Pharmaceuticals News and Research

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Internal Medicine board sanctions doctors for cheating on certification tests; APA to issue conflict-of-interest guidelines

The American Board of Internal Medicine has sanctioned 139 doctors for cheating on exams it uses for board certifications, CQ HealthBeat reports. "The board also sued a test prep firm, as well as a handful of doctors viewed as the worst offenders, in federal court." The board alleges that the company encouraged doctors to memorize questions on the board exams and then to e-mail them to the test prep firm after (Norman, 6/10).

14 Jun 2010

CTI announces AIFA approval for manufacture of pixantrone at NerPharMa facility

Cell Therapeutics, Inc. today announced that the Italian Medicines Agency ("AIFA"), the national authority responsible for drug regulation in Italy, has approved the facility at NerPharMa DS (a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences Srl, in Nerviano, Italy) for the production of CTI's drug candidate pixantrone.

14 Jun 2010

Australian rainforests may provide potential cancer cure

Queensland scientists have discovered a drug to cure cancer that has effectively worked in animals and is to be tried on humans in the next phase of trials. This drug is plant-derived and is called EBC-46 for trial purposes. The plant from which it is obtained is found in the Australian tropical rainforest. The drug has shown to reduce inoperable tumors in 150 dogs, cats and horses and a ferret to a significant extent. The drug was developed over the past six years from the seed of a rainforest plant found in the Atherton Tablelands. Scientists had cultivated their own plantation of the plant since forming the company QBiotics Limited in 2004.

14 Jun 2010

Telmisartan reduces hypertension, cardiovascular risk in ACE-intolerant patients: Boehringer Ingelheim

Telmisartan, an angiotensin receptor blocker, is one of the best researched drugs worldwide. It has been studied in clinical trials in more than 50,000 patients. Its positive safety profile has been confirmed also in a market exposure of 34.5 million patient years. Convincing safety data for patients with a high cardiovascular risk were collected in the three long-term outcome trials ONTARGET, PRoFESS and TRANSCEND which followed some of the patients for up to five years.

14 Jun 2010

New research project to identify tactics, strategies for working with patient advocacy groups

In the biopharma sector, collaborating with patient advocacy groups is a critical part of educating patients and physicians. Patient advocacy groups are a trusted resource for consumers as they seek out information on new therapies, especially novel therapies. Using an online research survey and deep-dive interviews with selected participants, Best Practices, LLC conducted a research project to identify winning practices in patient advocacy group collaboration and relationship management.

14 Jun 2010

First database of combined clinical trials on brain disease made available to qualified researchers

A new database of more than 4,000 Alzheimer's disease patients who have participated in 11 industry-sponsored clinical trials was released today by the Coalition Against Major Diseases. This is the first database of combined clinical trials to be openly shared by pharmaceutical companies and made available to qualified researchers around the world.

14 Jun 2010

Despite economic downturn, NJ biotechnology industry continues to grow

The number of biotechnology companies operating in New Jersey continues to increase significantly despite the downturn in the economy, ongoing difficulties in obtaining venture capital and other forms of funding and a contraction in the biotechnology and pharmaceutical industries at both the state and national levels, according to initial results from an industry survey released today by BioNJ, the trade association for the biotechnology industry in New Jersey.

14 Jun 2010

Chiasma successfully completes Phase I clinical study of Octreolin

Chiasma, Inc., a privately held biopharma company, announced that it has successfully completed a Phase I clinical study evaluating the safety and pharmacokinetics (PK) of its proprietary product Octreolin, which contains the active ingredient octreotide actetate and is administered orally

14 Jun 2010

Capitol Hill briefing addresses neglected tropical diseases

At a Global Network for Neglected Tropical Diseases (NTD) briefing, held in conjunction with the Congressional Malaria and NTD Caucus in Washington, D.C. on Thursday, "U.S. researchers, pharmaceutical companies and government officials [said] they are making progress in an effort to curb [NTDs], but that they need more money and outside help," VOA News.

14 Jun 2010

DRIVE4COPD initiative aims to raise awareness of COPD

In just four months since its launch, DRIVE4COPD has already encouraged more than 100,000 people to be screened to see if they may be at risk for chronic obstructive pulmonary disease. The country's newest health initiative that aims to raise awareness of COPD in the hopes that people will talk to their doctor and get diagnosed instead of suffering in silence. Currently, half of the estimated 24 million Americans who may have COPD remain undiagnosed and untreated, and most are not diagnosed until they have lost half their lung function.

11 Jun 2010

Phase II study results of riociguat for CTEPH and PAH published online

Bayer HealthCare Pharmaceuticals, Inc. today announced that the study "Riociguat for chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension: a phase II study" was published online this week by the European Respiratory Journal. Results of this study to assess the safety, tolerability and the feasibility of individual dose titration of riociguat were previously presented at the 2009 International Conference of the American Thoracic Society.

11 Jun 2010

Takeda receives pricing approval for NESINA in Japan

Furiex Pharmaceuticals, Inc. today confirmed that Takeda Pharmaceutical Company Limited has received pricing approval for NESINA® (alogliptin) in Japan. NESINA, a highly selective DPP-4 inhibitor for the treatment of type 2 diabetes, received regulatory approval from the Japanese Ministry of Health, Labour and Welfare on April 16, 2010. Furiex collaborated with Takeda to develop this product.

