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MAP Pharmaceuticals reports positive results from LEVADEX QT trial for migraine

MAP Pharmaceuticals, Inc. today reported successful results from a thorough QT trial of its investigational LEVADEX™ orally inhaled migraine therapy. The trial evaluated the potential of a supra-therapeutic dose to cause an increase in the QT interval. Results of the trial showed that a supra-therapeutic dose of LEVADEX does not increase QTc intervals. LEVADEX is a novel orally inhaled migraine therapy that has completed Phase 3 efficacy development for the acute treatment of migraine.

8 Nov 2010

Santarus's budesonide MMX drug shows positive result for active ulcerative colitis

Santarus, Inc. a specialty biopharmaceutical company, today announced positive top-line results from a second Phase III clinical study evaluating the safety and efficacy of budesonide MMX for the induction of remission of mild or moderate active ulcerative colitis.

8 Nov 2010

XenoPort third quarter net loss decreases to $19.9 million

XenoPort, Inc. announced today financial results for the third quarter and nine months ended September 30, 2010. Revenues for the third quarter were $0.4 million, compared to $0.4 million for the same period in 2009. Net loss for the third quarter was $19.9 million, compared to a net loss of $24.4 million for the same period in 2009.

8 Nov 2010

Apricus receives $733,437 grants under QTDP program

Apricus Biosciences, Inc., today announced the award of three grants totaling $733,437 under the Qualifying Therapeutic Discovery Project program for PrevOnco, RayVa and Femprox which are the Company's development programs in cancer, autoimmune/cardiovascular and female sexual dysfunction, respectively.

8 Nov 2010

Clinical Data receives $500,000 grants under QTDP program

Clinical Data, Inc. today announced that the Company has received two grants totaling nearly $500,000 under the Qualifying Therapeutic Discovery Project.

8 Nov 2010

FDA reviews GSK's response to Complete Response letter for Horizant

GlaxoSmithKline and XenoPort, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review GSK's response to FDA's Complete Response letter for Horizant (gabapentin enacarbil) Extended-Release Tablets. Horizant is under review for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

8 Nov 2010

Ortho-McNeil terminates collaboration agreement with Arena on APD597 trial program

Arena Pharmaceuticals, Inc. announced today that, following the completion of a Phase 1 clinical trial program for APD597 (JNJ-38431055) under its collaboration with Arena, Ortho-McNeil-Janssen Pharmaceuticals, Inc., has decided not to advance APD597 and has notified Arena that it is terminating the collaboration, effective December 28, 2010.

7 Nov 2010

Pisgah Labs receives QTDP grant to accelerate abuse deterrent technology

Pisgah Labs, Inc., an innovative drug development and active ingredient manufacturer located in Western North Carolina, has received a substantial federal grant.

4 Nov 2010

Phase III study suggests CYCLOSET tablets improve glycemic control

Santarus, Inc. and VeroScience LLC today announced that analyses of 379-patient subset data from a 3,070-patient Phase III safety study conducted with CYCLOSET (bromocriptine mesylate) tablets suggested that CYCLOSET as an add-on to oral antidiabetes drugs produced improvements in glycemic control irrespective of baseline duration of disease.

4 Nov 2010

Coronado completes series of private financings

Coronado Biosciences, Inc., a privately held company engaged in innovative oncology drug development, announced completion of a series of private financings in 2010, resulting in aggregate gross proceeds to the Company of approximately $21.6 million.

4 Nov 2010

Acton submits Manufacturing Supplement to FDA for AEROSPAN Inhalation Aerosol

Acton Pharmaceuticals, Inc. today announced that it has submitted to the U.S. Food and Drug Administration (FDA), a Manufacturing Supplement to the previously approved AEROSPAN Inhalation Aerosol NDA.

4 Nov 2010

ADVENTRX submits NDA for Exelbine to FDA

ADVENTRX Pharmaceuticals, Inc. announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate ANX-530 (vinorelbine injectable emulsion), or Exelbine.

3 Nov 2010

Safeguard Scientifics third quarter aggregate revenue of partner companies increases 73% to $109.6 million

Safeguard Scientifics, Inc., a holding company that provides growth capital for entrepreneurial and innovative life sciences and technology companies, today announced that aggregate revenue of its partner companies for the three months ended September 30, 2010 was $109.6 million, up 73% from $63.4 million for the same partner companies in the same period of 2009.

