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ArQule, Daiichi Sankyo initiate enrollment in tivantinib Phase 3 trial for hepatocellular carcinoma

Daiichi Sankyo Company, Limited and ArQule, Inc. today announced that the first patient has been enrolled in the pivotal Phase 3 METIV-HCC (MET-high patients with tivantinib in HCC) trial of tivantinib (ARQ 197).

31 Jan 2013

Celsion's ThermoDox does not meet primary endpoint in Phase III HCC study

Celsion Corporation, a leading oncology drug development company, today announced that ThermoDox in combination with radiofrequency ablation (RFA) did not meet the primary endpoint of the Phase III HEAT Study in patients with hepatocellular carcinoma (HCC), also known as primary liver cancer.

31 Jan 2013

Top-line results from Vanda's tasimelteon Phase IIb/III study on major depressive disorder

Vanda Pharmaceuticals Inc. today announced top-line results of the Phase IIb/III clinical study (MAGELLAN) in Major Depressive Disorder (MDD), investigating the efficacy and safety of tasimelteon as a monotherapy in the treatment of patients with MDD.

31 Jan 2013

Cerulean initiates CRLX101 Phase 2 study in extensive-stage small cell lung cancer

Cerulean Pharma Inc., a leader in developing dynamically tumor-targeted nanopharmaceuticals, today announced that the first patient has been dosed in a randomized Phase 2 study of its lead candidate, CRLX101, in patients with extensive-stage small cell lung cancer (SCLC) sensitive to first-line platinum-based chemotherapy.

31 Jan 2013

Positive results from PaxVax's Ad4-H5-Vtn vector vaccine Phase 1 trial on avian flu

PaxVax, Inc., which develops and commercializes innovative vaccines against infectious diseases in a socially responsible manner, today announced positive results in a Phase 1 clinical trial for its oral, replicating adenovirus serotype 4 (Ad4) vector vaccine for H5N1 (avian flu).

31 Jan 2013

Cerebrolysin: a promising new treatment for dementia

Dementia patients may benefit from a promising new treatment called Cerebrolysin, according to the results of a systematic review published in The Cochrane Library. The authors brought together the most up-to-date evidence on Cerebrolysin as a treatment for vascular dementia.

31 Jan 2013

Teva terminates collaboration with CureTech

Teva Pharmaceutical Industries Ltd. announced today the termination of its collaboration with CureTech Ltd.

31 Jan 2013

OncoEthix initiates OTX015 Phase I study in hematologic malignancies

OncoEthix, the Swiss-based specialist in oncology drug development, announces progress in its Phase I study of OTX015, a novel BET bromodomain inhibitor, with the first dosing of a patient.

31 Jan 2013

No added benefit from linagliptin in patients with type 2 diabetes

Linagliptin has been approved since August 2011 to improve blood glucose control in adults with type 2 diabetes. The assessment of the new dossier according to the German Act on the Reform of the Market for Medicinal Products (AMNOG) again showed that no added benefit of the drug over the appropriate comparator therapy (ACT) can be determined, because the pharmaceutical company has not submitted any relevant studies.

31 Jan 2013

DSMB recommends continuation of CTI’s OPAXIO Phase 3 trial on ovarian cancer

Cell Therapeutics, Inc. (CTI) today announced that the Gynecologic Oncology Group (GOG) informed CTI that an independent Data Safety Monitoring Board (DSMB) recommended continuation of the GOG-0212 Phase 3 clinical trial of OPAXIOTM (paclitaxel poliglumex) as maintenance therapy in ovarian cancer with no changes following a planned interim survival analysis.

31 Jan 2013

Genentech announces positive results from GA101 plus chlorambucil Phase III study on CLL

Genentech, a member of the Roche Group, today announced positive results from Stage 1 of CLL11, a Phase III randomized study to investigate the efficacy and safety profile of the investigational medicine obinutuzumab (GA101) plus chlorambucil chemotherapy compared with chlorambucil alone in people with previously untreated chronic lymphocytic leukemia (CLL).

31 Jan 2013

Mount Sinai to initiate immunological therapy trial against chronic pulmonary sarcoidosis

Patients are currently being enrolled in the first clinical trial to investigate the efficacy of immunological therapy for chronic pulmonary sarcoidosis. The trial is being conducted by researchers at the Icahn School of Medicine at Mount Sinai.

31 Jan 2013

No proof of added benefit from aclidinium bromide in adults with COPD

The drug aclidinium bromide has been approved since October 2012 for widening the narrowed airways of adults with chronic-obstructive pulmonary disease (COPD). The German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined the added benefit of the drug pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG).

31 Jan 2013

No added benefit from perampanel in patients with epileptic fits

The drug perampanel has been approved since July 2012 as adjunctive therapy for adults and children aged 12 years and older with epileptic fits (seizures).

30 Jan 2013

Dilaforette receives approval to initiate sevuparin Phase II malaria study in India

Dilaforette, a Karolinska Development portfolio company, today announces that the company has approval from the regulatory authority in India to start a Phase II study with sevuparin in patients with moderate to severe malaria.

30 Jan 2013

Acceleron commences ACE-536 phase 2 study in myelodysplastic syndromes

Acceleron Pharma, Inc., a biopharmaceutical company developing protein therapeutics for cancer and orphan diseases, today announced the initiation of a phase 2 study of its investigational protein therapeutic, ACE-536, to treat anemia in patients with myelodysplastic syndromes (MDS).

30 Jan 2013

OncoPep commences PVX-410 Phase 1/2a trial in smoldering multiple myeloma

OncoPep, Inc. today announced that the Company has initiated a Phase 1/2a clinical trial evaluating PVX-410, a multi-peptide therapeutic cancer vaccine, in patients with smoldering multiple myeloma, an asymptomatic precursor of multiple myeloma, which is an incurable cancer of the plasma cells.

30 Jan 2013

FDA allows IND application for ImmunoCellular’s ICT-140 to treat ovarian cancer

ImmunoCellular Therapeutics, Ltd. announced that the US Food and Drug Administration (FDA) has allowed the investigational new drug (IND) application for ICT-140, paving the way for conducting a clinical trial.

30 Jan 2013

Botulinum toxin A does not promote weight loss in obese patients

Despite conflicting data in support of the practice, some overweight Americans looking for an easy fix have turned to gastric botox injections to help them lose weight. This month in Clinical Gastroenterology and Hepatology, the official clinical practice journal of the American Gastroenterological Association, researchers from the Mayo Clinic publish a definitive study finding that Botox doesn't promote weight loss.

29 Jan 2013

Bone Medical announces initial findings from BN006 proof of concept RA study

Bone Medical Ltd, a biopharmaceutical company focused on the development of new medicines for musculoskeletal diseases, today announced initial findings from a proof of concept study of BN006, a treatment that it is developing for Rheumatoid Arthritis (RA) based on its Mozaic™ peptide discovery technology.

29 Jan 2013