Sanofi Pasteur Could Begin Commercial Production in June 

GoogleNews.com, May 26, 2009   –   Authorities in Mexico announced three more swine flu deaths and the United States and Canada one more death each as the world’s largest vaccine maker signed a deal with the United States to produce a swine flu vaccine.

The World Health Organization says at least 46 countries have confirmed more than 12,950 swine flu cases. The Mexican death toll now stands at 83, and Canada’s is two. The U.S. death is the 12th in the country.

The tiny nation of Bahrain reported Tuesday that a 20-year-old student had come down with mild swine flu – the first case in a citizen of a Gulf Arab country. Kuwait, another Gulf nation, reported Sunday that 18 U.S. soldiers who passed through were infected with swine flu but had recovered and left the country.

Puerto Rico and the Czech Republic both reported their cases on Monday.

Sanofi Pasteur said Monday it has won a $190 million order from the United States government to make a swine flu vaccine. Sanofi Pasteur, which operates flu vaccine production plants at Swiftwater, Pa., and in Val de Reuil, in France, said it could begin commercial production in June.

Mexico unveiled a $90 million campaign aimed at luring back tourists to the country where the illness has hit hardest. Tourism is Mexico’s third-largest source of legal foreign income, but worries over swine flu have sent hotel occupancy rates to a record low.

In the U.S., federal health authorities have confirmed 6,700 swine flu cases, most of them mild. But New York health officials reported another death during the weekend. And Dr. Damon Arnold, director of the Illinois Department of Public Health, said a resident of the Chicago area had died.

Canadian officials said Monday that a Toronto man who had swine flu but also suffered a chronic medical condition died Saturday.

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ScienceDaily (May 22, 2009) – A new article in the journal Risk Analysis assessed various ways in which aerosol transmission of the flu, a central mode of diffusion which involves breathing droplets in the air, can be reduced. Results show that face protection is a key infection control measure for influenza and can thus affect how people should try to protect themselves from the swine flu.

Lawrence M. Wein, Ph.D., and Michael P. Atkinson of Stanford University constructed a mathematical model of aerosol transmission of the flu to explore infection control measures in the home.

Their model predicted that the use of face protection including N95 respirators (these fit tight around the face and are often worn by construction workers) and surgical masks (these fit looser around the face and are often worn by dental hygienists) are effective in preventing the flu. The filters in surgical masks keep out 98 percent of the virus. Also, only 30 percent of the benefits of the respirators and masks are achieved if they are used only after an infected person develops symptoms.

“Our research aids in the understanding of the efficacy of infection control measures for influenza, and provides a framework about the routes of transmission,” the authors conclude.

This timely article has the potential to impact current efforts and recommendations to control the so-called swine flu by international, national and local governments in perspective.

This study is published in the journal Risk Analysis. Media wishing to receive a PDF of this article may contact .net.


Wiley-Blackwell (2009, May 22). Face Protection Effective In Preventing The Spread Of Influenza, Study Suggests

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Margaret A. Hamburg, M.D., and Joshua M. Sharfstein, M.D.

 

Published at www.nejm.org May 26, 2009 (10.1056/NEJMp0903764)   —  A little more than a century ago, concerned about the potential dangers of food preservatives such as formaldehyde, Congress passed, and President Theodore Roosevelt signed, the Pure Food and Drug Act. The act sought to prevent the “manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors.” The office initially charged with this responsibility was the Bureau of Chemistry of the Department of Agriculture.

Since that time, the bureau has grown into the Food and Drug Administration (FDA), an agency in the Department of Health and Human Services (DHHS) responsible for oversight of more than $2 trillion in medical products, food, and other consumer goods. What has remained constant is the agency’s “overriding purpose,” in the words of the Supreme Court, of protecting the public health.1 As the new commissioner and principal deputy commissioner of the FDA chosen by President Barack Obama, we would like to provide a broad overview of how we intend to embrace this role.

