FDA regulation related Press Releases

California Healthcare Institute Board Elects New Member

Mon, 07 Nov 2011 14:20:52 -0500

LA JOLLA, Calif.--(BUSINESS WIRE)-- CHI-California Healthcare Institute announced today the election of Rick Winningham, who serves as CEO of South San Francisco-based Theravance, to serve on the CHI board of directors. CHI is a non-profit public policy research organization, representing leading California academic institutions, biotechnology, medical device, diagnostics and pharmaceutical firms.

“We are pleased to welcome Theravance to our board,” said David L. Gollaher, Ph.D., CHI president and CEO. “Theravance is working to advance important innovations to patients in need. Rick will help inform our approach to the key issues facing our industry today, from FDA regulation to coverage and payment for novel therapeutics.”

Winningham joined Theravance as chief executive officer and member of the board of directors in October 2001, and was appointed chairman of the board in April 2010. Since assuming the role of CEO, Theravance has successfully transitioned from a private research-based small molecule discovery company to a public company with a robust portfolio of product candidates, both in clinical development and on the market. Prior to joining Theravance, Winningham held various management positions with Bristol-Myers Squibb and its predecessor, Bristol-Myers, since 1986. During his tenure with BMS, he was associated with the development and commercialization of several major pharmaceutical products, such as Taxol, Paraplatin, Zerit, Videx, Reyataz, and Abilify. He holds a bachelor’s degree from Southern Illinois University and a master’s of business administration from Texas Christian University. He serves the board of Jazz Pharmaceuticals Inc. and is a member of the external advisory board for the College of Business and Administration and Business Hall of Fame at Southern Illinois University.

About CHI

CHI represents more than 275 leading biotechnology, medical device, diagnostics, and pharmaceutical companies, and public and private academic biomedical research organizations. CHI’s mission is to advance responsible public policies that foster medical innovation and promote scientific discovery. CHI’s website is www.chi.org. Follow us on Twitter @calhealthcare and Facebook.

Editorial note: photo available upon request.

CONTACT:

California Healthcare Institute
Nicole Beckstrand, 858-456-8881
beckstrand@chi.org

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Health Biotechnology Medical Devices Pharmaceutical Research Science Managed Care

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Research and Markets: Cost-Contained Regulatory Compliance: For the Pharmaceutical, Biologics, and Medical Device Industri

Mon, 12 Sep 2011 15:20:33 -0400

DUBLIN--(BUSINESS WIRE)-- Research and Markets (http://www.researchandmarkets.com/research/852d5d/costcontained_reg) has announced the addition of John Wiley and Sons Ltd's new book "Cost-Contained Regulatory Compliance: For the Pharmaceutical, Biologics, and Medical Device Industries" to their offering.

This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries.

Key Topics Covered:

PREFACE.
Chapter 1. Controlling Regulatory Costs.
Chapter 2. Clear Operation Definitions of Requirements.
Chapter 3. Pre-Regulatory Audits.
Chapter 4. Quality by Design.
Chapter 5. Outsourcing.
Chapter 6. Electronic Submissions.
Chapter 7. EMEA/FDA Inspections.
Chapter 8. Managing FDA Inspections.
Chapter 9. Risk Assessment.
Chapter 10. Cases.
Chapter 11. Cost Containment Analysis.
Chapter 12. Managing Regulation In Times of Chaos.
Chapter 13. International Regulation.
Chapter 14. Cost Contained Regulatory Compliance.
Chapter 15. Future.
BIBLIOGRAPHY.
INDEX.

Author:

SANDY WEINBERG, PhD, is a professor of healthcare management at Clayton State University in Atlanta and an international regulatory consultant. He has thirty-five years' regulatory experience, including global executive responsibility at GE Healthcare and Tikvah Therapeutics. Dr. Weinberg has written thirteen books including, most recently, Guidebook for Drug Regulatory Submissions, also from Wiley.

