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PEAK Surgical Announces First Use Of PEAK PlasmaBlade(TM) In Europe
PEAK Surgical, Inc., announced the first use of its PEAK(R) Surgery System by surgeons in the European Union, where the innovative tissue dissection system received its CE Mark in January.
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Sotomayor Calls Roe 'Settled Law,' Says Health Of Woman Must Be Considered
During the second day of her Senate Judiciary Committee confirmation hearings, Supreme Court nominee Sonia Sotomayor said she views the 1973 Roe v. Wade decision legalizing abortion in the U.S. as settled law reaffirmed by subsequent Supreme Court rulings, the Washington Post reports (Goldstein et al., Washington Post, 7/15). At Tuesday"s hearing, lawmakers pressed Sotomayor on her views regarding abortion rights and Supreme Court precedent, the New York Times reports. She told committee members that the contraception rights case that is the foundation for Roe was "the precedent of the court, so it is settled law." She also said the 1992 ruling in Casey v. Planned Parenthood "reaffirmed the core holding of Roe," adding, "That is the precedent of the court and settled law in terms of the holding of the court" (Savage, New York Times, 7/15). Sotomayor said that "there is a right of privacy" and that the Supreme Court "has found it in various places in the Constitution." She cited the Fourth Amendment protection against unreasonable search and seizure and the 14th Amendment guaranteeing equal protection of the law (AP/Yahoo! News, 7/14).Sen. Orrin Hatch (R-Utah) asked Sotomayor if she considered the 2007 ruling in Gonzales v. Carhart an example of settled law. In the case, the court voted 5-4 to uphold the Partial-Birth Abortion Ban Act of 2003. The ruling was the first time since Roe that the court upheld an abortion restriction that made no exception for the health of the woman, the Times reports. In her response, Sotomayor said that "[a]ll precedent of the Supreme Court I consider settled law, subject to the deference the doctrine of stare decisis would counsel," although she did not address the health exception component of the Gonzales case.Sen. Dianne Feinstein (D-Calif.) later pressed Sotomayor to elaborate on her views on Gonzales. Feinstein noted that at least seven Supreme Court rulings prior to the 2007 case stated that abortion laws "cannot put a woman"s health at risk." She added that Gonzales "essentially removed this basic constitutional right for women." Feinstein asked Sotomayor, "When there are multiple precedents and a question arises, are all the previous decisions discarded, or should the court re-examine all the cases on point?" Sotomayor replied that she does not consider Gonzales to be a precedent making it settled law that health exceptions for abortion laws are constitutionally unnecessary. She said, "That was, I don"t believe, a rejection of its prior precedents," which are "still precedents of the court." Sotomayor added that the "health and welfare of a woman must be -- must be a compelling consideration." Feinstein pressed Sotomayor to clarify that she meant that it is still settled that abortion restrictions must have health exceptions. Sotomayor said, "It has been a part of the court"s jurisprudence and a part of its precedents. Those precedents must be given deference in any situation that arises before the court" (New York Times, 7/15).Sen. Lindsey Graham (R-S.C.) asked Sotomayor if the Constitution prohibits Congress or state legislatures "from defining life or regulating the rights of the unborn or protecting the right of the unborn in the first trimester?" Sotomayor began to cite the 14th Amendment to answer the question. Graham interrupted, asking, "[I]s there÷ anything in the document written about abortion?" Sotomayor said the "word "abortion" is not used in the Constitution, but the Constitution does have a broad provision concerning a liberty provision under the due process" clause (Holman, "NewsHour with Jim Lehrer," PBS, 7/14).Graham also asked Sotomayor about her work with the Puerto Rican Legal Defense and Education Fund, which had submitted legal briefs in the past that supported public funding for abortion coverage for low-income women. Sotomayor served on the group"s board from 1980 to 1992. She said that she "wasn"t aware of what was said in those briefs." She noted that she had served on the board but was not a lawyer for the gro
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Global Lupus Experts Gather For Historic Meeting -- Urgent And Unmet Needs Of Individuals With Lupus Dominate Agenda
The Lupus Foundation of America (LFA) convened an Expert Panel June 1-2 to address the urgent and unmet need for the development and approval of new, safe, effective, and tolerable medications for people with lupus. It has been more than 50 years since the U.S. Food and Drug Administration (FDA) approved a new drug specifically to treat lupus. Discussions during the two-day meeting in Washington, DC focused on how to better conduct studies of potential new lupus treatments, including clinical endpoints, diagnostic tools, background medications, and clinical trial design.
Cardiovascular

Ilaris® Recommended For European Approval As New Biologic Drug To Treat A Rare But Serious Group Of Auto-inflammatory Diseases