3 Nov 2010

FDA grants Cadence marketing approval for OFIRMEV injection in management of pain and fever

Cadence Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for OFIRMEV™ (acetaminophen) injection, the first and only intravenous (IV) formulation of acetaminophen to be approved in the United States. OFIRMEV is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.

3 Nov 2010

NeurogesX initiates NGX-1998 Phase 2 study in postherpetic neuralgia

NeurogesX, Inc., a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today announced dosing of the first patient in its Phase 2 clinical study of NGX-1998, a liquid formulation of high-concentration capsaicin, in patients with postherpetic neuralgia (PHN).

3 Nov 2010

Pro-Pharmaceuticals awarded $489,000 in federal grants under Qualifying Therapeutic Discovery Project

Pro-Pharmaceuticals, Inc., a developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, today announced it has been notified that it has been awarded approximately $489,000 total in two federal grants under the Qualifying Therapeutic Discovery Project ("QTDP") Program.

2 Nov 2010

Optimer third quarter net loss increases to $11.8 million

Optimer Pharmaceuticals, Inc. today reported financial results for the third quarter ended September 30, 2010. Optimer reported a net loss for the third quarter of 2010 of $11.8 million, or $0.30 per share, which was in line with the Company's expectations. This compares to a net loss for the third quarter of 2009 of $9.4 million, or $0.28 per share. The increase in net loss was primarily due to an increase in research and development and marketing expenses.

2 Nov 2010

Watson enters exclusive agreement with OMJPI to market authorized generic Concerta

Watson Pharmaceuticals, Inc. today announced that its subsidiary, Watson Laboratories, Inc., has entered into an exclusive agreement with Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI), to market the authorized generic version of Concerta® (methylphenidate hydrochloride extended-release tablets). Watson will launch its authorized generic of Concerta on May 1, 2011. Concerta is indicated for the treatment of attention deficit hyperactivity disorder (ADHD).

2 Nov 2010

Impax third quarter net income increases from $6.7 million to $75.2 million

Impax Laboratories, Inc. today reported adjusted net revenue in the third quarter of 2010, excluding the effect of a change in accounting for revenue received under the Company's Strategic Alliance Agreement with Teva, increased $42.6 million to $107.6 million compared to the prior year period, driven by sales of generic Adderall XR for which there were no sales in the third quarter of 2009, as well as increased sales of the Company's fenofibrate products.

2 Nov 2010

Positive preliminary data from Protalix's taliglucerase alfa switchover trial for Gaucher disease

Protalix BioTherapeutics, Inc., announced today positive preliminary data from the first 15 patients that completed the Company's nine month, worldwide, multi-center, open-label, switchover trial of taliglucerase alfa for the treatment of Gaucher disease under a protocol cleared by the U.S. Food and Drug Administration (FDA). The data indicate that patients can safely be switched to taliglucerase alfa from imiglucerase (Cerezyme®).

2 Nov 2010

New Drug Application News and Research

MAP Pharmaceuticals reports positive results from LEVADEX QT trial for migraine

Santarus's budesonide MMX drug shows positive result for active ulcerative colitis

XenoPort third quarter net loss decreases to $19.9 million

Apricus receives $733,437 grants under QTDP program

Clinical Data receives $500,000 grants under QTDP program

FDA reviews GSK's response to Complete Response letter for Horizant

Ortho-McNeil terminates collaboration agreement with Arena on APD597 trial program

Pisgah Labs receives QTDP grant to accelerate abuse deterrent technology

Phase III study suggests CYCLOSET tablets improve glycemic control

Coronado completes series of private financings

Acton submits Manufacturing Supplement to FDA for AEROSPAN Inhalation Aerosol

ADVENTRX submits NDA for Exelbine to FDA

Safeguard Scientifics third quarter aggregate revenue of partner companies increases 73% to $109.6 million

FDA grants Cadence marketing approval for OFIRMEV injection in management of pain and fever

NeurogesX initiates NGX-1998 Phase 2 study in postherpetic neuralgia

Pro-Pharmaceuticals awarded $489,000 in federal grants under Qualifying Therapeutic Discovery Project

Optimer third quarter net loss increases to $11.8 million

Watson enters exclusive agreement with OMJPI to market authorized generic Concerta

Impax third quarter net income increases from $6.7 million to $75.2 million

Positive preliminary data from Protalix's taliglucerase alfa switchover trial for Gaucher disease

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