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New drugs have longer clinical development times despite faster FDA review

While the U.S. Food and Drug Administration Drug has quickened review and approval of new medicines, the complex nature of diseases for which new therapeutics are being developed has resulted in longer clinical development times, according to the Tufts Center for the Study of Drug Development.

8 Jan 2009

Osteotech starts trial for DuraTech BioRegeneration Matrix

Osteotech, Inc. announced today that it has initiated a pivotal clinical trial for its DuraTech BioRegeneration Matrix.

7 Jan 2009

Onyx Pharmaceuticals acquires license option on novel JAK2 inhibitors from S*BIO

Onyx Pharmaceuticals, Inc. has announced that it has acquired an option to license rights to SB1518, an orally available, potent, and selective inhibitor of Janus Kinase 2 (JAK2), and SB1578, also a JAK2 inhibitor, from S*BIO Pte Ltd based in Singapore.

6 Jan 2009

Phase III studies of EXPAREL (DepoBupivacaine) from Pacira complete enrollment

Pacira Pharmaceuticals, Inc., an acute care specialty pharmaceutical company, announced today that enrollment has been completed in two pivotal Phase III SIMPLE trials to evaluate the safety and efficacy of a single intraoperative administration of EXPAREL(TM) (DepoBupivacaine) for prolonged postoperative analgesia.

6 Jan 2009

Cylene Pharmaceuticals starts CX-4945 trial - first-in class inhibitor of CK2

Cylene Pharmaceuticals announced today that it has initiated a Phase I clinical trial of its oral CK2 protein kinase inhibitor, CX-4945, in patients with advanced solid tumors, Castleman's disease, or multiple myeloma.

5 Jan 2009

Ingredient in cough medicine could treat prostate cancer

A study published today in the December issue of the European medical journal Anticancer Research demonstrates that an ingredient used in a common cough suppressant may be useful in treating advanced prostate cancer.

22 Dec 2008

World-first technique used to repair an injured donor lung

For the first time in the world, transplant surgeons at Toronto General Hospital, University Health Network used a new technique to repair an injured donor lung that was unsuitable for transplant, and then successfully transplanted it into a patient.

21 Dec 2008

VistaGen, WARF sign license agreement for human embryonic stem cell technology

VistaGen Therapeutics and the Wisconsin Alumni Research Foundation (WARF) have signed a license for human embryonic stem cell patents for the development and commercialization of stem cell-based research tools.

18 Dec 2008

Neuralstem files IND for amyotrophic lateral sclerosis stem cell trial

Neuralstem, Inc. announced this morning that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin a clinical trial to treat amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease).

18 Dec 2008

Bolder BioTechnology awarded NIH grant to continue development of growth hormone product

Bolder BioTechnology, Inc. today announced that it has been awarded a $1.9 million Phase II Small Business Innovation Research (SBIR) grant from the National Institute of Allergy and Infectious Diseases (NIAID) of The National Institutes of Health (NIH).

16 Dec 2008

New bone and tissue regeneration technique

Using stem cell lines not typically combined, researchers at Columbia University Medical Center have designed a new way to "grow" bone and other tissues.

15 Dec 2008

Lessons from Northwick Park drug-trial disaster

Scientists investigating the 2006 Northwick Park drug-trial disaster that left six healthy volunteers hospitalised say they have developed new pre-clinical tests that could have stopped the trial from ever going ahead.

From The University of Manchester 15 Dec 2008

Alzheimer's researcher explores the variety of animal models now being used in research

Very few species spontaneously develop the cognitive, behavioral and neuropathological symptoms of Alzheimer's disease (AD), yet AD research must progress at a more rapid pace than the rate of human aging.

15 Dec 2008

Novavax announces positive results in trial of seasonal influenza VLP (trivalent) vaccine candidate

Novavax, Inc. has announced favorable results from a Phase IIa human clinical trial of its seasonal influenza VLP (trivalent) vaccine candidate.

12 Dec 2008

Gene therapy used to treat periodontal disease

Scientists at the University of Michigan have shown that gene therapy can be used to successfully stop the development of periodontal disease, the leading cause of tooth loss in adults.

12 Dec 2008

$Proteolix announces positive data for carfilzomib in patients with relapsed and refractory multiple myeloma$

Proteolix announces positive data for carfilzomib in patients with relapsed and refractory multiple myeloma

Proteolix, Inc. today announced positive clinical data demonstrating that the company's lead product, carfilzomib, has single-agent activity and promotes durable responses in patients with relapsed and refractory multiple myeloma.

10 Dec 2008

Xencor presents data on anti-CD19 and anti-CD40 antibodies

Xencor, Inc. presented results Sunday at the 50th Annual Meeting of the American Society of Hematology from pre-clinical studies evaluating XmAb 5574, a monoclonal antibody engineered using Xencor's XmAb Fc technologies that targets the antigen CD19.

10 Dec 2008

Experimental drug successfully blocks mutation in bone marrow cancers

Oregon Health & Science University Knight Cancer Institute researchers have found that an experimental drug successfully blocks an enzyme that causes some bone marrow cancers.

10 Dec 2008

$EntreMed starts trial of ENMD-2076 in refractory multiple myeloma patients$

EntreMed starts trial of ENMD-2076 in refractory multiple myeloma patients

EntreMed, Inc. has announced that it has initiated a Phase 1 study of ENMD-2076 in refractory multiple myeloma patients.

10 Dec 2008

AstraZeneca and Targacept announce results from trial of AZD3480 for cognitive dysfunction in schizophrenia

AstraZeneca and Targacept, Inc. havey announced top-line results from a Phase IIb clinical trial of AZD3480 (TC-1734) conducted by AstraZeneca in cognitive dysfunction in schizophrenia (CDS), known as the HALO trial.

10 Dec 2008