Wed, 24/06/09 – 7:42 | No Comment

Amicus Therapeutics (Nasdaq: FOLD) announced it has commenced the U.S. registration Phase 3 trial with its investigational drug, Amigal(TM) (migalastat hydrochloride) for the treatment of Fabry disease. The Company has reached agreement with the …

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Transcept Pharmaceuticals Announces Expected FDA Extension Of Regulatory Review Period For Intermezzo(R)
Saturday, 13 Jun, 2009 – 2:00 | No Comment

Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced that the U.S. Food and Drug Administration (FDA) has informed the company that it should expect to receive formal notice of a three month extension of the review …

FDA Accepts Final Section Of NDA Filing For LUCASSIN(R)
Saturday, 13 Jun, 2009 – 2:00 | No Comment

Orphan Therapeutics, LLC and Ikaria Holdings, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the final section of the New Drug Application (NDA) filing seeking marketing approval for LUCASSIN(R) (terlipressin for …

FDA Accepts Final Section Of NDA Filing For LUCASSIN(R)
Saturday, 13 Jun, 2009 – 2:00 | No Comment

Orphan Therapeutics, LLC and Ikaria Holdings, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the final section of the New Drug Application (NDA) filing seeking marketing approval for LUCASSIN(R) (terlipressin for …

Lanreotide Confers Multiple Benefits In Acromegaly Patients
Saturday, 13 Jun, 2009 – 0:00 | No Comment

WASHINGTON D.C. - Most patients with acromegaly who are switched to the long-acting somatostatin analogue lanreotide (SomatulineR Depot) injection from initial treatment with octreotide cite a preference for lanreotide as their future therapy, according to …

Neurim Pharmaceuticals Reports Long Term Efficacy And Safety For Circadin(R) For Insomnia In Elderly Patients
Friday, 12 Jun, 2009 – 6:00 | No Comment

Neurim Pharmaceuticals presented the preliminary results of a large-scale Phase III study of Circadin(R) 2mg, prolonged release melatonin in insomnia, demonstrating long term efficacy and safety in elderly patients. The results were reported in the …

Medivation Completes Enrollment In Confirmatory, Pivotal Phase 3 ‘CONNECTION’ Trial Of Dimebon In Patients With Alzheimer’s Disease
Friday, 12 Jun, 2009 – 6:00 | No Comment

Medivation, Inc. (Nasdaq: MDVN) announced the completion of patient enrollment in the CONNECTION study, a six-month, confirmatory, pivotal Phase 3 trial of the investigational drug dimebon in patients with mild-to-moderate Alzheimer’s disease. …

VIA Pharmaceuticals Meets With FDA To Discuss Next Steps For VIA-2291 And Phase 3 Outcome Trial In Cardiovascular Disease
Friday, 12 Jun, 2009 – 6:00 | No Comment

VIA Pharmaceuticals, Inc. (Nasdaq: VIAP), a biotechnology company focused on the development of compounds for the treatment of cardiovascular and metabolic disease, announced today that an end of Phase 2a meeting for the Company’s …

Patient Upside Murky In Drug-Price Cases
Friday, 12 Jun, 2009 – 6:00 | No Comment

“The prices of hundreds of brand-name drugs are about to be cut 4%, and millions of Americans may soon receive a check in the mail as compensation for having overpaid for their prescriptions,” but “the …

Xcelience Reduces Time To Phase I Studies By 17 Weeks Using API Into Capsule Services
Friday, 12 Jun, 2009 – 4:00 | No Comment

Xcelience, a leader in early drug development services, has developed a faster, more cost effective path to Phase I studies using Xcelodose® 600 and 600 S precision powder micro-dosing systems (Xcelodose® is a registered trademark …

AVI BioPharma, Inc. To Present At 7th Annual Biodefense Vaccines & Therapeutics Conference In Washington, D.C.
Friday, 12 Jun, 2009 – 2:00 | No Comment

AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based drugs, announced that Patrick Iversen, Ph.D., Senior Vice President of Strategic Alliances, will present at the upcoming 7th Annual Biodefense Vaccines & Therapeutics conference taking place …

