that the trastuzumab-DM1 investigational new drug application submitted to the FDA has become effective...has initiated clinical trials of LY2275796 in cancer patients

PharmaMar SA, of Madrid, Spain, said its investigational new drug application was accepted to begin clinical testing of Zalypsis (PM00104/50), a marine antitumor agent

Washington Editor WASHINGTON - Early clinical testing could get easier, or at least more accessible, if product sponsors take note of recent FDA communications...As Acting FDA Commissioner Andrew von Eschenbach said in a teleconference, the new recommendations "can more rapidly establish whether or not a new compound truly has a real clinical benefit for people...BIO has submitted its opinions to the IRS, which is scheduled to hold a public hearing on the matter later this month. #kicker123

private equity fund, WFD Ventures LLC, with undisclosed proceeds expected to support its clinical development program for selected drug/device combination products under development in-house...In separate news, PSC signed a contract relating to Diamyd's lead product, a therapeutic diabetes vaccine, and will prepare to file an investigational new drug application for the product, as well as handle manufacturing for Phase III trials.

Sixty percent of the proceeds from the IPO, filed in October, will fund clinical trials for three development programs, with 20 percent earmarked for marketing, general and administrative expenses, and another 20 percent for other research and development expenses...BioCryst submitted the investigational new drug application for injectable peramivir in November

Under terms of that agreement, Optimer will fund all expenses associated with the clinical trials, while Par will be responsible for clinical development, the submission of a new drug application and manufacturing and marketing

The company also reported clinical data from Revlimid in myelofibrosis, showing that 59 percent of the evaluable patients who received 10 mg/day orally (5 mg daily for patients with a platelet count less than 100,000 at the study's start) exhibited a response to treatment...The overall clinical response rate increased from 49 percent at month three following Rituxan alone to 65 percent following the initiation of FavId...The company expects to file an investigational new drug application in late 2006

Staff Writer With its three lead products expected to be in clinical trials next year, Surface Logix Inc...Scolr said it intends to use proceeds from any offering to fund its research and development programs, clinical trials, capital expenditures and for other general corporate purposes...Kathy LaPorte, managing director of New Leaf Venture Partners, joined the company's board.

The company also plans to file an investigational new drug application for another compound...The company said it expects to use proceeds to fund clinical development and other research and development activities, as well as for working capital and general corporate purposes

The company expects to file an investigational new drug application for Myodur to begin clinical testing early next year

According to its prospectus, net proceeds of about $81.1 million will go toward clinical trials, research and development, general corporate purposes, capital expenditures, acquisitions of new technologies and working capital...The company expects to file an investigational new drug application for a second-generation maturation inhibitor during 2006

The company expects to file an investigational new drug application for the first one, a second-generation gluconeogenesis inhibitor, this quarter...The financing will help Tessera to prepare the technology for clinical trials and commercialization.

Staff Writer The Louisville, Colo.-based company plans to soon file a new drug application for its lead product, faropenem medoxomil, to treat skin infections and three respiratory tract infections: bronchitis, sinusitis and community-acquired pneumonia...And the company intends to conduct some higher-dose, shorter-course clinical trials in adults...Proceeds will be used to conduct clinical testing of the company's GP88 Biopsy Staining Kit for breast cancer

investigational new drug application...completed a $10.8 million financing to move into clinical development its cell-based therapies for cartilage regeneration and repair...The company said initial applications will target knee joints and spinal discs.

As of Oct. 1, the agency will charge $767,400 in application fees for a submission requiring clinical data, a $95,400 hike over the going rate...Additional application fees are climbing as well: It will cost $383,700 for an application not requiring clinical data or a supplement requiring clinical data, $264,000 for establishment fees and $42,130 for product fees...More than a year ago, Pozen received a not-approvable letter from the FDA on its new drug application for MT 100. (See BioWorld Today, Aug

A Phase II could start in early 2006, with a new drug application filing slated for the end of 2007 or early in 2008...Another Anadys clinical product, ANA380, is a Phase II hepatitis B virus compound that is co-developed with LG Life Sciences Ltd., of Seoul, South Korea

The Palo Alto, Calif.-based company, which is preparing to submit an amended new drug application for its lead product in angina, originally planned to sell about 6 million shares...The remaining net proceeds will go toward business operations, which could include preclinical and clinical trials, research and development, regulatory filings and product commercialization costs...and Dansk Erhvervsinvestering, also of Copenhagen.

CMS will reimburse drugs when used for indications other than their approved use, and Gottlieb said companies could take that into consideration when deciding whether to seek supplemental new drug applications through the FDA...Testing of liver function is recommended at intervals of one, three and six months following introduction to Betaseron therapy, and then periodically thereafter in the absence of clinical symptoms

This permits us to continue all of our clinical and research and development plans through at least the middle of next year," Krawiec said...It likely will be the first indication for which the company seeks regulatory approval, following the completion of a second Phase III study this year and a new drug application submitted around the end of the year...GeneOhm has two assays cleared by the FDA and Health Canada for rapid detection of Group B Streptococcus and methicillin-resistant Staphylococcus