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Curis reports topline results from GDC-0449 Phase II clinical trial for metastatic colorectal cancer

Curis, Inc., a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced topline results from a Phase II clinical trial conducted by Roche and Genentech, Curis' collaborator and a wholly owned member of the Roche Group, of GDC-0449, a first-in-class Hedgehog pathway inhibitor. GDC-0449 was tested in combination with Avastin® (bevacizumab) and FOLFOX or FOLFIRI chemotherapy in first-line metastatic colorectal cancer patients.

17 Jun 2010

DURECT reports European POSIDUR Phase IIb hysterectomy clinical trial results

DURECT Corporation announced today results from a European Phase IIb hysterectomy clinical trial conducted by Nycomed of POSIDUR™ (also known as SABER™-bupivacaine or Optesia™ in the E.U.), a proprietary product under development for the treatment of post-surgical pain.

17 Jun 2010

USPTO issues patent covering Probuphine for opiate addiction

Titan Pharmaceuticals, Inc. today announced that the United States Patent and Trademark Office (USPTO) has issued patent number 7,736,665 covering Probuphine for the treatment of opiate addiction.

16 Jun 2010

Relypsa commences enrollment for RLY5016 Phase 2 study in heart failure patients with chronic kidney disease

Relypsa, Inc., today announced the initiation of patient enrollment in a Phase 2, open-label titration clinical study of the company's lead drug candidate, RLY5016, in heart failure patients with chronic kidney disease. RLY5016 is a novel non-absorbed oral potassium binder intended to prevent and treat hyperkalemia, a serious condition characterized by elevated serum potassium levels.

16 Jun 2010

Phase 3 U.S. registration study of LODOTRA shows improvement in patients with RA

Horizon Pharma, Inc., announced today that data from the Phase 3 U.S. registration study of LODOTRA, a circadian cytokine modulator and novel modified-release, low-dose prednisone tablet, showed a statistically significant improvement in American College of Rheumatology response criteria in patients with rheumatoid arthritis.

16 Jun 2010

Phase IIb EMBLEM study demonstrates clinical efficacy of epratuzumab in patients with SLE

UCB and Immunomedics Inc. announced new lupus drug candidate, epratuzumab, provided a significant reduction in disease activity in patients with moderate to severe active systemic lupus erythematosus (SLE). Data presented at the European League Against Rheumatism (EULAR) meeting in Rome from the phase IIb study, EMBLEM™, showed the clinical efficacy of epratuzumab in patients with SLE.

16 Jun 2010

Nymox near completion of new NX-1207 follow-up study for BPH

Nymox Pharmaceutical Corporation announced today that the Company is nearing completion of a new multi-center U.S. long-term follow-up study of NX-1207, its investigational drug for the treatment of benign prostatic hyperplasia (BPH). Nymox expects to report final results and statistical analysis for the study in the next 1-2 weeks. The new study concerns assessment of the 48-60 month efficacy and benefits of a single treatment of NX-1207.

16 Jun 2010

New data from Phase 2a trial support further development of BMS-945429/ALD518 monoclonal antibody for RA

Bristol-Myers Squibb Company and Alder Biopharmaceuticals today announced that new data from a dose-ranging Phase 2a trial support further development of BMS-945429/ALD518, an investigational monoclonal antibody directed against interleukin-6 (IL-6), as a potential treatment for rheumatoid arthritis (RA). The Phase 2a data will be presented in a scientific session on June 18, 2010, at the Annual Congress of the European League against Rheumatism (EULAR).

16 Jun 2010

Results from ICH compliant Phase II study of MRX-4 presented at EAACI Congress

Morria Biopharmaceuticals Plc, a biopharmaceutical company focused on novel, anti-inflammatory drugs, announced today the results from its ICH compliant Phase II study of MRX-4>th EAACI Congress in London. The study's principal investigators were Drs. Eric Bateman, Mary Bateman and Paul Potter.

16 Jun 2010

Early administration of tranexamic acid to patients with severe bleeding injuries saves lives

If recently injured patients with serious bleeding were to receive a cheap, widely available and easily administered drug to help their blood to clot, tens of thousands of lives could be saved every year, according to a paper published on-line today by The Lancet.

15 Jun 2010

Trubion announces Pfizer's decision to discontinue development of TRU-015 for RA

Trubion Pharmaceuticals, Inc. today announced Pfizer's decision to discontinue development of TRU-015 (PF-05212374), an investigational drug in Phase 2 evaluation for the treatment of rheumatoid arthritis (RA) developed under the companies' CD20 collaboration. However, Pfizer has confirmed that it will continue to develop SBI-087 (PF-05230895), Trubion's next-generation, humanized, subcutaneous CD20 RA product candidate also in Phase 2 clinical evaluation.

15 Jun 2010

Cheap drug that prevents bleeding may save 100,000 lives each year: Study

Researchers have shown that a cheap and easy to use drug that stops bleeding may save up to 100,000 lives each year from injuries associated with road accidents and violence. The study was published this Tuesday in the acclaimed international journal The Lancet and was conducted by doctors at the London School of Hygiene and Tropical Medicine.

