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Catalyst Pharmaceutical Partners Reports Second Quarter 2009 Financial Results

... of Health ("NIH"), the National Institute on drug Abuse, and other agencies that operate under the ... "Fast Track" status by the U.S. Food & drug Administration (FDA) for the treatment of cocaine ... the clinical trials required for us to file a new drug application for CPP-109, our ability to complete ...

NeurogesX Reports Second Quarter 2009 Results

... topical anesthetic Announced FDA orphan drug designation for Qutenza in PHN Added to ... for data and analyses as part of the ongoing new drug application (NDA) review for Qutenza in ... In the United States, NeurogesX submitted a new drug application (NDA) for PHN to the Food ...

Viral Genetics Creates Subsidiary to Develop Cancer Therapy

... therapies, is very promising for combating drug resistant tumors," said Dr. Newell. Prior ... holds tremendous hope for patients with drug resistant tumors," said Haig Keledjian, CEO of ... California, Viral Genetics discovers and develops drug therapies to treat infectious, autoimmune, and ...

Synthetech Reports First Quarter Fiscal 2010 Results

... and revenues. As the uncertainties inherent in drug development projects remain outside of ... ( cGMP ) in compliance with U.S. Food and drug Administration ( FDA ) regulations. Our products ... base includes major pharmaceutical, contract drug synthesis firms, emerging biotechnology (virtual ...

Telik Announces Second Quarter 2009 Financial Results

... Telik, Inc. of Palo Alto, CA, is a clinical stage drug development company focused on discovering and ... The company's most advanced investigational drug candidates in clinical development are ... candidates were discovered using its proprietary drug discovery technology, TRAP(R), which enables the ...

PharmatrophiX, Initially Funded by the Alzheimer's Drug Discovery Foundation, Announces Exclusive Global Collaboration with Elan

... -- New therapeutics funded by the Alzheimer's drug Discovery Foundation (ADDF) , have achieved a ... only public charity whose sole mission is to fund drug discovery and development to prevent, treat, and ... cells and that had profiles suitable for further drug development. Once these molecules were ...

Curis and Debiopharm Sign an Exclusive License Agreement Covering the HSP90 Inhibitor CUDC-305

... /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS ), a drug development company focused on developing ... clinical development plan for our novel drug candidate, CUDC-305, which we believe may offer ... pre-clinical and clinical trials, manufacturing, drug delivery and formulation, and regulatory affairs. ...

Omnio Healer Selects Eden Biodesign for cGMP Production of its Candidate Wound Healing and Anti-Infection Treatments

... and anti-infection, Omnio Healer is developing drug candidates with potent pro-inflammatory ... Healer AB is a pioneer company developing novel drug candidates based on a series of conceptual ... healing and anti-infection. The company's lead drug candidate, aimed primarily at otological ...

Angiotech Pharmaceuticals, Inc. announces financial results for the second quarter ended June 30, 2009

... TAXUS(R) coronary stent systems incorporating the drug paclitaxel. TAXUS stents have been evaluated by ... we announced that the United States Food and drug Administration ("FDA") had granted 510(k) ... research and development and product and drug development. Such forward-looking statements ...

NeurogesX Announces New PDUFA Date for Qutenza(TM) New Drug Application

... today announced that the United States Food and drug Administration (FDA) has extended the Prescription drug User Fee Act (PDUFA) date from August 16, 2009 to November 16, 2009 to review the new drug application (NDA) for Qutenza(TM) to manage pain ...

Amicus Therapeutics Announces Second Quarter 2009 Financial Results

... Company reached agreement with the U.S. Food and drug Administration (FDA) on the key protocol design ... 2 clinical trial of the Company's investigational drug Plicera is ongoing. This 6-month study is ... the Phase 2 clinical trial of its investigational drug AT2220 for the treatment of Pompe Disease and ...

Cadence Pharmaceuticals Reports Second Quarter 2009 Financial Results

... second quarter of 2009, Cadence submitted its New drug Application (NDA) for Acetavance(TM) (intravenous ... NDA of November 13, 2009 under the Prescription drug User Fee Act (PDUFA). "We are very ... of the NDA; the risk that increased attention to drug safety issues in general may result in a more ...

Shire plc: Core Portfolio of Products Delivers 20% Sales Growth

... for the product. Rolling review of the New drug Application ("NDA") has started. Our core ... of oppositional symptoms. - The Prescription drug User Fee Act date ("PDUFA") for INTUNIV was July ... was also found to be well tolerated with no drug related serious adverse events reported in ...

Next Safety Releases Advanced Respirator for Infectious Diseases

... The company also develops pulmonary drug delivery products. It is a leader in the ... Next Safety is also developing other pulmonary drug delivery platforms for inhaled antibiotics and ... is developing combined respirator and pulmonary drug delivery systems for soldiers to have highly ...

