Efficacy News and Research

RSS

NeoPharm submits IL13-PE38QQR IND for the treatment of IPF

NeoPharm, Inc., announced today that it has filed an investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) for IL13-PE38QQR (IL13-PE) for the treatment of Idiopathic Pulmonary Fibrosis (IPF). IPF is the most deadly disease of the lungs in humans with very high morbidity. There is currently no proven effective treatment for the cure of this disease.

5 Jan 2010

Headline results from first phase III study of Balaglitazone announced

Dr. Reddy’s Laboratories Ltd. and Rheoscience, a subsidiary of Nordic Bioscience A/S, today announced the headline results from the first phase III study for their investigational agent, Balaglitazone.

4 Jan 2010

DSPA submits lurasidone NDA to the FDA

Dainippon Sumitomo Pharma America, Inc. (DSPA), a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd. (DSP), submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lurasidone, an investigational atypical antipsychotic agent for the treatment of schizophrenia. The application, submitted on December 30, 2009, includes data from more than 40 clinical studies involving more than 2,500 lurasidone-treated patients.

4 Jan 2010

Revance Therapeutics closes $35 million Series D financing

Revance Therapeutics, Inc. (“Revance”) today announced the first $25 million closing of a $35 million Series D financing. The round was led by Essex Woodlands Health Ventures Fund VIII.

4 Jan 2010

Novelos continues NOV-002 Phase 3 combination trial for lung cancer

BioMedReports.Com, the news portal which covers Wall Street's biomedical sector and delivers financial and investment intelligence to a community of highly informed investors, is reporting Pfizer Inc. has announced that it has decided to discontinue the late-stage study of its lung cancer candidate figitumumab (CP-751,871) while Novelos' pivotal Phase 3 trial, with a primary efficacy endpoint of improvement in median overall survival, continues across approximately 12 countries and 100 clinical sites.

4 Jan 2010

Bacterial enzyme decreases cocaine desire

A recent study shows that a bacterial protein may help cocaine addicts break the habit.

3 Jan 2010

New chromosomal screening strategy shows promise in PGS

A new strategy that researchers believe provides a more comprehensive screening of the entire chromosomal makeup of an embryo shows tremendous promise in the field of preimplantation genetic screening (PGS) according to a study published in the December issue of Fertility and Sterility.

31 Dec 2009

Multivariable analyses identify epidemiological risk factors for ovarian cancer

Concentrations of the biomarkers CA125, human epididymis protein 4 (HE4), and mesothelin began to rise 3 years before clinical diagnosis of ovarian cancer, according to a new study published online December 30 in the Journal of the National Cancer Institute. However, the biomarkers became substantially elevated only in the last year prior to diagnosis.

31 Dec 2009

Pfizer provides update on Prevnar 13

Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has not yet completed its review of the Biologics License Application (BLA) for Prevnar 13™, (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), the Company’s candidate 13-valent pneumococcal conjugate vaccine.

31 Dec 2009

FDA evaluates Phase III randomized trial in acute myeloid leukemia

VION PHARMACEUTICALS, INC., announced today that the U.S. Food and Drug Administration ("FDA") had responded to its Special Protocol Assessment ("SPA") request to evaluate the Phase III randomized trial HOVON AML 92 sponsored by the Dutch-Belgian Cooperative Group for Hematology Oncology ("HOVON") of its lead product Onrigin(TM).

31 Dec 2009

Biodel submits NDA to FDA for clearance to market VIAject

Biodel, Inc. announced today that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for clearance to market VIAject® as a treatment for diabetes.

30 Dec 2009

Santarus submits rifamycin SV MMX IND to the FDA

Santarus, Inc., a specialty biopharmaceutical company, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) requesting approval to begin a Phase III clinical program evaluating rifamycin SV MMX® in patients with travelers’ diarrhea.

30 Dec 2009

Chlorophyll and chlorophyllin effective in limiting aflatoxin absorption in humans

A new study has found that chlorophyll and its derivative chlorophyllin are effective in limiting the absorption of aflatoxin in humans. Aflatoxin is produced by a fungus that is a contaminant of grains including corn, peanuts and soybeans; it is known to cause liver cancer - and can work in concert with other health concerns, such as hepatitis.

30 Dec 2009

Significant limitations in new Ginkgo biloba study published in JAMA, says ABC

New research findings published this week on a standardized Ginkgo biloba extract are very limited and the public should focus on the well-documented cognitive and cardiovascular benefits of ginkgo, said the American Botanical Council (ABC), an independent nonprofit research and education organization.

30 Dec 2009

Advances in development of “lipidoid” formulations for systemic delivery of RNAi therapeutics

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, and collaborators from the David H. Koch Institute for Integrative Research at the Massachusetts Institute of Technology (MIT) today announced the publication of new data in the journal Proceedings of the National Academy of Sciences (PNAS) describing further advancements in discovery and development of novel “lipidoid” formulations for the systemic delivery of RNAi therapeutics.

30 Dec 2009

Scientists develop straightforward technique to find ethnic origin of stem cells

An international team of scientists led by researchers at The Scripps Research Institute has developed a straightforward technique to determine the ethnic origin of stem cells.

30 Dec 2009

VIVUS submits a NDA to the FDA for obesity drug Qnexa

VIVUS, Inc., a biopharmaceutical company developing innovative, next-generation medical therapies to address unmet needs in obesity, diabetes and sexual health, announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of Qnexa, its investigational drug for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with co-morbidities such as hypertension, type 2 diabetes, dyslipidemia or central adiposity.

30 Dec 2009

Emerald BioStructures engineers new allosteric small molecule modulators of the PDE4 enzyme

Emerald BioStructures (formerly deCODE biostructures) announced today a publication in the December 27, 2009 advance online issue of Nature Biotechnology, detailing the application of structure-based drug design (SBDD) to engineer new allosteric small molecule modulators of the enzyme phosphodiesterase-4 (PDE4), with reduced side effects. According to the paper, the researchers established the structural basis of PDE4 regulation through crystal structures of the PDE4 regulatory domain in contact with small molecules.

29 Dec 2009

Advaxis reports 3-year survival data from its ADXS11-001 Phase I trial for cervical cancer

The Phase I trial of ADXS11-001, the lead vaccine candidate of Advaxis, Inc., the company that pioneered the live, attenuated Listeria monocytogenes (Lm) vaccine, has shown thirty-six (36) month survival in two (2) of the thirteen (13) evaluable patients treated with Advaxis’ therapeutic cancer vaccine, indicating the possibility of persistent immune protection, from only a two (2) dose initial regimen.

29 Dec 2009

Over 5,000 "Not Recommended" Internet drug outlets

On December 11, 2009, the National Association of Boards of Pharmacy(R) (NABP(R)) reached a bitter-sweet milestone in its ongoing review of Web sites selling prescription medications. NABP now lists more than 5,000 Internet drug outlets as Not Recommended. These sites -- 96% of the total number of sites reviewed -- have been found to be out of compliance with pharmacy laws and practice standards established in the United States to protect the public health.

29 Dec 2009