Mediaboss Marketing

PHILADELPHIA, June 11, 2012 /PRNewswire/ --Halozyme Therapeutics, Inc. (HALO) today announced results from a Phase 2 study of prandial insulin formulations, which include the Company's recombinant human hyaluronidase (rHuPH20) enzyme, in patients with Type 1 diabetes. The study met its primary endpoint of A1C non-inferiority (A1C is a measure of average blood sugar over three months). Further, data from the study indicated that rHuPH20 reduced postprandial glycemic excursions, as well as significantly reduced hypoglycemic events. These findings were presented in an oral presentation at the 72nd Scientific Sessions of the American Diabetes Association (ADA) on Monday, June 11 from 6:15 - 6:30 PM EDT.

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"There is a real need for faster-acting mealtime insulins. By accelerating the absorption and action of prandial insulins, rHuPH20 may help reduce mealtime glucose fluctuations that make managing diabetes difficult," said Irl B. Hirsch, M.D., Professor of Medicine, Diabetes Treatment and Teaching Chair, University of Washington School of Medicine. "This faster-in, faster-out profile may also attenuate the risk of hypoglycemia. In this study, improved control of mealtime glucose significantly reduced hypoglycemic events in patients receiving treatments with the rHuPH20 enzyme. The data further indicated that Halozyme's ultrafast insulin formulations moderate glucose swings, thus more closely mimicking the effects of endogenous insulin and, if approved, could ultimately help patients with diabetes live healthier lives."

The study compared two rapid acting insulin analog products (lispro or aspart), formulated with rHuPH20 (lispro-PH20 and aspart-PH20, each an Analog-PH20), to an active comparator (lispro alone). The study met the primary endpoint, showing that the Analog-PH20 formulations were non-inferior for A1C, compared to lispro alone (0.4% margin) with no treatment difference (95% CI -.05, +.15). Patient groups in all treatment arms of this study achieved excellent blood glucose control, with endpoint A1C values <6.9%. Data from the study also showed that mean post-meal glycemic excursions (measured at 90 minutes) in the patient groups treated with Analog-PH20 were reduced by 82 percent (p=.0045), with more patients consistently achieving post-prandial glucose targets for at least two-thirds of their meals, as compared with the patient group treated with lispro alone. For those patient groups treated with Analog-PH20, overall hypoglycemic rates as defined by the ADA (glucose <70 mg/dL) were reduced by 5 percent (p=.035) and hypoglycemic events as defined by a more stringent definition (glucose <56 mg/dL) by 7 percent (p=.044), as compared with the patient group treated with lispro alone.

Additionally, over the 12 week study period total daily insulin dose with the Analog-PH20 treatment groups was comparable (54+27 U vs. 56+27 U, p=.057) as was weight change (-0.25 lbs. vs. +0.10 lbs., p=.27), compared with the patient group treated with lispro alone. Adverse events were also comparable between treatments, with no meaningful difference in adverse events, immunogenicity or injection site pain and Analog-PH20 was well tolerated. Treatment phase severe adverse events were limited to hypoglycemia, which occurred in two subjects treated with lispro alone.

Study Design

This 30 week, randomized, double-blind, two-way cross-over safety and efficacy study compared subcutaneously injected Analog-PH20 versus lispro alone in patients with Type 1 diabetes who were an average age of 43+14 years and had been treated with insulin for> 12 months. The study enrolled 117 patients with an average Body Mass Index (BMI) of 27.3+4.0, and A1C of 7.0+.5 percent. After a four to six week run-in period using prandial glulisine plus twice-daily glargine, patients were randomized to lispro-PH20 or aspart-PH20 versus lispro alone for two, 12-week intensive management periods. Prandial therapy was administered immediately before meals. The primary endpoint of the study was A1C non-inferiority. Secondary outcomes included rates of hypoglycemia, insulin dose, change in body weight, along with blood glucose measures.

About Halozyme

Halozyme Therapeutics is a biopharmaceutical company dedicated to developing and commercializing innovative products that advance patient care. With a diversified portfolio of enzymes that target the extracellular matrix, the Company's research focuses primarily on a family of human enzymes, known as hyaluronidases, that increase the absorption and dispersion of biologics. Halozyme's pipeline addresses therapeutic areas, such as diabetes, oncology and dermatology that have significant unmet medical need. The Company markets Hylenex recombinant (hyaluronidase human injection) and has partnerships with Roche, Baxter, ViroPharma and Intrexon. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at http://www.halozyme.com.

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Halozyme's Ultrafast Insulin Formulations Improved Postprandial Glycemic Control in Patients Living with Type 1 ...

