Genocea Biosciences Inc., of Cambridge, Mass., said it started a Phase I/IIa trial of GEN-003, a vaccine designed to stimulate T-cell and B-cell immune responses to potentially reduce the frequency and severity of clinical outbreaks associated with moderate to severe herpes simplex virus Type 2 (HSV-2) infection

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suicidal thoughts and behavior will be an added requirement in clinical trials of several investigational drugs under a draft guidance the FDA released this week...Prospective suicidal ideation and behavior assessments should be carried out in all clinical trials involving any drug being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.)

Agenus Inc., of Lexington, Mass., said clinical data from a Phase I trial of a Prophage Series vaccine (HSPPC-96, vitespen) to treat patients with recurrent glioblastoma multiforme (GBM) were published online by Clinical Cancer Research...In a multicenter Phase II study, the compound demonstrated symptomatic relief and clinical and mycological benefits after a single administration delivered as a vaginal suppository formulation

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

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

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.

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

In addition to updates on its revenues and clinical programs, Celgene provided information on its stock repurchase program...Its stock (NASDAQ:UTHR) gained $2.28 to close Thursday at $52.68.

Durata plans to use the proceeds to complete clinical development of lead anti-infective candidate dalbavancin, which is in a second pivotal Phase III study in acute bacterial skin and skin structure infections, and to fund commercialization activities in the U.S

The drug is used in 90 percent of the clinical locations where Lucentis has been used, indicating widespread acceptance and uptake of the product...Shares of Alexion (NASDAQ:ALXN) gained $7.51 to close Wednesday at $105.13.