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Public agencies must study ecological risks of synthetic biology

Experts say at least $20 million to $30 million in government research is needed over the next decade to adequately identify and address the possible ecological risks of synthetic biology, an emerging area of research focused on the design and construction of new biological parts and systems, or modification of existing ones, to create new applications in areas ranging from energy to chemicals and pharmaceuticals.

1 Mar 2012

IOM report identifies options that could further improve information obtained from pediatric studies

Federal laws that motivate or require drug and biologic developers to conduct pediatric studies have yielded beneficial information to guide the use of medications in children, says a new report by the Institute of Medicine. Still, studies involving children continue to be limited, especially in certain areas such as medications' use in newborns and long-term safety and effectiveness in children.

1 Mar 2012

New method for creating nanofibers could improve drug delivery methods

A new method for creating nanofibers made of proteins, developed by researchers at Polytechnic Institute of New York University (NYU-Poly), promises to greatly improve drug delivery methods for the treatment of cancers, heart disorders and Alzheimer's disease, as well as aid in the regeneration of human tissue, bone and cartilage.

1 Mar 2012

Bayer receives FDA approval for lower dose formulation of ANGELIQ

Bayer HealthCare Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a lower dose formulation of ANGELIQ (drospirenone and estradiol) tablets to treat moderate to severe vasomotor symptoms due to menopause in women who have a uterus.

29 Feb 2012

Biogen Idec announces new easier to use injection for multiple sclerosis

The Food and Drug Administration approved the company's Avonex pen, an injection designed to reduce pain and anxiety when patients self-administer the drug. The FDA also approved a new dosing schedule for the drug intended to reduce flu-like symptoms often associated with the drug.

29 Feb 2012

Novartis defends challenge to Indian medicines patent law

Pharmaceutical company Novartis "has spoken out following criticism about its challenge to India's patent laws, insisting that access to life-saving drugs is not under peril by the move," Pharma Times World News reports. The case, which the Indian Supreme Court is scheduled to hear next month, challenges "Indian patent law, notably Section 3(d), which states that a modification of a known chemical composition is non-patentable," the news service writes.

29 Feb 2012

Activists protest Novartis challenge to Indian patent law

In this guest post in the Center for Global Health Policy's "Science Speaks" blog, Brook Baker of the Northeastern University School of Law Program on Human Rights and the Global Economy, "describes and comments on pharmaceutical company Novartis's court challenge to India's strict standards of patenting medicine" and worldwide protests against the company that took place last week prior to its shareholder meeting.

29 Feb 2012

Shire, arGEN-X partner to create novel antibodies against rare diseases

arGEN-X, a biopharmaceutical company focused on the discovery and development of human monoclonal antibodies from its proprietary SIMPLE Antibody platform, announces today that it has entered into an alliance with Shire to create novel therapeutic antibody products against multiple targets submitted by Shire.

29 Feb 2012

EpiCept fourth quarter revenue decreases to $0.2 million

EpiCept Corporation today announced operating and financial results for the fourth quarter and full year ended December 31, 2011, and provided an update on the Company's key business initiatives.

29 Feb 2012

FDA accepts Tau Therapeutics' mibefradil IND for treatment of cancer

Tau Therapeutics LLC, a pharmaceutical company developing T-type calcium channel inhibitors for the treatment of solid tumors, announced today that its investigational new drug application (IND 109196) for its novel drug mibefradil has been accepted by the Food and Drug Administration (FDA).

28 Feb 2012

FDA grants orphan drug designation to Ultragenyx UX003 for treatment of MPS 7

Ultragenyx Pharmaceutical Inc., a biotechnology company focused on developing treatments for rare and ultra-rare genetic disorders, today announced that the FDA Office of Orphan Products Development has granted orphan drug designation for UX003 for the treatment of MPS 7.

28 Feb 2012

TAK-875 - an emerging therapy for Type 2 diabetes

In a trial of 426 patients with Type 2 diabetes, TAK-875 reduced blood sugar below a pre-determined level in as much as 48 percent of those receiving it after 12 weeks, compared with 40 percent of those who took glimepiride, the older drug, according to findings published online by The Lancet medical journal. The research was presented in June at the American Diabetes Association’s annual meeting in San Diego.

28 Feb 2012

Low levels of omega-3 in blood ‘ups’ risk of dementia and brain aging: Study

Researchers looked at 1,575 adults who averaged 67 years old and had no signs of dementia and had not had a stroke. They were given MRI brain scans and a battery of tests to measure memory and thinking abilities; they also had blood drawn to check the level of docosahexaenoic acid (DHA) or omega-3 fatty acids in their red blood cells. Those with the lowest levels of omega-3s showed signs of accelerated aging. They had lower brain volume, indicating shrinkage comparable to two additional years of aging. Compared with those with the highest blood levels of omega-3s, they scored lower on cognitive tests measuring such things as memory, problem solving, abstract thinking and multi-tasking.

28 Feb 2012

ICON announces acquisition of PriceSpective

ICON plc, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced the acquisition of PriceSpective LLC, a global leader in value strategy consulting.

28 Feb 2012

CNRS/Inserm researchers discover new family of anti-cancer compounds

A French-Italian team headed by researchers from CNRS and Inserm has discovered a new family of compounds that could make it possible to treat numerous cancers, particularly brain tumors and skin cancers.

28 Feb 2012

Dompé enters definitive agreement to acquire Anabasis

Dompé, one of Italy's leading biopharmaceutical companies, announced today that it has entered into a definitive agreement to acquire 100% of Anabasis Srl, a privately held Italian research and development biopharmaceutical company, focused on ocular diseases.

28 Feb 2012

Sleeping pills may increase risk of cancer-related death

People are relying on sleeping pills more than ever to get a good night's rest, but a new study by Scripps Clinic researchers links the medications to a 4.6 times higher risk of death and a significant increase in cancer cases among regular pill users.

28 Feb 2012

Cross-protective vaccines will make a bout with influenza less severe

An emerging class of long-lasting flu vaccines could do more than just save people the trouble of an annual flu shot.

27 Feb 2012

Opexa 2011 net loss increases to $5,968,448

Opexa Therapeutics, Inc., a biotechnology company developing a novel T-cell therapy for multiple sclerosis (MS), today reported financial results for the year ended December 31, 2011 and provided an overview of corporate developments during the last year.

27 Feb 2012

Biodesix, Kadmon enter Phase 3 non-small cell lung cancer study collaboration

Biodesix Inc., a fully integrated molecular diagnostic company dedicated to personalizing medicine, today announced a collaboration with Kadmon Corporation, LLC, to explore the utility of Biodesix' VeriStrat® test in a Phase 3 non-small cell lung cancer (NSCLC) study of Kadmon's KD019, a reversible tyrosine kinase inhibitor (TKI) targeting EGFR, HER2, VEGFR2 & 3, and SRC.

27 Feb 2012