For more information visit http://www.researchandmarkets.com/research/852d5d/costcontained_reg

CONTACT:

Research and Markets
Laura Wood, Senior Manager,
press@researchandmarkets.com
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716

KEYWORDS:

INDUSTRY KEYWORDS: Health Biotechnology Medical Devices Pharmaceutical

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FDA Takes Actions on Darvon, Other Pain Medications Containing Propoxyphene

Calisha Myers — Wed, 08 Jul 2009 10:52:23 -0400

FDA Takes Actions on Darvon, Other Pain Medications Containing Propoxyphene

The U.S. Food and Drug Administration is taking several actions to reduce the risk of overdose in patients using pain medications such as Darvon and Darvocet that contain propoxyphene. The actions were taken because of data linking propoxyphene and fatal overdoses.

The agency is requiring manufacturers of propoxyphene-containing products to strengthen the label, including the boxed warning, emphasizing the potential for overdose when using these products. These manufacturers will also be required to provide a medication guide to patients stressing the importance of using the drugs as directed.

In addition, the FDA is requiring a new safety study assessing unanswered questions about the effects of propoxyphene on the heart at higher than recommended doses. Findings from this study, as well as other data, could lead to additional regulatory action.

"Physicians need to be aware of the risk of overdose when prescribing these drugs. They should carefully review patient histories and make appropriate treatment decisions based on the warnings and directions stated within the drug's label," said Janet Woodcock, M.D, director of the FDA's Center for Drug Evaluation and Research. "Prescribers and patients should be aware of propoxyphene's potential risks when used at doses higher than those recommended. Therefore, the FDA is requiring manufacturers to provide more information to help physicians and patients decide whether propoxyphene is the appropriate pain therapy."

To further evaluate the safety of propoxyphene, the FDA plans to work with several groups including the Centers for Medicare & Medicaid Services and the Veterans Health Administration to study how often the elderly are prescribed propoxyphene instead of other pain relievers and the difference in the safety profiles of propoxyphene compared to other drugs.

Propoxyphene manufacturers are required to submit the requested safety labeling changes to the FDA within 30 days, or to provide a reason why they do not believe such changes are necessary. If they do not submit new language, or if the FDA disagrees with the language the companies propose, the Food, Drug, and Cosmetic Act provides strict timelines for discussions regarding the changes. At the end of these discussions, the FDA may issue an order directing the labeling changes as deemed appropriate to address the new safety information.

Also today, the FDA denied a citizen petition from the public interest group Public Citizen requesting a phased withdrawal of propoxyphene. The agency said in its response that despite the FDA's serious concerns about propoxyphene, the benefits of using the medication for pain relief at recommended doses outweighs the safety risks at this time. The FDA also noted that it plans to further evaluate the safety of propoxyphene and will take additional regulatory action if necessary. Details of this decision can be found at:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm170268.htm.

Propoxyphene has been on the market since 1957. It is a widely prescribed member of a group of drugs known as opioids and is used as a treatment for mild to moderate pain.

The most frequent side effects of propoxyphene include lightheadedness, dizziness, sedation, nausea, and vomiting.

FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban

Calisha Myers — Wed, 01 Jul 2009 12:46:38 -0400

FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban

The U.S. Food and Drug Administration today announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (buproprion). The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.

"The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking," said Janet Woodcock, M.D., director, the FDA's Center for Drug Evaluation and Research. "Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit."

Similar information on mental health events will be required for buproprion marketed as the antidepressant Wellbutrin and for generic versions of buproprion. These drugs already carry a Boxed Warning for suicidal behavior in treating psychiatric disorders.

Woodcock said health care professionals who prescribe Chantix and Zyban should monitor their patients for any unusual changes in mood or behavior after starting these drugs. She added that patients should immediately contact their health care professional if they experience such changes.

The FDA's request for the additional warnings is based on a review of reports submitted to the agency's Adverse Event Reporting System since the time the products were marketed and on an analysis of information from clinical trials and scientific literature.

The analyses revealed that some who have taken Chantix and Zyban have reported experiencing unusual changes in behavior, become depressed, or had their depression worsen, and had thoughts of suicide or dying. In many cases, the problems began shortly after starting the medication and ended when the medication was stopped. However, some people continued to have symptoms after stopping the medication. Also, in a few cases, the problems began after the medication was stopped.

