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BioSante to present LibiGel clinical trial update at NAMS Annual Meeting

BioSante Pharmaceuticals, Inc. today announced that it will present a LibiGel clinical trial update at the 21st Annual Meeting of The North American Menopause Society (NAMS) being held from October 6-9, 2010 at the Sheraton Chicago Hotel & Towers in Chicago, Illinois.

5 Oct 2010

Enzo commences clinical trial of Optiquel for chronic non-infectious uveitis

Enzo Biochem, Inc., announced today that, following filing of a investigational new drug (IND) application with the FDA, its Enzo Therapeutics division is commencing a clinical trial of Optiquel™ , the Company's proprietary oral therapeutic for chronic non-infectious uveitis. The trial is designed as a randomized, double-masked, placebo-controlled study with a long-term follow-up and is being conducted by the National Institute of Health's National Eye Institute (NEI).

4 Oct 2010

Neupro improves quality of life in Parkinson's disease patients

People with Parkinson's disease who used once-daily Neupro® (rotigotine) in the RECOVER trial achieved improvements in quality of life, in addition to previously reported beneficial effects on motor and non-motor symptoms.

4 Oct 2010

FDA grants Emergent Fast Track Designation for AVP-21D9 anthrax monoclonal antibody development program

Emergent BioSolutions Inc. announced today that its anthrax monoclonal antibody development program investigating AVP-21D9 for the treatment of inhalational anthrax has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). Emergent recently commenced a Phase I clinical trial for AVP-21D9, which is a fully human monoclonal antibody product candidate being developed as a parenteral post-exposure therapeutic to treat symptoms of inhalational anthrax disease.

1 Oct 2010

Achillion initiates ACH-1625 Phase II dosing for HCV infection

Achillion Pharmaceuticals, Inc., a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today announced that the Company has initiated patient dosing in a Phase II clinical trial of ACH-1625 for the treatment of hepatitis C virus (HCV) infection. ACH-1625 is a potent small molecule inhibitor of HCV protease, an enzyme necessary for viral replication. The drug candidate was discovered and is being advanced by Achillion.

1 Oct 2010

Study demonstrates rufinamide therapy is effective in reducing partial seizure frequency

Researchers from the Arkansas Epilepsy Program found treatment with rufinamide results in a significant reduction in seizure frequency compared with placebo, for patients with uncontrolled partial-onset seizures (POS).

1 Oct 2010

Erchonia launches Zerona body-contouring laser in South East Asia

Erchonia, the global leader in low level laser healthcare applications, today announces the launch of the Zerona® body-contouring laser in South East Asia's SAARC. Erchonia Asia will exclusively market and sell the Zerona throughout the region. This new expansion coincides with the recent U.S. FDA-approval of the Zerona Laser, a non-invasive, painless treatment that guarantees the removal of fat.

30 Sep 2010

Avila commences AVL-292 Phase 1 clinical study for B cell cancers and autoimmune diseases

Avila Therapeutics™, Inc., a biotechnology company developing targeted covalent drugs, announced today that it has initiated a phase 1 clinical trial to assess the safety, tolerability and pharmacokinetic profile of AVL-292, a novel, orally available, covalent drug that targets Bruton's tyrosine kinase (Btk). AVL-292 is the first product candidate to enter clinical evaluation from Avila's proprietary covalent drug platform, Avilomics™.

30 Sep 2010

Repligen Corporation completes patient enrollment in RG2417 Phase 2b clinical trial

Repligen Corporation reported today that it has completed enrollment of patients in its Phase 2b clinical trial of RG2417, an oral formulation of uridine, in patients with bipolar depression.

30 Sep 2010

sanofi-aventis announces top-line results from lixisenatide Phase III GETGOAL-L-ASIA trial for Type-2 Diabetes

Zealand Pharma A/S, the biopharmaceutical company dedicated to the discovery and development of innovative peptide-based drugs, is pleased to note that its partner, sanofi-aventis, has today announced positive top-line results of the Phase III GETGOAL-L-ASIA trial which assessed the efficacy and safety of lixisenatide, a once-daily GLP-1 receptor agonist discovered by Zealand Pharma, in combination with basal insulin.

30 Sep 2010

FDA grants Type B meeting to review Phase III pivotal efficacy protocols for Androxal

Repros Therapeutics Inc. today announced that the Company has been granted a Type B meeting to be held on November 8, 2010 with the Division of Reproductive and Urologic Products to review the Company's Phase III pivotal efficacy protocols for Androxal in the treatment of secondary hypogonadism. Androxal is an oral drug that normalizes both testosterone and sperm levels.

30 Sep 2010

Zyclara 3.75% more effective than cryotherapy alone in treatment of Actinic Keratoses: Study

Results from a randomized, double-blinded, placebo-controlled, multicentred study just published in the Journal of Drugs in Dermatology shows that treating Actinic Keratoses (AK) with imiquimod 3.75% (Zyclara®) following cryotherapy was more effective than cryotherapy alone in reducing total AK lesion count and achieving complete clearance of AK.