The Institute of Medicine has defined the mission of public health as “fulfilling society’s interest in assuring the conditions in which people can be healthy.” To be healthy, people need access to a safe and nutritious food supply and to innovative, safe, and effective medical products. The FDA’s job is to support this access and, in doing so, to promote health, prevent illness, and prolong life. The ultimate measures of the FDA’s success should reflect its fundamental goals and go beyond such intermediate measures as the number of facilities inspected or drugs approved.

The urgent need to develop and produce a vaccine against H1N1 influenza virus provides an illustration of the agency’s public health role. Laboratory scientists at the FDA are growing the virus and will make reagents for vaccine-potency testing, reviewers will help to design and oversee the clinical trials, and inspectors will oversee the quality of the production process. The agency’s success will be determined by the nation’s access to a safe and effective vaccine.

The traditional tools of a regulatory agency are regulation, approval or disapproval of applications, and enforcement. As a public health agency, the FDA should always ask whether delays in approval or safety problems can be prevented – a mandate that requires extensive and creative engagement with regulated industries, patient and consumer groups, and others. The FDA should actively pursue opportunities to help advance science in the domains it regulates and address threats to the safety of medical products and food – even if those opportunities and threats lie outside the realm of the agency’s usual routines. We expect to collaborate with other federal agencies and outside partners to address problems that the agency cannot solve alone.

In the domain of medical products, it has been said that the FDA has just two speeds of approval – too fast and too slow. Critics concerned about haste point out, accurately, that drugs and other products are generally approved on the basis of relatively small studies and that safety problems often emerge when large populations are exposed to the products. Those worried about delay note, correctly, that people with life-threatening diseases have no time to wait. A public health approach recognizes that the potential good of a new medical product or policy must be balanced against the potential harm. Some benefits are not worth the risk; some risks are worth taking. Key considerations are the severity of the illness at issue, the availability of alternative treatments or preventive interventions, and the current state of knowledge about individual responses.

The FDA must make difficult decisions in the absence of ideal information. For medical products, the FDA Amendments Act of 2007 strengthened the agency’s ability to place restrictions on the use of medications at the time of approval while requiring that additional safety data be gathered. These tools allow the FDA opportunities to change the regulatory oversight of products as they move from limited use in clinical trials to adoption in the medical system. The ability to detect and act on safety signals quickly can give an additional layer of confidence to support earlier approval of important medications.

Fortunately, not every FDA action is a challenging regulatory decision that requires balancing risk against benefit. Collaboration with sister public health agencies in DHHS, industry, consumer and patient organizations, and the public will lead to exciting opportunities for progress in public health.

We intend to work closely with the Centers for Disease Control and Prevention (CDC) to identify priority areas for joint action – such as the response to infectious-disease emergencies and outbreaks of foodborne illnesses and the development of safety systems to prevent lethal overdoses and drug interactions.

We look forward to working with the National Institutes of Health, the pharmaceutical and biotechnology industries, academic medical centers, and research universities to accelerate the development of cures. As scientists identify fruitful pathways for research on treatments for debilitating diseases, FDA regulators should discuss with them the level of evidence necessary for the initiation of human trials and the eventual approval of treatments.

To make important new treatments available to patients, the FDA should collaborate with the Centers for Medicare and Medicaid Services – one of the largest health care payers in the United States – as well as with industry and patient and consumer groups to explore ways of shortening the time from approval to reimbursement. One emerging opportunity is the area of personalized medicine, in which the agency should work with scientific leaders on novel approaches to treating illness.

In the domain of food safety, a public health approach starts with the use of data to identify the riskiest parts of an enormous and complex system. The FDA should partner with the Department of Agriculture and other federal agencies, states, and other authorities to establish a modern food-safety system focused on prevention of contamination. Working with Congress to modernize food-safety laws, the FDA must strive to build safeguards into every step of the production and distribution process.

From our vantage point, the recent salmonella outbreak linked to contaminated peanut butter represented far more than a sanitation problem at one troubled facility. It reflected a failure of the FDA and its regulatory partners to identify risk and to establish and enforce basic preventive controls. And it exposed the failure of scores of food manufacturers to adequately monitor the safety of ingredients purchased from this facility.