Neither Chantix nor Zyban contain nicotine and some of these symptoms may be a response to nicotine withdrawal. People who stop smoking may experience symptoms such as depression, anxiety, irritability, restlessness, and sleep disturbances. However, some patients who were using these products experienced the reported adverse events while they were still smoking.
In addition to the Boxed Warning, the FDA also is requesting more information in the Warnings section of the prescribing information and updated information in the Medication Guide for patients that further discuss the risk of mental health events when using these products.

Manufacturers also will be required to conduct a clinical trial to determine how often serious neuropsychiatric symptoms occur in patients using various smoking cessation therapies, including patients who currently have psychiatric disorders. The FDA's review of adverse events for patients using nicotine patches did not identify a clear link between those medications and suicidal events.

Chantix is manufactured by New York-based Pfizer Inc. Zyban is manufactured by GlaxoSmithKline, Brentford, Middlesex, United Kingdom.

Merck Statement in Response to FDA's June Communication with Updated Information on Leukotriene Inhibitors, Including Singulair

Calisha Myers — Mon, 15 Jun 2009 11:41:03 -0400

Merck Statement in Response to the FDA's June 12, 2009 Communication with Updated Information on Leukotriene Inhibitors, Including SINGULAIR® (montelukast sodium)

WHITEHOUSE STATION, N.J., June 12, 2009 - Merck & Co., Inc. issued the following statement in response to today's communication from the U.S. Food & Drug Administration (FDA) addressing updated information on leukotriene inhibitors, including SINGULAIR® (montelukast sodium).

Since the introduction of SINGULAIR in 1998, the Company has updated the post-marketing section of the prescribing information to communicate a range of adverse events reported with post-marketing use of the drug, including the types of neuropsychiatric events addressed in the FDA's communication. Merck will continue to work with the FDA to revise the prescribing information for SINGULAIR in the United States to include a precaution related to those events.

Merck is confident in the efficacy and safety of SINGULAIR, a medicine that has been prescribed to tens of millions of patients with asthma and allergic rhinitis since its approval more than 11 years ago.

"For the millions of people suffering from either asthma or allergic rhinitis, SINGULAIR is an important treatment option for appropriate patients," said Scott Korn, M.D., vice president, Clinical Risk Management and Safety Surveillance, Merck Research Laboratories.

SINGULAIR is indicated for the prevention and chronic treatment of asthma in adults and pediatric patients 12 months of age and older, for the relief of symptoms of seasonal allergic rhinitis (SAR) in adults and children 2 years and older, and for the relief of symptoms of perennial allergic rhinitis (PAR) in adults and children 6 months and older. The efficacy and safety profile of SINGULAIR is supported by available data from controlled clinical trials, in which more than 20,000 patients received SINGULAIR, and from a review of post-marketing adverse event reports collected since the drug was approved by the FDA.

Merck will continue communicating with patients, parents and health care providers about SINGULAIR in ways that will help inform their decisions about appropriate treatment choices. Patients and parents of children with asthma or allergies should talk with their health care providers if they have any questions about the benefits and risks of SINGULAIR. Patients should talk to their health care providers before starting or stopping treatment with any prescription medicine.

Important safety information about SINGULAIR
The use of SINGULAIR for chronic treatment of asthma may not eliminate the need for inhaled or oral corticosteroids. While the dose of inhaled corticosteroid may be reduced gradually under medical supervision, SINGULAIR should not be abruptly substituted for inhaled or oral corticosteroids. Patients should be advised to take SINGULAIR daily as prescribed for chronic treatment of asthma even when they have no symptoms, as well as during periods of worsening asthma, and to contact their physician if their asthma is not well controlled.

