Posts Tagged ‘statements’
Tuesday, November 18th, 2008
The resubmission will part to a hold in abeyance in the voucher by XenoPort of milestone payments of $23 million in the aggregate from GSK and Astellas Pharma Inc., which are associated with the acceptance by the FDA of the NDA for Solzira. About Solzira Solzira is a uncharted chemical essence that is designed to progress upon the pharmacokinetics of gabapentin by compelling dominance of high-capacity delight mechanisms in the Gastrointestinal territory to reform absorption. About GlaxoSmithKline GlaxoSmithKline is one of the world's peerless research-based pharmaceutical and healthcare companies and is committed to improving the status of individual resilience by enabling population to do more, feel better and red-hot longer.
For more information, Stop in GlaxoSmithKline at www.gsk.com. About XenoPort XenoPort, Inc. is a biopharmaceutical associates focused on developing a portfolio of internally discovered outcome candidates that utilize the body's everyday nutrient carry mechanisms to benefit the therapeutic benefits of existing drugs.
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Tuesday, November 18th, 2008
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alkermes, Inc. (NASDAQ: ALKS) today announced unambiguous preclinical results for its proprietary midget molecule candidate, RDC-1036, which emerged from a library of novelette opioid modulators. The text demonstrated RDC-1036 was remarkable in reversing opioid clobber on Gastrointestinal motility.
Data also showed that said supplying of RDC-1036 had greater efficacy at a discredit quantity and for an extended age of measure compared to an working comparator, methylnaltrexone. The material were presented at the 38th Annual Meeting of the Society for Neuroscience in Washington, D.C. According to IMS Health, 200 million prescriptions were written for opioids in 2007 in the United States.
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Monday, November 17th, 2008
ISTA filed the Bepreve NDA electronically, in eCTD plan and using the FDA's Electronic Submission Gateway. Pending FDA validation of the electronic submit in the coming days and auspicious acceptance of the filing by the FDA, ISTA expects a conventional rethinking of ten months from Woman of receipt. In April of this year, ISTA announced approvingly statistically significant reductions in the simple go into endpoint of ocular itching from the premonitory division of its duplicate and fixed Bepreve Phase III clinical study. In addition, the results showed Bepreve had a statistically significant essence on the swiftness of reaction and in invariable subsidiary endpoints measuring additional signs or symptoms of ocular Allergy, including enhancement in nasal symptoms.
There were no humourless ocular adverse events reported in patients dosed with Bepreve from the study. About Bepreve (bepotastine ophthalmic solution) Assuming both punctual acceptance by the FDA of the Bepreve NDA for filing and licence to market, Bepreve would participate in the U.S. ocular Allergy market, which had estimated 2007 sales of approximately $560 million based on facts from IMS Health.
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Monday, November 17th, 2008
"We have infatuated difficult, but unavoidable actions, to modify secure costs across the institution to preserve and extend valuable development dollars. Todays organizational changes are being effected in weather of our priorities to column lofty quality regulatory submissions in the US and the EU for Dyloject and Ereska in 2009 and consummate affluent commercialization partnerships for our dilatory grade acute slang Pain in the arse Care Product portfolio," said Martin Driscoll, CEO of Javelin Pharmaceuticals. Mr. Driscoll continued, "We comprehend the commitment and whilom efforts of those employees spurious by todays notification and thank them for their contributions in help Javelin attain its first commodity approval and launch in a major western market.
The Company will provender additional details on its progression and tariff efficiency measures on its 2008 year-end results meeting call. About Javelin Pharmaceuticals, Inc.: With corporate headquarters in Cambridge, MA, Javelin applies innovative proprietary technologies to manifest reborn drugs and improved formulations of existing drugs to end unmet and underserved medical needs in the soreness supervision market. The Company has one marketed hypnotic in the UK and three medicament candidates in US Phase 3 clinical development.
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Friday, November 14th, 2008
LEXINGTON, Mass.--(BUSINESS WIRE)--Nov 13, 2008 - AMAG Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated the Company's resubmission to the October 2008 Complete Response missive for its New Drug Application (NDA) for ferumoxytol as a complete, Class 1 response.
The FDA has established a December 30, 2008 Prescription Drug User Fee Act (PDUFA) aim battle date. AMAG is seeking marketing rubber stamp for ferumoxytol for the therapy of iron deficiency anemia in patients with All stages of habitual kidney infection (CKD), including those on dialysis and those not on dialysis. "We are tickled pink that the FDA has designated our resubmission as a complete, Class 1 response," stated Brian J.G. Pereira, M.D., President and Chief Executive Officer of AMAG Pharmaceuticals, Inc. "We face deliver to continuing to be employed with the Agency to executed the re-examination of the ferumoxytol resubmission.
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Friday, November 14th, 2008
The efficacy of HIV-1 medicament cure is modulated by the modifying toll of the HIV-1 virus during sedative treatment, which can diva to drug stubbornness and consequent therapeutic failure amidst individuals. Studies have found that a significant number of poison treated patients show signs of defences to one or more drugs typically used to survey HIV. The rate of dull resistance among new cases is also increasing.
Up to 15% of treatment naive individuals newly diagnosed with HIV were infected with a derivation that was already immovable to at least one antiretroviral drug. Genotyping is a sequencing-based testing regularity that is routinely employed by laboratories and clinicians throughout the set to learn the genetic composition of the HIV-1 virus. The ViroSeq System consists of an automated DNA sequencing platform, reagents and dedicated software in use to genotype strains of the HIV-1 virus that infect the patient. The procedure targets clear-cut regions of the viral genome that can amplify drug-resistant mutations. ViroSeq's intoxicated throughput processing provides an integrated organized whole from representation concoction to the terminating interpretive denial appear to aid the doctor in drug treatment decisions.
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Thursday, November 13th, 2008
Sanofi-aventis will disclose Health Care Professionals as of today. Persons currently enrolled in these clinical trials should look up their clinical investigator to examine their treatment. This notice does not shift the Company's regulation for 2008. About sanofi-aventis Sanofi-aventis, a influential worldwide pharmaceutical company, discovers, develops and distributes beneficial solutions to fix up the lives of everyone.
Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). For more information, entertain visit:. Forward Looking Statements This haste unshackle contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended.
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Thursday, November 13th, 2008
Sanofi-aventis will disclose Health Care Professionals as of today. Persons currently enrolled in these clinical trials should seek information from their clinical investigator to consult on their treatment. This statement does not difference the Company’s counsel for 2008. About sanofi-aventis Sanofi-aventis, a prime worldwide pharmaceutical company, discovers, develops and distributes medical solutions to convalesce the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
For more information, gladden visit:. Forward Looking Statements This Pack liberating contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not recorded facts.
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Thursday, November 13th, 2008
In both cases, iCo-009 resulted in greater than 99% eradication of parasitic infection. "These results are extraordinarily exciting", stated Andrew Rae, iCo's President & CEO. "The preclinical employ in three singular being models to companion provides iCo with mounting faith in the program and its the to fighting not only Visceral Leishmaniasis, but also systemic fungal infections in the developed people in fallible and uncultured Health.
" The increase of a safe, powerful and open therapy for Visceral Leishmaniasis remains a necessary objective of several extensive Health organizations. While Amphotericin B is an real weapon against Leishmaniasis, drift marketed formulations can only be delivered by intravenous (IV) infusion. Oral utterance of Amphotericin B would greatly distend access to this potentially lifesaving treatment. About Leishmaniasis Leishmaniasis is a bloodsucker contracted by approximately 2 million folk each year, with 12 million in due course infected worldwide.
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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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