The CDC and the FDA should also work closely to identify areas of potential progress in nutrition. A laissez-faire approach to nutritional claims can lead to more confusion than understanding. Working with industry and others, the FDA can support efforts to educate the public about nutrition and promote more healthful foods.

Globalization intensifies all the challenges the agency faces. With more than 200,000 companies from around the world selling food, cosmetics, or medical products in the United States, a public health framework provides the only viable way of protecting the American public. To anticipate the next import crisis like that involving contaminated heparin, the agency should assess imported products for their potential to cause significant problems.

The FDA should facilitate the development of safety standards where none exist and then, working with our international partners, build a system with multiple levels of oversight. Safety must be the shared responsibility of not only the producer but also the country of origin, the importer, the importing country, and the final company in the supply chain. Some elements of this system, such as international outreach and coordination, can be implemented quickly; others will take years to develop. Along the way, new challenges are likely to arise. As they do, the FDA must respond forcefully and provide timely and credible information to the public.

Indeed, one of the greatest challenges facing any public health agency is that of risk communication. We all accept small risks in our daily lives, from the risk of falling in the shower and sustaining a head injury to the risk of having a car accident on the way to the grocery store. One reason we are rarely fearful of these risks is our perception that we have control over them. When it comes to food and drugs, even small risks can cause considerable fear and anxiety, especially when they seem to be out of our control. Yet all pharmaceuticals have some potential adverse effects, and many raw foods may harbor natural pathogens.

The FDA’s job is to minimize risks through education, regulation, and enforcement. To be credible in all these tasks, the agency must communicate frequently and clearly about risks and benefits – and about what organizations and individuals can do to minimize risk. When, like the FDA, Americans must make choices about medication, devices, foods, or nutrition in the absence of perfect information, the FDA cannot delay in providing reasonable guidance – guidance that informs rather than causes unnecessary anxiety.

For these communications to have credibility, the public must trust the agency to base its decisions on science. We recognize the importance of a management approach that respects the expertise and dedication of the FDA’s career scientists. In recent years, the agency has struggled to handle controversies involving the safety of regulated products, opening the door to legitimate questions from the media, the public, and Congress about whether the public interest is being served. Establishing the FDA as a public health agency requires a culture that encourages scientific exchange and respects alternative viewpoints along the path of decision making. It also requires that the agency define and protect integrity in its basic processes.

Transparency is a potent element of a successful strategy to enhance the work of the FDA and its credibility with the public. Whenever possible, the FDA should provide the data on which it bases its regulatory decisions and other guidance and explain its decision-making process to the public.

We are honored to be chosen by President Obama and inspired by his commitment to the FDA and his proposed historic increase to its budget. More than a century ago, his predecessor President Roosevelt could not have foreseen the introduction of modern antibiotics, chemotherapy, and genomic medicine or the potential regulation of tobacco products – let alone the challenges of the 21st century. The FDA has always been a work in progress. Updating this work means modernizing scientific and legal regulatory approaches to a host of complex matters. Succeeding will require respecting the tradition of the FDA and its mission of public health.

No potential conflict of interest relevant to this article was reported.
Source Information

Dr. Hamburg is the commissioner, and Dr. Sharfstein the principal deputy commissioner, of the Food and Drug Administration, Silver Spring, MD.

This article (10.1056/NEJMp0903764) was published at NEJM.org on May 26, 2009. It will appear in the June 11 issue of the Journal.

References

United States v. Bacto-Unidisk, 394 U.S. 784 (1969). (Accessed May 18, 2009, at http://supreme.justia.com/us/394/784/case.html.)

26. May 2009 05:40 United Therapeutics Corporation announced today that the United States Food and Drug Administration (FDA) has approved Adcirca (tadalafil) tablets for oral administration, with a recommended dose of 40 mg, as the first once-daily phosphodiesterase type 5 (PDE5) inhibitor for the treatment of pulmonary arterial hypertension (PAH).

Adcirca is indicated to improve exercise ability in WHO Group I PAH patients, which encompasses patients with multiple forms of PAH including etiologies such as idiopathic and familial PAH as well as PAH associated with scleroderma and congenital heart disease.

