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Targacept commences two clinical studies of TC-5619 for schizophrenia and ADHD

Targacept, Inc., a clinical-stage biopharmaceutical company developing novel NNR Therapeutics, today announced the initiation of two clinical studies of TC-5619, a Phase 2b study evaluating the product candidate as a treatment for negative symptoms and cognitive dysfunction in schizophrenia and a Phase 2 study evaluating the product candidate in adults as a treatment for attention deficit/hyperactivity disorder (ADHD), inattentive-predominant.

5 Dec 2011

Zalicus commences Z160 Phase 1 clinical trial for pain

Zalicus Inc. a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases today announced the initiation of a Phase 1 clinical trial evaluating the pharmacokinetics and safety of a new formulation of Z160 (formerly NMED-160), a novel oral N-type calcium channel blocker.

5 Dec 2011

Post-baseline vision data from Lundbeck's Sabril patient registry presented at AES meeting

Post-baseline vision data from Lundbeck's Sabril patient registry is available for the first time today as a late-breaking poster presentation at the annual meeting of the American Epilepsy Society.

5 Dec 2011

CDER, Shire enter agreement for ProAmatine clinical trial to treat symptomatic orthostatic hypotension

Shire plc, the global specialty biopharmaceutical company, announces that it has reached an agreement with the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration to conduct additional clinical trials to confirm the clinical benefit of ProAmatine (midodrine HCl), a medicine approved in 1996 under Subpart H for the treatment of symptomatic orthostatic hypotension (SOH).

3 Dec 2011

Brazil's ANVISA grants registration for child-adapted formulation of benznidazole for Chagas disease

Today, at the occasion of the 4th DNDi Partners' Meeting in Rio de Janeiro, Brazil, Dr Carlos Gadelha, Secretary of Science, Technology and Strategic Products, Brazilian Ministry of Health, announced that Brazil's National Health Surveillance Agency (ANVISA) granted registration of a new paediatric dosage form of benznidazole, developed through a partnership between the Pernambuco State Pharmaceutical Laboratory (LAFEPE) of Brazil and the Drugs for Neglected Diseases initiative (DNDi).

3 Dec 2011

Progesterone can benefit women with catamenial seizures: Study

Seizures in women of childbearing age commonly show patterns of exacerbation that involve hormones as a factor. Investigators today reported the favorable outcome of a multicenter randomized, double-blinded, placebo-controlled phase III clinical trial of progesterone therapy in reducing these perimenstrually exacerbated (catamenial) seizures.

3 Dec 2011

Oncolytics REOLYSIN-Gemzar combination Phase 2 pancreatic cancer clinical trial meets primary endpoint

Oncolytics Biotech Inc. today announced that interim data from a Phase 2 clinical trial using intravenous administration of REOLYSIN® in combination with gemcitabine (Gemzar) in patients with advanced pancreatic cancer (REO 017) indicated that the clinical study had successfully reached its primary endpoint, and that the drug combination is active.

3 Dec 2011

Bristol-Myers Squibb and Tibotec partner to evaluate daclatasvir-TMC435 combination for HCV

Bristol-Myers Squibb Company announced today that it has entered into a clinical collaboration agreement with Tibotec Pharmaceuticals to evaluate the utility of daclatasvir (BMS-790052), Bristol-Myers Squibb's investigational NS5A replication complex inhibitor, in combination with Tibotec Pharmaceuticals' investigational NS3 protease inhibitor, TMC435, for the treatment of chronic hepatitis C virus (HCV).

3 Dec 2011

Bristol-Myers Squibb, Tibotec partner for TMC435 Phase II combination study in HCV

Medivir AB, the research-based speciality pharmaceutical company focused on the development of high-value treatments for infectious diseases, announces that its development partner, Tibotec Pharmaceuticals, has entered into an agreement with Bristol-Myers Squibb Company.

2 Dec 2011

John Theurer Cancer Center to present results of 31 studies at ASH 2011 meeting

The John Theurer Cancer Center at Hackensack University Medical Center, one of the nation's top 50 best hospitals for cancer, will present research updates and clinical trial results of 31 cutting-edge studies at the 2011 American Society of Hematology (ASH) Annual Meeting in San Diego from December 10-13.

2 Dec 2011

Scottsdale resident donates $1 million to TGen pancreatic cancer initiative

A son's passion to find a cure for the cancer that claimed the life of his mother has led to a new series of clinical trials under a Translational Genomics Research Institute (TGen) initiative to find a cure for pancreatic cancer.

2 Dec 2011

Idera receives FDA notification to proceed with IMO-3100 Phase 2 clinical trial for psoriasis

Idera Pharmaceuticals, Inc. today announced the receipt of verbal notification from the Food and Drug Administration that the company may proceed with a Phase 2 clinical trial of IMO-3100 in patients with psoriasis based on a trial protocol submitted by the company in October 2011.

