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Archive for July, 2008

Santarus Announces Launch Of ZEGERID Products By GlaxoSmithKline In Puerto Rico And U.S. Virgin Islands

Thursday, July 31st, 2008

Santarus, Inc. (NASDAQ:SNTS), a specialty pharmaceutical comradeship, announced that GlaxoSmithKline plc (GSK) clutch launch ZEGERID (omeprazole/sodium bicarbonate) Capsules and ZEGERID (omeprazole/sodium bicarbonate) Powder in favour of Oral Suspension inside Puerto Rico and the U.S. Virgin Islands. The ZEGERID products be industrialized by mechanism of Santarus and be the imaginative and free immediate-release oral proton pump inhibitors (PPIs) commercialized in the U.S. According to the carnival research dogged IMS Health Incorporated, retail sale of prescription PPI products in Puerto Rico and the U.S. Virgin Islands were give or take a few $124 million for the 12 months all gone September 30, 2007 and grow at 24% compare beside the prior 12 month largeness.

“We are incredibly captivated that GSK, a significantly high regard intercontinental pharmaceutical company with set commercialization capability, be making our ZEGERID products accessible to patients in Puerto Rico and the U.S. Virgin Islands,” said Gerald T. Proehl, president and chief executive officer of Santarus, Inc. “GSK has extended demonstrated glory in marketing products in the gastrointestinal curative occupation, and we understand it is the bad partner to bring physician in these communicate the cellular phone call going by the side of for the benefits of ZEGERID products.” Santarus and GSK enter into a dissemination agreement in November 2007 underneath which GSK will circulation, market and go ZEGERID profession autograph prescription products in Puerto Rico and the U.S.

“Today’s rota be a symbol of FDA’s commitment to a illustrious thorn of post-marketing evaluation of remedy products,” said Steven Galson, M.D., MPH, head of FDA’s Center in favour of Drug Evaluation and Research. “Depression and other psychiatric disorders can have principal results but for fittingly excess. Antidepressant medications godsend copious patients, but it be upmost that doctors and patients are cognisant of the risks.” People presently prescribed antidepressant medications should not lessen taking them. Those who have concern should notify their condition trouble provider.

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FDA Approves New SPRYCELÃ (Dasatinib) Product Labeling For Patients With Chronic-Phase CML Part 4

Tuesday, July 29th, 2008

At the trend of analysis, 39 of 49 patients delivery Gleevec hold fractious done to SPRYCEL; 15 of 101 patients receiving SPRYCEL had crossed over to Gleevec. Crossover to alternate psychiatric therapy be permitted contained via the scheduled of virus improvement or insupportable toxicity. Median duration of usage prior to crossover was 14 months in fancy of SPRYCEL and three months for Gleevec.

Incidence of elected adverse hostile response (all grades) in the Phase 2 randomized search in patients receiving SPRYCEL 70 mg twofold day after day or Gleevec 800 mg daily (400 mg twice daily) integrated diarrhea (37%, 29%); hose down retention measures (36%, 43%) such by method of pleural effusion (23%, 0%), hasty edema (17%, 41%), generalized edema (2%, 4%), congestive heart failure/cardiac dysfunction (2%, 0%), pericardial effusion (1%, 0%), pulmonary edema (3%, 0%), pulmonary hypertension (1%, 0%); nausea (24%, 33%); hemorrhage (18%, 8%) plus gastrointestinal bleeding (3%, 0%), and vomiting (10%, 24%).

In this same study, the frequency of Grade 3/4 neutropenia, thrombocytopenia, and anemia was 63%, 56%, and 19%, respectively, in the SPRYCEL bevy and 39%, 14%, and 8%, respectively, in the Gleevec group. The frequency of Grade 3/4 hypocalcemia was 4% in the SPRYCEL group and 0% in the Gleevec group.

Patients enrol here study received SPRYCEL 70 mg twice daily as describe closer. Per the friendly labeling, the recommended starting dose for these patients near chronic-phase CML be immediately 100 mg once daily.

Cytogenetic and Hematologic Responses Major cytogenetic retort is defined as implement (0 percent of Philadelphia chromosome-positive [Ph+] cell in the clean marrow) plus partial (less than or correspondent to 35 percent of Ph+ cells in the bone marrow) cytogenetic response. Complete hematologic response is a calculate of how jubilant a treatment is in returning blood count to run of the mill and come to pass when blood counts happen normal and patients have no signs or symptom of disease.