Poniard Pharmaceuticals Reports Second Quarter 2009 Financial Results and Provides a Corporate Update

... designed in collaboration with the U.S. Food and drug Administration (FDA), and evaluated the cardiac ... be incorporated into picoplatin's rolling New drug Application (NDA) filing, which the Company plans ... business objectives and strategic goals, drug development plans, the potential safety and ...

Oncothyreon appoints Diana Hausman as Vice President of Clinical Development

... oncologist who brings an extensive background in drug development to her new role at Oncothyreon," said ... leadership and knowledge of all aspects of cancer drug development will be very important as we prepare ... target at the forefront of current cancer drug research." Dr. Hausman joins Oncothyreon from ...

DOR BioPharma Receives FDA Orphan Drug Designation for orBec(R) for the Treatment of Chronic Gastrointestinal GVHD

... Development of the United States Food and drug Administration (FDA) has granted Orphan drug Designation to Oral BDP (beclomethasone ... cell transplantation. The US Orphan drug Act is intended to assist and encourage companies ...

Biotech Hot in July Driven by Positive Drug Data and Acquisitions

... -- Biotech was "hot" in July driven by drug data, positive drug sales/earnings and partnering and M&A deals. ... results for its experimental lupus injectable drug Benlysta, confounding all analysts' expectations ...

AEterna Zentaris Partner, Keryx, Announces Agreement with FDA on a Special Protocol Assessment for Phase 3 Trial with Perifosine (KRX-0401) for the Treatment of Multiple Myeloma

... has reached an agreement with the U.S. Food and drug Administration (FDA) regarding a Special Protocol ... This represents a major milestone in our oncology drug development strategy which could hold great ... that are intended to form the basis for a new drug application. Final marketing approval depends ...

Purdue Pharmaceutical Products L.P. and Transcept Pharmaceuticals, Inc. Sign Exclusive Agreement to Commercialize Intermezzo(R) in the United States

... United States. If approved by the U.S. Food and drug Administration (FDA), Intermezzo ((R)) has the ... established October 30, 2009 as the Prescription drug User Fee Act (PDUFA) action date for the Intermezzo ((R)) New drug Application (NDA). In the agreement ...

Advanced Life Sciences Receives Complete Response Letter From FDA for Restanza(TM) (Cethromycin) in Community Acquired Pneumonia

... response letter today from the U.S. Food and drug Administration (FDA) regarding its New drug Application (NDA) for Restanza(TM) (cethromycin) ... of CAP. The committee's negative vote on the drug candidate's efficacy followed a discussion that ...

NeurogesX to Hold Conference Call to Discuss Second Quarter 2009 Financial Results

... In the United States, NeurogesX submitted a new drug application (NDA) for PHN to the U.S. Food and drug Administration (FDA) which was accepted for ... FDA in December 2008 and was given a Prescription drug User Fee Act (PDUFA) date of August 16, 2009. ...

R-Tech Ueno Notifies R&D Items

... eyedrop 0.12%" that is marketed as a therapeutic drug for glaucoma and ocular hypertension. This drug is now being developed by R-Tech Ueno for the indication of retinitis pigmentosa. The drug is introduced to Sucampo Pharma Americas Ltd. in ...

Stemline Therapeutics CEO to Present at IBC's New Frontiers in Cancer Drug Development Conference

... invited to present at the New Frontiers in Cancer drug Development conference which is part of IBC's drug Discovery and Development Week in Boston, MA. Dr. Bergstein's presentation, entitled "Developing drug Candidates Directed to Cancer Stem Cell Targets: ...

Transave Enters Into Cooperative Research Agreement With NIH To Study ARIKACE(TM) In Nontuberculous Mycobacteria

... of the antibiotic amikacin, which encloses the drug in nanocapsules of lipid called liposomes. This ... ARIKACE has been granted orphan drug status in the United States by the FDA, and has received an orphan drug designation in Europe by the European Medicines ...

Lotus Pharmaceuticals, Inc. Announces Patent Pending Gliclazide-Controlled Release Tablets

... evaluation approved by the State Food and drug Administration in 2009. ... is a modified controlled-release antidiabetic drug to treat type 2 diabetes. The market size of ... (1) Source: CHINA ANTI-DIABETIC drug MARKET REPORT prepared by Life Science ...

Debiopharm and MSM Protein Technologies Sign Agreement for Research and Development of Debio 0929, a Novel Oncology Biologic

... MSM Protein Technologies (MSM), a human antibody drug discovery company with world class expertise in ... expertise, together with our experience in drug development should lead to innovative ... pre-clinical and clinical trials, manufacturing, drug delivery and formulation, and regulatory affairs. ...

