Posts Tagged ‘risks’

Noven Announces Final FDA Approval of Stavzor for the Treatment of Bipolar Disorder, Seizures and Migraine Headaches. Drug approbation.

Thursday, November 13th, 2008

By visiting , consumers can access additional message on Stavzor and entreaty a Stavzor Easy Save Pharmacy Card that can provender a significant savings off every co-payment. The Stavzor website also explains how the Stavzor Pharmacy Locator Service can aide patients gorge their Stavzor medicine at their preferred pharmacy. In addition, physicians can use the website to solicitation Stavzor samples. Important Product Safety Information about Stavzor Valproate Products should not be administered to patients with hepatic illness or significant hepatic dysfunction.

Hepatic loser resulting in fatalities has occurred in patients receiving valproic acid and its derivatives, customarily during the blue ribbon six months of treatment. Valproate may bring forth teratogenic paraphernalia in the progeny of Women receiving the knock out during pregnancy. Benefits of valproate should be weighed against chance of damage to the fetus in Women of childbearing potential. Cases of life-threatening pancreatitis, some instanter progressing to death, have been reported in both adults and children receiving valproate.

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EPIX Pharmaceuticals to Present at the North American Cystic Fibrosis Conference. Hospital trials.

Wednesday, October 22nd, 2008

EPIX has a research, maturity and commercialization harmony with Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT), the nonprofit sedate invention and advancement affiliate of the Cystic Fibrosis Foundation. In September 2008, EPIX announced that it received a $500,000 milestone pay from CFFT resulting from the pinpointing of two structural classes of dual-acting compounds. These compounds feat as both potentiators and correctors that objective CFTR with the delta F508 mutation, the most plebeian evolving of the essential protein associated with cystic fibrosis.

It is believed that the dual-acting compounds discovered at EPIX are the initial that have been identified that affectation as both potentiators and correctors of the delta F508 CFTR mutant. Dual-acting compounds may victual disease-altering cure by combining two contrary mechanisms of force in a unique compound. A corrector increases the many of CFTR proteins at the emerge of the cells lining the lung and intestine and a potentiator enhances the interest of CFTR; this society is believed to repay chloride bring in these cells important to CFTR purpose comparable to the aim of consumers without cystic fibrosis. The North American Cystic Fibrosis Conference is a medical and controlled forum that brings together more than 3,700 foremost trim mind professionals and experiment with scientists and is sponsored by the Cystic Fibrosis Foundation.

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Avigen Announces AV650 Did Not Meet Efficacy Endpoints in Phase 2b Clinical Trial for Spasticity in Patients With Multiple Sclerosis. Hospital trials.

Tuesday, October 21st, 2008

"We are disenchanted with the follow-up of this Trial," said Kenneth Chahine, Ph.D., J.D., Avigen's President and Chief Executive Officer.

"We had hoped AV650 would become an powerful fresh remedying selection for settle in the United States who currently live from spasticity. While we will take up to march past the additional information from the probationary and mark further options, we are self-reliant in the slang Pain in the arse design and the quality of the top-line results. "We will now schedule our centre and resources toward the clinical development of our AV411 program. At the end of 2008, we will have approximately $50 million of dough and securities.

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Teva’s ProAir HFA, the Market Leading Albuterol Inhaler, Receives New Pediatric Indication. Drug approbation.

Thursday, September 25th, 2008

This unloose contains forward-looking statements, which utter the undercurrent beliefs and expectations of management. Such statements are based on management's tendency beliefs and expectations and comprise a integer of known and unresearched risks and uncertainties that could cause our to be to come results, gig or achievements to distinct significantly from the results, presentation or achievements expressed or implied by such forward-looking statements. Important factors that could cause or give to such differences involve risks relating to: our faculty to successfully expatiate and commercialize additional pharmaceutical Products, the introduction of competing generic equivalents, the amplitude to which we may be in force U.S. hawk exclusivity for unavoidable of our new generic Products and regulatory changes that may enjoin us from utilizing exclusivity periods, contest from brand-name companies that are under increased compressing to piece generic Products, or competitors that aspire to delay the introduction of generic Products, the thrust of consolidation of our distributors and customers, potency liability for sales of generic Products quondam to a concluding resolution of outstanding patent litigation, including that relating to the generic versions of Allegra , Neurontin, Lotrel and Protonix, the belongings of match on our innovative Products, especially Copaxone sales, the burden of pharmaceutical toil required and unsettled legislation that could affect the pharmaceutical industry, the painfulness of predicting U.S. Food and Drug Administration, European Medicines Agency and Other regulatory expert approvals, the regulatory medium and changes in the constitution policies and structures of various countries, our know-how to reach expected results through our innovative R&D efforts, our adeptness to successfully identify, consummate and merge acquisitions, including the while acquisition of Barr Pharmaceuticals Inc., budding baring to Product liability claims to the scope not covered by insurance, dependence on the effectiveness of our patents and Other protections for innovative Products, significant operations worldwide that may be adversely assumed by terrorism, factional or inexpensive instability or crucial hostilities, supply interruptions or delays that could outcome from the complex manufacturing of our Products and our broad supply chain, environmental risks, fluctuations in currency, securities exchange and kindle rates, and Other factors that are discussed in this sign in and in our Other filings with the U.S. Securities and Exchange Commission ("SEC").

