology and advanced biomaterial products, has been notified by the Food and Drug Administration (FDA) that its HDE Supplement is approvable subject to an inspection by the FDA of its commercial manufacturing facility. [click link for full article]

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FDA Approves a New Drug for Colorectal Cancer, Vectibix
Vectibix, a monoclonal antibody that binds to a protein called epidermal growth factor receptor or EGFR on some cancer cells, received an accelerated approval after showing effectiveness in slowing tumor growth and, in some cases, reducing the size of the tumor

Read more about FDA Approves a New Drug for Colorectal Cancer, Vectibix Vectibix,

FDA Issues Approvable Letter to Ortec for Use of Cryopreserved OrCel(R) in Epidermolysis Bullosa Patients' Hand (PR Newswire via Yahoo! Finance)
Ortec International, Inc. , a company focused on advancing regenerative medicine through the development of cellular technology and advanced biomaterial products, has been notified by the Food and Drug Administration that its HDE Supplement is approvable subject to an inspection by the FDA of its commercial manufacturing facility.

FDA Approves Remicade for Severe Psoriasis (RedNova)
Johnson & Johnson unit Centocor has said that the FDA has approved Remicade for the treatment of patients with plaque psoriasis who are candidates for systemic therapy.

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Arbios Granted FDA Allowance to Expand SEPET(TM) Clinical Trial Eligibility (FinanzNachrichten)
WALTHAM, Mass., Sept. 29 /PRNewswire-FirstCall/ -- Arbios Systems, ( Nachrichten ) Inc. announced today that the U.S. Food&Drug Administration (FDA) has allowed expansion of the eligibility criteria for the ongoing clinical trial of its SEPET(TM) Liver Assist Device to include patients with hepatic encephalopathy due to combined liver and kidney (renal) failure.

Matritech Notified by AMEX of Continued Listing Standards Non-Compliance (Business Wire via Yahoo! Finance)
NEWTON, Mass.----Matritech , a leading marketer and developer of protein-based diagnostic products for the early detection of cancer, today reported that on September 21, 2006 it received a letter from the American Stock Exchange stating that AMEX has determined that the Company is not in compliance with certain continued listing standards including Section 1003 of the Company Guide with

Axcan Receives FDA Approval Letter for PYLERA'TM' -Formerly Known as HELIZIDE-, an Innovative 3-in-1 Capsule Triple (Market Wire via Yahoo! Finance)
Axcan Pharma Inc.(NASDAQ: AXCA) today announced that the US Food and Drug Administration has issued an approval letter for the Company's New Drug Application for PYLERA(TM). PYLERA(TM) is a patented 3-in-1 capsule triple therapy, for the eradication of Helicobacter pylori, which is a bacterium now recognized as being the main cause of gastric and duodenal ulcers.

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FDA Approves a New Drug for Colorectal Cancer, Vectibix
Vectibix, a monoclonal antibody that binds to a protein called epidermal growth factor receptor or EGFR on some cancer cells, received an accelerated approval after showing effectiveness in slowing tumor growth and, in some cases, reducing the size of the tumor

Read more about FDA Approves a New Drug for Colorectal Cancer, Vectibix Vectibix,

Women getting more choices for birth control (Baxter Bulletin)
Carolyn Westhoff runs a large federally funded family planning clinic at Columbia University.

A call for progressive breeders to bed down already (San Francisco Chronicle)
Let this be your rallying cry. Let it be your new hot-button topic, a raw, naked, condomless, blog-ready, wildfire, underground, grassroots crusade, your juiciest of incentive programs, your inspired call to hot, naked, impregnable sperm-a-riffic action.

Maureen's Medical Moment: Women have a new option in birth control (WNDU 16)
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Read more about Women getting more choices for birth control (Baxter Bulletin) Carolyn

Vitagel? Surgical Hemostat
Vitagel? Surgical Hemostat (Vitagel) is a product that assists the body in clotting blood. After Vitagel has performed its function, it is absorbed by the body. Vitagel includes the biological component thrombin, an enzyme that assists in the clotting... (Approved: 6/16/2006)

Read more about Vitagel? Surgical Hemostat Vitagel? Surgical Hemostat (Vitagel) is a product

RLB Food Distributors Issues a Multiple East Coast States Recall of Fresh Spinach Salad Products for Possible E. coli Contamination
FRLB Food Distributors is initiating a multiple east coast states voluntarily recall of certain salad products that may contain spinach with an Enjoy Thru date of 9/20/06.