In clinical studies in patients with asthma, adverse events were generally mild and varied by age. The most common adverse events in clinical trials in adults and adolescents with asthma ages 15 years and older were headache, influenza, abdominal pain, cough and dyspepsia. In clinical studies in patients with allergic rhinitis, SINGULAIR was generally well tolerated with a safety profile similar to placebo. The most common adverse events in these clinical trials included sinusitis, upper respiratory infection, sinus headache, cough, epistaxis, headache, otitis media, pharyngitis and increased alanine aminotransferase (ALT). Less common side effects that have happened with SINGULAIR include behavior and mood related changes [agitation including aggressive behavior, bad/vivid dreams, depression, feeling anxious, hallucinations (seeing things that are not there), irritability, restlessness, suicidal thoughts and actions (including suicide), tremor, trouble sleeping].

About Merck
Merck & Co., Inc., Whitehouse Station, N.J., U.S.A. which operates in many countries as MSD (Merck Sharp & Dohme) is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. For more information, visit www.merck.com.

Forward-looking statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2008, and in any risk factors or cautionary statements contained in the Company's periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.

FDA Requests Labeling Change for Leukotriene Modifiers

Calisha Myers — Mon, 15 Jun 2009 11:39:01 -0400

FDA Requests Labeling Change for Leukotriene Modifiers

The U.S. Food and Drug Administration today provided further updated safety information on a class of asthma drugs known as leukotriene modifiers. The FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling) regarding neuropsychiatric events (behavior, mood changes) that have been reported in some persons taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR).

Leukotrienes are chemicals the body releases in response to an inflammatory stimulus, such as when a person breathes in an allergen. Montelukast and zafirlukast are leukotriene receptor antagonists that work by blocking leukotrienes. Zileuton is a leukotriene synthesis inhibitor which works by stopping the formation of certain substances that cause swelling, tightening, and mucus production in the airways.

Agennix Receives Fast Track Designation From FDA for Talactoferrin in Combination With Sunitinib for Renal Cell Carcinoma a

Calisha Myers — Tue, 19 May 2009 12:09:30 -0400

Agennix Receives Fast Track Designation From FDA for Talactoferrin in Combination With Sunitinib for Renal Cell Carcinoma

HOUSTON, May 19 /PRNewswire/ -- Agennix announced today that talactoferrin alfa (talactoferrin) has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the first-line treatment of renal cell carcinoma (RCC) in combination with sunitinib (Sutent(R) - Pfizer).

The Fast Track program is designed to expedite the review of investigational drugs for the treatment of patients with serious or life-threatening diseases where there is an unmet medical need. Fast Track designations allow a company to file a New Drug Application (NDA) or Biologics License Application (BLA) on a rolling basis and permit the FDA to review the filing as it is received, rather than waiting for the complete submission prior to commencing the review process. Additionally, NDAs and BLAs for fast track development programs are eligible for priority review which may result in an abbreviated review time of six months.

Additional Clinical Updates

Agennix also announced that two pivotal Phase III trials in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) are underway at a number of leading U.S. clinical sites. FORTIS-M is a randomized, placebo-controlled, 720-patient trial of talactoferrin monotherapy in patients with Stage IIIB/IV NSCLC. Patients who have failed two or more prior systemic anti-cancer therapies will be randomly assigned (2:1) to receive either oral talactoferrin or placebo in additional to standard supportive care. The trial is designed to detect an improvement in overall survival in patients receiving talactoferrin, and results are expected in 2011.

FORTIS-C is a randomized, placebo-controlled trial evaluating 1100 chemo-naive NSCLC patients. Newly diagnosed patients with Stage IIIB/IV NSCLC will be randomly assigned (1:1) to receive standard first-line chemotherapy with carboplatin and paclitaxel plus either oral talactoferrin or placebo. Agennix has received Fast Track designation from the FDA for both NSCLC indications as well as favorable Scientific Advice from the EMEA. Agennix has also received approval of a Special Protocol Assessment from the FDA for the FORTIS-C trial. The designs of these two Phase III trials are based on previous successful randomized, placebo-controlled, Phase II trials which both met their primary endpoint with supporting results on the secondary endpoints.

