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Eisai's Dacogen five-day dosing regimen for treatment of MDS receives FDA approval

Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a five-day dosing regimen for Dacogen® (decitabine) for Injection to treat patients with myelodysplastic syndromes (MDS), a group of bone marrow diseases that alter the production of functional blood cells.

12 Mar 2010

Baxter International, DVC present Phase III clinical efficacy data for PREFLUCEL

Baxter International Inc., in conjunction with DynPort Vaccine Company LLC, a CSC Company, today presented Phase III study data measuring the clinical efficacy for PREFLUCEL, a trivalent seasonal influenza candidate vaccine. PREFLUCEL is made using Baxter’s Vero cell culture platform and does not contain an adjuvant or preservatives. The data were presented at the International Congress on Infectious Disease (ICID) in Miami, Florida.

From Baxter International Inc. 12 Mar 2010

In addition to anal and cervical cancer, HPV can also cause head and neck cancer

The Human Papillomavirus (HPV) is the causative agent responsible for most cases of cervical cancer, but is also associated with several other types of cancer.

12 Mar 2010

Abbott's sNDA for new six-month 45-mg formulation of Lupron Depot: FDA accepts for review

The U.S. Food and Drug Administration has accepted for review the supplemental new drug application (sNDA) of a new six-month 45-mg formulation of Lupron® Depot (leuprolide acetate for depot suspension) for use in the palliative treatment of advanced prostate cancer. Palliative treatment helps to relieve symptoms associated with advanced prostate cancer.

12 Mar 2010

Watson Pharmaceuticals' TRELSTAR receives FDA approval for treatment of advanced prostate cancer

Watson Pharmaceuticals, Inc., today announced the U.S. Food and Drug Administration approval of TRELSTAR® 22.5 mg (triptorelin pamoate for injectable suspension), a new twice-yearly formulation of TRELSTAR®, a proven, simple and effective palliative treatment of advanced prostate cancer.

11 Mar 2010

FDA provides guidance on Restanza clinical program in treatment of CABP

Advanced Life Sciences Holdings, Inc., a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, announced today that the U.S. Food and Drug Administration has provided guidance on the clinical program required to assess the approvability of Restanza™ (cethromycin), a novel oral once-a-day antibiotic, in the treatment of outpatient community acquired bacterial pneumonia (CABP) as well as biodefense indications including anthrax, plague and tularemia.

11 Mar 2010

Survey: Acute migraine therapy would earn 45% patient share in treatment of migraine

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that an acute migraine therapy that is not contraindicated in patients with a history, symptoms or signs of vascular disease and also offers improved efficacy and fast-acting oral delivery would earn a 45 percent patient share in the treatment of migraine, according to surveyed U.S. neurologists.

11 Mar 2010

Safeguard Scientifics' aggregate partner company revenue rises 46% in 2009

Safeguard Scientifics, Inc., a holding company that builds value in growth-stage life sciences and technology companies, today announced that aggregate revenue of its partner companies for the year was $262 million, up 46% from $179 million in 2008, exceeding the company’s 2009 guidance of $223 million to $243 million, as adjusted to reflect the inclusion of two new partner companies.

11 Mar 2010

StemCells reports net loss of $5.23M for fourth-quarter fiscal 2009

StemCells, Inc. today reported financial results for the fourth quarter and year ended December 31, 2009. The Company's results include the operations of Stem Cell Sciences Plc (SCS) since April 1, 2009.

11 Mar 2010

Fewer injections to treat neutropenia in childhood cancer patients

For patients like 10-year-old Sabrina Jo Spence, new research led by St. Jude Children's Research Hospital investigators meant fewer injections to combat the drop in white blood cells following her recent chemotherapy.

11 Mar 2010

Promising preliminary results from ProFibrix' Phase II trial of hemostat Fibrocaps

ProFibrix B.V., a leader in the development of innovative products for hemostasis and regenerative medicine, today announced the conclusion of the first Phase II trial testing its unique new hemostat Fibrocaps(TM). Promising preliminary data from the European multicenter, open-label trial show compelling safety and efficacy (time to hemostasis) profiles for Fibrocaps, and good performance of the delivery device.

11 Mar 2010

QLT announces results from Phase II clinical trials and device study for PPDS

QLT Inc. today announced results from Phase II clinical trials and a device study for the punctal plug delivery system (PPDS). These studies are part of a development program that is being conducted by QLT's wholly-owned subsidiary, QLT Plug Delivery, Inc. QLT also announced its plans to expand the program to evaluate a second drug for a new target indication.

