Articles Published in 2011

Biothera names chief medical officer

Monday, November 21, 2011 04:07 PM

Biothera has named Patricia Molloy, M.D., chief medical officer. In this role, Molloy is responsible for the clinical development of Imprime PGG, the company’s immunotherapeutic oncology drug that is currently in multiple clinical trials for colorectal and lung cancer and chronic lymphocytic leukemia.

More... »

Portola Pharmaceutials secures $89 million in financing

Monday, November 21, 2011 03:58 PM

Portola Pharmaceuticals has raised $89 million in a preferred stock financing. The financing round included existing investors who were joined by Temasek, an Asia investment company, and Eastern Capital Limited. Proceeds will be used primarily to advance betrixaban, a once-daily, oral Factor Xa inhibitor, through phase III clinical development and to advance development of its companion product, PRT064445, a recombinant Factor Xa inhibitor antidote designed to reverse anticoagulant activity in patients treated with Factor Xa inhibitors suffering major bleeds or requiring surgery. Portola plans to initiate a phase III betrixaban program to prevent venous thromboembolism (VTE) in acute medically ill patients in the first half of 2012.

More... »

Gilead to acquire Pharmasset for $11 billion

Monday, November 21, 2011 03:36 PM

Gilead Sciences and Pharmasset have signed a definitive agreement under which Gilead will acquire Pharmasset for $137 per share in cash. The transaction, which values Pharmasset at approximately $11 billion, was unanimously approved by Pharmasset's board of directors. Gilead plans to finance the transaction with cash on hand, bank debt and senior unsecured notes. The company expects the transaction, when completed, to be dilutive to Gilead's earnings through 2014 and accretive in 2015 and beyond. Further guidance will be provided when the transaction closes, which is expected to be in the first quarter of 2012.

More... »

Valeant Pharmaceuticals to acquire iNova

Monday, November 21, 2011 03:03 PM

Valeant Pharmaceuticals International has signed an agreement to acquire iNova, a private pharmaceutical group. iNova owns, develops and markets a diversified portfolio of prescription and OTC pharmaceutical products in the Asia Pacific region and South Africa.

More... »

FDA approves EYLEA injection

Monday, November 21, 2011 09:27 AM

The FDA has approved Regeneron Pharmaceuticals' EYLEA (aflibercept) injection for the treatment of patients with neovascular (wet) Age-related Macular Degeneration (AMD) at a recommended dose of 2 milligrams (mg) every four weeks (monthly) for the first 12 weeks, followed by 2 mg every eight weeks (2 months).

More... »

Coviden to acquire BARRX Medical for $325 million

Monday, November 21, 2011 09:17 AM

BARRX Medical, a developer of minimally invasive medical devices, has signed a definitive agreement to be acquired by Covidien. Covidien is a global provider of healthcare products and a worldwide leader in advanced energy-based devices.

More... »

Survey: Industry using medical imaging metrics to meet study milestones

Monday, November 21, 2011 09:09 AM

Boston-based Perceptive Informatics, an eClinical solutions provider and a subsidiary of CRO Parexel International, found in a global survey that over half (54%) of respondents review medical imaging-related study metrics on a regular basis. Of those respondents, 81% use medical imaging metrics as actionable data to inform progress toward the achievement of study milestones. Key performance indicators used by the respondents include the status of site qualification for imaging-based clinical trials, as well as progress of medical image submissions, query responses and radiology reviews.

More... »

DaVita to expand with two facilities in Denver

Monday, November 21, 2011 09:06 AM

DaVita, a provider of kidney care services, has chosen the Denver metropolitan area to locate two expanding parts of the company’s business. In total, DaVita will be bringing as many as 200 jobs with benefits to the metro area. The location of each facility has not yet been announced.

More... »

Industry watchers nervous as PDUFA V deadline looms

Monday, November 21, 2011 08:02 AM

PDUFA IV expires Sept. 30, 2012, and several parties already are nervous about its renewal. 

More... »

Site group continues expansion toward East Coast

Monday, November 21, 2011 08:00 AM

The Pheonix, Ariz.-based site group Clinical Research Advantage (CRA) is expanding. 

More... »