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King Pharmaceuticals receives FDA complete response letter for CorVue NDA

King Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for CorVue™ (binodenoson) for injection.

21 Oct 2009

Positive data from BioSante Pharmaceuticals' LibiGel Phase III clinical development program

BioSante Pharmaceuticals, Inc., today announced positive safety data in its ongoing LibiGel Phase III clinical development program. For the first time, unblinded data have been reviewed by the independent DMC of the LibiGel Cardiovascular and Breast Cancer Safety Study. Based on this review of unblinded data, the DMC unanimously recommended continuation of the study as described in the study protocol, with no modifications.

20 Oct 2009

A.P. Pharma to raise funds through placement

A.P. Pharma, a specialty pharmaceutical company, today announced it has entered into a definitive securities purchase agreement with certain existing accredited investors providing for a private placement of up to $13.1 million in two tranches, the first consisting of common stock and warrants with aggregate proceeds of approximately $8.1 million, and a second tranche of common stock with proceeds of approximately $5 million.

20 Oct 2009

AstraZeneca and POZEN announce the pivotal data from two POZEN clinical trials

AstraZeneca and POZEN Inc. today announced pivotal data from two POZEN clinical trials that were presented at the American College of Rheumatology (ACR) 2009 Annual Scientific Meeting in Philadelphia, PA.

20 Oct 2009

NicOx presents data on its phase 3 naproxcinod study at the ACR meeting

NicOx S.A. announced the presentation of detailed 26-week efficacy, safety and tolerability data from the second pivotal phase 3 study for naproxcinod (the 302 study) yesterday, at the American College of Rheumatology (ACR) and Association of Rheumatology Health Professionals (ARHP) Annual Scientific Meeting in Philadelphia, Pennsylvania.

20 Oct 2009

Alnara Pharmaceuticals’ announces results of its international Phase 3 study of liprotamase

Alnara Pharmaceuticals, a pharmaceutical company developing novel, non-systemic orally delivered protein therapeutics for the treatment of metabolic diseases, today announced results from an international, Phase 3 open-label, long-term safety study demonstrating the safety and nutritional benefits of liprotamase, a novel pancreatic enzyme replacement therapy (PERT) for patients with cystic fibrosis (CF).

19 Oct 2009

Hatch-Waxman patent infringement litigation concerning Duac Gel dismissed

Perrigo Company announced today that the Hatch-Waxman litigation relating to Duac® Gel (clindamycin phosphate (1%) and benzoyl peroxide (5%) gel) filed by the Stiefel Laboratories division of Glaxo SmithKline has been dismissed with prejudice.

19 Oct 2009

Amarin selects Medpace as CRO for its Phase 3 AMR101 MARINE clinical study

Amarin Corporation plc today announced that it has executed an agreement with Medpace, Inc. (‘Medpace’), a leading Contract Research Organization (CRO) with expertise in conducting clinical trials in cardiovascular and metabolic disease, to engage their services in the execution of its Phase 3 clinical trials with AMR101 in patients with very high triglyceride levels (the AMR101 MARINE Study) and mixed dyslipidemia.

19 Oct 2009

Boehringer Ingelheim Pharmaceuticals receives NDA approval from FDA for its Micardis Tablets 80 mg

Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for its angiotensin II receptor blocker (ARB) Micardis® (telmisartan) Tablets 80 mg for reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years of age or older at high risk of developing major cardiovascular events who are unable to take angiotensin-converting enzyme (ACE) inhibitors.(1) MICARDIS is the most studied ARB in this high-risk patient population and has been commercially available to treat hypertension (high blood pressure) since its approval in 1998.

19 Oct 2009

Update from Endo Pharmaceuticals regarding its New Drug Application for FORTESTA

Endo Pharmaceuticals today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for FORTESTA(TM) (testosterone) 2% Gel for men diagnosed with low testosterone (Low T), also known as hypogonadism.

19 Oct 2009

Lux Biosciences raises $50 million through Series B venture financing

Lux Biosciences, Inc., a privately held biotechnology company focused on the development and commercialization of therapies for serious ophthalmic diseases, today announced that the company has closed a $50 million Series B venture financing. Participants in the funding were current investors in Lux Biosciences, HBM Bioventures, Novo A/S, Prospect Venture Partners and SV Life Sciences (SVLS), as well as SVLS' publicly traded fund, International Biotechnology Trust plc.

19 Oct 2009

Phase 3 clinical trial of macimorelin (AEZS-130) to be completed by AEterna Zentaris

AEterna Zentaris Inc., a global biopharmaceutical company focused on endocrine therapy and oncology, today announced that it has initiated activities intended to complete the clinical development of the growth hormone secretagogue (GHS) / ghrelin agonist compound macimorelin (AEZS-130) which could be the first oral diagnostic test approved for growth hormone deficiency (GHD). Macimorelin is the International Non-proprietary Name (INN) designated for the compound by the World Health Organization (WHO).

