July 3rd, 2009
R-baclofen is an agonist of the end known as gamma amino-butyric acid(B), or GABA(B), receptor. Racemic baclofen (a medley of R and S isomers) has been approved for the healing of spasticity and has been shown in clinical studies to have efficacy in a handful of Other restorative indications, including gastroesophageal reflux virus (GERD) and cutting back spasms. About Spasticity Spasticity is a debilitating fettle that is associated with some shared neurological disorders, such as multiple sclerosis, apoplectic fit and cerebral palsy, as well as spinal rope injury. Spasticity is a shape in which unnamed muscles are continuously contracted, interfering with moving parts or speech.
According to text from Wolters Kluwer Health, Source ® Pharmaceutical Audit Suite, for the 12 months ended December 31, 2008, there were approximately 7.0 million prescriptions written in the United States for the two most extensively prescribed drugs for the therapy of spasticity, racemic baclofen and tizanidine. About XenoPort XenoPort, Inc. is a biopharmaceutical corporation focused on developing a portfolio of internally discovered offering candidates that utilize the body's usual nutrient enrapture mechanisms to refurbish the salutary benefits of existing drugs. XenoPort is developing its vanguard effect candidate, XP13512, in collaboration with Astellas Pharma Inc. and GlaxoSmithKline.
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Posted in Hospital trials | No Comments »
July 3rd, 2009
The efficacy of FDA-approved Creon was demonstrated in a randomized, double-blind, placebo-controlled crossover writing-room which enrolled 32 patients with CF. The simple efficacy endpoint was the coefficient of paunchy absorption (CFA), which measures the cut of abundance absorption relevant to dietary plumpness intake. Creon produced significantly greater medium CFA values compared to placebo in this study. The tight CFA during healing with Creon was 89% versus 49% during therapy with placebo, representing a modest imbalance in CFA of 41%. Creon showed statistically-significant increases in CFA for both adults (age >18 years) and adolescents (age 12-18 years).
There was no allied variation in the extent of effect between the lifetime groups. The frequency of adverse events (regardless of causality) was higher during placebo curing (71%) than during Creon Care (50%). Treatment-emergent adverse events occurring in at least two patients (greater than or colleague to 6%) receiving Creon or placebo were abdominal Pain, abdominal cut to the quick upper, strange feces, cough, dizziness, flatulence, inconvenience and majority decreased. "As the opening and only offshoot in the pancreatic enzyme discernment to be FDA-approved under the rejuvenated guidelines, Creon helps bump into a depreciative emergency for thousands of patients with EPI," said Dr. Stephen Hill, President, Solvay Pharmaceuticals, Inc. "For more than 20 years, Solvay Pharmaceuticals has been committed to the pancreatic enzyme market-place in the United States and is high and mighty to dethrone FDA-approved Creon to patients misery from EPI.

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Posted in New drug approbation | No Comments »
July 3rd, 2009
FDA notified healthcare professionals and patients that it has required the manufacturers of the Smoking cessation aids varenicline (Chantix) and bupropion (Zyban and generics) to unite supplementary Boxed Warnings and expatiate serene Medication Guides highlighting the jeopardize of urgent neuropsychiatric symptoms in patients using these Products. These symptoms comprise changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide. The added warnings are based on the continued procession of postmarketing adverse occurrence reports for varenicline and bupropion received by the FDA. These reports included those with a non-ecclesiastic relation between the use of varenicline or bupropion and suicidal events and the materialization of suicidal ideation and suicidal behavior in patients with no summary of psychiatric disease.

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July 2nd, 2009
Drugs.com reported a immense 20,900% better (yes, you interpret that correctly – twenty thousand, nine hundred percent) in stake for intelligence on the medication medication – allegedly prescribed for the acclaimed entertainer Michael Jackson. More than 135,000 messenger views were logged on the Drugs.com entanglement neighbourhood by population researching Demerol this old days Friday – the single biggest annul in daily interest for a medication since the similarly horrible and untimely demise of Heath Ledger. Demerol (meperidine) is a soporific Pain relieving medication.
It workshop by dulling the irritation perception center in the brain. Interest in the medication exploded from around 650 send for views per daytime on customary to 135,164 page views on Friday, June 26.

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July 2nd, 2009
Under the terms of the union agreement, Cell Genesys stockholders will inherit 0.1615 of a pay out of BioSante collective horses for each interest of Cell Genesys inferior goods they own. Based on the companies' closing set prices on June 29, 2009, this represents $0.347 per split of deliberation to be received by the Cell Genesys stockholders, or a utter backsheesh of approximately $38 million, and a Premium of 12 percent to the closing white sale expense of Cell Genesys' common supply on that date.
Upon completion of the transaction, BioSante stockholders old to the commingling are expected to own approximately 60.4 percent of the on-going shares of the combined friends and the former Cell Genesys stockholders are expected to own 39.6 percent. Stephen M. Simes, president and CEO of BioSante, and Phillip B. Donenberg, CFO of BioSante, will pick up to accommodate in those positions in the merged company. Dr. Louis W. Sullivan, chairman of the food of BioSante, will on in that position. It is anticipated that Stephen A. Sherwin, M.D., chairman and CEO of Cell Genesys, and John T. Potts, Jr., M.D., a reported colleague of the Cell Genesys board, will enlist the take meals of the merged flock upon finalization of the merger.

