Pharmaceuticals News and Research

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Pediatric pain experts discuss safety, efficacy of pain medications in children

Can we be certain that pain medications considered safe for adults, based on extensive clinical data and experience, are equally safe for use in young children? Pediatric pain experts discussed this question today in a panel session at the American Pain Society, www.ampainsoc.org, annual scientific meeting and agreed more short term and long-term clinical data are needed to provide assurances about the safety and efficacy of several pain medications in children.

21 May 2011

China Ruitai first quarter 2011 total revenue decreases 6% to $9.6 million

China Ruitai International Holdings Co., Ltd., a manufacturer and distributor of cellulose ether additives for use in the production of pharmaceuticals, construction materials, PVC products, foods and beverages and cosmetics, today announced its results for the three months ended March 31, 2011.

20 May 2011

Neuland Labs fiscal 2011 revenues increase 41% to $88.8 million

Neuland Laboratories Ltd., a pharmaceutical manufacturer providing active pharmaceutical ingredients, complex intermediates, and contract research and manufacturing services to customers located in 85 countries, today announced financial results for the 2011 fiscal year ended March 31, 2011.

20 May 2011

Accovion establishes new subsidiary in the UK

As a European full-service Clinical Research Organization, Accovion supports local and global projects of all types and phases for the Pharmaceutical, Biotechnology and Medical Device industries.

20 May 2011

Medivir reports positive results from ASPIRE TMC435 phase 2b study for genotype 1 chronic hepatitis C

Medivir AB, the emerging research-based specialty pharmaceutical company focused on infectious diseases, today announced results from the ASPIRE phase 2b study that evaluates the addition of once daily TMC435 to pegylated interferon and ribavirin in patients with genotype 1 chronic hepatitis C whose prior treatment with pegylated-interferon (PegIFN) and ribavirin (RBV) was unsuccessful either because they relapsed, had a partial response or had a null response.

20 May 2011

Abbott appreciates FDA Advisory Committee recommendations to retain Trilipix indication for mixed dyslipidemia

The U.S. Food and Drug Administration today held an Endocrinologic and Metabolic Drugs Advisory Committee to review the results of the ACCORD Lipid study as they relate to the use of fenofibric acid (sold as Trilipix in the United States) in combination with a statin in patients with mixed dyslipidemia and at high risk of heart disease.

20 May 2011

Bayer, Onyx to present Nexavar-chemotherapy combination Phase 2b trial data in breast cancer at ASCO 2011

Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. today announced results from a Phase 2b trial evaluating Nexavar® (sorafenib) tablets in patients with locally advanced or metastatic breast cancer previously treated with a bevacizumab-containing regimen, which showed that Nexavar was associated with statistically significant improvements in progression-free survival and time-to-progression.

20 May 2011

$Positive results from Onyx's carfilzomib Phase 2b 003-A1 study in relapsed and refractory multiple myeloma$

Positive results from Onyx's carfilzomib Phase 2b 003-A1 study in relapsed and refractory multiple myeloma

Onyx Pharmaceuticals, Inc. today announced updated results from the Phase 2b 003-A1 study of single-agent carfilzomib, a next generation proteasome inhibitor, in patients with relapsed and refractory multiple myeloma. Carfilzomib achieved a clinical benefit rate (CBR) (minimal response or greater) in the study population of 37 percent with a duration of response (DOR) of 8.3 months.

20 May 2011

CEL-SCI initiates global Multikine Phase III trial for head and neck cancer in Russia

CEL-SCI Corporation announced today that it has commenced its global Phase III clinical trial for Multikine®, the Company's flagship immunotherapy, in Russia at the State Budgetary Healthcare Institution of Sverdlovsk Region - Sverdlovsk Regional Oncology Center in Ekaterinburg, Russia.

20 May 2011

Viewpoints: Coburn on his dropout; Malpractice reform and states

For the past several months I have been meeting with a small group of senators from both parties, informally known as the Gang of Six, that was designed to force the idle — not gridlocked — Senate, and then the House and the president, to enact a long-term deficit-reduction package.

20 May 2011

CSL welcomes historic pandemic agreement

CSL Biotherapies welcomed news overnight of a decision by the World Health Assembly to adopt the Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and Other Benefits. The Framework is the culmination of several years work by a dedicated working group of the World Health Organisation (WHO) and paves the way for greater global collaboration between public and private stakeholders in preparing the world for possible future influenza pandemics.

19 May 2011

Enzon to discontinue PEG-SN38 clinical program in metastatic colorectal cancer

Enzon Pharmaceuticals, Inc. today announced that, in light of evolving standards of care for the treatment of metastatic colorectal cancer (mCRC), the Company will discontinue its PEG-SN38 (EZN-2208) clinical program in this disease, following conclusion of its Phase II study.

