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CPEX Pharmaceuticals completes enrollment in Nasulin Phase 2a clinical trial

CPEX Pharmaceuticals, Inc. today announced that the ongoing Phase 2a clinical trial of Nasulin™, the Company’s intranasal insulin candidate, has now completed enrollment. The study was initiated in February of this year and randomized 94 subjects. Results are expected at the end of the first quarter or beginning of the second quarter of 2010.

21 Dec 2009

Swedish agency approves Medivir's Xerclear for treatment of cold sores

The Swedish Medical Products Agency has now approved Xerclear™ for treatment of cold sores. It is the first and only topical treatment that has been demonstrated to prevent the incidence of cold sores and shorten healing-times. Xerclear™ will be available from pharmacies in the first half-year 2010.

21 Dec 2009

Positive interim results from Medicago's H5N1 vaccine Phase I human clinical trial

Medicago Inc. a biotechnology company focused on developing highly effective and affordable vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today reported positive interim results from a Phase I human clinical trial with its H5N1 Avian Influenza vaccine candidate ("H5N1 vaccine"). The vaccine was found to be safe, well tolerated and also induced a solid immune response.

21 Dec 2009

Preliminary results from Phase III study of afamelanotide in EPP announced

Clinuvel Pharmaceuticals Limited today announced that it has obtained promising 4-months results in testing afamelanotide in a multicentre randomised double-blind placebo controlled Phase III study in EPP (CUV017).

21 Dec 2009

Bourbon causes a worse hangover than vodka

Many alcoholic beverages contain byproducts of the materials used in the fermenting process. These byproducts are called "congeners," complex organic molecules with toxic effects including acetone, acetaldehyde, fusel oil, tannins, and furfural. Bourbon has 37 times the amount of congeners that vodka has. A new study has found that while drinking a lot of bourbon can cause a worse hangover than drinking a lot of vodka, impairment in people's next-day task performance is about the same for both beverages.

19 Dec 2009

Initial data from REVLIMID Phase III trial in multiple myeloma patients announced

Celgene Corporation today announced the National Cancer Institute (NCI), a part of the National Institutes of Health, reported initial data from a Phase III, randomized, double-blind, multi-center clinical study led by the Cancer and Leukemia Group B (CALGB).

18 Dec 2009

European CHMP announces positive opinion for Amgen's Prolia marketing authorization

Amgen Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has announced a positive opinion for the marketing authorization of Prolia((TM)) (denosumab) for the treatment of osteoporosis in postmenopausal women at increased risk of fractures, and for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures.

18 Dec 2009

Pico-Tesla commences enrollment in its Magneceutical therapy study for type 2 diabetes

Pico-Tesla, The Magneceutical™ Therapy Company, announced today that it has enrolled the first seven patients for a randomized, double-blind, placebo-controlled Pilot Study of persons who have type 2 diabetes, the most common form of diabetes. The Pilot Study seeks to determine whether the application of magnetic fields generated by the Company’s patented Resonator™ system can be effective as an adjunctive therapy to oral medications in reducing hemoglobin A1c levels.

18 Dec 2009

Treprostinil drug reduces breathlessness in PAH patients, says study

Patients with a rare, deadly disease that mostly affects young women felt a dramatic reduction in breathlessness using an approved drug, according to study results published online today in The Journal of Heart and Lung Transplantation.

18 Dec 2009

ARIAD Pharmaceuticals completes enrollment of patients for Phase 3 clinical trial of ridaforolimus

ARIAD Pharmaceuticals, Inc. today announced the completion of patient enrollment in its pivotal, Phase 3 clinical trial of oral ridaforolimus, its investigational mTOR inhibitor, in patients with metastatic soft-tissue and bone sarcomas.

18 Dec 2009

Update on Phase 2 clinical trial of oral interferon announced by Amarillo Biosciences

Amarillo Biosciences, Inc. (ABI) today announced that its ongoing study of oral interferon as prevention/treatment of influenza and other respiratory illnesses in Perth, Australia is nearing completion.

17 Dec 2009

Positive results from DURECT's Phase IIb POSIDUR clinical trial for post-surgical pain

DURECT Corporation announced today positive results from a 60 patient Phase IIb clinical trial of POSIDUR(TM), a proprietary product under development for the treatment of post-surgical pain.

17 Dec 2009

Anadys Pharmaceuticals reports positive 4-week results from its ANA598 Phase II study for HCV

Anadys Pharmaceuticals, Inc. today announced preliminary results from a planned interim analysis of data at four weeks for the first dose cohort, 200 mg bid, in an ongoing Phase II study of ANA598 in combination with pegylated interferon and ribavirin (SOC) in HCV patients.