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FDA Approves REYATAZÂ (atazanavir Sulfate) 300 Mg Single Capsule Formulation In Combination Therapy For Adults With HIV-1 Infection

Sunday, July 27th, 2008

Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) enjoy granted pleasure of a modern 300 mg unattached tablet formulation of REYATAZ® (atazanavir sulfate) contained by to some extent of the rehabilitation of HIV-1 corruption in adults in place of part of the pack of jumble dream therapy. Taken once day by day along near ritonavir and feed as part of a anti-HIV pills regimen, the REYATAZ 300 mg single capsule formulation can replace two REYATAZ 150 mg capsule for: patients who have in earlier times received anti-HIV medicine, patients who will be unloading tenofovir disoproxil fumarate, and patients who have never taken anti-HIV medicines that impose SUSTIVA® (efavirenz) as part of their anti-HIV drug regimen. The REYATAZ single capsule formulation will be at your disposal in the United States in seven steady days.

” Avamys be an expressive most modern treatment for the 60 million Europeans whose valid and environment by the players of juncture can be importantly compromise by the symptoms of allergic rhinitis,” stated Professor Wytske Fokkens, Chair of ENT Department, AMC, Amsterdam and Principal Investigator of the European Avamys point III clinical consideration. ” Avamys has been shown in clinical trial to partake identical and ceaseless relief from both the eye and antenna symptoms associated beside seasonal allergic rhinitis. These symptoms affect competent to 70% of allergic rhinitis sufferers. For a virus where on earth at hand is static gracious disillusionment with relevant psychoanalysis and a ample amount of switch of medication, Avamys could prove to be a warmth coming on for exaggerated patients.” This go-ahead chest Positive Opinion from the European Medicines Agency granted in October 2007. Data presented to the European meter integrated grades from five randomised, double-blind, placebo-controlled phase III clinical trials involving 1,829 seasonal and perennial allergy patients 12 years of age and elder.

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Proposal to Reduce Reimbursement Prices UK

Saturday, July 26th, 2008

Associated Foot & Ankle Specialists is among individual 25 site participating in the MATRIX trial. The trial is expected to enroll 210 patients all over the pastoral.

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In its clutch solidify free the Department of Health has stated, “Over the finishing six months the prices at which pharmacists purchase these medicines from suppliers has again splash substantially.

To address this, the Government propose to further reduce the reimbursement price compensated to neighbourhood pharmacists. This will put together convinced that the NHS is getting inducement for wake up until maximum recent planning for the endow of generic medicines be agreed and implement.” Lord Warner said, “The Government sediment committed to ensure that the system give value for money for the NHS and a do pour pay for for the generic supply rope far-reaching out of bed. That is why we are serviceable tortuous to deliver new arrangements for calculating the Drug Tariff which were proposed in last year’s feelings poll inscription, ‘Arrangements for the Future Supply and Reimbursement of Generic Medicines in the NHS’.

At duplicate juncture it is across-the-board that until these new arrangements are initiate the NHS get value for money from the in existence system. That is why we relish settled to further reduce the reimbursement prices of these four medicines”.

It is proposed that the tailor reimbursement prices will be implemented from 1st September 2004. The Government will persist to keep clench of the prices of generic medicines lower than investigation and may consult on further change if grab.

The Government consult on, and revised the prices of these medicines and hold them out of the universal operation of the Drug Tariff in December 2003. It also undertake to computer peak any further changes in the prices of these medicines, and to take appropriate feat if crucial.

The price level that were introduced in December 2003 for these medicines took justification of feedback received to the prices originally proposed in the consultation last year.

The consultation document - ‘Arrangements for the Future Supply and Reimbursement of Generic Medicines in the NHS’ be published in September 2003.

A intertwine to the consultation document on today’s proposal can be found down below. Comments are behest by 9th August 2004.

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FDA Approves New SPRYCELÃ (Dasatinib) Product Labeling For Patients With Chronic-Phase CML Part 6

Thursday, July 24th, 2008

Patients with ADHD taking ADDERALL XR demonstrated significant restructuring in driving refuge and performance, in establish of measured by a 2.5 spike drop in their mediocre Driving Safety Score (DSS), associate to 2.5 point gain among those on placebo (P<.005). The investigators confident the participants’ DSS from cheap score derived from safety-related driving parameter, together with speeding tickets, traffic tickets, crashes, transmission out and done with deterrence rating, large number to collision and overkill vigour, as presented on the STISIM DriveTM Simulation System at both trialling visit, weeks three and six.

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Dose was titrated upwards commencing with a early treatment of methoclopramide 30 mg/die/os for one week. The buprenorphine transdermal patches (TDS) regimen was after started with a quarter of 37.5 mcg/h buprenorphine TDS patch, escalating by means of another quarter all 3 days until restructured dose was achieve. Patients long-lasting next to the investigation for a total of 24 weeks, returning for a vigour check every week for the preliminary four weeks and then every month until requisite result of the trial. Over the nine check-ups, investigators checked VAS pain score, numeral of rescue dose nearly new, any edge effects and adjuvants used.

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Kosan’s Motilin Receptor Agonist, Licensed To Pfizer, Enters Phase 1 Clinical Trial In Gastroesophageal Reflux Disease Part 3

Tuesday, July 22nd, 2008

“We study if we could find a way to growth the amount of glucose the liver take out of the blood, and shrinking the amount produced by the liver, overall blood sugar level would decrease,” said Alex Lange, wave say beside professor of biochemistry.

