Content about FDAPhase

03.23.10

Garnet BioTherapeutics, Inc., a regenerative medicine company focused on developing cell based therapies, today announced that the first patient has been treated in a Phase 2 multicenter, double-blind, placebo-controlled study of its lead product candidate GBT009 at Unity Hospital in Rochester, New York. GBT009 gives off a variety of pro-regenerative growth factors and cytokines which help repair damaged tissue and reduce inflammation, ultimately augmenting the body's ability to heal itself.

03.22.10

Galderma Laboratories, L.P. today announced the U.S. Food and Drug Administration approval of Differin® (adapalene) Lotion, 0.1%, the first-ever lotion formulation of the well-tolerated retinoid adapalene, for the treatment of acne. Differin Lotion, 0.1% will be available by prescription in April 2010.

03.19.10

Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia characterized by difficulty with sleep maintenance...

03.15.10

AngioScore, Inc., a developer of novel angioplasty catheters for use in the treatment of cardiovascular disease, announced today favorable clinical trial results from the MASCOT Trial, an important study evaluating the AngioSculpt® PTA Scoring Balloon Catheter for the treatment of femoro-popliteal PAD (peripheral artery disease)...

03.14.10

Baxter International Inc. (NYSE:BAX), in conjunction with DynPort Vaccine Company LLC (DVC), a CSC Company (NYSE:CSC), 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.

03.12.10

Affymax, Inc. (Nasdaq: AFFY) today announced that it has received a $5 million development milestone payment from Takeda Pharmaceutical Company as part of the companies' exclusive global agreement to develop and commercialize Hematide™, Affymax's investigational drug for the treatment of anemia in chronic renal failure patients...

03.12.10

Athena Feminine Technologies, Inc., in partnership with the National Association of Nurse Practitioners in Women's Health, announced the initiation of a nationwide enrollment for Phase IV of the DUETS (Device for Urinary Incontinence, Effectiveness, Tolerability and Satisfaction) research study for its Athena Pelvic Muscle Trainer™ (PMT)...

03.12.10

Boston Scientific Corporation (NYSE: BSX) today announced that the U.S. Food and Drug Administration (FDA) has approved its Express® LD Iliac Premounted Stent System for use in iliac arteries. The Express LD Iliac Stent is the first and only low-profile, premounted, balloon-expandable stent approved by the FDA for use in treating iliac artery disease...

03.12.10

Neoprobe Corporation, a diversified developer of innovative oncology and surgical diagnostic and treatment products, today announced that it recently met with the United States Food and Drug Administration to review the clinical trial results of a Phase 3 investigational new drug, Lymphoseek®.

03.12.10

Neoprobe Corporation, a diversified developer of innovative oncology and surgical diagnostic and treatment products, today announced that it recently met with the United States Food and Drug Administration to review the clinical trial results of a Phase 3 investigational new drug, Lymphoseek®.

03.12.10

Pfizer Inc. announced today the discontinuation of A4021018 (also known as ADVIGO 1018), a Phase 3 trial examining the effects of investigational compound figitumumab (CP-751,871) in combination with erlotinib as a second/third-line treatment in patients with previously treated advanced non-adenocarcinoma non-small cell lung cancer (NSCLC).

03.12.10

Pfizer Inc. announced today that two Phase 3 studies of Sutent® (sunitinib malate) in advanced breast cancer did not meet their primary endpoints. The SUN 1064 Phase 3 study of sunitinib in combination with docetaxel for the first-line treatment of patients with advanced HER-2 negative breast cancer did not show a statistically significant improvement in progression-free survival compared with docetaxel alone.

03.12.10

Pfizer Inc. announced today that two Phase 3 studies of Sutent® (sunitinib malate) in advanced breast cancer did not meet their primary endpoints. The SUN 1064 Phase 3 study of sunitinib in combination with docetaxel for the first-line treatment of patients with advanced HER-2 negative breast cancer did not show a statistically significant improvement in progression-free survival compared with docetaxel alone.

03.12.10

XOMA Ltd., a leader in the discovery and development of therapeutic antibodies, today announced the initiation of a Phase 2 clinical trial of XOMA 052, its antibody to interleukin-1 beta (IL-1 beta), in Type 1 diabetes patients. Funding for the trial is being provided by the Juvenile Diabetes Research Foundation International, the largest patient advocacy organization of Type 1 diabetes research worldwide.

03.12.10

XOMA Ltd., a leader in the discovery and development of therapeutic antibodies, today announced the initiation of a Phase 2 clinical trial of XOMA 052, its antibody to interleukin-1 beta (IL-1 beta), in Type 1 diabetes patients. Funding for the trial is being provided by the Juvenile Diabetes Research Foundation International, the largest patient advocacy organization of Type 1 diabetes research worldwide.

03.11.10

Boston Scientific Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved its Express® LD Iliac Premounted Stent System for use in iliac arteries. The Express LD Iliac Stent is the first and only low-profile, premounted, balloon-expandable stent approved by the FDA for use in treating iliac artery disease. The Company said it plans to launch the product immediately in the United States.

03.11.10

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.

03.10.10

Mylan today reported that it has identified multiple flaws within a purported bioequivalence study sponsored by Bayer Inc. of Canada. The study compared Bayer's antihypertensive Adalat(R) XL(R) tablets, 60 mg, marketed in Canada, to Mylan's approved generic version, Mylan-Nifedipine Extended Release tablets, 60 mg, marketed in Canada.

03.10.10

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.