11 Jun 2010

Trevena's scientists present research data on GPCR biased ligands at two scientific conferences

Trevena Inc., a leader in the discovery of G-protein coupled receptor biased ligands, today announced that its scientists are presenting research data at two scientific conferences. These oral presentations highlight Trevena's research demonstrating that ligand bias at the angiotensin II type I receptor translates into differentiable and beneficial cardiovascular pharmacology in vivo.

11 Jun 2010

NeoPharm first-quarter net loss decreases to $1.4 million

NeoPharm, Inc., a publicly traded biopharmaceutical company dedicated to the research, development and commercialization of new and innovative therapeutic applications of drugs for cancer and other diseases, today announced its first quarter 2010 financial results.

11 Jun 2010

Cook Medical files for PMA of Zilver PTX Drug-Eluting Peripheral Stent with FDA

Cook Medical has submitted its Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the company's unique polymer-free Zilver® PTX® Drug-Eluting Peripheral Stent. Intended for use in patients with peripheral arterial disease (PAD) in the superficial femoral artery (SFA), Zilver PTX is a self-expanding, highly durable nitinol stent that uses a proprietary, polymer-free technology to deliver a locally therapeutic dose of paclitaxel, an antiproliferative drug, to the target lesion.

11 Jun 2010

Patheon second-quarter total revenues increase 4.8% to $175.4 million

Patheon Inc., a leading provider of contract development and manufacturing services to the global pharmaceutical industry, announced today its results for the second quarter and six months ended April 30, 2010. Total revenues for the second quarter were $175.4 million or 4.8% higher than the same period last year.

11 Jun 2010

AVEO Pharmaceuticals presents tivozanib’s Phase 2 trial data at ASCO meeting

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced data from a subgroup analysis of a Phase 2 randomized discontinuation trial showing that the median progression-free survival (PFS) achieved by patients with advanced clear cell renal cell carcinoma (RCC) who had undergone a prior nephrectomy was 14.8 months.

11 Jun 2010

Delcath Systems to host conference call to update shareholders about recent progress

Delcath Systems, Inc. a development stage, specialty pharmaceutical and medical device company focused on oncology will host a conference call to discuss recent corporate developments on Tuesday, June 15, 2010 at 4:30 p.m., Eastern. Eamonn P. Hobbs, the Company's President and CEO, David McDonald, CFO, and Krishna Kandarpa, MD, Chief Medical Officer, will be on hand during the call and webcast.

11 Jun 2010

Cubist to oppose Teva’s attempt to add new defense in patent infringement litigation

Cubist Pharmaceuticals, Inc. today announced that it will oppose a motion filed by the Teva defendants to amend their answer to add a new defense in the patent litigation between Cubist and Teva pending in the US District Court for the District of Delaware. A motion for leave to amend the answer is a request to be permitted to add a new allegation. The Teva defendants seek leave to amend their answer to allege that US Patent Nos. 6,468,967 and 6,852,689 are unenforceable due to inequitable conduct.

11 Jun 2010

Perceptive Informatics releases new web-based version of DataLabs Designer module

Perceptive Informatics, a leading eClinical solutions provider and a subsidiary of PAREXEL International Corporation, today released a new web-based version of the DataLabs Designer™ module, which is part of Perceptive's DataLabs® Electronic Data Capture (EDC) solution. The web-based study design tool, which can be hosted by Perceptive, provides clinical study teams worldwide with online access to collaboratively design trials. This core capability assists in streamlining workflow and improving the efficiency of the study design process.

11 Jun 2010

Pharmaceuticals News and Research

Internal Medicine board sanctions doctors for cheating on certification tests; APA to issue conflict-of-interest guidelines

CTI announces AIFA approval for manufacture of pixantrone at NerPharMa facility

Australian rainforests may provide potential cancer cure

Telmisartan reduces hypertension, cardiovascular risk in ACE-intolerant patients: Boehringer Ingelheim

New research project to identify tactics, strategies for working with patient advocacy groups

First database of combined clinical trials on brain disease made available to qualified researchers

Despite economic downturn, NJ biotechnology industry continues to grow

Chiasma successfully completes Phase I clinical study of Octreolin

Capitol Hill briefing addresses neglected tropical diseases

DRIVE4COPD initiative aims to raise awareness of COPD

Phase II study results of riociguat for CTEPH and PAH published online

Takeda receives pricing approval for NESINA in Japan

Trevena's scientists present research data on GPCR biased ligands at two scientific conferences

NeoPharm first-quarter net loss decreases to $1.4 million

Cook Medical files for PMA of Zilver PTX Drug-Eluting Peripheral Stent with FDA

Patheon second-quarter total revenues increase 4.8% to $175.4 million

AVEO Pharmaceuticals presents tivozanib’s Phase 2 trial data at ASCO meeting

Delcath Systems to host conference call to update shareholders about recent progress

Cubist to oppose Teva’s attempt to add new defense in patent infringement litigation

Perceptive Informatics releases new web-based version of DataLabs Designer module

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