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Alexza Pharmaceuticals submits its NDA for Staccato loxapine to FDA

Alexza Pharmaceuticals, Inc. today announced that it has submitted its New Drug Application (NDA) for Staccato® loxapine (AZ-004) to the US Food and Drug Administration (FDA).

15 Dec 2009

Vion Pharmaceuticals receives complete response letter related to its NDA for Onrigin injection

VION PHARMACEUTICALS, INC. today announced that it had received a complete response letter from the U.S. Food and Drug Administration ("FDA") related to its New Drug Application ("NDA") for Onrigin(TM) (laromustine) injection submitted in February 2009.

14 Dec 2009

ZYPREXA RELPREVV approved by FDA

The U.S. Food and Drug Administration (FDA) approved ZYPREXA RELPREVV (olanzapine) For Extended Release Injectable Suspension for the treatment of schizophrenia in adults, Eli Lilly and Company announced today.

14 Dec 2009

CTRC-AACR San Antonio Breast Cancer Symposium presents new data on emerging breast cancer therapies

Breast cancer continues to be a dynamic field of research, and the CTRC-AACR San Antonio Breast Cancer Symposium, now in its 32nd year, is the premier destination to present new data on emerging therapies.

14 Dec 2009

Preclinical graft study supports Cytori’s proposed mechanism of action

Cytori Therapeutics reported results from a preclinical cell-enriched fat grafting study supporting the safety and efficacy of Cytori’s method for enriching fat grafts with adipose-derived regenerative cells (ADRCs).

14 Dec 2009

Researchers present new data for diagnosis and management of beast cancer

As therapies for breast cancer continue to emerge, the issues of how to best monitor success and gauge prognosis remain important questions.

14 Dec 2009

Pfizer announces results from studies evaluating neratinib

Pfizer Inc. today announced results from studies evaluating neratinib (HKI-272), an investigational, orally administered, pan-ErbB inhibitor, in patients with human epidermal growth factor receptor-2 (HER2, also known as ErbB2) positive breast cancer at the 2009 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS).

14 Dec 2009

Texas researchers identify new detection method for circulating tumor cells

Circulating metastatic breast cancer cells can lose their epithelial receptors, a process that enables them to travel through the bloodstream undetected, according to research from The University of Texas M. D. Anderson Cancer Center.

14 Dec 2009

Positive Phase 2 study results of CDX-011 reported by Celldex Therapeutics

Celldex Therapeutics, Inc. today announced the results of a positive Phase 2 study of CDX-011 (formerly CR011-vcMMAE), in patients with heavily pre-treated, locally advanced or metastatic breast cancers.

13 Dec 2009

Enrollment of patients for Phase IIb clinical trial of WBI-1001 commenced

Welichem today announced that the Company has begun to enroll patients in a Phase IIb clinical trial with its lead candidate, WBI-1001. The Phase IIb clinical trial is a double-blinded, placebo-controlled, 12-week-treatment study.

12 Dec 2009

Phase 2 pivotal trial of AC220 initiated by Ambit Biosciences

Ambit Biosciences Corporation announced today the enrollment and dosing at the University of Texas M. D. Anderson Cancer Center of the first patient in the ACE (AC220 Monotherapy Efficacy) Phase 2 pivotal trial in patients with relapsed or refractory acute myeloid leukemia (AML).

11 Dec 2009

Zevalin clinical data presented at 2009 ASH meeting

Spectrum Pharmaceuticals, Inc., a commercial stage biotechnology company with a primary focus in oncology, today announced that clinical data on ZEVALIN (ibritumomab tiuxetan) was presented at the 51st Annual Meeting of the American Society of Hematology (ASH), which was held December 5-8, 2009 at the Ernest N. Morial Convention Center in New Orleans, Louisiana.

11 Dec 2009

Pfizer's Prevenar 13 granted European marketing authorization

The European Commission has granted Pfizer Inc. a European marketing authorization for its pneumococcal conjugate vaccine, Prevenar 13 (Pneumococcal Polysaccharide Conjugate Vaccine [13-valent, adsorbed]). Prevenar 13 is indicated for active immunization for the prevention of invasive disease, pneumonia, and acute otitis media caused by 13 Streptococcus pneumoniae serotypes in infants and children from 6 weeks to 5 years of age. Invasive pneumococcal disease includes sepsis, meningitis, bacteremia, bacteremic pneumonia, and empyema.

11 Dec 2009

Murad expands its product development department

Murad, Inc. announced it has tripled the size of its product development department to meet escalating demand for support functions sparked by the growing pipeline of innovative products created when Jeff Murad, Vice President of Product Development for Murad, joined the development team.

11 Dec 2009

ThromboGenics initiates Phase II trial of microplasmin for wet AMD

ThromboGenics NV, a biopharmaceutical company focused on innovative medicines for eye disease, vascular disease and cancer, announces today that it has started a Phase II trial of microplasmin for the treatment of exudative (wet) Age-related Macular Degeneration (AMD).

11 Dec 2009

HST Global and HMD team up to develop curriculum for FIT protocol

HST Global, Inc. (OTCBB: HSTC) today announced a Partnership with Dr. James W. Forsythe to facilitate the development of a curriculum for the licensing and/or certification to administer Dr. Forsythe’s immune therapy in clinics to be built or acquired by HST Global, Inc.

11 Dec 2009

Italy's economically disadvantaged people have higher rates of hospitalization for ACSC disorders

Despite free public healthcare, Italy's poor are more likely to end up in hospital with avoidable conditions, new research shows. This pattern, reported today in the online open access journal BMC Public Health, mirrors findings from a number of different healthcare systems around the world, although to date fewer studies have been completed in Europe.

11 Dec 2009

Tasigna demonstrates greater efficacy over Gleevec in chronic Ph+ CML patients

In a large Phase III clinical trial, Tasigna (nilotinib capsules) demonstrated greater efficacy over Gleevec (imatinib) in the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. The new clinical data were just presented as a late breaking abstract at the 51st annual meeting of the American Society of Hematology (ASH), in New Orleans, Louisiana.

11 Dec 2009

Initiation of multi-national Phase III study of Stimuvax announced

Merck KGaA, Darmstadt, Germany, today announced the initiation of its multi-national Phase III study of the investigational therapeutic cancer vaccine Stimuvax® (BLP25 liposome vaccine) in Asian patients with advanced non-small cell lung cancer (NSCLC).

11 Dec 2009

DMC recommends Novartis and Nordic Bioscience to continue oral calcitonin Phase III studies

Unigene Laboratories, Inc. (http://www.unigene.com) announced that an independent Data Monitoring Committee (DMC) has recommended that Novartis and its partner Nordic Bioscience proceed as planned with their ongoing oral calcitonin Phase III studies for osteoporosis and osteoarthritis.

11 Dec 2009