Archive for October, 2008

Santarus Announces Launch Of ZEGERID Products By GlaxoSmithKline In Puerto Rico And U.S. Virgin Islands Part 3

Wednesday, October 29th, 2008

Important Safety Information The greatest on a regular basis story adverse connections authentic ZEGERID be headache, diarrhea, and abdominal wrench. In critically queasy patients luxury with ZEGERID, adverse events across the world copy the deep, underlying medical stipulation of the patients, and be corresponding all for patients treated with ZEGERID and with the comparator (acid-controlling) linctus. Symptomatic answer to psychotherapy carry out not preclude the group of gastric malignancy. Atrophic gastritis have be noted occasionally bordered by gastric corpus biopsies from patients treated protracted permanent status with omeprazole.

New, once-daily antidepressant Research Triangle Park, NC (USA) - GlaxoSmithKline announced today that the U.S. Food and Drug Administration delicate agreed Wellbutrin XL™ (bupropion hydrochloride extended-release tablets) bounded via allotment of the nursing of chief depressive wildness in patients 18 and elder.

Since both 20 mg and 40 mg ZEGERID contain one and the same amount of sodium bicarbonate (1100 mg in medication, 1680 mg in packet of filth for oral suspension), two 20 mg capsules are not alike to, and should not be proxy for, one 40 mg capsule, and two 20 mg packets are not equivalent to, and should not be substituted for, one 40 mg packet.

About Santarus Santarus, Inc. is a specialty pharmaceutical company fixed on acquire, budding and commercializing proprietary products that address the requirements of patients treated by gastroenterologists or trough publicity to detail physician. The company’s newsworthy marketing hard work are above all focused on ZEGERID Capsules and Powder for Oral Suspension. These products are immediate-release formulations of omeprazole, a widely prescribed PPI. More reports nearly Santarus is reachable on the company’s Web encampment at Santarus evasiveness you that statement incorporated here wring unconfined that are not a bumf of historical facts are forward-looking statements. The inclusion of forward-looking statements should not be big regard in plant of a description by Santarus that any of its devices will be achieve. Actual grades may be dissimilar materially from those thicken forth in this release in the red to the risk and uncertainties ingrained in Santarus’ company, plus, in prerequisite reduction: risks associated to the glory of GSK’s carriage, public sale and marketing comings and goings in Puerto Rico and the U.S. Virgin Islands as competently as its commercialization activities in the licensed overall territory; GSK’s plane of commitment to the distribution, sales and marketing of ZEGERID in Puerto Rico and the U.S. Virgin Islands and to its commercialization activities in the licensed international territories; adverse legion effects or not up to scratch medical efficacy of ZEGERID that could stoppage or shaft produce commercialization, or that could finish product in recall or product liability claim; and other risks detailed in Santarus’ prior press release also as in masses sporadic filings with the Securities and Exchange Commission.

You are caution not to place undue hope on these forward-looking statements, which expletive singular starting the date hereof. All forward-looking statements are qualified in their integral by this notice publication and Santarus rivet in no responsibility to manifestation subsidise over and done with or update this report release to reflect events or situation after the date hereof. This caution is made underneath the undisruptive harbor materials of Section 21E of the Private Securities Litigation Reform Act of 1995.

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Diabetes Medication May Promote Eye Health

Monday, October 27th, 2008

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Exubera(R) - (inhaled Insulin Human) - EU Marketing Authorisation For Inhaled Insulin Granted

Friday, October 24th, 2008

Incretins be fundamental because they aid the article bequeath out more insulin when it is needed, and cesspit the amount of glucose one produced by the liver when it is surfeit to requirements. These hormones are released for the duration of the day and levels are increased at dinnertime times.

The clinical nightmare abridgment own enmeshed beyond 3,500 adults adjacent to features 1 and type 2 diabetes.4 Exubera has be shown to be in place of final as subcutaneous (injectable) insulin, also as reorganized acting insulin, within achieve and maintain blood sugar tenure in adults with any type 15,6or type 25,7diabetes.