"We are pleased with the continued development progress with talactoferrin including our most recent Fast Track designation and the initiation of our Phase III NSCLC trials," said Rick Barsky, Chief Executive Officer, Agennix Incorporated. "This progress, along with the recent success and renewed interest in immunotherapies, will help us reach our goal of making talactoferrin available to patients for the treatment of these devastating diseases."

About Talactoferrin

Talactoferrin is a novel targeted dendritic cell recruiter and activator (DCRA) being studied for the treatment of several life-threatening diseases including RCC and NSCLC. Talactoferrin mediates its anti-cancer activity by targeting dendritic cells which play an important role in activating innate and adaptive immunity. After being transported into the gut associated lymphoid tissue (GALT), the largest immune organ in the body, orally administered talactoferrin induces the recruitment of immature dendritic cells to the GALT and promotes their maturation. This unique aspect of its function results in recruitment of dendritic cells that have captured tumor antigens while in the peripheral circulation. Following maturation, these dendritic cells activate Natural Killer (NK) and Natural Killer T-cells (NK-T) of the innate immune pathway and CD8+ lymphocytes of the adaptive immune pathway. Initiating the immune response in the GALT, and away from the tumor, reduces the effect of anti-immune factors produced by the tumor.

Talactoferrin Fast Track Designations

Agennix has received Fast Track designation for talactoferrin for the first-line treatment of RCC in combination with sunitinib. Agennix's RCC submission included the results from a Phase I trial, and a multi-center, single arm Phase II trial of talactoferrin in 44 patients with clear cell RCC who had failed standard therapy. Patients receiving oral talactoferrin in this Phase II trial had a median progression-free survival of 6.4 months, median overall survival of 21.1 months, and a one-year survival rate of 77%. Talactoferrin appeared to be well tolerated, which was consistent with other talactoferrin studies. The results from the Phase II trial were published in Cancer in 2008.

Talactoferrin was previously awarded Fast Track designations in NSCLC both for first line treatment and for patients who have failed two or more prior systemic anti-cancer therapies. These NSCLC Fast Track designations were based upon the clinical activity and tolerability data from two randomized placebo-controlled Phase II trials. Both Phase II trials met their primary endpoint with supporting results on the secondary endpoints.

About Renal Cell Carcinoma (RCC)

RCC is the most common type of kidney cancer, accounting for approximately 90 percent of kidney tumors. According to the American Cancer Society, there are approximately 49,000 new cases of kidney cancer diagnosed each year in the United States. Kidney cancer is uncommon under age 45, and its incidence is highest between the ages of 55 and 84. For non-metastatic RCC, the current standard of care is surgical removal of the kidney (nephrectomy), followed by observation. If the cancer spreads beyond the kidneys, treatment may include chemotherapy, cytokine therapy, targeted therapy, and/or radiation. Currently, sunitinib is the most prescribed targeted therapy for first-line treatment of RCC.

About Agennix

Agennix is a private biopharmaceutical company developing a first-in-class molecule with immunological activity for the treatment of cancer and other unmet medical needs. Agennix's lead molecule, talactoferrin, is an immunomodulatory protein with a novel mechanism of action. The Company is developing an oral liquid formulation of talactoferrin for cancer indications and a topical gel formulation for the treatment of diabetic foot ulcers. Agennix has more than 90 issued patents and more than 50 pending patents broadly protecting talactoferrin. Agennix has recently initiated Phase III trials in two non-small cell lung cancer indications (talactoferrin monotherapy in patients who have failed two or more previous therapies, and talactoferrin in combination with chemotherapy in previously untreated patients), and is planning a Phase IIb trial in patients with renal cell cancer, and Phase II trials in other cancer indications.

The company has recently agreed to merge its business with GPC Biotech, a publicly traded biopharmaceutical company focused on developing anti-cancer drugs. The merger is subject to the approval of the shareholders' meeting of GPC Biotech and to further closing conditions, and is expected to be completed by the end of 2009.

More information about Agennix is available on the Company's web site at http://www.agennix.com.