NUVIGIL Jet Lag Disorder Data Presented At The SLEEP 2009 23rd Annual Meeting Of The Associated Professional Sleep Societies
Thursday, 11 Jun, 2009 – 6:00 | No Comment

Cephalon, Inc. (Nasdaq: CEPH) presented results from a pivotal trial that showed NUVIGIL(R) (armodafinil) Tablets [C-IV] significantly improved wakefulness in people with excessive sleepiness associated with jet lag disorder. These phase three data were …

Lethality Of H1N1 Influenza Virus Increasing According To Latest Analysis Of Virus Peptide Genomic Data
Thursday, 11 Jun, 2009 – 6:00 | No Comment

An analysis of the latest peptide genomic data for the H1N1 influenza virus indicates that the current global outbreak of H1N1 is increasing in its capacity for lethality. The new sequence data on PubMed of …

New Survey Finds Majority Of Adults Don’t Understand A Key Source Of High Blood Pressure
Thursday, 11 Jun, 2009 – 5:00 | No Comment

A new survey released shows that 3 out of 4 (75%) adults with high blood pressure are not at all familiar with the role of the renin system(1) — a key regulator of blood pressure …

Strativa’s New Drug Application For Ondansetron Orally Dissolving Film Strip Accepted By FDA
Thursday, 11 Jun, 2009 – 5:00 | No Comment

Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE: PRX), today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application …

MonoSol Rx Announces FDA Acceptance Of NDA For Ondansetron Orally Dissolving Film Strip
Thursday, 11 Jun, 2009 – 5:00 | No Comment

MonoSol Rx, the developers of PharmFilm(R) technology and a drug delivery company specializing in dissolving thin film pharmaceutical products, announced that the new drug application (NDA) for ondansetron orally dissolving film strip (ODFS) has been …

InteKrin Therapeutics Announces INT131 Phase 2a Results At The 2009 American Diabetes Association Annual Meeting
Thursday, 11 Jun, 2009 – 5:00 | No Comment

InteKrin Therapeutics Inc presented Phase 2a clinical study results at the American Diabetes Association annual meeting in New Orleans demonstrating that once a day oral treatment with INT131 provides anti-diabetic efficacy consistent with maximal dose …

Pharmasset Initiates Phase 1b Multiple Ascending Dose Clinical Trial Of PSI-7851 In Chronic Hepatitis C Patients
Wednesday, 10 Jun, 2009 – 2:00 | No Comment

Pharmasset, Inc. (Nasdaq: VRUS) announced that it had completed the single ascending dose study and begun dosing in a multiple ascending dose trial with PSI-7851, a nucleotide analog polymerase inhibitor for the treatment of …

Study Results Present Efficacy And Safety Findings From The PHIRST-1 Study Of Patients With Pulmonary Arterial Hypertension
Wednesday, 10 Jun, 2009 – 2:00 | No Comment

United Therapeutics Corporation (Nasdaq: UTHR) and Eli Lilly and Company (NYSE: LLY) today announced the results of a pivotal 16-week study showing that a once-daily dose of tadalafil was generally well tolerated, improved …

Merz Pharmaceuticals Announce Three Studies Of NT-201 - (Botulinum Neurotoxin Type A Free From Complexing Proteins)
Wednesday, 10 Jun, 2009 – 2:00 | No Comment

Results from three placebo controlled studies conducted to assess NT-201 in upper limb post-stroke spasticity, pre-treated cervical dystonia, and treatment-naive cervical dystonia patients represent the second data set presented at the Movement Disorder Society (MDS) …

Isis Highlights New Data On Antisense Drugs To Treat Type 2 Diabetes And Obesity At ADA Scientific Sessions
Wednesday, 10 Jun, 2009 – 2:00 | No Comment

Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) announced that Isis’ antisense drugs were highlighted with eight presentations (including three oral talks and two late-breaking posters) during the American Diabetes Association’s (ADA) 69th Scientific Sessions in New …