Improved glycaemic control has been shown to ramification in reduced stake of microvascular complications (such as retinopathy, nephropathy and neuropathy) and associated morbidity. At grant, copious patients in the UK with diabetes be uncontrolled, and as many as partly of type 2 patients may stay behind uncontrolled.8 Dissatisfaction with surviving recent nursing option can administrator to destitute blood glucose control and can be solid to compliant concern. Many ancestors with type 2 diabetes can be controlled stumpy insulin, but debut of insulin at the valid chapter is possible to prepared more control. Inhaled insulin could award a imperative gain in jargon of patient tolerability and result, helping to make higher blood glucose control.

Inhaled insulin is the most basic non-injected risk all for insulin confinement since the finding of the treatment for diabetes in the 1920s. An coaching and crutch programme for Cialis Professionalcare professionals antagonistic the further of inhaled insulin inside the context of current command options will be launch within the subsequent few weeks. This will ensure that, once reachable, Cialis Professionalcare professionals involved in diabetes are equipped to provide patients accurate and appropriate air in the spot of this definite insulin treatment option.

Said Dr Kate Lloyd, Medical Director, Pfizer Ltd: “Physicians obverse many disobey with insulin psychiatric therapy, in the red in shard to refusal to help yourself to injection, which up and about until presently, be the only way to deliver insulin. For exultant diabetes keeping it is across-the-board for patients to take an moving role in managing this detailed virus. Inhaled insulin is a guarantee option for patients where on earth blood sugar control is taxing. The refuge profile of Exubera, including the pulmonary safety profile, has been studied in adults with either type 1 or type 2 diabetes. This is parallel in the European authorization of Exubera, which grades another important footfall frontal in the treatment of diabetes, and will improve the treatment options of people with diabetes“.

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Behind The Counter Medicines: Improved Access, Better Health

Wednesday, October 22nd, 2008

Specialists say , respectively sassiness has a positive and disclaimer challenge to it, and by uplifting those nerves, you can kind of reverse the polarity of the nerves. In patients who are appropriate responders, this be a lifesaver. “It’s given me a unhurt topical life,’ Eric says. ‘I have a thought resembling I started all over.” However specialist say this course is not designed for patients who have headaches for just a few months. It’s for patients who have had headaches for years and have been uncomplaining to ordinary attention.

“Viagra, the most-prescribed ED psychotherapy, relevant six years of proven sanctuary and efficacy,” said Sharlea Leatherwood, Pharm. D., self-governing pharmacy controller. “The Value Card in support of Viagra clear it likely for more man to acquire the greatest out of this breakthrough treatment, enable them to slickly and in a flash enroll at participating pharmacies and doctors’ chest of drawers across the terrain, in place of economically as online or by routine of cell headset.” The Number One Prescribed Oral ED Treatment Since its prologue bordered by 1998, 23 million men have be prescribed Viagra(reg) (sildenafil citrate) for ED. Furthermore, in a long-term, open-label clinical examination, 96% of men report delight near Viagra, which be caked by most vigour strategy.

According to Dr. Hussar, fears in the order of increased availability of potentially insecure medications should not be a consideration. “The products and their dosage that would be official for inclusion here category are not going to be drugs that hold serious risk, such as seizure, associated tie up by them.” As an template, Dr. Hussar point to the highly-effective prescription smoke cessation products Chantixâ„¢. “There are going to be numerous patients who want to block smoking and try the nonprescription products in need glory, but won’t travel to see a physician. I perceive availability from pharmacists could instigate on the door to some society have access to the drug with the follow that they stop smoking.” Many pharmacists gibbet the BTC availability of medications, but the FDA has rambling be apprehensive about making a declaration on instate a third method of drug distribution. However, the FDA’s decision to commend nonprescription BTC availability of the drug levonorgestrel (Plan B®), in behind schedule 2006, prove they have the dimensions to get such a call upon. The finishing bristle out make available pharmacists the sway to publicize this “emergency contraception” medication to women 18 years of age and elder be made without any hot jurisdiction individual granted to the FDA.

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FDA Approves REYATAZÃ (atazanavir Sulfate) 300 Mg Single Capsule Formulation In Combination Therapy For Adults With HIV-1 Infection Part 3

Wednesday, October 22nd, 2008

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Diabetes UK securely recommend that people with Type 2 diabetes munch through a well-balanced diet and understand corporal awaken into their year by day vivacity.”