Forward Looking Statements

This press release contains forward-looking statements, which express the current beliefs and expectations of the management of Agennix. Such statements are based on current expectations and are subject to risks and uncertainties, many of which are beyond our control, that could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Actual results could differ materially depending on a number of factors, and we caution investors not to place undue reliance on the forward-looking statements contained in this press release. There can be no guarantee that the merger with GPC Biotech will be completed. Forward-looking statements speak only as of the date on which they are made and Agennix undertakes no obligation to update these foward-looking statements even if new information becomes available in the future.

Stem Cell Therapeutics Corp. Announces the FDA Has Lifted Its Clinical Hold on the Phase IIb Stroke Trial

Calisha Myers — Thu, 14 May 2009 12:34:25 -0400

Stem Cell Therapeutics Corp. Announces the FDA Has Lifted Its Clinical Hold on the Phase IIb Stroke Trial

CALGARY, ALBERTA--(Marketwire - May 14, 2009) - Stem Cell Therapeutics Corp. ("SCT" or "the Company") (TSX VENTURE:SSS) is pleased to announce the U.S. Food and Drug Administration ("FDA") has provided a verbal confirmation to remove its clinical hold placed on NTx^®-265 on September 18, 2008. This will allow SCT to commence the recruitment of patients under an amended protocol using NTx^®-265 for the Company's Phase IIb clinical trial treating acute ischemic stroke.

Dr. Alan Moore, President and CEO, commented as follows:

"We are very pleased that our series of collaborative meetings with the FDA has resulted in this positive development. We are expecting to receive written notification from the FDA in the near future following which we will finalize the plans for our stroke trial. We will issue another press release once this has been determined."

About REGENESIS: NTx^®-265 is SCT's lead therapeutic regimen of two approved and clinically well-defined drugs, human Chorionic Gonadotropin ("hCG") and Erythropoietin ("EPO"), targeting the treatment of stroke. The twin objectives of the treatment are to stimulate the growth and differentiation of new neurons to replace the brain cells that were lost or damaged by the stroke, and importantly, to direct motor, visual, and cognitive recovery after the acute ischemic stroke. Encouraging clinical results from SCT's BETAS Phase IIa stroke trial were presented at the International Stroke Conference in February 2009, showing clinically relevant recovery in 12 of 12 patients who received the complete treatment.

About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp. is a Canadian public biotechnology company (TSX VENTURE:SSS) focused on the development and commercialization of drug-based therapies to treat central nervous system diseases. SCT is a leader in the development of therapies that utilize drugs to stimulate a patient's own resident stem cells. The Company's programs aim to repair brain and nerve function lost due to disease or injury. The Company's extensive patent portfolio of owned and licensed intellectual property supports the potential expansion into future clinical programs in numerous neurological diseases such as traumatic brain injury, multiple sclerosis, Huntington's disease, Alzheimer's disease, and ALS.

For further information on Stem Cell Therapeutics Corp., visit www.stemcellthera.com.

These securities have not been registered under the United States Securities Act of 1933, as amended, or the securities laws of any state, and may not be offered or sold within the United States or to, or for the account or benefit of U.S. persons unless an applicable exemption from U.S. registration requirements is available.

Except for historical information, this press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting.

The TSX Venture Exchange does not accept responsibility for the adequacy or accuracy of this release.

FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers to Help Consumers Use Products Safely

Calisha Myers — Tue, 28 Apr 2009 14:38:09 -0400

FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers to Help Consumers Use Products Safely

The Food and Drug Administration issued a final rule today that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and liver damage, associated with the use of these popular drugs.

Products covered by the FDA action include acetaminophen, and a class of drugs known as the nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs include aspirin, ibuprofen, naproxen, and ketoprofen. Acetaminophen is in a class by itself. The revised labeling applies to all OTC pain relievers and fever reducers, including those that contain one of these ingredients in combination with other ingredients, such as in cold medicines containing pain relievers or fever reducers.