17 Dec 2009

BDSI's BEMA Buprenorphine Phase 2 study meets primary efficacy endpoint

BioDelivery Sciences International, Inc. announced that the primary efficacy endpoint was achieved in the Company’s Phase 2 pain study assessing the efficacy and safety of BEMA Buprenorphine. The positive results follow BDSI’s March 2009 announcement of favorable Phase 1 study results.

17 Dec 2009

Investigational study of TRT to alleviate debilitating effects of tinnitus commenced

A University of Alabama researcher is embarking on a $5.6 million phase-three, randomized, controlled clinical trial to evaluate the effectiveness of an innovative treatment that uses a noise-generating device, along with counseling, to alleviate the debilitating effects of tinnitus - that ringing in the ears that drives some people to distraction.

17 Dec 2009

Roche discloses results of two of eight taspoglutide T-emerge phase III studies in diabetes patients

Ipsen, an innovation-driven global specialty pharmaceutical group, today announced that its partner Roche has disclosed headline results of the fourth and fifth of eight T-emerge phase III studies in patients with diabetes for taspoglutide, the first once weekly glucagon-like peptide-1 (GLP-1) analogue based on a human sequence.

17 Dec 2009

FDA Advisory Committee votes against the approval of Tarceva

OSI Pharmaceuticals, Inc. and Genentech, Inc., a wholly owned member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 to one recommending against approval of the daily pill Tarceva® (erlotinib) for first-line maintenance use in people with advanced or metastatic non-small cell lung cancer (NSCLC) whose cancer has not progressed (grown or spread) following first-line treatment with platinum-based chemotherapy.

17 Dec 2009

Top-line efficacy and safety results from Phase 2b clinical trial of XIAFLEX announced

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products, today announced top-line efficacy and safety results from a Phase 2b clinical trial of XIAFLEX(TM) for the treatment of Peyronie's disease.

17 Dec 2009

Phase 3 registration clinical trial for perifosine initiated by Keryx Biopharmaceuticals

AEterna Zentaris Inc. (the "Company"), a global biopharmaceutical company focused on oncology and endocrine therapy, today announced the initiation, by its partner Keryx Biopharmaceuticals Inc. ("Keryx") ( KERX), of a Phase 3 registration clinical trial for perifosine (KRX-0401), the Company's PI3K/Akt pathway inhibitor, in relapsed/refractory multiple myeloma patients.

16 Dec 2009

Advanced Life Sciences Holdings' Restanza promising against tularemia

Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), today announced positive top-line results from a pivotal, non-human primate study of its novel, once-a-day, oral antibiotic Restanza(TM) (cethromycin) against an inhaled lethal dose of tularemia. A 14-day course of Restanza achieved a 100% survival rate at the doses tested. All of the ten animals in the study that received 16 mg/kg once-a-day of Restanza (approximate to a human dose of 300 mg) within 24 hours after exposure to a lethal dose of inhaled tularemia survived while only one of the ten animals that received placebo survived.

16 Dec 2009

Placebo News and Research

CPEX Pharmaceuticals completes enrollment in Nasulin Phase 2a clinical trial

Swedish agency approves Medivir's Xerclear for treatment of cold sores

Positive interim results from Medicago's H5N1 vaccine Phase I human clinical trial

Preliminary results from Phase III study of afamelanotide in EPP announced

Bourbon causes a worse hangover than vodka

Initial data from REVLIMID Phase III trial in multiple myeloma patients announced

European CHMP announces positive opinion for Amgen's Prolia marketing authorization

Pico-Tesla commences enrollment in its Magneceutical therapy study for type 2 diabetes

Treprostinil drug reduces breathlessness in PAH patients, says study

ARIAD Pharmaceuticals completes enrollment of patients for Phase 3 clinical trial of ridaforolimus

Update on Phase 2 clinical trial of oral interferon announced by Amarillo Biosciences

Positive results from DURECT's Phase IIb POSIDUR clinical trial for post-surgical pain

Anadys Pharmaceuticals reports positive 4-week results from its ANA598 Phase II study for HCV

BDSI's BEMA Buprenorphine Phase 2 study meets primary efficacy endpoint

Investigational study of TRT to alleviate debilitating effects of tinnitus commenced

Roche discloses results of two of eight taspoglutide T-emerge phase III studies in diabetes patients

FDA Advisory Committee votes against the approval of Tarceva

Top-line efficacy and safety results from Phase 2b clinical trial of XIAFLEX announced

Phase 3 registration clinical trial for perifosine initiated by Keryx Biopharmaceuticals

Advanced Life Sciences Holdings' Restanza promising against tularemia

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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