ACRX Files Zalviso NDA, BGMD Gets A Booster, UK's NICE Turns Nice To PSDV

(RTTNews) - AcelRx Pharmaceuticals Inc. (ACRX) has submitted a New Drug Application to the FDA for Zalviso, seeking approval in the management of moderate-to-severe acute pain in adult patients in the hospital setting.

Zalviso is a patient-activated, non-invasive analgesic system, which delivers 15 mcg sufentanil per dose as needed for pain control, subject to a 20 minute lockout period between doses.

ACRX closed Monday's trading 1.79% higher at $10.78.

Alnylam Pharmaceuticals Inc. (ALNY) has completed enrollment in its phase II trial with ALN-TTR02 for the treatment of TTR-mediated amyloidosis. The company is also on track to begin phase III trial with ALN-TTR02 in Familial Amyloidotic Polyneuropathy (FAP) patients by the end of this year.

ALNY closed Monday's trading at $64.01, down 0.09%.

BG Medicine Inc. (BGMD) rose 6 percent to close Monday's trading at $0.92 after the company announced that the Centers for Medicare and Medicaid Services, or CMS, has agreed to reconsider the payment rate for BGM Galectin-3 test.

In the U.S. and Europe, the company's Galectin-3 test is indicated for use in patients with chronic heart failure who are at increased risk for hospitalizations or death based on elevated levels of galectin-3. In Europe, the test is indicated for an additional indication as well - to identify individuals who do not currently have heart failure, but who are at increased risk for developing heart failure in the future.

Accordingly, the 2013 national limitation amount for the test is $30.24, subject to a final determination by CMS by year-end 2013. The new payment rate, if finalized, will replace the BGM Galectin-3 test's national limitation amount of $17.80.

Cardiome Pharma Corp. (CRME) (COM.V) has received approval for its atrial fibrillation treatment - BRINAVESS (vernakalant intravenous), in South Africa. BRINAVESS is already approved in Europe and other territories but is not approved for use in the United States or Canada.

Last September, Merck returned the global marketing and development rights for intravenous (IV) and oral formulations for Vernakalant to Cardiome Pharma.

Immunomedics Inc. (IMMU) has received a three-year grant from the Department of Defense totaling more than $1.6 million to evaluate Milatuzumab in a clinical trial as a treatment for lupus. The company's lead product candidate for lupus is Epratuzumab, which is currently in two Phase III clinical trials.

Omeros Corp.'s (OMER) investigational drug OMS824 has received orphan drug designation from the FDA for the treatment of Huntington's disease. A phase II trial of OMS824 in Huntington's disease is slated to begin this year.

pSivida Corp.'s (PSDV) Iluvien, an intravitreal implant for diabetic macular edema, has now been recommended by the United Kingdom's National Institute for Health and Care Excellence (NICE) as an option for the treatment of chronic diabetic macular edema in pseudophakic eyes.

Iluvien, which is licensed to Alimera Sciences Inc. (ALIM), is currently commercially available in the U.K. and Germany.

Having been issued a complete response letter twice by the FDA - in December 2010 and in November 2011, Iluvien NDA is currently under FDA review, with a decision date set for October 17, 2013.

PSDV closed Monday's trading at $4.11.

Roche's (RHHBY.PK) Genentech unit announced that the FDA has granted accelerated approval for Perjeta for use before surgery in people with HER2-positive early stage breast cancer.

The accelerated approval will be converted to a full approval after a full review of data from the ongoing phase III study, dubbed APHINITY, which compares Perjeta, Herceptin and chemotherapy with Herceptin and chemotherapy for adjuvant (post-surgery) treatment in people with HER2-positive early stage breast cancer. Data from APHINITY are expected in 2016.

Transcept Pharmaceuticals Inc. (TSPT) said Monday that it has turned down Retrophin Inc.'s request seeking permission to increase its ownership stake up to 15%. Retrophin is said to own 4.9% of the outstanding common stock of Transcept.

TSPT closed Monday's trading at $3.18, down 2.75%.