11 Mar 2010

Chelsea Therapeutics announces financial results for fourth quarter 2009

Chelsea Therapeutics International, Ltd. reported financial results for the fourth quarter and full year 2009 and will host a conference call this afternoon at 4:30 PM ET to discuss these results and provide a quarterly update on the Company's development progress.

11 Mar 2010

Lithera announces positive results from Phase IIa clinical study of LIPO-102

Lithera, Inc. today announced positive results from a Phase IIa clinical study of LIPO-102, its novel injectable combination of salmeterol xinafoate (SX) and fluticasone propionate (FP) for selective, non-ablative fat reduction.

11 Mar 2010

Positive results from Limerick BioPharma's LIM-0705 Phase 1a trial

Limerick BioPharma, Inc., a developer of innovative therapies that help cells pump unwanted or toxic substances away from vulnerable tissues, has announced positive results of a Phase 1a trial for its lead compound, LIM-0705, which has completed its first in man study.

10 Mar 2010

DSPA's lurasidone NDA accepted for FDA review

Dainippon Sumitomo Pharma America, Inc., a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd., today announced that the U.S. Food and Drug Administration recently accepted for review the lurasidone New Drug Application (NDA) for the treatment of patients with acute schizophrenia. The NDA was submitted to FDA on December 30, 2009 and will receive a standard review.

10 Mar 2010

Aastrom Biosciences treats final patient in IMPACT-DCM Phase 2 surgical clinical trial

Aastrom Biosciences, Inc., a leading developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, today reported the final patient treatment in the company's ongoing U.S. Phase 2 surgical clinical trial designated IMPACT-DCM.

10 Mar 2010

$Long-term use of bisphosphonates may adversely affect bone quality and increase risk of atypical fractures$

Long-term use of bisphosphonates may adversely affect bone quality and increase risk of atypical fractures

Bisphosphonate treatments, proven to enhance bone density and reduce fracture incidence in post-menopausal women, may adversely affect bone quality and increase risk of atypical fractures of the femur when used for four or more years, according to preliminary research presented today at the 2010 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS).

10 Mar 2010

AMT initiates dosing in Phase I/II gene therapy clinical trial for hemophilia B

Amsterdam Molecular Therapeutics, a leader in the field of human gene therapy, announced today that the first patient has been dosed in the Phase I/II exploratory clinical trial with a gene therapy product for hemophilia B, a seriously debilitating and potentially lethal disease.

10 Mar 2010

Cellectar completes enrollment in (131)I-CLR1404 Phase I dosimetry trial for advanced solid malignancies

Cellectar, Inc., a privately held radiopharmaceutical company that designs and develops products to detect, treat and monitor human cancers, today announced that enrollment for its Phase I dosimetry trial for its lead drug candidate, (131)I-CLR1404 has been completed. Results of this trial will be used to set the starting dose in a follow-on Phase I dose escalation study planned for later this year. Institutions that participated in the trial include City of Hope, Duke University Medical Center, Georgetown University/Lombardi Cancer Center, and Johns Hopkins Hospital.

10 Mar 2010

Efficacy News and Research

Eisai's Dacogen five-day dosing regimen for treatment of MDS receives FDA approval

Baxter International, DVC present Phase III clinical efficacy data for PREFLUCEL

In addition to anal and cervical cancer, HPV can also cause head and neck cancer

Abbott's sNDA for new six-month 45-mg formulation of Lupron Depot: FDA accepts for review

Watson Pharmaceuticals' TRELSTAR receives FDA approval for treatment of advanced prostate cancer

FDA provides guidance on Restanza clinical program in treatment of CABP

Survey: Acute migraine therapy would earn 45% patient share in treatment of migraine

Safeguard Scientifics' aggregate partner company revenue rises 46% in 2009

StemCells reports net loss of $5.23M for fourth-quarter fiscal 2009

Fewer injections to treat neutropenia in childhood cancer patients

Promising preliminary results from ProFibrix' Phase II trial of hemostat Fibrocaps

QLT announces results from Phase II clinical trials and device study for PPDS

Chelsea Therapeutics announces financial results for fourth quarter 2009

Lithera announces positive results from Phase IIa clinical study of LIPO-102

Positive results from Limerick BioPharma's LIM-0705 Phase 1a trial

DSPA's lurasidone NDA accepted for FDA review

Aastrom Biosciences treats final patient in IMPACT-DCM Phase 2 surgical clinical trial

Long-term use of bisphosphonates may adversely affect bone quality and increase risk of atypical fractures

AMT initiates dosing in Phase I/II gene therapy clinical trial for hemophilia B

Cellectar completes enrollment in (131)I-CLR1404 Phase I dosimetry trial for advanced solid malignancies

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