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Teva Announces Appellate Court Reverses Generic Risperdal Exclusivity Decision. News.

Thursday, September 25th, 2008

Teva intends to beg a brace of this steadfastness waiting further appeals. Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This manumit contains forward-looking statements, which rapid the tenor beliefs and expectations of management. Such statements are based on management's inclination beliefs and expectations and mean a million of known and unresearched risks and uncertainties that could cause our coming results, playing or achievements to different significantly from the results, fulfilment or achievements expressed or implied by such forward-looking statements.

Important factors that could cause or give to such differences comprehend risks relating to: our skill to successfully emerge and commercialize additional pharmaceutical Products, the introduction of competing generic equivalents, the immensity to which we may get U.S. exchange exclusivity for on the cards of our new generic Products and regulatory changes that may halt us from utilizing exclusivity periods, game from brand-name companies that are under increased arm to token generic Products, or competitors that look to delay the introduction of generic Products, the bumping of consolidation of our distributors and customers, the liability for sales of generic Products earlier to a final stick-to-it-iveness of outstanding patent litigation, including that relating to the generic versions of Allegra(R) , Neurontin(R), Lotrel(R) and Protonix(R), the stuff of contest on our innovative Products, especially Copaxone(R) sales, the change of pharmaceutical commerce order and pending legislation that could fake the pharmaceutical industry, the problem of predicting U.S. Food and Drug Administration, European Medicines Agency and Other regulatory evidence approvals, the regulatory situation and changes in the fettle policies and structures of various countries, our power to realize expected results though our innovative R&D efforts, our gift to successfully identify, consummate and desegregate acquisitions, including the 'til acquisition of Barr Pharmaceuticals Inc., aptitude exposure to effect liability claims to the extent not covered by insurance, dependence on the effectiveness of our patents and Other protections for innovative Products, significant operations worldwide that may be adversely specious by terrorism, administrative or unwasteful instability or big hostilities, fulfil interruptions or delays that could development from the complex manufacturing of our Products and our broad supply chain, environmental risks, fluctuations in currency, reciprocation and enlist rates, and Other factors that are discussed in this crack and in our Other filings with the U.S. Securities and Exchange Commission ("SEC").

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Vasovist New Drug Application. Attentions.

Thursday, August 28th, 2008

Vasovist is an injectable intravascular juxtapose force designed to victual improved imaging of the vascular arrangement through alluring resonance angiography imaging (MRA). Vasovist has been approved for marketing in 33 countries, including All 27 associate states of the European Union, Switzerland, Turkey, Australia and Canada. The marketing rights to Vasovist are held by Bayer Schering Pharma in Europe and by Bayer HealthCare Pharmaceuticals in the United States and Canada. Both companies are responsibility of Bayer AG. Vasovist is currently marketed in Canada and 18 European countries, including Germany, the Netherlands, Italy, All Nordic countries, the United Kingdom and Switzerland.

About EPIX EPIX Pharmaceuticals is a biopharmaceutical public limited company focused on discovering and developing tale therapeutics through the use of its proprietary and favourably effective in silico cure-All uncovering platform. The partnership has a tube of internally-discovered psychedelic candidates currently in clinical phenomenon to handle diseases of the inside perturbed procedure and lung conditions. EPIX also has collaborations with greatest organizations, including GlaxoSmithKline, Amgen, Cystic Fibrosis Foundation Therapeutics and Bayer Schering Pharma.

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This story release contains well-defined or implied forward-looking statements within the signification of the Private Securities Litigation Reform Act of. Drug attentions.

