Pharmaceuticals News and Research

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PERSEUS clinical program comparing TAXUS Element Stent to prior-generation stents: 12-month results

Angiotech Pharmaceuticals, Inc. today announced that its corporate partner, Boston Scientific Corporation, announced 12-month results from its PERSEUS clinical program that demonstrated positive safety and efficacy outcomes in workhorse lesions for the platinum chromium TAXUS(R) Element(TM) Paclitaxel-Eluting Stent System compared to the TAXUS(R) Express(TM) Paclitaxel-Eluting Stent System.

16 Mar 2010

Hitachi, NextDocs form partnership in document management solutions for pharmaceutical manufacturers

Hitachi, Ltd. and NextDocs Corporation today announced their newly formed partnership in document management solutions for pharmaceutical manufacturers.

16 Mar 2010

EXPLORE-Xa study: Betrixaban reduces CRNM bleeds compared to dose-adjusted warfarin

Portola Pharmaceuticals and Merck today announced the results of EXPLORE-Xa, a Phase 2 exploratory, dose finding study of betrixaban, an investigational oral direct Factor Xa inhibitor. Results showed that a once-daily dose of oral betrixaban, given to patients with non-valvular atrial fibrillation or atrial flutter and at least one risk factor for stroke, reduced the incidence of major and clinically relevant non-major (CRNM) bleeds compared to dose-adjusted warfarin.

16 Mar 2010

Simcere Pharmaceutical Group report 15.5% sequential growth in fourth quarter revenues

Simcere Pharmaceutical Group, a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals in China, today reported unaudited financial results for the quarter and the fiscal year ended December 31, 2009.

16 Mar 2010

Poniard Pharmaceuticals sells over 4.2M common shares to Commerce Court Small Cap Value Fund

Poniard Pharmaceuticals, Inc., a biopharmaceutical company focused on innovative oncology therapies, today announced the sale of 4,229,000 of its common shares to Commerce Court Small Cap Value Fund, Ltd. for gross proceeds of approximately $6.3 million, or approximately $1.49 per share, under its existing committed equity financing facility with Commerce Court.

16 Mar 2010

Genzyme, Isis Pharmaceuticals: Phase 3 study of mipomersen in hoFH patients meets primary endpoint

Genzyme Corp. and Isis Pharmaceuticals Inc. today announced that data from a phase 3 study of mipomersen in patients with homozygous familial hypercholesterolemia (hoFH) were published in The Lancet. This study met its primary endpoint, resulting in an average LDL-C reduction of greater than 100 mg/dL in this very high-risk patient population.

16 Mar 2010

EHSI signs profit sharing deal with Celulas Genetica

Emerging Healthcare Solutions, Inc. announced today that it locked down an option for a profit participation deal with biotech firm Celulas Genetica. Celulas Genetica works to develop new major medical solutions using adult stem cell research.

16 Mar 2010

Clinical evaluation of benzodiazepine products is now allowed using Acura's Aversion Technology

Acura Pharmaceuticals, Inc. today announced clinical evaluation is now allowed under an Investigational New Drug application ("IND") filed with the U.S. Food and Drug Administration ("FDA") for a benzodiazepine product candidate utilizing our Aversion® Technology.

16 Mar 2010

Dove Medical Press, Athena Healthcare Consultancy enter alliance to publish clinical research

Dove Medical Press, a leading open-access publisher, has entered into an alliance with Athena Healthcare Consultancy, a well established CRO and pharmaceutical medical marketing consultancy based in Shanghai.

16 Mar 2010

Savient Pharmaceuticals resubmits KRYSTEXXA BLA

Savient Pharmaceuticals, Inc. announced that it has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for KRYSTEXXA™ (pegloticase) as a treatment for chronic gout in patients refractory to conventional therapy. Chronic gout that is refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.

16 Mar 2010

FDA approves Watson Pharmaceuticals' ANDA for generic Cardizem LA

Watson Pharmaceuticals, Inc. today announced that its subsidiary, Watson Laboratories, Inc. – Florida, has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Diltiazem Hydrochloride Extended-Release tablets, the generic equivalent to Biovail Laboratories International SRL's Cardizem® LA product. Watson intends to launch its generic version of Cardizem® LA immediately.

16 Mar 2010

Impax Laboratories initiates challenge of patent over generic TRILIPIX

Impax Laboratories, Inc. today confirms that it has initiated a challenge of the patent listed by Abbott Laboratories and Fournier Laboratories Ireland Ltd. in connection with its TRILIPIX® (choline fenofibrate) delayed-release capsules, 135 mg and 45 mg.

15 Mar 2010

TCAD therapy superior to double combinations and monotherapy against influenza viruses

Adamas Pharmaceuticals, Inc., a privately held company, announced today results from in vivo animal studies and in vitro tests demonstrating that its triple combination antiviral drug (TCAD) therapy is superior relative to double combinations and monotherapy against multiple strains of pandemic and avian influenza viruses. Results of these studies were presented Sunday evening in an oral session at the XII International Symposium on Respiratory Viral Infections being held in Taipei.