Monterey Mushrooms Recalls Fresh Sliced White and Baby Bella Mushrooms in PA, MD, NC, NJ, NY, OH, and VA Because of Possible Health Risk
Monterey Mushrooms of Watsonville, CA is recalling approximately 10,000 cases of fresh sliced white mushrooms and fresh sliced baby bella mushrooms, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

U.S. Trading Co. Issues Allergy Alert on Undeclared Milk Protein in Dragonfly Pudding Products
People who have an allergy or severe sensitivity to dairy (casein) run the risk of serious or life-threatening allergic reaction if they consume these products.

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Broad Group Calls for More FDA Funding (WebMD)
A broad group of organizations and former health officials called for increased funding for the FDA Monday, warning that the agency's waning reputation won't improve without more spending.

FDA Approves REMICADE(R) For Treatment Of Chronic Severe Plaque Psoriasis: Marks Major Milestone For Patients With High (Medical News Today)
Centocor, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved REMICADE(R) (infliximab) for the treatment of adult patients with chronic severe (i.e. extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. [click link for full article]

Boston Scientific Announces FDA Approval Of Harmony(TM) HiResolution(R) Bionic Ear System (Medical News Today)
Boston Scientific Corporation (NYSE: BSX) today announced the approval of its new Harmony(TM) HiResolution(R) Bionic Ear System (Harmony System) by the U.S. Food and Drug Administration (FDA). [click link for full article]

Read more about FDA Approvals - Broad Group Calls for More FDA Funding (WebMD) A broad

Tibotec Expands Access Program for HIV Research (RedNova)
Tibotec Pharmaceuticals has expanded its access program for TMC125, its investigational agent developed to combat resistant strains of the HIV virus. The program has opened in the US and will open shortly in Canada and Europe, subject to the necessary approvals.

Panel slams FDA's internal politics, lack of follow-up for approved drugs (EARTHtimes.org)
The US Food and Drug Administration (FDA) needs reforms to better ensure the safety of medicines, go easy on approvals of new medicines and study in-depth the side effects of post-approval drugs. These are only some of the recommendations that a panel empowered by the FDA has come up with to make the drugs regulator efficient.

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FDA Statement on Foodborne E. coli O157:H7 Outbreak in Spinach Update: Sunday, September 17, 2006
FDA update on the expanded recall of fresh packaged spinach due to foodborne illness

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Torc Investments and Research Initiates Coverage of Generex Biotechnology With a Buy Rating and 12-Month Price Target (RedNova)
Generex Biotechnology Corporation (NASDAQ: GNBT) announced today that Torc Investments and Research LLC, a NASD registered broker-dealer, initiated research coverage of the Company today with a Buy rating and a 12-month price target of $3-$3.50.

Balancing Compliance with Economics: The New Role of Manufacturing (Logistics Management)
Continuing pressures on life sciences manufacturing, from increased competition to expiring patents, are forcing organizations to achieve tighter operating efficiencies, while improving their ability to satisfy quality compliance standards.

Matritech Notified by AMEX of Continued Listing Standards Non-Compliance (Business Wire via Yahoo! Finance)
NEWTON, Mass.----Matritech , a leading marketer and developer of protein-based diagnostic products for the early detection of cancer, today reported that on September 21, 2006 it received a letter from the American Stock Exchange stating that AMEX has determined that the Company is not in compliance with certain continued listing standards including Section 1003 of the Company Guide with

Read more about Torc Investments and Research Initiates Coverage of Generex Biotechnology With

FDA Told U.S. Drug System Is Broken (Washington Post)
The federal system for approving and regulating drugs is in serious disrepair, and a host of dramatic changes are needed to fix the problem, a blue-ribbon panel of government advisers concluded yesterday in a long-awaited report.

OraSure Technologies Commences Initial Studies for FDA Approval of Home Use Rapid HIV Test Kit (Business Wire via Yahoo! Finance)
BETHLEHEM, Pa.----OraSure Technologies, Inc. , the market leader in oral fluid diagnostics and the manufacturer of the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test, announced today that it has commenced several laboratory-based operational studies as the initial stage of the process to obtain U.S.