14 Jun 2010

UCB announces availability of Vimpat oral solution formulation

UCB today announced the availability of an oral solution formulation of Vimpat- (lacosamide) C-V, an antiepileptic drug (AED) for add-on treatment of partial-onset seizures in people with epilepsy age 17 years and older. Vimpat 10 mg/mL solution is now available in U.S. pharmacies.

14 Jun 2010

Upsher-Smith commences global USL255 Phase III clinical trial for management of epilepsy

Upsher-Smith Laboratories, Inc. today announced the initiation of a global Phase III clinical trial for USL255 (extended-release topiramate), an internally developed program for the management of epilepsy in adults, using the company's proprietary formulation technology. USL255 is designed to provide convenient once-daily dosing and reduce fluctuations in topiramate blood levels observed with currently available topiramate options.

14 Jun 2010

Nexavar does not meet primary endpoint in Phase 3 NExUS trial for advanced NSCLC

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. today announced that the final analysis of the Phase 3 NExUS (NSCLC research Experience Utilizing Sorafenib) trial evaluating Nexavar® (sorafenib) tablets in patients with advanced non-squamous non-small cell lung cancer (NSCLC) showed that the study did not meet its primary endpoint of improving overall survival in the first-line setting.

14 Jun 2010

Telmisartan reduces hypertension, cardiovascular risk in ACE-intolerant patients: Boehringer Ingelheim

Telmisartan, an angiotensin receptor blocker, is one of the best researched drugs worldwide. It has been studied in clinical trials in more than 50,000 patients. Its positive safety profile has been confirmed also in a market exposure of 34.5 million patient years. Convincing safety data for patients with a high cardiovascular risk were collected in the three long-term outcome trials ONTARGET, PRoFESS and TRANSCEND which followed some of the patients for up to five years.

14 Jun 2010

Phase 2b RESTORE-CLI clinical trial in patients with CLI reaches statistical significance

Richard J. Powell, M.D., section chief of vascular surgery at the Dartmouth-Hitchcock Medical Center in Lebanon, NH and a principal investigator of the U.S. Phase 2b RESTORE-CLI clinical trial sponsored by Aastrom Biosciences, will present the full results from the interim analysis at today's session of the annual meeting of the Society for Vascular Surgery.

11 Jun 2010

Otonomy completes $10 million Series A financing with Avalon Ventures

Otonomy, Inc. announced today that it has completed a $10 million Series A financing with Avalon Ventures. Proceeds from the financing will be used to support the ongoing clinical trial for OTO-104 in Meniere's disease, initiate IND-enabling studies for OTO-203, and continue early-stage development of a third program.

11 Jun 2010

AVEO Pharmaceuticals presents tivozanib’s Phase 2 trial data at ASCO meeting

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced data from a subgroup analysis of a Phase 2 randomized discontinuation trial showing that the median progression-free survival (PFS) achieved by patients with advanced clear cell renal cell carcinoma (RCC) who had undergone a prior nephrectomy was 14.8 months.

11 Jun 2010

Repros receives FDA confirmation on lifting of full clinical hold on Proellex

Repros Therapeutics Inc. today announced it has received written confirmation from the FDA noting the full clinical hold on Proellex® has been lifted. The Company will be allowed to run a single study under the new partial clinical hold status. The new low dose study is designed to explore both safety and signals of efficacy in an escalating dose fashion.

11 Jun 2010

Placebo News and Research

Curis reports topline results from GDC-0449 Phase II clinical trial for metastatic colorectal cancer

DURECT reports European POSIDUR Phase IIb hysterectomy clinical trial results

USPTO issues patent covering Probuphine for opiate addiction

Relypsa commences enrollment for RLY5016 Phase 2 study in heart failure patients with chronic kidney disease

Phase 3 U.S. registration study of LODOTRA shows improvement in patients with RA

Phase IIb EMBLEM study demonstrates clinical efficacy of epratuzumab in patients with SLE

Nymox near completion of new NX-1207 follow-up study for BPH

New data from Phase 2a trial support further development of BMS-945429/ALD518 monoclonal antibody for RA

Results from ICH compliant Phase II study of MRX-4 presented at EAACI Congress

Early administration of tranexamic acid to patients with severe bleeding injuries saves lives

Trubion announces Pfizer's decision to discontinue development of TRU-015 for RA

Cheap drug that prevents bleeding may save 100,000 lives each year: Study

UCB announces availability of Vimpat oral solution formulation

Upsher-Smith commences global USL255 Phase III clinical trial for management of epilepsy

Nexavar does not meet primary endpoint in Phase 3 NExUS trial for advanced NSCLC

Telmisartan reduces hypertension, cardiovascular risk in ACE-intolerant patients: Boehringer Ingelheim

Phase 2b RESTORE-CLI clinical trial in patients with CLI reaches statistical significance

Otonomy completes $10 million Series A financing with Avalon Ventures

AVEO Pharmaceuticals presents tivozanib’s Phase 2 trial data at ASCO meeting

Repros receives FDA confirmation on lifting of full clinical hold on Proellex

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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