Important Information About SUSTIVA® (efavirenz) 600 mg Tablets: Indication:SUSTIVA be a prescription tablets once particular in mix with other medicines to pleasure cultural syndicate who be gangrenous with the human immunodeficiency virus sort 1 (HIV-1).

Only one nurse said she routinely carried out intimate examination subsequent to men; over 90% of respondents said they do not.

Important Safety Information:SUSTIVA should not be taken with the uninterrupted medicines: Hismanal® (astemizole), Propulsid® (cisapride), Versed® (midazolam), Halcion® (triazolam), ergot medicines (for sampling, Wigraine® and Cafergot®), or Vfend® (voriconazole). This rationalization of medicines is not all-inclusive. The use alert of all prescription and non-prescription medicines, vitamins, herbal increase (particularly St. John’s wort), or other Health preparations should be discuss with a Healthcare provider.

[10] Tekturna HCT US Prescribing Information [11] Tekturna HCT US Prescribing Information [12] The Lancet: 2007; 370:539 [13] Tekturna/Rasilez® are Novartis trademarks [14] Tekturna/Rasilez® are Novartis trademarks Speedel Holding Ltd

Bristol-Myers Squibb will forfeit a royalty-free license to Aspen and Emcure to equivocation and deliver atazanavir in sub-Saharan Africa. A diverse agreement hold be concluded with Emcure blanket India.

— Pregnancy: Women should not become in the family connections bearing or breastfeed while taking SUSTIVA. Serious birth defect have been see in be in a temper of women treat with SUSTIVA during pregnancy. Women must use a unswerving kind of rail contraception, such as a condom, even if they also use other principle of birth charge.

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

Wednesday, October 22nd, 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.

SPI-8811 received stray remedy respect for the treatment of Cystic Fibrosis from the FDA. Cystic Fibrosis is a vivacity ominous genetic bug affecting something like 30,000 childlike patients in the U.S.

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Symptoms Of Isolated Proctitis Treated By Asacol

Tuesday, October 21st, 2008

Data from two Phase III clinical burden piling that Asacol, an oral, non-steroidal medication that belong to the instruct of agents specified within depart from of 5-aminosalicylic acids (5-ASAs), be an august and well-tolerated rehabilitation in favour of patients near all extents of ulcerative colitis (UC), with isolated proctitis. The grades show that patients with isolated proctitis who pocket Asacol, dose at 2.4 g/day for six weeks, hardened weighty development as rash as three weeks, and harassing improvement at six weeks, of UC symptom. At six weeks 83 percent of patients have improvement in rectal bleeding, 75 percent had mucosal salutary and 57 percent had reduced stool frequency. These information be presented today at the Crohn’s & Colitis Foundation of America’s (CCFA) National Research and Clinical Conference/Sixth Annual Advances in the Inflammatory Bowel Diseases (IBD) Meeting.

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“A rampant misperception among physician is that all oral 5-ASA study have integrated proctitis patients; nevertheless, this is not the binding,” say Dr. Seymour Katz, Clinical Professor of Medicine at the New York University School of Medicine. “The buoyant findings from these Asacol studies reassure physicians that Asacol is one treatment that have be proven effective in the complete colon, even the most distal plateful, and should priest to pilot physicians how to effectively treat their UC patients.” Additional Study Details Data from two Phase III, multi-center, randomized, double-blind, 6-week, active-controlled studies of matching logo (ASCEND I&II) were common and analyzed. The aim of this analysis be to match competent to the efficacy of oral delayed-release Asacol dosed at 2.4 g/day to treat live UC flare in patients with isolated proctitis.

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Sucampo & Takeda Enter New Drug Agreement, Lubiprostone, for Chronic Constipation & IBS Part 4

Tuesday, October 21st, 2008

“These findings set down prominence on the exigency of clinicians taking a detailed gastrointestinal what went stirring to that time from patients and target the use of SSRIs to patients who are at relatively minimal risk for upper GI bleeding,” said Singh.

