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Soligenix's revenues for 2009 increase by 22%

Soligenix, Inc., a late-stage biopharmaceutical company, today announced its financial results for 2009.

1 Apr 2010

Repros Therapeutics announces response to FDA critique on proposed Phase II Androxal study

Repros Therapeutics Inc. today announced that the Company is sending a reply to the FDA's Division of Metabolism and Endocrinology Products following the Company's receipt of FDA's comments on the proposed Phase II study of Androxal® (enclomiphene) in the treatment of Type II diabetes under Repros' open IND. On February 2, 2010 the Company announced that Repros received confirmation from the Agency that the new IND is effective.

1 Apr 2010

Dutasteride reduces risk of prostate cancer

There is good news for those at high risk for prostate cancer. The drug dutasteride which is manufactured by GlaxoSmithKline as the drug Avodart, has been found to reduce the risk of prostate cancer by a quarter. The drug is at present being used to treat enlarged prostates.

1 Apr 2010

Hormone ghrelin may improve appetite in gastric cancer patients

In gastric cancer patients who have had part or all of their stomach removed, the hormone ghrelin may lessen post-operative weight loss and improve appetite, according to a new study in Gastroenterology, the official journal of the American Gastroenterological Association Institute.

1 Apr 2010

Orexigen Therapeutics announces submission of Contrave NDA for treatment of obesity

Orexigen® Therapeutics, Inc. announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Contrave® (naltrexone SR/bupropion SR), its investigational drug for the treatment of obesity. The NDA is based on a substantial body of evidence gathered through the Contrave Obesity Research (COR) clinical program, which included over 4,500 patients.

1 Apr 2010

Positive results from Ardea Biosciences' Phase 2b study of RDEA594 for hyperuricemia and gout

Ardea Biosciences, Inc. announced positive, preliminary, top-line results from its Phase 2b monotherapy study of RDEA594, its lead product candidate for the treatment of hyperuricemia and gout. In this 28-day, randomized, double-blind, placebo-controlled, dose-escalation study, 123 gout patients with hyperuricemia (serum urate levels greater than or equal to 8 mg/dL) received 200 mg once-daily (qd) RDEA594, 400 mg qd RDEA594, 600 mg qd RDEA594 or matching placebo.

1 Apr 2010

ARQ 197 demonstrates 66% improvement in median PFS in patients with advanced NSCLC

ArQule, Inc. today announced that ARQ 197, when used in combination with erlotinib, demonstrated a 66% improvement in median Progression-Free Survival in patients with advanced, refractory non-small cell lung cancer.

31 Mar 2010

PolyMedix completes Phase 1B clinical study with PMX-30063 defensin-mimetic antibiotic

PolyMedix, Inc., an emerging bio-technology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has successfully completed a Phase 1B clinical study with its novel defensin-mimetic antibiotic, PMX-30063. The data from the study demonstrate that administration of multiple doses of PMX-30063 are safe and well-tolerated at dose levels which showed bactericidal activity in blood samples drawn from subjects in the study.

31 Mar 2010

Depomed licensee submits DM-1796 NDA for management of PHN

Depomed, Inc. today announced that its licensee has submitted a New Drug Application (NDA) for DM-1796 to the U.S. Food and Drug Administration (FDA) for the management of postherpetic neuralgia (PHN), or pain after shingles. DM-1796 is an investigational, extended release, once-daily tablet formulation of gabapentin designed to reduce dosing frequency and have a low incidence of side effects.

31 Mar 2010

Titan Pharmaceuticals commences Phase 3 study of Probuphine for opioid addiction

Titan Pharmaceuticals, Inc. today announced the initiation of a randomized, placebo and active controlled, multi-center Phase 3 clinical study of Probuphine in the treatment of opioid addiction. This confirmatory Phase 3 study will be conducted at approximately 23 sites in the United States and randomize approximately 250 patients into three arms: Probuphine (100 patients), Suboxone® (100 patients) and placebo (50 patients).

31 Mar 2010

Two Phase I studies of Stedivaze demonstrate safety in patients with asthma and COPD

Clinical Data, Inc., today announced results from two Phase I studies of Stedivaze™ (apadenoson), which demonstrated that Stedivaze was safe and well tolerated in patients with asthma and chronic obstructive pulmonary disease (COPD). Stedivaze is a potent and highly selective agonist of the adenosine A2A receptor subtype in development as a pharmacologic stress agent for myocardial perfusion imaging (MPI).

30 Mar 2010

Cumberland Pharmaceuticals submits Acetadote sNDA for non-acetaminophen acute liver failure

Cumberland Pharmaceuticals Inc. has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration for the use of Acetadote® (acetylcysteine) Injection in patients with non-acetaminophen acute liver failure. Acetadote was launched by Cumberland in 2004 as the first U.S.-approved injectable drug to treat acetaminophen overdose.