2 Dec 2011

AVEO, Boehringer Ingelheim enter development and manufacturing agreement for ficlatuzumab

AVEO Pharmaceuticals, Inc. and Boehringer Ingelheim today announced that they have entered into an agreement for large-scale process development and clinical manufacturing of ficlatuzumab, AVEO's novel HGF inhibitory antibody that is currently in Phase 2 clinical development in patients with non-small cell lung cancer.

2 Dec 2011

ADVENTRX, FDA discuss ANX-188 development plans for treatment of sickle cell crisis

ADVENTRX Pharmaceuticals, Inc. announced today that it met with the U.S. Food and Drug Administration (FDA) to review development plans for ANX-188 (purified poloxamer 188), the Company's first-in-class treatment for sickle cell patients experiencing vaso-occlusive crisis.

1 Dec 2011

Positive interim data from Anthera's PEARL-SC phase 2b clinical study in systemic lupus erythematosus

Anthera Pharmaceuticals, Inc., a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced positive interim biomarker data from the PEARL-SC phase 2b clinical study in patients with systemic lupus erythematosus.

1 Dec 2011

Enrollment complete in Ceregene's CERE-120 Phase 2b trial for Parkinson's

Ceregene, Inc. reported today that it has completed enrollment in its Phase 2b trial of CERE-120, a gene therapy product expressing the neurturin (NRTN) gene for the treatment of Parkinson's disease.

1 Dec 2011

Auxilium initiates XIAFLEX phase IIa trial in Frozen Shoulder syndrome

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced that the first patient has been dosed in its open-label phase IIa trial of XIAFLEX (collagenase clostridium histolyticum) for the treatment of idiopathic adhesive capsulitis of the shoulder, also known as Frozen Shoulder syndrome.

1 Dec 2011

Celldex launches rindopepimut Phase 3 trial in EGFRvIII-positive glioblastoma

Celldex Therapeutics, Inc. today announced that it has launched a pivotal, randomized, double-blind, controlled Phase 3 trial of rindopepimut in patients with surgically resected epidermal growth factor variant III (EGFRvIII)-positive glioblastoma, the "ACT IV Study."

1 Dec 2011

Statens Serum Institut, Aeras initiate new candidate TB vaccine Phase I trial

Statens Serum Institut and Aeras today announce the initiation of the first Phase I clinical trial of a new candidate TB vaccine designed to protect people latently infected with TB from developing active TB disease.

1 Dec 2011

Idera regains global rights to IMO-2055 from Merck KGaA for treatment of cancer

Idera Pharmaceuticals, Inc. today announced that it has regained global rights to IMO-2055, an agonist of Toll-like Receptor (TLR) 9, as part of an agreed-upon termination of its oncology collaboration with Merck KGaA, Darmstadt, Germany.

1 Dec 2011

Drug Trial News

Targacept commences two clinical studies of TC-5619 for schizophrenia and ADHD

Zalicus commences Z160 Phase 1 clinical trial for pain

Post-baseline vision data from Lundbeck's Sabril patient registry presented at AES meeting

CDER, Shire enter agreement for ProAmatine clinical trial to treat symptomatic orthostatic hypotension

Brazil's ANVISA grants registration for child-adapted formulation of benznidazole for Chagas disease

Progesterone can benefit women with catamenial seizures: Study

Oncolytics REOLYSIN-Gemzar combination Phase 2 pancreatic cancer clinical trial meets primary endpoint

Bristol-Myers Squibb and Tibotec partner to evaluate daclatasvir-TMC435 combination for HCV

Bristol-Myers Squibb, Tibotec partner for TMC435 Phase II combination study in HCV

John Theurer Cancer Center to present results of 31 studies at ASH 2011 meeting

Scottsdale resident donates $1 million to TGen pancreatic cancer initiative

Idera receives FDA notification to proceed with IMO-3100 Phase 2 clinical trial for psoriasis

AVEO, Boehringer Ingelheim enter development and manufacturing agreement for ficlatuzumab

ADVENTRX, FDA discuss ANX-188 development plans for treatment of sickle cell crisis

Positive interim data from Anthera's PEARL-SC phase 2b clinical study in systemic lupus erythematosus

Enrollment complete in Ceregene's CERE-120 Phase 2b trial for Parkinson's

Auxilium initiates XIAFLEX phase IIa trial in Frozen Shoulder syndrome

Celldex launches rindopepimut Phase 3 trial in EGFRvIII-positive glioblastoma

Statens Serum Institut, Aeras initiate new candidate TB vaccine Phase I trial

Idera regains global rights to IMO-2055 from Merck KGaA for treatment of cancer

How agentic AI is reshaping laboratory workflows

Fourier 80: bringing benchtop NMR systems to the laboratory

How industrial hygiene flow calibration supports defensible exposure data

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