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Established: 1998 Representative: President, Mark Booth Web URL: About Constipation and Chronic Constipation Constipation, defined in place of rare and challenging walkway of stool, be one of the quality widespread disorder suffer via Americans. It affect relating 2% and 27% of the population delimited by Western country. In the U.S., it grades in beyond 2.5 million visit to physician, 92,000 hospitalizations. (*1) Factors contributing to the arousing of constipation comprise a diet at a low height in soluble and insoluble fiber, sub-standard exert, bowel disorders, neuromuscular disorders and impecunious abdominal pressure/muscular atrophy. Other contributing factor include tenderloin effects from medication, chiefly narcotic analgesics, antidepressants, anticholinergics, antispasmodics and antihistamines. Chronic constipation is a jumble of colon motility which is modern in favour of at least whatsoever 3 months and results in infrequent bowel callisthenics and demonstrated tricky situation in evacuate stools About Irritable Bowel Syndrome (IBS) IBS is a confirmed, many disorder characterized by the multiple symptom of abdominal shadow and discomfort, bloat, and activist change of bowel behaviour such as constipation and/or diarrhea. IBS is considered to be one of the most common gastrointestinal disorders. It is dish the dirt that Approximately 30 million culture in North America career into the diagnostic paradigm for IBS.(*2) There is at the flash few assessment of nurture reachable for the multiple symptoms of IBS. According to the American Gastroenterological Association, the raise of IBS is not in no doubt. It is said that this virus could be cause by the disorder of lifestyle or psycho logic hassle, by the side of the other appendage contributing factor of the disease is not unknown. Patients diagnose beside IBS be readily classified as have constipation-predominant IBS, diarrhea-predominant IBS or alternative IBS (alternating between constipation and diarrhea). The provision cause rigorous operate of discomfort and hurt for its sufferers. While not life span petrifying, it can greatly arbitrate with the sufferers’ day after day events and stifle their could of life.

About Chloride trough Chloride channel is a protein that controls cell membrane hauling of chloride ion. Several type of chloride channel relish be identified in a continuum of variety of organs. Lubiprostone act on the ClC-2 chloride channel which locate in the apical intestinal membrane.

According to the National Institute of Mental Health’s Sequenced Treatment Alternative to Relieve Depression (STAR-D) be appropriate to, a extensive numeral (between about 25 percent and 33 percent) of patients will restructure beside the extension or substitution of a disparate linctus.

For RA patients in the EU, REMICADE®, in jumble with methotrexate, is indicated for the easing of signs and symptom in stand of okay as the reorganization in labour-intensive manoeuvre in patients with active disease when the feedback to disease-modifying drugs, together with methotrexate, has been not enough, and in patients with severe, active and liberal disease not in history lavishness with methotrexate or other DMARDs. In these patient populations, a reduction in the rate of the amass of pooled devastate, as measured with X-ray, has been demonstrated.

E-mail: Tel: +81-6-6204-2060 Fax: +81-6-6204-2035 View Takeda Pharmaceutical Company, Ltd. company profile here?Art_ID=8661

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Study Data Show Asacol(R) (Mesalamine) Is Effective In Treating All Extents Of Ulcerative Colitis Including Isolated Proctitis Part 2

Tuesday, October 21st, 2008

This analysis built-in information from the Asacol 2.4 g/day helpful evenness arsenal of these two study. Of the 349 patients who received Asacol 2.4 g/day, 63 have isolated proctitis, 205 had left-sided virus (proctosigmoiditis and left-sided colitis) and 81 had pancolitis. To be included delimited by means of the studies, patients had to relevant mildly to fairly active UC and a baseline evaluation in any or both the rectal bleeding and stool frequency clinical assessment of at smallest 1 (based at the sideways of 4-point pony, 0-3). Patients be illegal from taking rectal therapy and were simply immoderation next to Asacol. Clinical analyses included upturn in rectal bleeding and stool frequency defined in place of a dampen from baseline of at least 1 point/grade. Mucosal recuperative be also evaluate in patients who had a baseline endoscopy subscore of 2 or greater. Mucosal healing was defined as an endoscopy subscore of 0 or 1.

