Cerexa, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for PPI-0903, a next-generation, broad-spectrum, cephalosporin antibiotic, for the treatment of complicated skin and skin structure infections (cSSSI) caused by methicillin-resistant Staphylococcus aureus (MRSA). Cerexa initiated a Phase 2 trial of PPI-0903 for the treatment of cSSSI in October 2005. Under the FDA Modernization Act of 1997, the Fast Track program of the FDA is designed to facilitate the development and expedite the review of a new drug that is intended for the treatment of a serious or a life-threatening condition, and demonstrates the potential to address unmet medical needs for such a condition.
FDA Grants Cerexa Fast Track Designation for PPI-0903
CoLucid Pharmaceuticals Announces $16.5 Million Series A Financing
CoLucid Pharmaceuticals, Inc., a biopharmaceutical company focused on new therapeutics for neurological diseases, announced a $16.5 million Series A financing. The company was formed with a novel clinical stage migraine molecule licensed from Eli Lilly and Company and a portfolio of preclinical assets based on a robust bifunctional neuromodulator chemistry platform, which originated at Sention, Inc. Pappas Ventures seed funded and formed the company. The Series A financing was co-led by Domain Associates and Pappas Ventures with other investors including Triathlon Medical Ventures and Pearl Street Venture Funds.
Significant Decision Gives Patients Better Access to LipoScience's Heart Disease Test
The Centers for Medicare & Medicaid Services (CMS) announced a Medicare reimbursement rate for CPT code 83704, a new code that describes the main component of the NMR LipoProfile® test. This test is used to help identify patients at risk for heart disease and determine optimal cardiovascular drug therapy. Earlier this year, the American Medical Association's (AMA) Current Procedural Terminology (CPT) Editorial Panel established a unique Category I code, 83704, described as "the quantitation of lipoprotein particle numbers and lipoprotein subclasses when measured (e.g. nuclear magnetic resonance spectroscopy)." The establishment of a new code and a CMS payment rate are key steps in making new medical technologies more widely available to patients.
CeNeRx BioPharma Announces $18.5 Million Series A Financing
CeNeRx BioPharma, Inc., a start up bio-pharmaceutical company focused on developing new therapeutics for disorders of the central nervous system, today announced the completion of $18.5 million in series A financing.
After Change Up Top, Syntonix Inks Boehringer Ingelheim Deal Worth Up to $63M
After a management change over the summer, drug formulation and delivery company Syntonix Pharmaceuticals Inc. has kicked off autumn with a collaboration with Boehringer Ingelheim GmbH that could bring in as much as $63 million.
Syntonix and Boehringer Ingelheim Enter Collaboration for Up to $63 Million to Optimize Therapeutic Peptide Candidates for Inhalation
Syntonix Pharmaceuticals, Inc. and Boehringer Ingelheim announced today that they have entered into a collaboration to optimize certain Boehringer Ingelheim therapeutic peptides for inhalation, using Syntonix’ SynFusionTM and TransceptorTM technologies. Under the terms of the agreement, Syntonix will receive an upfront fee and research support. Boehringer Ingelheim has the option to develop and commercialize the peptide candidates. Syntonix will receive milestone and royalty payments on any products developed and commercialized under the agreement.
BrainCells, Inc. Appoints James A. Schoeneck Chief Executive Officer
BrainCells, Inc. (BCI), a privately held, neuroscience-focused, drug development and discovery company targeting novel and /or best-in- class therapies for neuropsychiatric disorders and other central nervous system diseases, announced today the appointment of James A. Schoeneck as Chief Executive Officer and member of the board. Schoeneck, 48, will be responsible for continuing to develop the strategic direction and capabilities of the company.
Dynogen Initiates Phase II Trial of Ddp225 for Treatment of Patients with Diarrhea-Predominant Irritable Bowel Syndrome
Dynogen Pharmaceuticals, Inc. announced today that it has initiated a Phase II proof-of-concept trial of DDP225 for diarrhea-predominant irritable bowel syndrome (IBS-d), and the first patients have been dosed. DDP225 is an orally-active compound that targets two key pathways that control the gastrointestinal (GI) system, thus giving it the potential to address multiple symptoms associated with IBS-d. This DDP225 Phase II trial is a randomized, double-blind, placebo controlled study that is enrolling patients with IBS-d at multiple centers in Canada and is assessing safety and pharmacodynamic efficacy as well as symptom-based endpoints. In September 2005, Dynogen began dosing patients in a Phase II study of DDP733 for the treatment of patients with constipation-predominant IBS (IBS-c), the other common form of IBS.
A Better Way to Ambush Aids? Panacos Pharmaceutical's experimental drug opens the door to a new line of attack (Business Week)
In the U.S., AIDS may not seem to be the urgent problem it once was. Powerful drugs introduced since 1996 have slashed the annual death rate in the U.S. from nearly 50,000 in 1995 to 16,000 in 2004. But the picture is still grim. New cases of infection continue unabated, at about 44,000 per year, with more Americans than ever—more than 1 million—infected with HIV. Around the world the epidemic is growing, with more than 40 million people carrying the virus. What's more, HIV increasingly outwits today's drugs even as side effects take a toll.
TargeGen, Inc. Selects Lead Drug for Clinical Development As A Topical (Eyedrop) Treatment For Wet Macular Degeneration and Other Eye Diseases
TargeGen, Inc., a biopharmaceutical company focusing on the development of small molecule drugs for the treatment of edema and angiogenesis related diseases, today announced that TG 100801, a potent, selective, and topically administered multi target kinase inhibitor, has been designated as a lead drug for clinical development in the treatment of major eye diseases including macular degeneration, diabetic macular edema and diabetic retinopathy. Current treatments for wet macular degeneration have demonstrated limited efficacy to date and require injection into the eye, thus increasing the risk of infection and retinal detachment.
