Pharmaceuticals News and Research

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SPI and Neuralstem sign licensing agreement for major depression drug, NSI-189

Neuralstem, Inc. announced that it has signed an exclusive agency licensing agreement with Summit Pharmaceuticals International Corporation, of Tokyo, Japan (SPI), a wholly owned subsidiary of Sumitomo Corporation Group.

8 Jun 2011

Top-line results from Cipher's CIP-ISOTRETINOIN Phase III study against severe nodular acne

Cipher Pharmaceuticals Inc. today provided top-line safety and efficacy results from the Phase III safety study of CIP-ISOTRETINOIN, the Company's novel, patented formulation of isotretinoin for the treatment of severe, nodular acne.

8 Jun 2011

FDA approves Mylan's ANDA for Donepezil HCl Tablets to treat dementia linked with Alzheimer's

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Donepezil Hydrochloride (HCl) Tablets, 5 mg and 10 mg, the generic version of Eisai's Aricept Tablets, which are used to treat dementia associated with Alzheimer's disease.

8 Jun 2011

Thermo Fisher Scientific launches new triple quadrupole gas chromatography-mass spectrometry system

Thermo Fisher Scientific Inc. has announced the launch of its new triple quadrupole gas chromatography-mass spectrometry (GC-MS/MS) system designed to offer best-in-class selectivity, analytical performance and productivity. The Thermo Scientific TSQ Quantum XLS Ultra delivers the increased matrix selectivity needed for challenging applications that require lower levels of quantitation in extremely complex matrix extracts. With its exceptional sensitivity, easy detection and reliable peak integration, the system provides superior performance for the most difficult of matrix challenges.

From Thermo Fisher Scientific Inc. 7 Jun 2011

Shire Canada receives expanded indication for MEZAVANT for treatment of ulcerative colitis

Shire Canada Inc., a division of Shire plc, the global specialty biopharmaceutical company, is proud to announce that MEZAVANT® (mesalamine delayed and extended release tablets), the first and only once-daily mesalamine indicated for the induction of clinical and endoscopic remission in patients with mild-to-moderate, active ulcerative colitis (UC), has received an expanded indication to include maintenance of clinical and endoscopic remission (mucosal healing) in patients with ulcerative colitis.

7 Jun 2011

Promising results from KAI-4169 program for CKD-MBD presented at ENDO 2011

KAI Pharmaceuticals, Inc., a privately held drug discovery and development company, today announced clinical and preclinical data from its lead program, KAI-4169, at the Endocrine Society's 93rd Annual Meeting (ENDO 2011) taking place in Boston, June 4-7, 2011. KAI-4169 is a novel pharmaceutical agent being developed for the treatment of chronic kidney disease-mineral and bone disorder (CKD-MBD).

7 Jun 2011

Cyterix raises $9.2M in Series A financing from The Column Group and SV Life Sciences

Cyterix Pharmaceutics, Inc. announced today that the company has raised $9.2 million in a Series A financing from The Column Group and SV Life Sciences. Cyterix is developing novel cancer therapeutics based on a prodrug approach that targets extra-hepatic cytochrome P450 enzymes that are over-expressed in many cancers to a high frequency, but not in normal tissues.

7 Jun 2011

FDA accepts Topaz's ivermectin NDA for treatment for head lice infestations

Topaz Pharmaceuticals Inc., a privately held specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application (NDA) for the use of ivermectin topical cream as a treatment for head lice infestations in children and adults.

7 Jun 2011

Simcere announces settlement agreement with former Jiangsu Quanyi shareholders

Simcere Pharmaceutical Group, a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded and proprietary pharmaceuticals in China, today announced that a settlement agreement with certain former shareholders and directors of Jiangsu Quanyi Biological Technology Stock Co., Ltd. has become effective.

7 Jun 2011

Proteus, Avery Dennison partner for patch-based wearable sensors

Avery Dennison Medical Solutions, a division of Avery Dennison Corporation and a global leader in pressure-sensitive adhesive technologies for medical applications, in cooperation with Proteus Biomedical, Inc., a leader in intelligent medicine and mobile health products, today announced a partnership focusing on patch-based wearable sensors for consumer, home health care and remote medical applications.

7 Jun 2011

MMV honors UT Southwestern with Project of the Year for new anti-malarial drug discovery

The discovery of a potential new anti-malarial drug by a UT Southwestern Medical Center-led research team has been awarded Project of the Year by Medicines for Malaria Venture.

7 Jun 2011

Ligand's LGD-4033 Phase I clinical trial data presented at the Endocrine Society annual meeting

Ligand Pharmaceuticals Incorporated today announced that data from a comprehensive Phase I multi-dose program with its selective androgen receptor modulator (SARM) LGD-4033 was featured in a poster presentation today at the Endocrine Society Annual Meeting in Boston, June 4-7, 2011.