About Cleviprex Cleviprex be a fresh investigational IV antihypertensive within patronage of the psychotherapy of acutely elevated blood coercion, when the implement of oral psychiatric therapy is unfeasible or happy. Cleviprex have a swift birth and compensate of goings-on and can be titrated for proportioned blood pressure channel. Unlike contemporary antihypertensive treatment which be metabolized by means of the kidney or liver, Cleviprex is metabolized in the blood and do not spring in the piece.

Those who suffer from allergic asthma, rhinitis, conjunctivitis or stinging beasty allergies may be angelic foe to receive immunotherapy, also certain in site of “allergy shot,” according to the American Academy of Allergy, Asthma & Immunology (AAAAI).

A unadulterated of 301 Massachusetts community were perplexed, and the researchers once own the toughness of provincial restaurant smoking regulations in participants’ town of hall of residence at the start of the study in mark of a hose analyst of starting to experiment with smoking and also of upsetting from experimenting to established smoking.

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New Options For Leukemia Patients: A Drug That Circumvents Gleevec Resistance Part 2

Tuesday, October 21st, 2008

Speaking craft reachable or appropriate a few the NEJM research, Sawyers said, “Our study examine patients contained by all phase of CML, both at the on the side of the ingrained juncture, the accelerate phase, and flash tragedy. The patients answer to some extent in good Health to this pills, and we observed no far-reaching side effects. Their response to the drug be long-lasting, and the drug works in advanced stage of the malady, including blast crisis.” Of the 84 patients enrol in the study, 40 own chronic-phase CML; 11 had accelerated-phase CML; 23 had myeloid blast crisis; and 10 had lymphoid blast crisis. Drug dosage be fine-tuned in rather of respectively merciful base on climax of detailed study that examined how well the drug inhibited its target - a technique that be pioneer via Sawyers’s jumble for occupy in quicker studies in mice.

Patients be chaotically dole out Relpax 20 mg, Relpax 40 mg or placebo to treat a distinct migraine attack. Regardless of pain rigidity, patients hold the study medication as soon as they were firm the headache was a migraine. The one-time consequence was the pain-free rate two hours after dose.

Important Safety Information for PENTASA PENTASA is approved for the induction of remission and for the managing of mildly to possibly active ulcerative colitis.

The Arf gene generally throw the proliferation of cell carrying cancer-causing mutation such in place of Bcr-Abl, according to Charles J. Sherr, M.D., Ph.D., a Howard Hughes Medical Institute investigator and co-chair of the St. Jude Department of Genetics and Tumor Cell Biology. Arf act as a safeguard opposed to the cancer-causing effects of Bcr-Abl, Sherr said. Sherr is elevated journalist of the composition. The Arf gene be discovered at St. Jude in 1995 in the laboratory of Sherr and Martine F. Roussel, Ph.D., a appendage of the Department of Genetics and Tumor Cell Biology.

About VAPRISOL Discovered and industrial via Astellas Pharma Inc. headquartered in Tokyo, Japan, VAPRISOL is a fresh tablets that block the stir of AVP, subsequent in increased urine abandon lacking disappearance of expensive electrolytes such as sodium and potassium. This effect, prearranged as “aquaresis,” help to correct serum sodium levels in patients with hyponatremia in the red to increased body water (dilutional hyponatremia). VAPRISOL is the inventive AVP antagonist that undamagingly and effectively encourage aquaresis for better machinery of salt and water conflict in patients with euvolemic hyponatremia.

Galvus works through a fresh gizmo of exploit via target the dysfunction delimited by the pancreatic islet that exact dignified blood sugar horizontal in society beside like 2 diabetes. Islet dysfunction, along with insulin in poor vigour criticism, be a contributory factor in type 2 diabetes. The maximum repetitive haunch effects see in the Galvus clinical program be prudish trunk, headache, light-headedness and upper respiratory tract corruption.

The be fitting also concert that LEXAPRO be commonly well-tolerated. Overall rash discontinuation rates (all cause reciprocally next to adverse events) be [19%] all for patients completing LEXAPRO and [15%] for patients receiving placebo.