“Today, thanks to the clinical development efforts led by Eli Lilly & Company, we are thrilled to make available an effective, convenient and economical therapy for PAH patients,” said Martine Rothblatt, Ph.D., United Therapeutics’ Chairman and Chief Executive Officer. “The FDA’s action in approving once-a-day Adcirca is a big plus for all three P’s: patients, physicians and payors.”

In the PHIRST-1 randomized, double-blind, 16-week placebo-controlled Phase 3 clinical trial of Adcirca for PAH, patients taking Adcirca 40 mg (administered as two 20 mg tablets) once daily achieved a 33 meter improvement in six-minute walk distance compared to the placebo group. In addition, PHIRST-1 patients taking Adcirca 40 mg experienced less clinical worsening (defined as death, lung transplantation, atrial septostomy, hospitalization because of worsening PAH, initiation of new PAH therapy, or worsening WHO functional class) compared to the placebo group. The most common adverse events in the trial were generally transient, mild to moderate in intensity and included headache, muscle pain, flushing, nasopharyngitis, respiratory tract infection, nausea, pain in the arms, legs or back, upset stomach and nasal congestion.

“Our dedicated team at United Therapeutics looks forward to working closely with the PAH community as we prepare to launch Adcirca in the United States at the beginning of August this year,” said Roger Jeffs, Ph.D., United Therapeutics’ President and Chief Operating Officer.

Conference Call

United Therapeutics will host a half-hour teleconference today, May 26, 2009, at 9:00 a.m. Eastern Time. The teleconference is accessible by dialing                877-857-6147        , with international callers dialing                719-325-4797        . A rebroadcast of the teleconference will be available for one week and can be accessed by dialing                888-203-1112        , with international callers dialing                719-457-0820        , and using passcode: 2104929.

This teleconference is also being webcast and can be accessed via United Therapeutics’ website at http://ir.unither.com/events.cfm.

About Adcirca

Adcirca is a prescription medicine used to treat PAH, a life-threatening disease that constricts the flow of blood through the pulmonary vasculature.

United Therapeutics licensed the rights to develop, market, promote and commercialize Adcirca for pulmonary hypertension in the United States and Puerto Rico from Eli Lilly & Company in November 2008. Adcirca contains the same active ingredient as CIALIS (tadalafil), which is marketed by Eli Lilly & Company to treat erectile dysfunction (impotence) in more than 100 countries.

Safety Information for Adcirca

Adcirca should not be used in patients taking medicines that contain nitrates (often used for chest pain) as the combination could cause a sudden, unsafe drop in blood pressure. If a patient experiences anginal chest pain after taking Adcirca they should seek immediate medical attention. Patients with a known serious hypersensitivity to tadalafil (Adcirca or CIALIS) should not take Adcirca.

PDE5 inhibitors, including tadalafil, have mild systemic vasodilatory properties that may result in transient decreases in blood pressure. Before prescribing Adcirca, physicians should carefully consider whether their patients with underlying cardiovascular disease could be adversely affected by such effects. Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD) and administration of Adcirca to these patients is not recommended. Patients should discuss their medical condition and all medications with their physician before starting Adcirca.

The use of Adcirca with alpha blockers, blood pressure medications, and alcohol may cause a lowering of blood pressure. Use of Adcirca with potent CYP3A inhibitors, such as ketoconazole and itraconazole, should be avoided. For patients on Adcirca therapy that require treatment with ritonavir, dosage adjustments are required. Certain populations of PAH patients such as those with mild-to-moderate renal or hepatic impairment or those taking the drug ritonavir should use a dose of 20 mg daily when beginning therapy with Adcirca. Use of Adcirca with potent inducers of CYP3A, such as rifampin, should be avoided. The safety and efficacy of combinations of Adcirca with CIALIS or other PDE5 inhibitors have not been studied. Therefore, the use of such combinations is not recommended.

The most common side effects with Adcirca seen in the PHIRST-1 clinical trial were headache, myalgia, nasopharyngitis, flushing, respiratory tract infection, extremity pain, nausea, back pain, dyspepsia and nasal congestion.

