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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

Successful RNA interference to turn off multiple genes raises hope for new liver disease treatments

Researchers at MIT and Alnylam Pharmaceuticals report this week that they have successfully used RNA interference to turn off multiple genes in the livers of mice, an advance that could lead to new treatments for diseases of the liver and other organs.

29 Dec 2009

Promising results from Soligenix' RiVax vaccine against ricin toxin

Soligenix, Inc., formerly known as DOR BioPharma, Inc., a late-stage biotechnology company, announced today the publication of an article in the January 2010 edition of Infection and Immunity, detailing the characteristics of several immunodominant regions of ricin A chain, the antigenic component of RiVax((TM)). RiVax((TM)) is Soligenix's vaccine to protect against exposure to ricin toxin and is currently being evaluated in Phase 1 human safety and immunogenicity trials, as well as nonhuman primate trials for efficacy.

29 Dec 2009

Aeolus Pharmaceuticals reports financial results for three months and twelve months ended September 30, 2009

Aeolus Pharmaceuticals, Inc. announced today financial results for the three months and twelve months ended September 30, 2009. The Company reported a net loss of $746,000, or $0.02 per share, for the three months ended September 30, 2009 compared to a loss of $1,055,000, or $0.03 per share, for the three months ended September 30, 2008.

28 Dec 2009

Sudden worldwide increase in antibiotic-resistant bacterium, a cause for concern

A sudden worldwide increase in an antibiotic-resistant bacterium is cause for concern, according to a review in f1000 Medicine Reports.

28 Dec 2009

Publication validates company's structure-based approach for addressing undruggable targets

28 Dec 2009

FDA provides guidance on applying for orphan drug designation

As part of its continuing effort to make the agency more transparent and accessible, the FDA has scheduled a series of workshops about orphan drug designation for academics, biotechnology companies, and those unfamiliar with the process. The

24 Dec 2009

AstraZeneca signs definitive agreement to acquire Novexel

Novexel, a speciality pharmaceutical company focused on the discovery and development of novel antibiotics designed to overcome the significant global problem of microbial drug resistance, announces today that its shareholders have signed a definitive agreement whereby Novexel shall be acquired by AstraZeneca for a total cash consideration of up to $505 million, including contingent payments and the net cash position of the company at closing.

24 Dec 2009

New energy receptor theory of brain function

Dr. Mitchell Earl Gibson, best-selling author, board-certified physician, and CEO of Tybro Publications, has proposed a new energy receptor theory of brain function that might explain the efficacy of mantras and prayer in human illness.

24 Dec 2009

Merck discontinues MK-1903 niacin receptor agonist development program with Arena Pharmaceuticals

Arena Pharmaceuticals, Inc. announced today Merck and Co., Inc.'s decision (through an affiliate) to discontinue development of MK-1903, an investigational niacin receptor agonist to treat atherosclerosis being developed under its research collaboration with Arena. Merck also informed Arena that the company will not continue the collaboration.

24 Dec 2009

Positive results from Alimera Sciences' Iluvien FAME trial for DME

Alimera Sciences, Inc., a privately held biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today reported top-line results from the month 24 readout of the FAME Study.

23 Dec 2009

RPC declares 2010 business plans

Radient Pharmaceuticals Corporation, a US-based vertically integrated pharmaceutical company, whose wholly-owned subsidiary AMDL Diagnostics, Inc. (ADI) announced today it 2010 Business Plan. This forecast is based upon the Company raising at least $2 million during the first half of 2010.

23 Dec 2009

Embryo biopsy safe for singleton pregnancies

The largest and longest running study of children born after preimplantation genetic diagnosis and screening has shown that embryo biopsy does not adversely affect the health of babies born as the result of a subsequent singleton pregnancy.

23 Dec 2009

ARCA biopharma submits Gencaro trial protocol for review under the FDA’s SPA process

ARCA biopharma, Inc. today announced that it has submitted a study protocol for review under the U.S. Food and Drug Administration’s (FDA) Special Protocol Assessment (SPA) process for the design of a clinical trial to assess the safety and efficacy of GencaroTM, in approximately 3,000 patients with chronic heart failure who have the genotype that appears to respond most favorably to Gencaro. Gencaro is the Company’s investigational, pharmacologically unique beta-blocker and mild vasodilator.

23 Dec 2009

Eritoran well tolerated in Phase II trial for severe sepsis

The investigational compound, eritoran tetrasodium ("eritoran," also known as E5564) appeared to be well tolerated in patients with severe sepsis in a Phase II trial published in the January issue of Critical Care Medicine, the official journal of the Society of Critical Care Medicine, the largest multiprofessional organization dedicated to ensuring excellence and consistency in the practice of critical care.

22 Dec 2009

Arena Pharmaceuticals submits lorcaserin NDA to the FDA

Arena Pharmaceuticals, Inc. announced today that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for lorcaserin, Arena's internally discovered and developed drug candidate for weight management, including weight loss and maintenance of weight loss. The submission is based on an extensive data package from lorcaserin's clinical development program that includes 18 clinical trials totaling 8,576 patients.

22 Dec 2009

Matrix Laboratories receives FDA tentative approval for Efavirenz NDA under PEPFAR

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Efavirenz Tablets, 50 mg, 100 mg and 200 mg. These innovative pediatric dosages in tablet form were developed by Matrix for use in treating pediatric HIV/AIDS.

22 Dec 2009

Efficacy News and Research

VIVUS submits a NDA to the FDA for obesity drug Qnexa

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

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

Over 5,000 "Not Recommended" Internet drug outlets

Successful RNA interference to turn off multiple genes raises hope for new liver disease treatments

Promising results from Soligenix' RiVax vaccine against ricin toxin

Aeolus Pharmaceuticals reports financial results for three months and twelve months ended September 30, 2009

Sudden worldwide increase in antibiotic-resistant bacterium, a cause for concern

Publication validates company's structure-based approach for addressing undruggable targets

FDA provides guidance on applying for orphan drug designation

AstraZeneca signs definitive agreement to acquire Novexel

New energy receptor theory of brain function

Merck discontinues MK-1903 niacin receptor agonist development program with Arena Pharmaceuticals

Positive results from Alimera Sciences' Iluvien FAME trial for DME

RPC declares 2010 business plans

Embryo biopsy safe for singleton pregnancies

ARCA biopharma submits Gencaro trial protocol for review under the FDA’s SPA process

Eritoran well tolerated in Phase II trial for severe sepsis

Arena Pharmaceuticals submits lorcaserin NDA to the FDA

Matrix Laboratories receives FDA tentative approval for Efavirenz NDA under PEPFAR

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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