The company was formed in 2007 with a $33 million Series A and raised another $70 million in 2010. (See BioWorld Today, Oct. 31, 2007, and Sept. 14, 2010.) Clinical development has chugged along just as quickly, with patiromer moving from a Phase I to pivotal studies in five years...In November 2011, the company held an end-of-Phase II meeting with the FDA to gain consensus on patiromer's clinical development plan, including the design of Phase III trials...is acting as sole book-running manager

Trials to Assess Suicidality Assessing suicidal thoughts and behavior will be an added requirement in clinical trials of several investigational drugs under a draft guidance the FDA released this week...Prospective suicidal ideation and behavior assessments should be carried out in all clinical trials involving any drug being developed for any psychiatric indication, as well as for all antiepileptic drugs and other neurologic drugs with central nervous system...Comments on the guidance are due by Oct

The trial will be carried out at clinical centers in the U.S

The current financing will be used to support clinical trials for its gut sensory modulators (GSM) – Lovidia, for use in nutritional supplement, food and beverage applications, and NewMet, a delayed-release formulation of generic metformin, indicated for patients with Type II diabetes

Intercept is currently conducting POISE, a Phase III clinical trial of OCA in PBC

Earlier this year, a clinical trial evaluating Doribax in patients with ventilator-associated pneumonia was stopped because of significant safety concerns. (See BioWorld Today, Jan. 9, 2012.)

The company plans to use the proceeds to fund clinical trials in posterior uveitis and for other business purposes

Data from the trial suggested clinical benefit, defined as partial response and stable disease of more than four months following up to eight cycles of treatment, with aldoxorubicin at the maximum-tolerated dose in 10 of 13 evaluable patients with relapsed or refractory soft-tissue sarcoma

The company said it will use the proceeds for further development of its clinical and preclinical programs, capital expenditures and for other corporate purposes

To help fuel its clinical trials programs on lead product candidate, cabozantinib, Exelixis Inc. (NASDAQ:EXEL) said it is planning an underwritten debt offering of $225 million convertible senior subordinated notes due 2019 and a concurrent sale of 20 million shares of its common stock...According to the SEC filing, Exelixis will use some of the net proceeds from the offerings to help drive its clinical trials program...BofA Merrill Lynch, J.P. Morgan and Morgan Stanley are acting as joint book

With an eye on the bottom line and the same reimbursement level regardless of the drug they use, some hospitals choose the cheaper, and older, generics to treat CDAD. (See BioWorld Today, March 31, 2011, and Oct. 4, 2011.) Recognizing the challenges its DRG reimbursement could create for promising new therapies, CMS developed the NTAP program in 2001 to provide Medicare beneficiaries in inpatient settings timely access to new technologies that demonstrate a substantial clinical improvement and

Spectrum Pharmaceuticals Inc., of Henderson, Nev., said data published in the Journal of Clinical Oncology showed first-line consolidation with Zevalin (ibritumomab tiuxetan) injection in patients with mantle-cell lymphoma, following initial therapy consisting of Rituxan (rituximab, Biogen Idec Inc. and Roche AG) with cyclophosphamide, doxorubicin, vincristine and prednisone (RCHOP) given for four courses, was well tolerated and improved overall response rate from 68 percent after RCHOP to 82

Proceeds will be used to support its continued regulatory efforts in the development of Fatty Acid Synthase Assays, including clinical trials and new hires...Funds will be used for general corporate purposes, which may include funding clinical trials in posterior uveitis and for other business operations

Incyte's clinical updates included highlights of presentations at the recent American Society of Clinical Oncology (ASCO) meeting in Chicago and the 17th Congress of the European Hematology Association in Amsterdam, the Netherlands...Incyte has two clinical trials under way with Novartis for advanced polycythemia vera

The fee for filing an application not requiring clinical data or a supplement requiring clinical data will be $979,400, up 6.4 percent from the $920,750 charged this year...Novo Nordisk was remanded to the district court.

The FDA did not cite clinical safety or efficacy issues and did not request additional pre-approval studies, but the agency did raise questions relating to chemistry, manufacturing and controls, as well as issues related to a facility inspection at a third-party manufacturer. (See BioWorld Today, March 28, 2012.) The company completed an end-of-review meeting with the FDA in June to seek clarity from the agency in developing its response...FREEDOM-301 demonstrated a statistically significant

Immatics biotechnologies GmbH, of Tübingen, Germany, published data from two clinical trials of IMA901, a cancer vaccine candidate, showing that patients experience longer survival times when their immune system responds to more than one of the peptides in the vaccine

Ponatinib already has demonstrated efficacy in patients with resistant or intolerant CML and Philadelphia chromosome-positive acute lymphoblastic leukemia, with data presented last month at the American Society of Clinical Oncology meeting in Chicago, and the company expects to file for approval of ponatinib in those patient populations this quarter. (See BioWorld Today, June 5, 2012

Infectex, of Moscow, said it received approval from the Russian Ministry of Health to begin a pivotal clinical trial for antibiotic SQ109 in multidrug-resistant tuberculosis (MDR-TB) patients at TB centers in three major Russian cities (Moscow, Saint Petersburg and Ekaterinburg