ImmuneRegen BioSciences Confirms Homspera's Therapeutic Anti-Influenza Effect on Pandemic H1N1 Influenza Virus After Oral Administration

... of Homspera resulted in measurable amounts of the drug in lung tissue. Systemic absorption and ... development and licensing of the potential drug candidate Homspera and its derivatives Radilex(R) ... Management is focused on the development of these drug candidates as potential treatments for blood ...

Marinus Pharmaceuticals Adds Two Life Sciences Veterans to its Board of Directors

... whom have tremendous track records for advancing drug pipelines, leading pharmaceutical and life ... FDA approval for Tetrabenazine (TBZ), the first drug ever licensed in the United States to treat ... 2a data for a novel first in class antiepileptic drug that will address unmet medical needs for adults ...

Amgen to Collaborate With GlaxoSmithKline to Commercialize Denosumab in Europe for Postmenopausal Osteoporosis (PMO)

... in these countries. Amgen will commercialize the drug for PMO and oncology in the United States (U.S.) ... more effectively than if we commercialized the drug globally on our own," said Amgen CEO Kevin ... candidates are not approved by the U.S. Food and drug Administration (FDA) or other regulatory bodies, ...

PTC Therapeutics Initiates Phase 2 Clinical Trial of PTC299 in Patients with Neurofibromatosis Type 2

... a novel, orally administered investigational new drug that is designed to selectively block ... NF2, building upon ongoing evaluations of the drug in patients with metastatic breast cancer, ... proprietary technologies that it applies in its drug discovery activities have been the basis for ...

PROLOR Biotech Acquires License Option from Yeda for Development of Long-Acting Anti-Obesity Drug

... Yeda a license to develop a number of peptide drug candidates, including an anti-obesity peptide, ... president of PROLOR. "The first preclinical drug candidate we will evaluate under the agreement is ... for us to explore entering this market with a drug candidate that may have strong competitive ...

DNA Software, Inc. Awarded $2.5 M in NIH Funding to Develop Pioneering Nucleic Acid-based Technologies

... 3D Structure Prediction to Improve and Accelerate drug Discovery The genomics era has produced a ... target for structural prediction and future drug development, including antibiotics for pathogenic bacteria that have developed drug resistance. DNA Software has a breakthrough ...

Junying Yu, Leading Stem Cell Researcher, Joins Cellular Dynamics International

... differentiate into essential cell types for drug discovery and development and eventually ... neural cells, etc.) derived from iPS cells for drug development. This progress has been highlighted ... towards personalized therapeutics. In vitro drug testing can be severely limited by the lack of ...

Lexicon to Provide Clinical Pipeline Update and Report Second Quarter 2009 Financial Results on July 28, 2009

... for human disease. Lexicon currently has five drug candidates in development for autoimmune disease, ... technology to identify more than 100 promising drug targets. Lexicon has focused drug discovery efforts on these biologically-validated ...

A drug-dispensing contact lens

... director of the Laboratory for Biomaterials and drug Delivery at Children's Hospital Boston, have ... amounts of drug; typically, a burst of drug is delivered in the first few hours, followed by ... already approved for ocular use by the Food and drug Administration. In laboratory testing, the ...

Sumavel(TM) DosePro(TM) (sumatriptan injection) Approved by FDA for Acute Migraine and Cluster Headache: First Product Featuring Novel DosePro Needle-Free Delivery System

... it has received approval from the U.S. Food and drug Administration (FDA) for its New drug Application (NDA) for Sumavel DosePro ... system could transform the future of subcutaneous drug delivery of pharmaceuticals. This first approval ...

Champions Biotechnology Partners with Do-Coop Technologies to Advance Its Novel Oncology Compound Into Biomerk Tumorgraft(TM) Testing

... compound, is the first agent in Champions' drug development pipeline. Using Neowater((R)), a ... nearly a year of efforts to build our oncology drug pipeline we expect to in-license additional drugs ... path for the compound in terms of indication, drug combination, and target patient populations. ...

Chimerix, Inc. Appoints Kenneth I. Moch Chief Operating Officer

... a rich pipeline of next-generation antiviral drug candidates, productive platform technology, an ... necessary to emerge at the forefront of antiviral drug development," said Mr. Moch. "I am excited to ... lipid technology, Chimerix is able to develop drug candidates with oral availability or topical ...

UCSF researchers help crack parasite genome, identify drug leads

... other biomedical contexts has provided valuable drug targets. Findings are published in the July 16, ... of Quantitative Biosciences (QB3). Just one drug is currently widely available to treat ... say poses the risk of encouraging the parasite's drug resistance as aid organizations extend the ...
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(Date:1/22/2015)... TORONTO , Jan. 13, 2015 /PRNewswire/ - Today, FindBiometrics, the ... announced the launch of its new website design. ... in its infancy", says Peter O,Neill , founder and ... ever, the industry needs involvement from the key players on ...
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