7 Jun 2011

FDA lifts BioSante's GVAX Prostate Cancer Vaccine clinical hold

BioSante Pharmaceuticals, Inc. today announced that the FDA's clinical hold on the GVAX Prostate Cancer Vaccine for the treatment of prostate cancer has been lifted by FDA.

7 Jun 2011

Independent investigators report Lymphoseek meets all endpoints in NEO3-09 Phase 3 study

Independent investigators reported today full results from the NEO3-09 study, reaffirming earlier top-line results that showed Lymphoseek met all primary and secondary endpoints and exhibited superior performance to vital blue dye in intraoperative lymphatic mapping (ILM) procedures.

7 Jun 2011

Ridaforolimus Phase III SUCCEED clinical trial on metastatic sarcoma meets primary endpoint

Merck, known outside the United States and Canada as MSD, and ARIAD Pharmaceuticals, Inc.,, today announced the presentation of detailed results from the Phase III SUCCEED clinical trial. SUCCEED evaluated oral ridaforolimus, an investigational mTOR inhibitor, in patients with metastatic soft-tissue or bone sarcomas who previously had a favorable response to chemotherapy.

7 Jun 2011

Bayer HealthCare seeks EU marketing authorization of VEGF Trap-Eye for treatment of wet AMD

Regeneron Pharmaceuticals, Inc. and Bayer HealthCare announced that Bayer HealthCare has submitted an application for marketing authorization in Europe for VEGF Trap-Eye for the treatment of the neovascular form of age-related macular degeneration (wet AMD).

7 Jun 2011

SPI to commence enrollment in SPI-1005 clinical trial to prevent hearing loss induced by loud music

Sound Pharmaceuticals (SPI) will begin recruiting a new clinical trial testing the oral drug SPI-1005 to prevent the hearing loss induced by loud music. Exposure to loud music or noise can induce temporary and permanent auditory threshold shifts (TTS or PTS). In some people, a repeated TTS will ultimately give way to a PTS that is irreversible.

7 Jun 2011

Agilent Technologies introduces mass spectrometry systems at ASMS 2011

Agilent Technologies Inc. today introduced mass spectrometry systems raising performance standards for biology and analytical chemistry analyses at the annual conference of the American Society of Mass Spectrometry.

7 Jun 2011

Synta presents ganetespib Phase 1, 2 trial results against solid tumors at ASCO 2011

Synta Pharmaceuticals Corp. today presented results at the Annual Meeting of the American Society for Clinical Oncology (ASCO) from a Phase 2 single agent clinical trial of ganetespib in gastrointestinal stromal tumors (GIST) and a Phase 1 trial of ganetespib in solid tumors evaluating a twice-weekly administration schedule.

7 Jun 2011

Millennium, Seattle Genetics' new brentuximab vedotin trial data presented at ASCO 2011

Seattle Genetics, Inc. and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, today reported updated data from a pivotal trial of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma and a phase II trial in relapsed or refractory systemic anaplastic large cell lymphoma.

7 Jun 2011

Pharmaceuticals News and Research

SPI and Neuralstem sign licensing agreement for major depression drug, NSI-189

Top-line results from Cipher's CIP-ISOTRETINOIN Phase III study against severe nodular acne

FDA approves Mylan's ANDA for Donepezil HCl Tablets to treat dementia linked with Alzheimer's

Thermo Fisher Scientific launches new triple quadrupole gas chromatography-mass spectrometry system

Shire Canada receives expanded indication for MEZAVANT for treatment of ulcerative colitis

Promising results from KAI-4169 program for CKD-MBD presented at ENDO 2011

Cyterix raises $9.2M in Series A financing from The Column Group and SV Life Sciences

FDA accepts Topaz's ivermectin NDA for treatment for head lice infestations

Simcere announces settlement agreement with former Jiangsu Quanyi shareholders

Proteus, Avery Dennison partner for patch-based wearable sensors

MMV honors UT Southwestern with Project of the Year for new anti-malarial drug discovery

Ligand's LGD-4033 Phase I clinical trial data presented at the Endocrine Society annual meeting

FDA lifts BioSante's GVAX Prostate Cancer Vaccine clinical hold

Independent investigators report Lymphoseek meets all endpoints in NEO3-09 Phase 3 study

Ridaforolimus Phase III SUCCEED clinical trial on metastatic sarcoma meets primary endpoint

Bayer HealthCare seeks EU marketing authorization of VEGF Trap-Eye for treatment of wet AMD

SPI to commence enrollment in SPI-1005 clinical trial to prevent hearing loss induced by loud music

Agilent Technologies introduces mass spectrometry systems at ASMS 2011

Synta presents ganetespib Phase 1, 2 trial results against solid tumors at ASCO 2011

Millennium, Seattle Genetics' new brentuximab vedotin trial data presented at ASCO 2011

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