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FDA accepts Otsuka's aripiprazole depot formulation NDA for review

Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announced today that the U.S. Food and Drug Administration has determined that a new drug application (NDA) for Otsuka's investigational once-monthly aripiprazole depot formulation for the indication of maintenance treatment of schizophrenia in adults is sufficiently complete to permit a substantive review.

22 Nov 2011

International consortium develops first-in-class adiponectin receptor agonist

A compound that mimics the effects of adiponectin, a beneficial protein that is produced by fat tissue in healthy weight individuals and may exhibit protective effects against cancer, cardiovascular disease, inflammatory conditions and insulin resistance has been developed by an international consortium lead by Dr. Eva Surmacz, Associate Professor in Biology (Adjunct) and director of the Obesity and Cancer Program at the Sbarro Institute for Cancer Research and Molecular Medicine at Temple University's College of Science and Technology.

16 Nov 2011

Idera third quarter net loss increases to $5.5 million

Idera Pharmaceuticals, Inc. today reported financial results for the third quarter ended September 30, 2011. Idera is a biotechnology company engaged in the discovery and development of DNA- and RNA-based drug candidates targeted to Toll-like receptors (TLRs).

9 Nov 2011

Amylin and Lilly terminate exenatide alliance, resolve litigation

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced an agreement to terminate their alliance for exenatide and resolve the outstanding litigation between the companies.

9 Nov 2011

Celldex Therapeutics initiates CDX-1127 Phase 1 study in malignant solid tumors

Celldex Therapeutics, Inc. today announced initiation of a Phase 1 study of its therapeutic human antibody candidate, CDX-1127, in patients with selected malignant solid tumors or hematologic cancers.

8 Nov 2011

GTx third quarter net loss increases to $9.3 million

GTx, Inc. today reported financial results for the third quarter of 2011. The net loss for the quarter ended September 30, 2011 was $9.3 million compared with a net loss of $8.6 million for the quarter ended September 30, 2010, reflecting increased research and development costs in connection with the Company's Ostarine™ and Capesaris™ clinical development programs.

4 Nov 2011

Teva third quarter net sales increase 2% to $4.34 billion

Teva Pharmaceutical Industries Ltd. today reported results for the quarter ended September 30, 2011.

2 Nov 2011

Positive results from DARA's DB959 Phase 1b study on type 2 diabetes

DARA BioSciences, Inc., announces the positive results from a successfully completed Phase 1b clinical study for DB959, its peroxisome proliferator activated receptor (PPAR)-delta/gamma agonist, a non-TZD oral drug in development for the treatment of type 2 diabetes.

2 Nov 2011

AgonOx, MedImmune partner to advance OX40 agonist programs for cancer treatment

AgonOx today announced that it has entered into an exclusive global partnership with MedImmune, the global biologics arm of AstraZeneca, to develop agonists using its OX40 platform. MedImmune will lead further preclinical and clinical studies of this tumor-specific T-cell immunity stimulator for the potential treatment of cancer.

31 Oct 2011

GC-C agonists have potential to delay progression of colitis into colon cancer

Synergy Pharmaceuticals, Inc., a developer of new drugs to treat gastrointestinal (GI) disorders and diseases, today announced that poster P409 presented at the upcoming 2011 annual scientific meeting of the American College of Gastroenterology highlights the potential use of guanylate cyclase-C agonists to delay progression of colitis into colon cancer.

31 Oct 2011

Thyroid researcher to receive ATA's John B. Stanbury Pathophysiology Medal

Each year, the American Thyroid Association (ATA) recognizes the outstanding research contributions of one of its members to a greater understanding of thyroid physiology or the pathophysiology of thyroid disease, with its presentation of the John B. Stanbury Pathophysiology Medal at its Annual Meeting.

29 Oct 2011

UCLA professor to receive ATA's Sidney H. Ingbar Distinguished Lectureship Award

The American Thyroid Association's (ATA) Sidney H. Ingbar Distinguished Lectureship Award recognizes outstanding academic achievements in thyroidology. An honorarium is conferred each year at the ATA Annual Meeting to an established investigator who has made major contributions to thyroid-related research over many years.

28 Oct 2011

Byetta combination with insulin glargine gets FDA nod in type 2 diabetes

The US Food and Drugs Administration (FDA) has approved Byetta (exenatide) injection as add-on treatment for use with insulin glargine, together with exercise and diet for diabetes type 2 patients who are not responding well enough to glargine alone. Byetta's add-on therapy is for those on glargine with metformin and/or a TZD (thiazolidinedione) or without.

20 Oct 2011

Forest Laboratories second quarter net sales increase 9.0% to $1,130.3 million

Forest Laboratories, Inc., an international pharmaceutical manufacturer and marketer, announced that reported earnings per share equaled $0.91 in the second quarter of fiscal 2012. Reported earnings per share in the second quarter of fiscal 2011 were $1.00.

18 Oct 2011

Takeda commences TAK-875 Phase 3 clinical trial program for type 2 diabetes

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiaries, Takeda Global Research & Development Center, Inc., and Takeda Global Research & Development Centre (Europe), Ltd., announced today the initiation of the Company's Phase 3 clinical trial program for TAK-875, an investigational therapy for type 2 diabetes.

18 Oct 2011

AHRQ: Asthma drug usage among children doubles

The proportion of children who used a prescribed controller drug to treat their asthma doubled from 29 percent in 1997-1998 to 58 percent in 2007-2008, according to the latest News and Numbers from the Agency for Healthcare Research and Quality.

18 Oct 2011

Simmons Center to evaluate CGEN-25009 for treatment of idiopathic pulmonary fibrosis

Compugen Ltd. and the Pulmonary Fibrosis Foundation announced today that the Pulmonary Fibrosis Foundation will provide a grant to scientists at the University of Pittsburgh Dorothy P. and Richard P.

13 Oct 2011

Almirall seeks European approval for linaclotide to treat irritable bowel syndrome with constipation

Almirall, S.A. announced today that it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for linaclotide, an investigational guanylate cyclase-C (GC-C) receptor agonist for the treatment of irritable bowel syndrome with constipation (IBS-C). Once approved, linaclotide will be marketed in Europe under the trademark Constella®.

29 Sep 2011

Almirall submits linaclotide MAA to EMA for treatment of IBS-C

Ironwood Pharmaceuticals, Inc. today announced that its European partner Almirall, S.A. submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for linaclotide, a guanylate cyclase type-C (GC-C) agonist, for the treatment of irritable bowel syndrome with constipation.

29 Sep 2011

Arena, Eisai announce new data from lorcaserin Phase 3 clinical trial program

Arena Pharmaceuticals, Inc. and Eisai Inc. announced today that new data analyses from the lorcaserin Phase 3 clinical trial program will be presented in poster sessions at Obesity 2011, the 29th Annual Scientific Meeting of The Obesity Society in Orlando, Florida.

27 Sep 2011