In rare instances, patients taking PDE5 inhibitors (including tadalafil) reported a sudden decrease or loss of vision or hearing, or in men, an erection lasting more than four hours. A patient who experiences a decrease or loss in vision or hearing or prolonged erection should seek immediate medical attention.

For full patient information and/or full prescribing information, visit http://www.Adcirca.com/ or call 1-800-545-5979         (1-800-LILLY-RX).

20090526-1

Caption: Barbara Boyan (pictured center), serves as director of the Georgia Tech Center for Advanced Bioengineering for Soldier Survivability, which is developing clinically valuable, safe and effective tools to improve the recovery of soldiers with severe injuries.

Georgia Tech Center, May 26, 2009  —  When a soldier is wounded during combat, surgeons must focus on reducing infection and reconstructing damaged bone and tissues. Technologies that could improve the repair and regeneration processes are being developed in research laboratories across the country, but they are not being moved quickly enough into military trauma centers.

Organizers of the recently established Georgia Tech Center for Advanced Bioengineering for Soldier Survivability want to change that.

“The goal of the center is to rapidly move new technologies from the laboratory to patients so that we can improve the quality of life for our veterans as they return from the wars the United States is fighting,” said center director Barbara Boyan, the Price Gilbert, Jr. Chair in Tissue Engineering at the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University.

The center will leverage the expertise of Georgia Tech researchers in musculoskeletal biology and regenerative medicine to quickly move tools that are clinically valuable, safe and effective from laboratories to use in trauma centers. To reduce the amount of time from invention to clinical use, engineers and scientists in the center work in teams that include a clinician with experience in combat medical care and a medical device industry partner.

20090526-2

Bone Defect

IMAGE: X-ray images of bone bridging across a massive bone defect treated with a nanofiber mesh protein release technology developed in the laboratory of Georgia Tech mechanical engineering professor Robert Guldberg. 

Support for the center is provided by the Armed Forces Institute of Regenerative Medicine, the U.S. Army Institute of Surgical Research’s Orthopedic Trauma Research Program, the U.S. Department of Defense and industry.

Researchers in the center will initially focus on ways to improve the healing of wounds, segmental bone defects and massive soft tissue defects. Traumatic injuries that affect the arms, legs, head and neck require technologies for treatment at the time of injury and in the ensuing days and months.

“These combat injuries are complicated to treat because they are large and typically infected, so even determining when a soldier should be treated for optimal recovery is a challenge,” said Boyan, who is also the associate dean for research in Georgia Tech’s College of Engineering. “It is not known whether a regenerative therapy will be most effective if used immediately following injury or at some later time after scar tissue has been established at the wound site.”

By developing models that accurately reflect the complex aspects of injuries sustained by soldiers in combat, the researchers will be able to test assumptions about when to employ specific strategies and how to ensure their effectiveness. The models must also allow them to examine the use of technologies on both male and female patients, and on complex tissues that consist of nerves, a blood supply and multiple cell types.

“Since the processes of bone, vascular and neural formation are naturally linked during normal tissue development, growth and repair, our approach is to harness this knowledge by developing delivery strategies that present the right biologic cues in the right place at the right time to promote functional regeneration of multiple integrated tissues,” said associate director of the center Robert Guldberg, a professor in Georgia Tech’s Woodruff School of Mechanical Engineering.

To enhance tissue repair and regeneration following a traumatic injury, the researchers are focusing their efforts on stem cells. Even though stem cells have tremendous potential for repairing such defects, effective methods do not yet exist for delivering them to an injury site and of ensuring that they survive and remain at that site long enough to impact the regeneration process.

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IMAGE: Robert Guldberg, associate director of the Georgia Tech Center for Advanced Bioengineering for Soldier Survivability, is developing delivery strategies to promote functional regeneration of multiple integrated tissues. 

“Clinicians currently inject stem cells into a vein and hope that the cells will migrate to sites of injury and remain at those sites long enough to participate in the repair process. While some cells certainly do migrate to injury sites, the actual percentage is very small and those that arrive at the site do not remain to engraft with the host tissue,” explained Boyan.