19 Oct 2009

XenoPort commences Phase 2b arbaclofen placarbil clinical trial for treating gastroesophageal reflux disease

XenoPort, Inc. announced today that it has initiated a Phase 2b clinical trial of arbaclofen placarbil (AP), also known as XP19986, in patients with gastroesophageal reflux disease (GERD) who remain symptomatic despite treatment with a proton pump inhibitor (PPI). The trial is a multi-center, randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of AP as adjunctive therapy to PPIs.

19 Oct 2009

AstraZeneca's CRESTOR approved for treating pediatric patients with HeFH

AstraZeneca today announced the U.S. Food and Drug Administration (FDA) approved CRESTOR® (rosuvastatin calcium) for use in pediatric patients ages 10-17 with heterozygous familial hypercholesterolemia (HeFH) when diet therapy fails to reduce elevated cholesterol. HeFH, a genetic disease, is characterized by high LDL cholesterol (the "bad" cholesterol) and increased risk of early cardiovascular disease.

19 Oct 2009

PHARMACIA & UPJOHN COMPANY to pay the largest criminal fine ever imposed in the U.S.

PHARMACIA & UPJOHN COMPANY, INC., a subsidiary of Pfizer Inc. ("Pfizer") today was sentenced today in federal court for a felony violation of the Food, Drug & Cosmetic Act, for misbranding the drug, Bextra, with the intent to defraud or mislead.

19 Oct 2009

Mylan Pharmaceuticals receives approval for Topiramate Capsules

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Topiramate Capsules (Sprinkle), 15 mg and 25 mg.

15 Oct 2009

Soligenix commences enrollment in its Phase 3 Orbec clinical trial for acute GI GVHD

Soligenix, Inc., formerly known as DOR BioPharma, Inc., a late-stage biotechnology company, announced today that it has initiated enrollment in its confirmatory Phase 3 randomized, double-blind, placebo-controlled, multicenter clinical trial evaluating orBec(®) for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD).

15 Oct 2009

Vasogen reports results of operations for third quarter 2009

Vasogen Inc. today reported the results of operations for the three and nine months ended August 31, 2009. All dollar amounts referenced herein are in Canadian dollars unless otherwise noted.

15 Oct 2009

Positive results from Protalix BioTherapeutics Phase III UPLYSO clinical trial

Protalix BioTherapeutics, Inc., announced today positive top-line results from the Company's pivotal Phase III clinical trial of UPLYSO (taliglucerase alfa, previously referred to as prGCD) in treatment naive patients diagnosed with Gaucher disease.

15 Oct 2009

pSivida achieves milestone in Phase III Iluvien trial, last patient completes two-year follow up visit

pSivida Corp., a leading drug delivery company that has developed two of the only three products approved by the FDA for the long-term, sustained release delivery of drug to treat chronic back of the eye disease, today announced that the last patient in the Phase III clinical trial being conducted by its collaborative partner, Alimera Sciences, for a new treatment for diabetic macular edema (DME) has completed the two-year follow up visit.

15 Oct 2009

New Drug Application News and Research

King Pharmaceuticals receives FDA complete response letter for CorVue NDA

Positive data from BioSante Pharmaceuticals' LibiGel Phase III clinical development program

A.P. Pharma to raise funds through placement

AstraZeneca and POZEN announce the pivotal data from two POZEN clinical trials

NicOx presents data on its phase 3 naproxcinod study at the ACR meeting

Alnara Pharmaceuticals’ announces results of its international Phase 3 study of liprotamase

Hatch-Waxman patent infringement litigation concerning Duac Gel dismissed

Amarin selects Medpace as CRO for its Phase 3 AMR101 MARINE clinical study

Boehringer Ingelheim Pharmaceuticals receives NDA approval from FDA for its Micardis Tablets 80 mg

Update from Endo Pharmaceuticals regarding its New Drug Application for FORTESTA

Lux Biosciences raises $50 million through Series B venture financing

Phase 3 clinical trial of macimorelin (AEZS-130) to be completed by AEterna Zentaris

XenoPort commences Phase 2b arbaclofen placarbil clinical trial for treating gastroesophageal reflux disease

AstraZeneca's CRESTOR approved for treating pediatric patients with HeFH

PHARMACIA & UPJOHN COMPANY to pay the largest criminal fine ever imposed in the U.S.

Mylan Pharmaceuticals receives approval for Topiramate Capsules

Soligenix commences enrollment in its Phase 3 Orbec clinical trial for acute GI GVHD

Vasogen reports results of operations for third quarter 2009

Positive results from Protalix BioTherapeutics Phase III UPLYSO clinical trial

pSivida achieves milestone in Phase III Iluvien trial, last patient completes two-year follow up visit

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