19 May 2011

Advantagene reaches SPA agreement with FDA for ProstAtak Phase 3 trial to prevent prostate cancer recurrence

Advantagene, Inc., a Massachusetts-based biopharmaceutical company, announced today that it reached an agreement with the U.S. Food and Drug Administration on a Special Protocol Assessment (SPA) for a pivotal Phase 3 clinical trial of ProstAtak™, its lead agent for patients with newly diagnosed prostate cancer.

19 May 2011

Metabolex commences arhalofenate Phase 2 clinical trial for treatment of hyperuricemia and gout

Metabolex, Inc., a biopharmaceutical company focused on the discovery and development of proprietary new medicines for the treatment of metabolic diseases, announced that it has initiated a Phase 2 clinical trial of arhalofenate (MBX-102), its product candidate for the management of hyperuricemia in patients with gout.

19 May 2011

RXi to present updated NeuVax Phase II trial data in breast cancer at ASCO 2011

RXi Pharmaceuticals Corporation, a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using RNA-targeted and immunotherapy technologies, will be presenting data from the NeuVax Phase II adjuvant breast cancer clinical trial at the 2011 annual meeting of The American Society of Clinical Oncology in Chicago.

19 May 2011

ShangPharma first quarter net revenues increase 25.6% to $24.8 million

ShangPharma Corporation, a leading China-based pharmaceutical and biotechnology research and development outsourcing company, today announced its financial results for its first quarter ended March 31, 2011.

19 May 2011

Isis receives $5M milestone payment from GSK for initiating ISIS-TTRRx Phase 1 study

Isis Pharmaceuticals, Inc. announced today that it has earned a $5 million milestone payment from GlaxoSmithKline related to the initiation of a Phase 1 clinical study for ISIS-TTRRx.

19 May 2011

USPTO grants four key patents for Alvine's proteases to detect celiac disease

Alvine Pharmaceuticals, Inc., a biopharmaceutical company focused on the treatment of autoimmune and gastrointestinal diseases, today announced that the United States Patent and Trademark Office has issued four key patents: 7,943,312; 7,928,056; 7,923,532; and 7,910,541, protecting various aspects of Alvine's core technology.

19 May 2011

Takeda reaches agreement to acquire Nycomed

Takeda Pharmaceutical Company Limited and Nycomed A/S jointly announced today that Takeda has reached an agreement with the shareholders of Nycomed in which Takeda will acquire the Zurich-headquartered company for 9.6 billion Euro on a cash-free, debt-free basis.

19 May 2011

Iroko Cardio deploys Veeva CRM in nine European countries

Iroko Cardio International, a privately held pharmaceutical company dedicated to reducing the incidence of major adverse cardiac events (MACE), has adopted Veeva CRM to support all of its representatives in nine European countries.

19 May 2011

Pharmaceuticals News and Research

Pediatric pain experts discuss safety, efficacy of pain medications in children

China Ruitai first quarter 2011 total revenue decreases 6% to $9.6 million

Neuland Labs fiscal 2011 revenues increase 41% to $88.8 million

Accovion establishes new subsidiary in the UK

Medivir reports positive results from ASPIRE TMC435 phase 2b study for genotype 1 chronic hepatitis C

Abbott appreciates FDA Advisory Committee recommendations to retain Trilipix indication for mixed dyslipidemia

Bayer, Onyx to present Nexavar-chemotherapy combination Phase 2b trial data in breast cancer at ASCO 2011

Positive results from Onyx's carfilzomib Phase 2b 003-A1 study in relapsed and refractory multiple myeloma

CEL-SCI initiates global Multikine Phase III trial for head and neck cancer in Russia

Viewpoints: Coburn on his dropout; Malpractice reform and states

CSL welcomes historic pandemic agreement

Enzon to discontinue PEG-SN38 clinical program in metastatic colorectal cancer

Advantagene reaches SPA agreement with FDA for ProstAtak Phase 3 trial to prevent prostate cancer recurrence

Metabolex commences arhalofenate Phase 2 clinical trial for treatment of hyperuricemia and gout

RXi to present updated NeuVax Phase II trial data in breast cancer at ASCO 2011

ShangPharma first quarter net revenues increase 25.6% to $24.8 million

Isis receives $5M milestone payment from GSK for initiating ISIS-TTRRx Phase 1 study

USPTO grants four key patents for Alvine's proteases to detect celiac disease

Takeda reaches agreement to acquire Nycomed

Iroko Cardio deploys Veeva CRM in nine European countries

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