30 Mar 2010

NICE appraisal committee publishes preliminary recommendation of Multaq for AF

Sanofi-aventis announced today that the National Institute for Health and Clinical Excellence (NICE) in England and Wales, has just published a new appraisal consultation document for Multaq(R) (dronedarone) indicating its intention to recommend Multaq(R) use for the management of patients with atrial fibrillation.

30 Mar 2010

Cephalon receives FDA Complete Response Letter for NUVIGIL supplemental new drug application

Cephalon, Inc. today announced the company has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for its supplemental new drug application for NUVIGIL® (armodafinil) Tablets [C-IV] in the treatment of patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel.

30 Mar 2010

Final results from Novavax' Phase II clinical trial of trivalent seasonal influenza VLP vaccine announced

Novavax, Inc. a clinical-stage vaccine company, released the final results from a Phase II clinical trial evaluating Novavax's trivalent seasonal influenza Virus-like particle (VLP) vaccine candidate in healthy adults. The study enrolled healthy volunteers 18 to 49 years in age who were immunized with a single injection of Novavax's trivalent seasonal influenza VLP vaccine matched to the influenza strains recommended for the 2008-2009 influenza vaccine.

29 Mar 2010

Ligand Pharmaceuticals' LGD-4033 SARM Phase I study data featured at 14th endocrinology congress

Ligand Pharmaceuticals Incorporated today announced that data from a Phase I study with its selective androgen receptor modulator (SARM) LGD-4033 was featured today in a poster presentation at the 14th International Congress of Endocrinology in Kyoto, Japan. This Phase I clinical trial was the first study in humans of LGD-4033, and evaluated the safety, tolerability and pharmacokinetic profiles of the molecule in a single escalating dose, double blind, placebo-controlled study in 48 healthy volunteers.

29 Mar 2010

Glue ear: Bacterial nasal spray may help children

Many children have long-term problems with fluid in the middle ear, and sometimes surgery is the only way to shift it. However, a bacterial nasal spray can have the same effect in some children, reveals a thesis from the Sahlgrenska Academy at the University of Gothenburg, Sweden.

29 Mar 2010

Early stopping of clinical trials result in misleading estimates of treatment effects: Study

An international study of nearly 100 clinical trials that were stopped early due to positive treatment effects has found that many of those effects were exaggerated. The authors of the study — published in the current issue of the Journal of the American Medical Association — recommend that researchers resist pressures to end clinical trials early and continue trials for longer periods before even considering premature termination.

27 Mar 2010

FDA approves Graceway Pharmaceuticals' NDA for Zyclara

Graceway® Pharmaceuticals announced today that the Food and Drug Administration has approved the New Drug Application for Zyclara™, determining it to be safe and effective for the treatment of clinically typical, visible or palpable actinic keratoses.

27 Mar 2010

Anxiety may rise again, says Rutgers University dean

Poet W.H Auden dubbed the post-World War II nuclear era the "age of anxiety" and indeed, at the time, anxiety disorders were the most commonly diagnosed mental illnesses. Yet, by the 1990s, American psychiatry was "Listening to Prozac" and instead of obsessing about angst, it focused its attention on depression.

26 Mar 2010

Placebo News and Research

Soligenix's revenues for 2009 increase by 22%

Repros Therapeutics announces response to FDA critique on proposed Phase II Androxal study

Dutasteride reduces risk of prostate cancer

Hormone ghrelin may improve appetite in gastric cancer patients

Orexigen Therapeutics announces submission of Contrave NDA for treatment of obesity

Positive results from Ardea Biosciences' Phase 2b study of RDEA594 for hyperuricemia and gout

ARQ 197 demonstrates 66% improvement in median PFS in patients with advanced NSCLC

PolyMedix completes Phase 1B clinical study with PMX-30063 defensin-mimetic antibiotic

Depomed licensee submits DM-1796 NDA for management of PHN

Titan Pharmaceuticals commences Phase 3 study of Probuphine for opioid addiction

Two Phase I studies of Stedivaze demonstrate safety in patients with asthma and COPD

Cumberland Pharmaceuticals submits Acetadote sNDA for non-acetaminophen acute liver failure

NICE appraisal committee publishes preliminary recommendation of Multaq for AF

Cephalon receives FDA Complete Response Letter for NUVIGIL supplemental new drug application

Final results from Novavax' Phase II clinical trial of trivalent seasonal influenza VLP vaccine announced

Ligand Pharmaceuticals' LGD-4033 SARM Phase I study data featured at 14th endocrinology congress

Glue ear: Bacterial nasal spray may help children

Early stopping of clinical trials result in misleading estimates of treatment effects: Study

FDA approves Graceway Pharmaceuticals' NDA for Zyclara

Anxiety may rise again, says Rutgers University dean

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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