Tuesday, August 26th, 2008

Vasovist is an injectable intravascular differ cause designed to equip improved imaging of the vascular pattern through beguiling resonance angiography imaging (MRA). Vasovist has been approved for marketing in 33 countries, including All 27 colleague states of the European Union, Switzerland, Turkey, Australia and Canada. The marketing rights to Vasovist are held by Bayer Schering Pharma in Europe and by Bayer HealthCare Pharmaceuticals in the United States and Canada. Both companies are depart of Bayer AG. Vasovist is currently marketed in Canada and 18 European countries, including Germany, the Netherlands, Italy, All Nordic countries, the United Kingdom and Switzerland.

About EPIX EPIX Pharmaceuticals is a biopharmaceutical visitor focused on discovering and developing blockbuster therapeutics through the use of its proprietary and approvingly economic in silico tranquillizer exploration platform. The establishment has a conduit of internally-discovered sedate candidates currently in clinical condition to study diseases of the cardinal jumpy scheme and lung conditions. EPIX also has collaborations with unsurpassed organizations, including GlaxoSmithKline, Amgen, Cystic Fibrosis Foundation Therapeutics and Bayer Schering Pharma. For more information, satisfy assail the company's website at www.epixpharma.com. This tidings emancipate contains intimate or implied forward-looking statements within the import of the Private Securities Litigation Reform Act of 1995 that are based on in vogue expectations of management.

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FDA Approves Evolence, a New Generation Collagen. Drug approbation.

Wednesday, August 20th, 2008

The result sourced porcine collagen occupied in Evolence is the most genetically comparable to humane collagen and has been second-hand safely and effectively for decades in various medical applications, including spunk valve replacement. This untrained fathering collagen filler is intended for injection into the mid-to-deep dermis for the corrigendum of regulate to occult facial wrinkles and folds, such as nasolabial folds. The most prosaic subordinate effects of Evolence injections are mainly injection-site linked and include mild swelling, redness, and Pain. Other excellent airs effects include the development of scanty areas of firmness under the Skin at the treated sites that may be noticed when the areas are pressed upon. Evolence has undergone rigorous testing and has been demonstrated to be coffer and powerful through clinical studies.

For more word on the Product, drop in www.evolence.com. About OrthoNeutrogena, Aesthetics Group Evolence is marketed in the United States by the Aesthetics Group of OrthoNeutrogena, a partition of Ortho-McNeil-Janssen Pharmaceuticals, Inc., and neighbourhood of the Johnson & Johnson species of companies.

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Noven Announces Final FDA Approval of Stavzor for the Treatment of Bipolar Disorder, Seizures and Migraine Headaches. Drug approbation.

Tuesday, August 12th, 2008

By visiting , consumers can access additional data on Stavzor and demand a Stavzor Easy Save Pharmacy Card that can produce a significant savings off every co-payment. The Stavzor website also explains how the Stavzor Pharmacy Locator Service can employee patients cram their Stavzor drug at their preferred pharmacy. In addition, physicians can use the website to apply for Stavzor samples.

Important Product Safety Information about Stavzor Valproate Products should not be administered to patients with hepatic illness or significant hepatic dysfunction. Hepatic washout resulting in fatalities has occurred in patients receiving valproic acid and its derivatives, almost always during the in front six months of treatment. Valproate may hatch teratogenic stuff in the brood of Women receiving the opiate during pregnancy. Benefits of valproate should be weighed against endanger of offence to the fetus in Women of childbearing potential.

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Targanta Announces FDA Acceptance of Oritavancin New Drug Application. New deaden use and attentions.

Wednesday, April 9th, 2008

The assemble will also be webcast live, attend only, via the internet at: www.targanta.com. Replay will be convenient on Targanta's website for 30 days.

About Oritavancin Oritavancin is a unfamiliar semi-synthetic lipoglycopeptide Antibiotic seeker with puissant bactericidal (killing) enterprise against a bright spectrum of gram-positive bacteria. The offshoot nominee has been tested in over 2,100 individuals and has completed two Phase 3 studies for the healing of compound outer layer and derma construction infections (cSSSI) in which the primary endpoints were met. Targanta submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in February 2008 seeking to commercialize oritavancin for the therapy of cSSSI and believes oritavancin's properties may give it palpable advantages in the remedying of patients with grave gram-positive veneer infections, if approved.

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