15 Mar 2010

Also in Global Health News: East Africa food security; Issues with humanitarian aid; Texting to fight counterfeit drugs

The Intergovernmental Committee of Experts (ICE) meeting this week in Kigali, Rwanda "will provide a forum for experts, government ministers, regional economic communities and other stakeholders to discuss how best to handle the food security issue in" East Africa, New Times/allAfrica.com reports. The U.N. Economic Commission for Africa's Sub-Regional Office, East Africa (SRO-EA) will host the meeting. "East Africa is the sub-region most affected by food insecurity," according to an SRO-EA report, New Times/allAfrica.com writes (3/13).

15 Mar 2010

Democrats confident health overhaul bill will pass despite hurdles

Democrats spent Sunday trying to pull enough votes together in the House to pass a health care reform bill later this week but said they were optimistic that they can get the support they need.

15 Mar 2010

Progenics Pharmaceuticals to advance oral methylnaltrexone for OIC into late stage clinical development

Progenics Pharmaceuticals, Inc. today announced that it plans to advance oral methylnaltrexone for the treatment of opioid-induced constipation (OIC) into late stage clinical development and will commence a phase 2b/3 clinical trial of a methylnaltrexone tablet in chronic-pain patients in the second half of 2010. Progenics also announced data from a clinical trial of this methylnaltrexone tablet.

15 Mar 2010

CytRx plans five Phase 2 clinical trials with oncology drug candidates

CytRx Corporation, a biopharmaceutical company specializing in oncology, today reported financial results for the twelve months ended December 31, 2009, and affirmed its 2010 milestones of commencing up to five Phase 2 clinical trials with its oncology drug candidates.

15 Mar 2010

Ranbaxy resolves generic Actos patent litigation

Ranbaxy Laboratories Limited, along with its wholly owned subsidiary Ranbaxy Pharmaceuticals Inc. (collectively, "Ranbaxy"), announced today that they have reached an agreement with Takeda Pharmaceutical Company Limited and Takeda Pharmaceuticals North America resolving outstanding patent litigation related to Ranbaxy's generic equivalent version of Actos® (Pioglitazone Hydrochloride) 15 mg, 30 mg and 45 mg tablets.

15 Mar 2010

MicuRx Pharmaceuticals files IND for MRX-I antibiotic drug candidate with Chinese SFDA

MicuRx Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing next-generation antibiotics, today announced that it has filed an Investigational New Drug (IND) application with the State Food and Drug Administration (SFDA) in China for MRX-I, its first development-stage antibiotic drug candidate. MRX-I, an orally-administered oxazolidinone, targets multi-drug resistant Gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE).

15 Mar 2010

Metastatic melanoma: Involvement of immune system in response to PV-10 therapy

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, announced today that Dr. Sanjiv Agarwala, in his presentation at the Seventh International Symposium on Melanoma and Other Cutaneous Malignancies on March 12, 2010, commented on the involvement of the immune system in response to PV-10 therapy and its role in the “bystander effect” in treating metastatic melanoma. Dr. Agarwala’s presentation, entitled “Chemoablation in Melanoma: An Update,” was given in the session entitled “Unique Approaches to Melanoma Therapy.”

15 Mar 2010

Pharmaceuticals News and Research

PERSEUS clinical program comparing TAXUS Element Stent to prior-generation stents: 12-month results

Hitachi, NextDocs form partnership in document management solutions for pharmaceutical manufacturers

EXPLORE-Xa study: Betrixaban reduces CRNM bleeds compared to dose-adjusted warfarin

Simcere Pharmaceutical Group report 15.5% sequential growth in fourth quarter revenues

Poniard Pharmaceuticals sells over 4.2M common shares to Commerce Court Small Cap Value Fund

Genzyme, Isis Pharmaceuticals: Phase 3 study of mipomersen in hoFH patients meets primary endpoint

EHSI signs profit sharing deal with Celulas Genetica

Clinical evaluation of benzodiazepine products is now allowed using Acura's Aversion Technology

Dove Medical Press, Athena Healthcare Consultancy enter alliance to publish clinical research

Savient Pharmaceuticals resubmits KRYSTEXXA BLA

FDA approves Watson Pharmaceuticals' ANDA for generic Cardizem LA

Impax Laboratories initiates challenge of patent over generic TRILIPIX

TCAD therapy superior to double combinations and monotherapy against influenza viruses

Also in Global Health News: East Africa food security; Issues with humanitarian aid; Texting to fight counterfeit drugs

Democrats confident health overhaul bill will pass despite hurdles

Progenics Pharmaceuticals to advance oral methylnaltrexone for OIC into late stage clinical development

CytRx plans five Phase 2 clinical trials with oncology drug candidates

Ranbaxy resolves generic Actos patent litigation

MicuRx Pharmaceuticals files IND for MRX-I antibiotic drug candidate with Chinese SFDA

Metastatic melanoma: Involvement of immune system in response to PV-10 therapy

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