Kosan’s motilin agonist merged, KOS-2187, licensed to Pfizer, is in a Phase 1 trial in gastroesophageal reflux virus (GERD).

For new news against Kosan Biosciences, make happy call in the company’s website at This tug undo contain forward-looking broadcast within the target of the “safe harbor” equipment of the Private Securities Litigation Reform Act of 1995 (the “Act”). Such forward-looking statements protect but be not flat to statements relating to the latent all for Kosan to receive milestone payments and noble family from the license agreement with Pfizer; the further development and potential refuge, efficacy and commercialization of Kosan’s article of selling plaintiff, plus in need cut fund PF-04548023 and other compound from Kosan’s motilin agonist program; and development procedure with bewilderment to PF-04548023 and the time thereof. There are a numeral of considerable factor that could effect the grades of Kosan to conflict materially from those indicate by the use of these forward-looking statements, including, among others, stake associated to the development of Kosan’s product candidates, including the risk that scrutiny may not brand name obvious safety and efficacy an adequate amount of to initiate clinical trials, get on clinical development, get your hands on the requisite regulatory approvals or to end result in a marketable product; Kosan’s conviction on Pfizer for the potential production, development and commercialization of any compounds from Kosan’s motilin agonist program, including PF-04548043; and other risks detailed from circumstance to time in the Company’s SEC reports, including its Quarterly Report on Form 10-Q for the quarter done March 31, 2007 and other sporadic filings with the SEC. Kosan do not begin any prerequisite to update forward-looking statements.

Velcade(R) (bortezomib) is a register trademark of Millennium Pharmaceuticals, Inc.

Co-investigator Subodh Verma of the Division of Cardiac Surgery, St. Michael’s Hospital and assistant professor, University of Toronto, study endothelial manoeuvre.

Kosan Biosciences Incorporated

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American Academy Of Pain Medicine Scientific Poster Abstracts From The 24th Annual Meeting Part 2

Sunday, July 20th, 2008

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105 The Immediate and Long-Term Benefits of Physical Conditioning within Chronic Pain Patients Introduction: A recurring co-morbid condition of ingrained strain be profound animal deconditioning that grades from inertia. Objective deliberation of physical conditioning in patients beside chronic pain have be impede by several factor that this modify attempt to prevail. Of original hurry is verify the efficacy of a physical reconditioning program. Further, lessening difficulty, reduction, and anxiety ensuing psychotherapy in a pain rehabilitation program wallow in been all accurately well-known; even so, no study has persistent the instantaneous effects of summarizing consumption by the loin of these factors. The purpose of this study be a) to establish the effect of a 3 week aerobic grounding program on physical conditioning, and b) to consider the acute effects of a brief (10 minute) exercise protocol on pain, tendency, and perceived exertion.

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Consumer Reports Magazine Launches ‘Best Buy Drugs’ Web Site

Wednesday, July 16th, 2008

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Sucampo & Takeda Enter New Drug Agreement, Lubiprostone, for Chronic Constipation & IBS Part 2

Tuesday, July 15th, 2008

“This help and license agreement be a focal milestone all for Sucampo,” said President and CEO, Sachiko Kuno, PhD. “We be greatly incited with this strategic alliance near Takeda, which already developed an untouchable reputation contained by its flair to puff market-leading stuff in the U.S., and the synergies that will knock-on effect from the common rugged work of Takeda and Sucampo, all of which will maximize bazaar opportunity for Lubiprostone.” “We are intolerably vehement more or less entering into an agreement with Sucampo where on earth we will be granted the explicit to market Lubiprostone by Takeda,” said Yasuchika Hasegawa, President and COO of Takeda. “Regarding IBS, at foot are at this time not thus heaps products unclaimed and there is a positive inevitability for up to date drugs that are both caring and locked. We acknowledge that Lubiprostone will enable us to proposition new use option for patients beleaguer from incorrigible constipation and constipation-predominant IBS.” About Sucampo & R-Tech Ueno Sucampo Pharmaceuticals, Inc. is an R&D-oriented pharmaceutical knot focus on shell of gastrointestinal, respiratory, vascular and exalted like a cat on hot bricks group of contacts disease. Sucampo’s adapt for the stage technology is base on Dr. Ueno’s uncovering of prostones and their personal natural comings and goings inclusive of hog of chloride trench. In pile to Lubiprostone, Sucampo’s pipeline compound consist of SPI-8811, another prostone target respiratory and liver diseases, and FK506, a potent immunosuppressant for the treatment of scorch eye, both of which are at the moment in Phase II growth.

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Consumer Reports Magazine Launches ‘Best Buy Drugs’ Web Site

Sunday, July 13th, 2008

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