The biotechnology medicine Ilaris® (canakinumab) has passed another major milestone with a recommendation for approval in the European Union to treat patients with a life-long and potentially fatal auto-inflammatory disease called cryopyrin-associated periodic syndrome (CAPS). When approved, Ilaris will be the only treatment in the EU indicated for CAPS patients aged four years and older[1]. Ilaris represents an important advance in the development of personalized medicines because it targets a condition that is triggered by a specific genetic mutation. In CAPS patients, this mutation drives the overproduction of interleukin 1-beta (IL-1Ãÿ) which causes the widespread sustained inflammation and tissue damage associated with the disease[3],[4],[5]. Because Ilaris normalizes the production of IL-1Ãÿ[1],[2],[3], it is also being studied in other diseases in which IL-1Ãÿ plays a pivotal role such as systemic juvenile idiopathic arthritis (SJIA), gout, chronic obstructive pulmonary disorder (COPD), and type 2 diabetes. "By concentrating initially on a rare syndrome with a well-defined disease process such as CAPS, we have been able to demonstrate a clear therapeutic advantage with Ilaris," said Trevor Mundel, MD, Head of Global Development at Novartis Pharma AG. "Our focus now is to establish whether this could also provide a new approach to the treatment of other diseases involving a similar underlying process." A positive opinion recommending the approval of Ilaris for CAPS was issued by the Committee for Medicinal Products for Human Use (CHMP), which reviews medicines for the European Commission. The recommendation comes shortly after approvals in the US and Switzerland where Ilaris was granted priority review based on its potential to fulfil an important unmet need for CAPS patients. The EU submission was supported by data showing that Ilaris, a monoclonal antibody formerly known as ACZ885, produced rapid and sustained remission of symptoms in up to 97% of CAPS patients, with most responding from the first injection[2]. Ilaris is given by subcutaneous injection only once every two months making it a convenient treatment, especially for younger patients[2]. More than 90% of patients studied were free from painful injection-site reactions[2]. CAPS includes three distinct auto-inflammatory disorders. These are familial cold auto-inflammatory syndrome (FCAS) which is the mildest form of CAPS, Muckle-Wells syndrome (MWS), and neonatal-onset multisystem inflammatory disease (NOMID, also known as chronic infantile neurological cutaneous articular syndrome or CINCA) - the most severe form of the disease[2],[3]. "CAPS is a life-long and potentially fatal condition for which there are currently no approved medications in the European Union," said Helen J. Lachmann, MD of the UK National Amyloidosis Centre at UCL Medical School in London, UK. "In clinical trials, canakinumab has been shown to switch off disease activity in as little as 24 hours following a single dose. It has the potential to transform patients" lives, not only providing relief from their debilitating daily symptoms but also offering the possibility of long-term control of the disease." The symptoms of CAPS, such as debilitating fatigue, rash, fever, headaches, joint pain and conjunctivitis, can be present from birth or infancy, and can occur daily throughout patients" lives[2],[3]. Serious long-term consequences may include deafness, bone deformities, erosive joint destruction, and central nervous system damage leading to loss of vision[1],[2],[3]. Around 25% of CAPS patients develop amyloidosis, a condition in which the build-up of proteins can cause vital organs to fail, resulting in renal failure and death within five to 10 years[1]. CAPS is believed to occur in around 6,500 patients worldwide and 2,500 in the EU[3],[6]. However due to lack of diagnosis or misdiagnosis, fewer than 1,000 cases have been officially reported worldwide[1],[3]. The Ilaris filing was based on a clinical trial program involving more than 100 CAPS patients. The pivotal study is a three-part, one-year Phase III study involving 35 patients aged nine to 74 years old with varying degrees of disease severity[2]. Data published in The New England Journal of Medicine in June 2009 show that Ilaris produced a rapid, complete and sustained response in the majority of patients[2]. Results for the primary endpoint showed that none of the patients treated with Ilaris (0 out of 15) experienced a disease outbreak or "flare" compared to 13 of the 16 patients who received placebo (0% vs. 81% respectively, pDisclaimer The foregoing release contains forward-looking statements that can be identified by terminology such as "potentially," "will," "could," "potential," "can," "may," or similar expressions, or by express or implied discussions regarding potential future regulatory filings or marketing approvals for Ilaris, or the timing of any such potential filings or approvals, or regarding potential future revenues from Ilaris. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of the Company regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Ilaris to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Ilaris will be approved for sale in any additional market, or for any additional indication, or that any such approvals will occur at any particular time. Nor can there be any guarantee that Ilaris will achieve any levels of revenue in the future. In particular, management"s expectations regarding Ilaris could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company"s ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Group"s assets and liabilities as recorded in the Group"s consolidated balance sheet, and other risks and factors referred to in Novartis AG"s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Novartis Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas. In 2008, the Group"s continuing operations achieved net sales of USD 41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 99,000 full-time-equivalent associates and operate in more than 140 countries around the world. Novartis


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