"Acetaminophen and NSAIDs are commonly used drugs for both children and adults because they are effective in reducing fevers and relieving minor aches and pain, such as headaches and muscle aches, " said Charles Ganley, M.D., director, FDA's Office of Nonprescription Drugs in the Center for Drug Evaluation and Research. "However, the risks associated with their use, need to be clearly identified on the label so that consumers taking these drugs are fully aware of the potential harm they can cause. It is important that they know how to take these medications safely to reduce their risk."

Under the final rule, manufacturers must ensure that the active ingredients of these drugs are prominently displayed on the drug labels on both the packages and bottles. The labeling also must warn of the risks of stomach bleeding for NSAIDs and severe liver damage for acetaminophen.

Since 2006, some manufacturers have voluntarily revised their product labeling to identify these potential safety concerns. However, the voluntary changes to labeling do not address all of the labeling requirements in the new rule. For example, the new rule includes a warning on products containing acetaminophen that instructs consumers to ask a doctor before they are taking the blood thinning drug warfarin. The new rule requires all manufacturers to relabel their products within one year of today's date.

Safety data reported in medical literature indicate that people sometimes take more acetaminophen than the labeling recommends. Others unknowingly take multiple products containing acetaminophen at the same time. Exceeding the recommended dosage of acetaminophen may increase the risks for severe liver damage. Alcohol use can also increase the risk of liver damage with acetaminophen.

The risk for stomach bleeding may increase in people who use NSAIDs and who are taking blood-thinning drugs (anticoagulants) or steroids. Stomach bleeding risks also increase for people who take multiple NSAIDs at the same time, or in people who take them longer than directed. Alcohol use can increase the risk for stomach bleeding with NSAIDs use.

An FDA Advisory Committee meeting will be convened on June 29 & 30, 2009, to discuss further steps the FDA could take to reduce the risk of liver damage associated with acetaminophen overdoses.

FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans

Calisha Myers — Tue, 28 Apr 2009 11:26:35 -0400

FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans

The U.S. Food and Drug Administration, in response to requests from the U.S. Centers for Disease Control and Prevention, has issued Emergency Use Authorizations (EUAs) to make available to public health and medical personnel important diagnostic and therapeutic tools to identify and respond to the swine flu virus under certain circumstances. The agency issued these EUAs for the use of certain Relenza and Tamiflu antiviral products, and for the rRT-PCR Swine Flu Panel diagnostic test.

The EUA authority allows the FDA, based on the evaluation of available data, to authorize the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products following a determination and declaration of emergency, provided certain criteria are met. The authorization will end when the declaration of emergency is terminated or the authorization revoked by the agency.

Currently, Relenza is approved to treat acute uncomplicated illnesses due to influenza in adults and children 7 years and older who have been symptomatic for less than two days, and for the prevention of influenza in adults and children 5 years and older. Tamiflu is approved for the treatment and prevention of influenza in patients 1 year and older.

The EUAs allow for Tamiflu also to be used to treat and prevent influenza in children under 1 year, and to provide alternate dosing recommendations for children older than 1 year. In addition, under the EUAs, both medications may be distributed to large segments of the population without complying with the label requirements otherwise applicable to dispensed drugs, and accompanied by written information pertaining to the emergency use. They may also be distributed by a broader range of health care workers, including some public health officials and volunteers, in accordance with applicable state and local laws and/or public health emergency responses.

In authorizing an EUA for the rRT-PCR Swine Flu Panel diagnostic test, the FDA has determined that it may be effective in testing samples from individuals diagnosed with influenza A infections, whose virus subtypes cannot be identified by currently available tests. This EUA allows the CDC to distribute the swine flu test to public health and other qualified laboratories that have the needed equipment and the personnel who are trained to perform and interpret the results.

The test amplifies the viral genetic material from a nasal or nasopharyngeal swab. A positive result indicates that the patient is presumptively infected with swine flu virus but not the stage of infection. However, a negative result does not, by itself, exclude the possibility of swine flu virus infection.

The EUA authority is part of Project BioShield, which became law in July 2004.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.
--Online: www.fda.gov/MedWatch/report.htm
--Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
--Fax: (800) FDA-0178
--Phone: (800) FDA-1088