30 Sep 2010

Santarus, Cosmo announce positive results from budesonide MMX Phase III study in ulcerative colitis

Santarus, Inc. and Cosmo Pharmaceuticals S.p.A. today announced positive top-line results from the Phase III clinical study conducted in the U.S. and India to evaluate the safety and efficacy of budesonide MMX® for the induction of remission of mild or moderate active ulcerative colitis. The study results show that budesonide MMX 9 mg taken once daily met the primary endpoint of superiority to placebo.

30 Sep 2010

Austrian AGES approves Baxter's PREFLUCEL vaccine for seasonal influenza

Baxter International Inc. today announced the first approval of PREFLUCEL by the Austrian Agency for Health and Food Safety (AGES). The vaccine was shown to be effective in preventing seasonal influenza and is indicated for prophylaxis of influenza in adults and the elderly. PREFLUCEL is manufactured using Baxter's proprietary advanced Vero cell technology.

From Baxter International Inc. 30 Sep 2010

Alnylam Pharmaceuticals publishes ALN-RSV01 Phase IIa study results

Alnylam Pharmaceuticals, Inc. a leading RNAi therapeutics company announced today that it has published results in the American Journal of Respiratory and Critical Care Medicine from its double-blind, placebo-controlled, randomized Phase IIa study of ALN-RSV01 in lung transplant patients naturally infected with respiratory syncytial virus (RSV).

30 Sep 2010

Memantine enhances language and communication skills in patients with Alzheimer's disease

Memantine enhances language and communication skills in patients with moderate to severe Alzheimer’s disease (AD), a valuable contribution for patient independence and quality of life for both the patient and the family/caregivers. These are the findings discussed at the 14th Congress of the European Federation of Neurological Societies (EFNS).

30 Sep 2010

Unique genetic markers point to patient response to SCV-07 treatment

SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced that researchers have identified two unique gene clusters that differentiated subjects who responded to treatment in the Company’s phase 2a proof of concept study of SCV-07 for the prevention of severe oral mucositis (OM; WHO grades 3-4) in patients with advanced head and neck cancer.

29 Sep 2010

Medivation and Astellas commence MDV3100 second Phase 3 clinical trial in advanced prostate cancer

Medivation, Inc. and Astellas Pharma Inc. today announced treatment of the first patient in a second Phase 3 clinical trial of the investigational drug MDV3100, which expands the Phase 3 development of the novel, triple-acting oral androgen receptor antagonist into an earlier-stage patient population. Known as PREVAIL, the trial will evaluate MDV3100 in men with advanced prostate cancer who have not yet received chemotherapy. Initiation of the PREVAIL trial triggers a milestone payment to Medivation under its collaboration agreement with Astellas.

29 Sep 2010

Keryx commences Zerenex Phase 3 study for hyperphosphatemia in patients with ESRD on dialysis

Keryx Biopharmaceuticals, Inc. announced today the initiation of the long-term Phase 3 study of Zerenex™ (ferric citrate), the Company's iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis.

29 Sep 2010

XOMA completes patient enrollment in XOMA 052 Phase 2a trial

XOMA Ltd., a leader in the discovery and development of therapeutic antibodies, announced that patient enrollment was recently completed for the company's Phase 2a trial of XOMA 052 in patients with Type 2 diabetes.

29 Sep 2010

Placebo News and Research

BioSante to present LibiGel clinical trial update at NAMS Annual Meeting

Enzo commences clinical trial of Optiquel for chronic non-infectious uveitis

Neupro improves quality of life in Parkinson's disease patients

FDA grants Emergent Fast Track Designation for AVP-21D9 anthrax monoclonal antibody development program

Achillion initiates ACH-1625 Phase II dosing for HCV infection

Study demonstrates rufinamide therapy is effective in reducing partial seizure frequency

Erchonia launches Zerona body-contouring laser in South East Asia

Avila commences AVL-292 Phase 1 clinical study for B cell cancers and autoimmune diseases

Repligen Corporation completes patient enrollment in RG2417 Phase 2b clinical trial

sanofi-aventis announces top-line results from lixisenatide Phase III GETGOAL-L-ASIA trial for Type-2 Diabetes

FDA grants Type B meeting to review Phase III pivotal efficacy protocols for Androxal

Zyclara 3.75% more effective than cryotherapy alone in treatment of Actinic Keratoses: Study

Santarus, Cosmo announce positive results from budesonide MMX Phase III study in ulcerative colitis

Austrian AGES approves Baxter's PREFLUCEL vaccine for seasonal influenza

Alnylam Pharmaceuticals publishes ALN-RSV01 Phase IIa study results

Memantine enhances language and communication skills in patients with Alzheimer's disease

Unique genetic markers point to patient response to SCV-07 treatment

Medivation and Astellas commence MDV3100 second Phase 3 clinical trial in advanced prostate cancer

Keryx commences Zerenex Phase 3 study for hyperphosphatemia in patients with ESRD on dialysis

XOMA completes patient enrollment in XOMA 052 Phase 2a trial

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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