This limited effect may be the result of the injection process, according to Boyan, so researchers in the center are developing ways to protect the cells from damaging forces they might encounter when inserted into the body.

“Studies in our laboratory have shown that when stem cells are encapsulated in microbeads, they can be injected by needle without loss of cell viability and they remain at the injury site for at least two months,” said Boyan.

Protecting the cells during insertion is just the first step toward improved tissue repair. The researchers must also examine whether the stem cells will turn into cells typical of the implanted tissue and if they produce or should be paired with molecules that can enhance the healing of the implanted tissues.

Center researchers are also investigating whether bone marrow-derived stem cells can be used in the body to heal large defects in bone and cartilage if they are inserted in fiber mesh scaffolds and silk sponges during a surgical procedure.

Additional projects in the center include assessing tissue viability, preventing the growth of bone in the soft tissues of the body and improving pre-hospital care of orthopedic injuries. Since effective treatment of traumatic injuries is an important goal for the general public as well as the military population, the researchers also hope to adapt their technologies for use in hospitals.

###

Other researchers in the center include Ravi Bellamkonda, a professor in the Coulter Department; Andres Garcia, the Woodruff Faculty Fellow in the Woodruff School of Mechanical Engineering; Robert Taylor, a professor in the Coulter Department and Emory’s Division of Cardiology; Zvi Schwartz, a visiting professor in the Coulter Department; and U.S. Army surgical medicine consultants Michael Yaszemski and David Cohen.

Bioinformatician – Genomic Profiling, Regenerative Medicine : Cambridge, UK

Science Positions from Pfizer: job description

Bioinformatician – Genomic Profiling, Regenerative Medicine
£35,000 – £46,000 + benefits
Cambridge, UK

In a pioneering new collaboration with the Institute for Ophthalmology in London, Pfizer’s Regenerative Medicine Research Unit are developing stem cell therapies to treat macular degeneration.

The potential is huge. Both for patients and for those with a more professional interest, like you. By helping us further understand the biological events in the differentiation of stem cells into therapeutically relevant retinal cell types, your work will directly contribute to the progression of this work into clinical trials.

Your role

Utilising genomic profiling, you’ll construct a comprehensive map of the molecular basis of retinal cell generation. This will involve working closely with our biologists to analyse the data from a range of experiments and generate new hypotheses around the cellular pathways involved and the molecular events determining stem-cell differentiation. Ultimately, this will help us identify novel mechanisms to efficiently generate the specific therapeutically relevant cell types.

What you’ll need

To take part in our pioneering collaboration, you’ll need the following:

  • Recently qualified with a PhD in bioinformatics/molecular biology or a relevant PhD with experience working in a similar role.
  • Experience of assisting in the design of molecular profiling experiments.
  • A good understanding of high-throughput genomic data such as microarray, ChIP-Seq and next-generation sequencing.
  • Experience of primary data analysis such as QC and normalization, and statistical analysis using tools such as R/Bioconductor, dChip and GenePattern.
  • A good working knowledge of scripting languages such as Perl and genomic resources such as Ensembl and GEO.

Apply

To find out more and to apply, visit www.pfizer.co.uk/careers and enter the job opening I.D. 932674.

Tue May 26, 2009

Shares in Intercytex (ICX.L) rise 30 percent, building on last week’s gains, after a report in the Sunday Times says the world’s largest drugmaker Pfizer (PFE.N) is one of a number of potential bidders to have expressed an interest in the skin regeneration specialist.

Intercytex said last week that it had received a number of approaches which could lead to an offer being made for the business. Pfizer’s interest is reported to be based on the work Intercytex is doing on a research project to cure age-related macular degeneration (AMD), which causes blindness.

“It is interesting that such a major player would weigh in on the deal,” says Daniel Stewart analyst Vadim Alexandre.

“They (Pfizer) have a regenerative medicine centre that they’ve opened up recently in Cambridge so they are moving in that direction. Clearly Intercytex is a company that has some interesting intellectual property.”