Read more about FDA Approvals - FDA Told U.S. Drug System Is Broken (Washington Post) The

FDA Warning on Serious Foodborne E.coli O157:H7 Outbreak
FDA is issuing an alert to consumers about an outbreak of E. coli O157:H7 in multiple states that may be associated with the consumption of produce. To date, preliminary epidemiological evidence suggests that bagged fresh spinach may be a possible cause of this outbreak.

Read more about FDA Warning on Serious Foodborne E.coli O157:H7 Outbreak FDA is

Maureen's Medical Moment: Women have a new option in birth control (WNDU 16)
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Implanon offers new birth control option (WTHR Indianapolis)
Women now have a new option in birth control. Implanon is a new generation hormone implant that has been widely used outside the United States and was just recently FDA-approved. Doctors believe it's both safe and effective.

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Immunicon Achieves Endpoints in its Pivotal Clinical Trial in Metastatic Colorectal Cancer (FinanzNachrichten)
Immunicon Corporation ( Nachrichten ) (NASDAQ-GM:IMMC) announced today that the Company met the primary and secondary endpoints associated with its pivotal clinical trial in metastatic colorectal cancer.

Glivec Receives Additional EU Approvals For Use In Treating A Rapidly Progressive Form Of Leukemia And A Hard-to-treat (Medical News Today)
Novartis has received additional European Union approvals for Glivec (imatinib) to help patients with a rapidly progressive form of leukemia as well as a hard-to-treat solid cancer tumor. Both are rare and potentially life-threatening diseases with few, if any, approved treatments that have resulted in poor long-term outcomes. [click link for full article]

Drug Safety Overhaul Is Urged (KTLA 5)
The FDA spends far more time on approvals than on follow-ups, a review finds. Calls for reform include warning labels and limits on ads.

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AxSYM HBsAg Assay
This device is a lab test used to confirm whether or not a person is infected with hepatitis B virus (HBV). The reagents are used with the Abbott AxSYM Instrument System to identify certain virus proteins associated with HBV. If these virus proteins are (Approved: 6/1/2006)

Read more about AxSYM HBsAg Assay This device is a lab test used

RLB Food Distributors Issues a Multiple East Coast States Recall of Fresh Spinach Salad Products for Possible E. coli Contamination
FRLB Food Distributors is initiating a multiple east coast states voluntarily recall of certain salad products that may contain spinach with an Enjoy Thru date of 9/20/06.

Monterey Mushrooms Recalls Fresh Sliced White and Baby Bella Mushrooms in PA, MD, NC, NJ, NY, OH, and VA Because of Possible Health Risk
Monterey Mushrooms of Watsonville, CA is recalling approximately 10,000 cases of fresh sliced white mushrooms and fresh sliced baby bella mushrooms, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

FDA Warning on Serious Foodborne E.coli O157:H7 Outbreak
FDA is issuing an alert to consumers about an outbreak of E. coli O157:H7 in multiple states that may be associated with the consumption of produce. To date, preliminary epidemiological evidence suggests that bagged fresh spinach may be a possible cause of this outbreak.

Read more about RLB Food Distributors Issues a Multiple East Coast States Recall

FDA Statement on Foodborne E. coli O157:H7 Outbreak in Spinach--Updated 9/16/06
The U.S. Food and Drug Administration (FDA) will continue to provide the public with regular updates on the E. coli O157:H7 outbreak each day until further notice.

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Windhover Information's FDA/CMS Summit for BioPharma Executives: Commercial Success in the Regulatory Environment (Business Wire via Yahoo! Finance)
NORWALK, Conn.----Sept. 22, 2006--The agenda for Windhover Information's blockbuster FDA/CMS Summit is shaping up to be one of the most significant of the year in the regulatory arena.

Selecting and Using a Manufacturing Execution System (Medical Device Link)
All medical device manufacturers share a common goal: quality. By relentlessly pursuing this goal, device manufacturers seek to satisfy existing customers and win new ones, while avoiding the costly and reputation-sullying consequences of repeated field failures and product recalls.

FDA Drug Safety Reform Urged (Washington Post)
More authority over drug industry needed to better track safety of post-market medicines, report says.

Read more about Windhover Information's FDA/CMS Summit for BioPharma Executives: Commercial Success in