PARIS, France, June 9, 2012 /PRNewswire/ -- Sanofi (EURONEXT: SANand NYSE: SNY) announced today that people with early type 2 diabetes uncontrolled on metformin demonstrated superior HbA1c - glycated hemoglobin - reduction with Lantus (insulin glargine [rDNA origin] injection) versus sitagliptin. These data from the EASIE (Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-Naive Patients) study were presented at the American Diabetes Association 72nd Scientific Sessions. Results of the study were also published today online in The Lancet.

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"The findings of this study comparing insulin glargine with sitagliptin provide evidence to support the recent ADA-EASD proposal to consider early basal insulin therapy as add-on to metformin to help achieve glycemic control in people with type 2 diabetes," said principal investigator Pablo Aschner, Pontificia Universidad Javeriana, Hospital Universitario San Ignacio, Colombia.

In insulin-naive people with type 2 diabetes, who were inadequately controlled by metformin once-daily, insulin glargine produced superior HbA1c reduction (-1.7%) versus once daily sitagliptin (-1.1%; p<0.001). Notably 50% more patients on insulin glargine achieved HbA1c <7% (68 vs. 42%) and <6.5% (40 vs. 17%) compared to sitagliptin (p<0.0001 for both), indicating improved glycemic control for a greater number of insulin glargine patients. Additionally, a statistically significant improvement in fasting plasma glucose (FPG), a key contributor to glycemic control, was observed for patients on insulin glargine compared to sitagliptin. The mean difference in self-monitored FPG was -41.4 mg/dL (95% CI: -46.8 to -36.0 mg/dL) lower with insulin glargine than with sitagliptin (p<0.0001).

Treatment-emergent adverse events were less frequent in patients on insulin glargine (108 patients [46%]) versus sitagliptin (143 patients [54%]). Hypoglycemia rates were higher with insulin glargine (4.21 events per patient year versus 0.50 for sitagliptin; p<0.0001). The number of patients with overall symptomatic hypoglycemia and nocturnal symptomatic hypoglycemia, with plasma glucose (PG) < 56 mg/dL, was 56 with insulin glargine compared to 12 with sitagliptin, and 20 vs. 2, respectively. Severe symptomatic hypoglycemia was reported in 3 patients receiving insulin glargine compared to 1 receiving sitagliptin. Severe nocturnal symptomatic hypoglycemia was reported in 1 patient in each group. Mean body weight slightly increased with glargine (+0.4 kg) and decreased with sitagliptin (-1.1 kg).

"The EASIE study adds valuable data to further strengthen the efficacy profile of Lantus when initiated early in the treatment pathway after metformin," said Pierre Chancel, Senior Vice President, Global Diabetes, Sanofi. "EASIE is a demonstration of the continued commitment of Sanofi to helping people with type 2 diabetes reach their glycemic targets."

The study findings are highlighted at the American Diabetes Association Scientific Sessions in the following abstract: Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-Naive Patients (EASIE) With Type 2 Diabetes Mellitus (T2DM) Uncontrolled in Metformin (Aschner et al.) [CT-SY22].

About EASIEEASIE was a multicenter, international, randomized, open-label, six-month study that compared once-daily insulin glargine with sitagliptin (100 mg) once daily, as add-on therapy to metformin, in insulin-naive people with early type 2 diabetes (median disease duration after diagnosis: 4.5 years). The primary endpoint was to demonstrate superiority of insulin glargine (n = 227 at study end) over sitagliptin (n = 253 at study end) in change in HbA1c from baseline to study end. Baseline characteristics were similar for both groups.

About Lantus (insulin glargine [rDNA origin] injection)Prescription Lantus is a long-acting insulin used to treat adults with type 2 diabetes and adults and children (6 years and older) with type 1 diabetes for the control of high blood sugar. It should be taken once a day at the same time each day to lower blood glucose.

Do not use Lantus to treat diabetic ketoacidosis.

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Lantus® Initiation after Metformin Achieved Superior Glycemic Control versus Sitagliptin in Type 2 Diabetes

THE May 30 mass shooting in Seattle that claimed the lives of five innocent victims, plus the 40-year-old gunman by his own hand, sent shock waves through the city. And the fact that this latest episode followed on the heels of an apparent short-term spike in homicide by gunfire has intensified the levels of anger, fear and concern among the residents of Seattle.

Understandably, politicians and pundits alike are calling for stiffer gun-control measures, particularly at the state level. As City Councilmember Nick Licata put it, "The problem isn't in Seattle, but in Olympia." Actually, the problem is far greater than what the Washington state Legislature can address, and the solution far broader than any Band-Aid gun-control measures.

While violence, and gun violence in particular, is sadly all too common on the streets of Seattle, as it is elsewhere, mass murder remains a rare and unpredictable event. In fact, the only predictable thing about mass murder is that it will generate a surge of anti-gun rhetoric that will dissipate as soon as residents, politicians and the media inevitably turn their attention to other matters.