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July 2nd, 2009
Serdolect derives from Lundbeck's in-house investigation and the actors holds the pandemic rights. Serdolect has a one of a kind neuropharmacological profile, characterized by inhibitory property on dopamine D2, serotonin 5-HT2 and 5-HT6 receptors, as well as on alpha1-adrenergic receptors. Serdolect has a excessive limbic selectivity, indicating antipsychotic action without capability for extrapyramidal motor indirect effects.
It has no import on muscarinic cholinergic and histamine H1 receptors, which could be associated with cognitive and tranquillizing philosophy effects. The preclinical limn has been confirmed in clinical trials. About schizophrenia Schizophrenia is a life-and-death and often confirmed cerebral upset affecting up to one percent of the world's population. In many patients the disorders institute during fresh adolescence or primitive adulthood best to severe changes in the patient's respect of thinking and perceiving the outside world.
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Posted in New drug use and attentions | No Comments »
July 2nd, 2009
The permit compatibility executed with AstraZeneca in August 2006 established a Phase III clinical improvement program for PN 400, an investigational compound, that combines the sadden reliever naproxen (an NSAID) with esomeprazole magnesium, a proton grill inhibitor (PPI), to help a future sign for the healing of the signs and symptoms of osteoarthritis, rheumatoid Arthritis and ankylosing spondylitis in patients who are at chance of developing gastric ulcers. About Pozen Pozen is a pharmaceutical society committed to developing healthy advancements for diseases with unmet medical needs where it can revive efficacy, safety, and/or untiring convenience. Pozen's efforts are focused generally on the maturation of pharmaceutical Products for the curing of discriminating and persistent cut to the quick and Other Pain-related conditions.
Pozen has phenomenon and commercialization alliances with GlaxoSmithKline for Treximet®, which was approved in 2008 by the United States Food and Drug Administration for the alert Care of migraine attacks, with or without aura, in adults, and with AstraZeneca for proprietary prearranged dosage combinations of naproxen with the proton question inhibitor esomeprazole magnesium in a solitary bolus for conditions such as osteoarthritis and rheumatoid Arthritis in patients who are at jeopardy for developing NSAID-associated gastric ulcers. The Company's proletarian father is traded on The NASDAQ Stock Market under the standard "POZN". For complex attendance information, including copies of this and Other squeeze releases, discern Pozen's website: www.pozen.com. Statements included in this take in one's arms publicity release that are not factual in nature are "forward-looking statements" within the purport of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995.
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Posted in New drug use and attentions | No Comments »
July 2nd, 2009
[Posted 05/08/2009] Biosite and FDA notified healthcare professionals of the Class 1 summon of the Biosite tag Triage Cardiac Panel, a examine is utilized by constitution professionals as an comfort in the diagnosis of a concern onset (myocardial infarction).The use of the seized lot may lead to false negative results with unaggressive samples containing troponin I at very bawl levels, with CK-MB, and with myoglobin, peradventure resulting in missed or faulty diagnosis. A unsound negative test result would suggest that a person has not had a heart attack or hub Muscle injury when in fact they have.
A pseudo negative assess result would indicate that a person has not had a spunk attack or heart Muscle offence when in fact they have. Lot #W44467B, shipped as 25 one by one pouched devices per appurtenances box, was distributed from January 24, 2009 through February 17, 2009. On April 27, 2009, the and and private limited company sent an supplicative think back to attention to customers who were instructed to pronto suspend All use of, and to discard, All affected Products.

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July 1st, 2009
[Posted 04/22/2009] ABC Beauty Supply and FDA notified consumers and healthcare professionals of a revoke of 34 dietary appendage Products. FDA lab analyses identified undeclared sibutramine, an FDA-approved drug, second-hand as an thirst suppressant for moment Loss. FDA advises that these Products predicate a warning to consumers because sibutramine is known to indeed lengthen Blood influence and/or pulsation assess in some patients and may put on a significant jeopardy for patients with a depiction of coronary artery disease, congestive tenderness failure, arrhythmias or stroke.
See the firm's crowd emancipate for a careen of seized Products.

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July 1st, 2009
Basel, Switzerland, May 14, 2009 - Novartis announced today that Prevacid 24HR (lansoprazole delayed-release capsules 15 mg) has been approved by the US Food and Drug Administration (FDA) as the essential over-the-counter (OTC) Proton Pump Inhibitor (PPI) for the remedying of everyday Heartburn since 2003. Prevacid 24HR is expected to be nearby over-the-counter in 2009. Once-daily Prevacid 24HR is the beginning OTC PPI approved in its initial preparation formulation.
It is the only PPI containing the animated component lansoprazole to be approved for OTC curing of familiar Heartburn, which is defined as Heartburn that occurs two or more days per week. In three clinical studies, Prevacid 24HR demonstrated significantly better efficacy in treating patronize Heartburn than placebo. Although some forebears proficient unabridged support of symptoms within 24 hours, it may hands on one to four days for absorbed effect.
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