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
-- Curis, Inc. (NASDAQ: CRIS ), a drug
development company focused on
developing ... clinical development plan for our novel drug
which we believe may offer ... pre-clinical and clinical trials,
delivery and formulation, and regulatory affairs. ...
Omnio Healer Selects Eden Biodesign for cGMP Production of its Candidate Wound Healing and Anti-Infection Treatments
anti-infection, Omnio Healer is developing drug
candidates with potent
pro-inflammatory ... Healer AB is a pioneer company developing novel drug
based on a series of conceptual ... healing and anti-infection. The company's lead drug
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
("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
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
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
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
approved by the State Food and drug
Administration in 2009.
... is a modified controlled-release
to treat type 2 diabetes. The market size of ...
(1) Source: CHINA ANTI-DIABETIC drug
MARKET REPORT prepared by Life
Debiopharm and MSM Protein Technologies Sign Agreement for Research and Development of Debio 0929, a Novel Oncology Biologic
... MSM Protein Technologies (MSM), a human
discovery company with world class expertise in ... expertise, together with our
experience in drug
development should lead to innovative ... pre-clinical and clinical trials,
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
The genomics era has produced a ... target for structural prediction and future drug
development, including antibiotics for pathogenic bacteria that have developed drug
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
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 ...