Since the mid-1970s and up until this recent incident, Seattle has endured five episodes of mass murder, cases in which at least four victims were killed (not counting the assailant). One incident involved a disgruntled family member, but the remainder implicated acquaintances or strangers. All involved firearms, as it is difficult though not impossible to slaughter large numbers of people by means of stabbing, bludgeoning, beating or strangling.

The kinds of proposals being advanced in the press and over the airwaves closing the gun-show loophole, enhancing background checks, aggressively prosecuting gun crimes may be reasonable and well-meaning; but when it comes to preventing mass murder, they are meaningless.

Would Kyle Huff, who in 2006 killed six and wounded two others at a Capitol Hill address just before committing suicide, have been deterred by state restrictions on gun purchasing when his shotgun was brought from his hunting-rich home state of Montana?

Would the three assailants Kwan Fai Mak, Wai-Chiu Ng and Benjamin Ng in the 1983 Wah Mee Club massacre have needed to find a gun show to secure the weapons they used to rob and murder 13 people?

Would Ian Stawicki, implicated in the latest mass murder, have been concerned about violating laws that punish gun crimes when he was apparently prepared to end his own life rather than be captured by the police? And would Stawicki, known for being belligerent and quick to anger, have been disqualified from gun ownership no matter how restrictive the qualifications?

The answers to these questions are strikingly similar, all ranging from probably not to definitely not.

Gun-control measures that work to reduce single-victim homicide would be ineffective against mass murder.

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Gun control is a good crime-prevention measure but not for mass murder

Vedomosti

Demyan Kudryavtsev

Two high-ranking media executives have been pushed out of their jobs in shake-ups that both said were business driven, but that still raised worries among some observers about politically motivated censorship.

Kommersant holding company CEO Demyan Kudryavtsev was fired, it was announced Thursday just months after the companys owner, Alisher Usmanov, sacked an outspoken editor at Kommersant Vlast under reported pressure from the Kremlin.

Bolshoi Gorod editor-in-chief Phillip Dzyadko also unexpectedly announced Thursday that he would resign as head of the popular lifestyle magazine.

Both said that politics had nothing to do with their departures, but in his farewell column published Thursday, Dzyadko painted a bleak picture of the media landscape.

In the first summer month of Putins third term, a purge of sources of independent media is taking place in front of everybodys eyes, he wrote.

Kudryavtsev said his exit from Kommersant was largely driven by new business priorities.

Its not a corporate secret, he said in an interview with business news website Slon.ru. Its just that people who have proved their success in media have been given the task of developing strategies for growth. There is no need to seek a direct political connection.

But Galina Timchenko, editor-in-chief of Lenta.ru, told Openspace.ru that Kudryavtsevs dismissal means that they are shutting off our channels of access to independent information.

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Media Shake-Up Stirs Worries of Political Control

Members of Congress have sided with the media to blast a new Labor Department policy that tightens control over the distribution of employment data, saying the new rules threaten press freedom and raise concerns of possible Big Brother government interference.

The policy an attempt to improve data cybersecurity would prohibit news organizations from using their own computers and telephone lines when filing stories about embargoed unemployment numbers and consumer prices from the Labor Department's Bureau of Labor Statistics. Instead, news organizations will be required to use only government-owned software and hardware.

The department currently gives journalists gathered in lockdown rooms the data a half-hour early, allowing reporters time to compile stories that can be published simultaneously when the information is officially released.

The Labor Department says the new policy is necessary to ensure that sensitive government information doesnt leak ahead of the embargoes. Early access to this data, even if just by a few seconds, can allow traders to unfairly manipulate markets and reap millions of dollars.

Media groups say theyve long supported government procedures to guard against leaks. But at a House Oversight and Government Reform Committee hearing on the matter Wednesday, they said the impending new rules go much too far, would trample First Amendment rights, reduce government transparency and increase not lower threats to market volatility.

The media takes government interference with its work product very seriously. So does the Constitution, Lucy Dalglish, executive director of the Reporters Committee for Freedom of the Press, told the panel.

Daniel Moss, Bloomberg News executive editor for economics and international government, complained the policy would give the government unfettered access to reporters notes and drafts.

No administration anywhere should have access to a reporters thoughts, drafts or notes as a condition for covering the news, let alone news of such importance, he said.

Mr. Moss also said the policy threatens national security because the transmission of data would shift away from secure, dedicated lines operated by news outlets to the less-secure Internet, a potentially catastrophic scenario.

Bloomberg and three other news-gathering organizations the Associated Press and Dow Jones and Reuters have requested a meeting with the White House to voice their opposition to the pending policy change.

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Media, lawmakers balk at new labor-news rules